GSK press releases

GSK tops Antimicrobial Resistance (AMR) Benchmark Report

Tue, 10 Mar 2026 11:00:00 GMT

GSK welcomes independent recognition of our leadership in addressing the urgent global threat of antimicrobial resistance (AMR).

GSK and Alfasigma announce agreement on worldwide rights for linerixibat

Mon, 09 Mar 2026 12:00:00 GMT

GSK and Alfasigma today announced a licence agreement under which Alfasigma will acquire worldwide exclusive rights to linerixibat

GSK completes acquisition of RAPT Therapeutics

Tue, 03 Mar 2026 15:00:00 GMT

GSK plc (LSE/NYSE: GSK) today announced the completion of its previously announced acquisition of RAPT Therapeutics

Bepirovirsen accepted for regulatory review in Japan as a potential first-in-class treatment for chronic hepatitis B

Thu, 26 Feb 2026 12:00:00 GMT

Nearly 1 million people in Japan live with chronic hepatitis B, a leading cause of liver cancer

Linerixibat accepted for priority review in China for cholestatic pruritus in patients with primary biliary cholangitis

Thu, 26 Feb 2026 07:05:00 GMT

Submission based on data from positive GLISTEN phase III trial

GSK enters agreement to acquire 35Pharma Inc.

Wed, 25 Feb 2026 12:00:00 GMT

Includes HS235, a potentially best-in-class activin signaling inhibitor in clinical development for treatment of cardiopulmonary diseases

ViiV Healthcare reports positive 12-month data showing investigational bNAb lotivibart (N6LS) maintains high levels of viral suppression in long-acting HIV treatment regimen

Wed, 25 Feb 2026 12:00:00 GMT

Results reinforce lotivibart’s ultra long-acting potential with the trial progressing to evaluate a twice-yearly intravenous dosing interval

ViiV Healthcare presents pipeline data for two investigational HIV treatment therapies with potential for twice-yearly dosing

Wed, 25 Feb 2026 12:00:00 GMT

VH184, the first, third‑generation integrase inhibitor in development shows potential for up to twice-yearly dosing intervals

ViiV Healthcare’s long-acting Cabenuva (cabotegravir + rilpivirine) for HIV demonstrates superior efficacy compared to daily oral therapy for people with adherence challenges; results published in NEJM

Wed, 18 Feb 2026 12:00:00 GMT

Final data from LATITUDE study show switch to long-acting injectable treatment reduced the risk of virological failure by nearly half.

Exdensur (depemokimab) approved by the European Commission for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps

Tue, 17 Feb 2026 12:00:00 GMT

Exdensur is the first and only ultra-long-acting biologic in the EU to treat respiratory diseases

GSK’s Arexvy associated with reductions in certain RSV-related risks including heart attack, stroke and severe flare-ups of COPD and asthma, real world study shows

Tue, 17 Feb 2026 12:00:00 GMT

Reduction observed in RSV-related hospitalisations in adults aged ≥60 years

GSK’s RSV vaccine, Arexvy, accepted for regulatory review in China for adults aged 60 years and older

Tue, 10 Feb 2026 07:00:00 GMT

RSV affects over six million people aged 60 and older in China each year

Nucala (mepolizumab) approved by the European Commission for the treatment of chronic obstructive pulmonary disease (COPD)

Fri, 06 Feb 2026 12:00:00 GMT

Approval based on results from MATINEE showing significant reduction in the rate of moderate/severe exacerbations versus placebo

GSK delivers strong 2025 performance and re-affirms long-term outlooks

Wed, 04 Feb 2026 00:00:00 GMT

Full year and Q4 2025 highlights

GSK’s RSV vaccine, Arexvy, receives European approval for expanded use in all adults 18 years and older

Mon, 26 Jan 2026 07:00:00 GMT

In the EU, an average of 158,000 adults are hospitalised with RSV-related illness every year

Trelegy Ellipta approved in China for use in adults with uncontrolled asthma

Fri, 23 Jan 2026 12:00:00 GMT

Asthma indication introduces an important option for patients with uncontrolled symptoms

GSK enters agreement to acquire RAPT Therapeutics

Tue, 20 Jan 2026 12:00:00 GMT

Acquisition adds to Respiratory, Immunology & Inflammation pipeline

GSK, Pfizer and Shionogi agree on changes to ViiV Healthcare shareholding

Tue, 20 Jan 2026 07:00:00 GMT

Following Pfizer’s exit, Shionogi’s holding increases to 21.7%, with GSK maintaining 78.3% majority share.

GSK’s Shingrix (Recombinant Zoster Vaccine) prefilled syringe presentation approved by the European Commission

Wed, 07 Jan 2026 12:00:00 GMT

Prefilled syringe offers healthcare professionals a convenient administration option.

GSK announces positive results from B-Well 1 and B-Well 2 phase III trials for bepirovirsen, a potential first-in-class treatment for chronic hepatitis B

Wed, 07 Jan 2026 07:00:00 GMT

Bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate

Exdensur (depemokimab) approved in Japan for severe asthma and chronic rhinosinusitis with nasal polyps

Tue, 06 Jan 2026 12:00:00 GMT

Exdensur is the first and only ultra-long-acting biologic in Japan for the treatment of severe asthma and CRSwNP

Nucala (mepolizumab) approved in China for use in adults with chronic obstructive pulmonary disease (COPD)

Mon, 05 Jan 2026 12:05:00 GMT

Nucala is the first and only monthly biologic approved in China studied in a wide COPD population

GSK enters agreement with U.S. government to lower drug prices and expand access to respiratory medicines for millions of Americans

Fri, 19 Dec 2025 12:00:00 GMT

Voluntary agreement delivers on all four of President Trump’s requests and reduces the cost of medicines for Americans.

Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma

Tue, 16 Dec 2025 12:00:00 GMT

SWIFT data included reduction in exacerbations requiring hospitalisation and/or emergency department visits with depemokimab.

Exdensur (depemokimab) approved in the UK for treatment of asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps

Mon, 15 Dec 2025 16:00:00 GMT

Approval based on data from the SWIFT and ANCHOR phase III trials.

Nucala (mepolizumab) receives positive CHMP opinion for treatment of chronic obstructive pulmonary disease (COPD)

Fri, 12 Dec 2025 13:55:00 GMT

Nucala is the only monthly biologic studied in a wide COPD population with an eosinophilic phenotype.

Depemokimab receives positive CHMP opinion for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps

Fri, 12 Dec 2025 13:50:00 GMT

If approved, depemokimab will be the first and only ultra-long-acting biologic in the EU to treat respiratory diseases.

GSK’s RSV vaccine, Arexvy, receives positive CHMP opinion for all adults 18 years and older

Fri, 12 Dec 2025 12:00:00 GMT

Marketing authorisation expected in February 2026

Blujepa (gepotidacin) approved by US FDA as oral option for treatment of uncomplicated urogenital gonorrhoea (uGC)

Thu, 11 Dec 2025 12:00:00 GMT

Blujepa is the first in a new antibiotic class for the treatment of gonorrhoea approved in over three decades.

GSK’227, a B7-H3-targeted antibody-drug conjugate, granted Orphan Drug Designation in small-cell lung cancer by the US FDA

Wed, 10 Dec 2025 12:00:00 GMT

Designation supported by early clinical data showing durable responses in certain types of small-cell lung cancer (SCLC)

GSK data at ASH show potential to redefine outcomes for people living with blood cancers

Mon, 01 Dec 2025 12:00:00 GMT

GSK will present new data from its haematology portfolio at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.

TESARO, a GSK subsidiary, initiates litigation against AnaptysBio, Inc.

Thu, 20 Nov 2025 12:00:00 GMT

TESARO, Inc., confirms it has initiated litigation against AnaptysBio, Inc. in the Delaware Chancery Court.

GSK and LTZ announce strategic collaboration to advance novel myeloid cell engagers in oncology

Wed, 19 Nov 2025 12:00:00 GMT

Supports GSK's focus of using novel technologies in areas of disease expertise to advance medicines with transformative potential

GSK and Fleming Initiative scientists unite to target AMR with advanced AI

Tue, 18 Nov 2025 06:00:00 GMT

£45m GSK funding allocated to 6 new research programmes combining expertise and using cutting edge AI technology to accelerate AMR research.

GSK presents data from its advancing liver pipeline at AASLD 2025

Fri, 07 Nov 2025 13:00:00 GMT

21 abstracts highlight advances in the treatment of liver conditions, building from GSK’s expertise in inflammation and fibrosis

GSK delivers strong Q3 performance and upgrades 2025 guidance

Wed, 29 Oct 2025 00:00:00 GMT

Q3 2025 performance highlights

GSK and Empirico enter license agreement for clinical-stage, first-in-class oligonucleotide candidate to treat respiratory diseases

Tue, 28 Oct 2025 07:05:00 GMT

siRNA candidate EMP-012 in phase I for treatment of COPD.

GSK’s B7-H3-targeted antibody-drug conjugate, GSK’227, receives Orphan Drug Designation in the EU

Tue, 28 Oct 2025 07:00:00 GMT

Regulatory designation based on encouraging early clinical data showing potential for GSK’227 in small-cell lung cancer

GSK acquires exclusive rights from Syndivia for antibody-drug conjugate (ADC) in prostate cancer

Mon, 27 Oct 2025 07:00:00 GMT

ADC complements GSK’s diverse pipeline in prostate cancer anchored by GSK’227, a B7H3-targeted ADC.

Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma

Thu, 23 Oct 2025 12:00:00 GMT

Blenrep is the only anti-BCMA accessible in the community setting where 70% of patients receive care.

GSK announces positive pivotal phase III data for next-generation low carbon version of Ventolin (salbutamol) metered dose inhaler

Wed, 22 Oct 2025 07:00:00 GMT

Data confirm therapeutic equivalence and comparable safety profile for Ventolin (salbutamol) containing innovative low carbon propellant.

GSK’s Shingrix new prefilled syringe presentation receives positive CHMP opinion

Tue, 21 Oct 2025 07:05:00 GMT

Prefilled syringe offers a convenient ready-to-use administration option to healthcare professionals.

Positive PIVOT-PO phase III data show tebipenem HBr’s potential as the first oral carbapenem antibiotic for patients with complicated urinary tract infections (cUTIs)

Tue, 21 Oct 2025 07:00:00 GMT

Data presented at IDWeek 2025 after study stopped early for efficacy

Global Fund welcomes renewed commitment from GSK and ViiV Healthcare to expand community-led health solutions with £6 million joint pledge ahead of 8th Replenishment

Mon, 20 Oct 2025 21:00:00 GMT

The Global Fund to Fight AIDS, Tuberculosis and Malaria welcomed a new £6 million investment by GSK plc and ViiV Healthcare.

ViiV Healthcare’s CLARITY study shows long-acting cabotegravir more acceptable than lenacapavir injections after a single dose, with 90% preferring cabotegravir

Wed, 15 Oct 2025 12:00:00 GMT

Findings could help inform expectations and decision-making when initiating long-acting HIV injectables

GSK’s Shingrix approved in China for prevention of shingles in adults aged 18 and over who are at increased risk due to immunodeficiency or immunosuppression

Tue, 14 Oct 2025 07:00:00 GMT

Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) is the first and only vaccine approved in this population in China.

Luke Miels appointed CEO designate for GSK

Mon, 29 Sep 2025 12:00:00 GMT

Luke to assume full responsibilities as CEO from 1st January 2026

GSK to submit label update for Wellcovorin (leucovorin) at US FDA’s request

Mon, 22 Sep 2025 12:00:00 GMT

GSK confirmed today that it will submit a supplemental New Drug Application (sNDA) for Wellcovorin (leucovorin)

GSK to invest $30 billion in R&D and Manufacturing in the United States over next 5 years

Wed, 17 Sep 2025 12:00:00 GMT

New facilities will bridge R&D and manufacturing across both the US and UK, strengthening the two countries’ leadership in life sciences.

GSK to showcase new research from its broad respiratory portfolio at the European Respiratory Society (ERS) Congress 2025

Mon, 15 Sep 2025 17:00:00 GMT

60+ abstracts highlight GSK ambition in respiratory diseases to reduce exacerbations, prevent hospitalisations & limit disease progression.

Gepotidacin accepted for priority review by the US FDA for the oral treatment of uncomplicated urogenital gonorrhoea

Mon, 11 Aug 2025 12:00:00 GMT

Submission supported by positive phase III data in patients with uncomplicated urogenital gonorrhoea in EAGLE 1 trial

GSK provides update on US settlement of CureVac/BioNTech mRNA patent litigation

Fri, 08 Aug 2025 12:00:00 GMT

CureVac will make an upfront settlement of $370 million to GSK

GSK delivers continued strong performance

Wed, 30 Jul 2025 00:00:00 GMT

Q2 2025 performance highlights

GSK highlights new findings on Dementia and Alzheimer’s Disease at AAIC 2025, building on leadership in immunology and inflammation

Tue, 29 Jul 2025 12:00:00 GMT

Real-world data shows an association between Recombinant Zoster Vaccine (RZV) and potential reduced risk of dementia.

GSK and Hengrui Pharma enter agreements to develop up to 12 innovative medicines across Respiratory, Immunology & Inflammation and Oncology

Mon, 28 Jul 2025 12:00:00 GMT

Includes license for potential best-in-class PDE3/4 inhibitor (HRS-9821) in clinical development for treatment of COPD

Blenrep (belantamab mafodotin) combinations approved in EU for treatment of relapsed/refractory multiple myeloma

Thu, 24 Jul 2025 12:00:00 GMT

Sixth regulatory approval for Blenrep combinations with applications under review in all major markets

GSK announces extension of US Food and Drug Administration review period for Blenrep (belantamab mafodotin-blmf) in relapsed/refractory multiple myeloma

Wed, 23 Jul 2025 12:00:00 GMT

New PDUFA date scheduled for 23 October 2025.

GSK provides update on US FDA advisory committee review of Blenrep (belantamab mafodotin-blmf) combinations for patients with relapsed/refractory multiple myeloma

Thu, 17 Jul 2025 12:00:00 GMT

The US FDA Oncologic Drugs Advisory Committee voted against the proposed dosage of Blenrep (belantamab mafodotin-blmf) combinations.

US FDA approves GSK’s Shingrix in a prefilled syringe presentation

Thu, 17 Jul 2025 07:00:00 GMT

Prefilled syringe presentation offers a convenient administration option to healthcare professionals

US FDA accepts application to review expanded use of GSK’s RSV vaccine, Arexvy, for adults 18-49 at increased risk

Mon, 14 Jul 2025 12:00:00 GMT

More than 21 million US adults under the age of 50 have at least one risk factor for severe RSV infection

ViiV Healthcare data show 89% of treatment-naïve people with HIV choose to switch to long-acting injectable Vocabria + Rekambys from daily pills after achieving rapid viral suppression

Mon, 14 Jul 2025 12:00:00 GMT

Multiple real-world studies show consistent high effectiveness of Vocabria + Rekambys across a broad range of populations.

ViiV Healthcare extends voluntary licensing agreement with Medicines Patent Pool to enable access to innovative long-acting injectable HIV treatment

Mon, 14 Jul 2025 12:00:00 GMT

Agreement allows manufacturers to develop, manufacture and supply generic LA injectable cabotegravir for treatment in 133 countries.

ViiV Healthcare presents new data demonstrating positive real-world impact of its innovative long-acting injectables for HIV at IAS 2025

Tue, 08 Jul 2025 12:00:00 GMT

Real-world and implementation data describe effectiveness of long-acting Vocabria + Rekambys (CAB+RPV LA) for HIV treatment.

GSK completes acquisition of efimosfermin, a potential best-in-class specialty medicine to treat and prevent progression of steatotic liver disease (SLD)

Mon, 07 Jul 2025 12:00:00 GMT

GSK plc today announced the completion of its previously announced acquisition of efimosfermin alfa from Boston Pharmaceuticals

Price of world’s first malaria vaccine (RTS,S) for children in endemic countries to be reduced by more than half, to less than $5

Wed, 25 Jun 2025 08:00:00 GMT

Price reduction is commitment by Bharat Biotech made possible through partnership with GSK.

Linerixibat accepted for review by the European Medicines Agency for cholestatic pruritus in patients with primary biliary cholangitis (PBC)

Mon, 23 Jun 2025 12:00:00 GMT

Submission based on data from positive GLISTEN phase III trial

Japan’s Ministry of Health, Labour and Welfare accepts regulatory application to expand use of GSK’s RSV vaccine, Arexvy, in adults aged 18-49 at increased risk of severe RSV disease

Fri, 20 Jun 2025 12:00:00 GMT

If approved, GSK’s RSV vaccine would be the first available in Japan to help protect this group

GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the European Medicines Agency to expand use in adults 18 years and older

Fri, 13 Jun 2025 12:00:00 GMT

Regulatory decision anticipated H1 2026.

GSK licenses Shigella vaccine candidate to Bharat Biotech for continued development

Thu, 12 Jun 2025 09:00:00 GMT

GSK plc announced today that it has licensed its Shigella vaccine candidate, altSonflex1-2-3, to Bharat Biotech International Limited.

Linerixibat New Drug Application (NDA) accepted for review by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC)

Mon, 02 Jun 2025 06:06:00 GMT

Application based on data from positive GLISTEN phase III trial

GSK data at ASCO and EHA showcase latest research and innovation across the oncology portfolio

Thu, 29 May 2025 13:54:00 GMT

GSK today announced that data across the oncology pipeline and portfolio will be presented at ASCO and EHA.

PIVOT-PO phase III study for tebipenem HBr stopped early for efficacy following review by Independent Data Monitoring Committee

Wed, 28 May 2025 09:43:00 GMT

Data to be part of a planned US FDA filing in H2 2025

Blenrep (belantamab mafodotin) combinations receive positive CHMP opinion in relapsed/refractory multiple myeloma

Fri, 23 May 2025 12:57:00 GMT

Positive opinion supported by superior efficacy shown in two head-to-head phase III trials, including overall survival in DREAMM-7.

Nucala (mepolizumab) approved by US FDA for use in adults with chronic obstructive pulmonary disease (COPD)

Thu, 22 May 2025 13:06:00 GMT

Approval based on the positive MATINEE and METREX phase III trials

Blenrep (belantamab mafodotin) combinations approved in Japan for treatment of relapsed/refractory multiple myeloma

Mon, 19 May 2025 06:06:00 GMT

Second major approval for Blenrep combinations, with more expected in 2025

GSK to acquire efimosfermin, a phase III-ready potential best-in-class specialty medicine to treat and prevent progression of steatotic liver disease (SLD)

Wed, 14 May 2025 06:10:00 GMT

Affecting up to 5% of the global population, SLD represents an area of significant unmet medical need with limited treatment options.

GSK provides update on belrestotug development programme

Tue, 13 May 2025 12:55:00 GMT

GSK with its development partner iTeos Therapeutics, Inc., has confirmed it is ending the development programme for belrestotug.

GLISTEN phase III trial results show linerixibat significantly improves cholestatic pruritus (relentless itch) in primary biliary cholangitis (PBC)

Thu, 08 May 2025 10:00:00 GMT

Late-breaking results presented at the European Association for the Study of the Liver (EASL) Congress 2025

GSK continues to advance the future of respiratory medicine and patient care with new data at ATS

Fri, 02 May 2025 12:15:00 GMT

40+ abstracts across GSK’s inhaled and respiratory biologics portfolio

Nucala (mepolizumab) delivers clinically meaningful and statistically significant reduction in COPD exacerbations, with positive MATINEE trial results published in New England Journal of Medicine

Wed, 30 Apr 2025 08:17:00 GMT

21% reduction in annualised rate of moderate/severe exacerbations in a wide COPD population

GSK makes strong start to 2025 with growth in sales, profits and earnings

Wed, 30 Apr 2025 07:00:00 GMT

Q1 2025 performance highlights

Blenrep (belantamab mafodotin) combinations approved by UK MHRA in relapsed/refractory multiple myeloma

Thu, 17 Apr 2025 12:15:00 GMT

Superior efficacy shown in two head-to-head phase III trials, including overall survival in DREAMM-7.

Arexvy recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices

Wed, 16 Apr 2025 16:05:00 GMT

Over 13 million adults aged 50-59 at increased risk in the US can potentially benefit from RSV immunisation.

GSK’s 5-in-1 meningococcal vaccine Penmenvy receives positive recommendation from US Advisory Committee on Immunization Practices

Wed, 16 Apr 2025 16:05:00 GMT

Vaccine recommended to help protect persons over 10 years old in the US against disease-causing serogroups of Neisseria meningitidis.

Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older

Tue, 25 Mar 2025 16:50:48 GMT

Blujepa is the first in a new class of oral antibiotics for uUTIs in nearly 30 years.

GSK, UK Dementia Research Institute (UK DRI) and Health Data Research UK (HDR UK) to collaborate on first-of-its-kind dementia research initiative

Tue, 25 Mar 2025 16:01:13 GMT

New collaboration aims to deepen understanding of neurodegeneration using the UK’s unique health data ecosystem.

GSK’s application to expand use of Nucala (mepolizumab) for the treatment of COPD accepted for review by the European Medicines Agency

Mon, 24 Mar 2025 06:12:19 GMT

Nucala (mepolizumab) could be the first biologic with monthly dosing for patients with COPD, if approved

ViiV Healthcare’s investigational broadly neutralising antibody - N6LS - successfully maintains viral suppression in long-acting treatment of HIV

Wed, 12 Mar 2025 15:44:00 GMT

Results from the study demonstrate that N6LS effectively maintained undetectable viral load when combined with long-acting cabotegravir.

ViiV Healthcare announces new implementation study data showing zero cases of HIV with Apretude, the only long-acting injectable approved for HIV PrEP

Wed, 12 Mar 2025 15:32:33 GMT

New data at CROI 2025 show zero cases of HIV acquisition reported with Apretude in varied clinical settings and populations.

ViiV Healthcare showcases leadership in long-acting injectables innovation at CROI 2025 with data on third-generation integrase inhibitor (INSTI) and highly potent capsid inhibitor against HIV-1

Tue, 11 Mar 2025 15:50:26 GMT

Results illustrate ViiV Healthcare’s pipeline is generating multiple options for the development of new ultra long-acting HIV regimens.

ViiV Healthcare continues to deliver long-acting injectable HIV innovation with late-breaking data and real-world insights across pipeline and portfolio at CROI 2025

Sun, 09 Mar 2025 09:12:30 GMT

Real-world and implementation data highlight effectiveness of Cabenuva and Apretude.

GSK to showcase latest research at the International RSV Symposium to advance RSV prevention in adults

Thu, 06 Mar 2025 10:53:44 GMT

17 abstracts to evaluate unmet medical need and approaches to RSV prevention in adults.

Depemokimab applications accepted for review by the US FDA for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps (CRSwNP)

Mon, 03 Mar 2025 06:16:59 GMT

If approved, depemokimab will be the first ultra-long-acting biologic with 6-month dosing

Depemokimab delivers clinically meaningful and statistically significant improvements for patients with chronic rhinosinusitis with nasal polyps (CRSwNP)

Sat, 01 Mar 2025 13:28:02 GMT

ANCHOR-1 and ANCHOR-2 phase III trials show improvements in nasal polyp size and obstruction for depemokimab with twice-yearly dosing.

GSK plc commences share buyback programme

Mon, 24 Feb 2025 06:59:16 GMT

GSK plc announces the commencement of its share buyback programme, as announced in its 2024 full year results announcement.

GSK completes acquisition of IDRx, Inc.

Mon, 24 Feb 2025 06:10:07 GMT

GSK plc has completed the acquisition of IDRx, Inc. (IDRx), a Boston-based, clinical-stage biopharmaceutical company.

GSK announces Dr Gavin Screaton to join the Board as Non-Executive Director

Fri, 21 Feb 2025 07:00:15 GMT

GSK plc has today announced that Dr Gavin Screaton has been appointed to the Board of the Company as a Non-Executive Director.

Nucala (mepolizumab) application for COPD accepted for review in China

Thu, 20 Feb 2025 06:16:34 GMT

Around 100 million people live with COPD in China, accounting for almost 25% of all COPD cases globally

Penmenvy, GSK’s 5-in-1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY

Sat, 15 Feb 2025 15:29:09 GMT

Vaccine helps protect against five common disease-causing serogroups of Neisseria meningitidis (A, B, C, W and Y).

GSK delivers strong 2024 performance with further improvement to long-term growth outlook

Wed, 05 Feb 2025 07:00:00 GMT

Q4 and full year 2024 performance highlights

European Commission authorises ViiV Healthcare’s long-acting injectable Vocabria + Rekambys for HIV treatment in adolescents

Fri, 31 Jan 2025 09:42:21 GMT

Vocabria + Rekambys (cabotegravir + rilpivirine) is the first and only complete long-acting injectable for the treatment of HIV.

Depemokimab accepted for review by the European Medicines Agency for use in asthma with type 2 inflammation and CRSwNP

Tue, 28 Jan 2025 07:16:13 GMT

If approved, depemokimab will be the first ultra-long-acting biologic with 6-month dosing.

Depemokimab applications accepted for review in China and Japan for asthma with type 2 inflammation and CRSwNP

Tue, 28 Jan 2025 06:14:42 GMT

If approved, depemokimab will be the first ultra-long-acting biologic with 6-month dosing

GSK and Oxford establish the GSK-Oxford Cancer Immuno-Prevention Programme to advance novel cancer research

Mon, 27 Jan 2025 16:15:59 GMT

Collaboration unites GSK and Oxford’s complementary expertise in the science of the immune system, vaccines and cancer biology.

GSK’s Shingrix new prefilled syringe presentation accepted for review by European Medicines Agency

Mon, 27 Jan 2025 14:25:59 GMT

Over 25 million people in Europe have received GSK’s shingles vaccine since 2018.

European Commission expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer

Mon, 20 Jan 2025 07:00:36 GMT

Expanded approval includes MMRp/MSS tumours, which represent approximately 75% of endometrial cancer cases.

GSK enters agreement to acquire IDRx, Inc.

Mon, 13 Jan 2025 06:08:06 GMT

Acquisition adds to GSK’s growing portfolio in gastrointestinal (GI) cancers

GSK’s Shingrix new prefilled syringe presentation accepted for review by US FDA

Fri, 10 Jan 2025 16:55:32 GMT

If approved, the new presentation will offer a convenient administration option to healthcare professionals.

GSK’s B7-H3-targeted antibody-drug conjugate, GSK’227, receives US FDA Breakthrough Therapy Designation in late-line relapsed or refractory osteosarcoma

Tue, 07 Jan 2025 07:25:11 GMT

Regulatory designation based on promising early data in this rare bone cancer.

GSK’s Nucala (mepolizumab) approved in China for treatment of adults with chronic rhinosinusitis with nasal polyps

Fri, 03 Jan 2025 06:12:29 GMT

This is the third indication for mepolizumab in China for an IL-5 mediated condition

GSK announces FIRST trial met its primary endpoint of progression free survival in first line advanced ovarian cancer

Fri, 20 Dec 2024 07:00:51 GMT

GSK announces headline results from the FIRST-ENGOT-OV44 phase III trial.

ViiV Healthcare announces CHMP positive opinion for Vocabria + Rekambys, the first and only complete long-acting HIV treatment, for adolescents in Europe

Mon, 16 Dec 2024 15:05:31 GMT

Vocabria + Rekambys is the first and only complete long-acting regimen for the treatment of HIV, reducing dosing days from 365 to 6 per year

GSK’s B7-H3-targeted antibody-drug conjugate, GSK’227, receives EMA Priority Medicines (PRIME) Designation in relapsed extensive-stage small-cell lung cancer

Mon, 16 Dec 2024 14:39:33 GMT

Regulatory designation based on promising preliminary clinical data.

Jemperli (dostarlimab) receives US FDA Breakthrough Therapy Designation for locally advanced dMMR/MSI-H rectal cancer

Mon, 16 Dec 2024 07:10:08 GMT

Designation based on data showing no evidence of disease in 100% of all 42 patients who completed treatment with dostarlimab.

Jemperli (dostarlimab) plus chemotherapy receives positive CHMP opinion to expand approval to all adult patients with primary advanced or recurrent endometrial cancer

Mon, 16 Dec 2024 07:00:18 GMT

Positive opinion based on statistically significant and clinically meaningful progression-free and overall survival data.

Blenrep shows significant overall survival benefit, reducing the risk of death by 42% in multiple myeloma at or after first relapse

Mon, 09 Dec 2024 18:30:03 GMT

DREAMM-7 trial shows sustained overall survival benefit for Blenrep (belantamab mafodotin) combination versus daratumumab combination

US FDA accepts GSK’s submission for the use of Nucala (mepolizumab) in COPD

Mon, 09 Dec 2024 06:11:55 GMT

Nucala could be the first approved biologic with monthly dosing for patients with COPD

Blenrep (belantamab mafodotin) combination accepted for priority review in China in relapsed/refractory multiple myeloma

Mon, 09 Dec 2024 06:10:38 GMT

Regulatory submission supported by phase III head-to-head DREAMM-7 trial showing statistically significant efficacy.

GSK and Zhifei revise and extend strategic vaccine collaboration in China

Thu, 05 Dec 2024 06:11:22 GMT

Shingrix collaboration extended to 2034

First single-dose medicine for P. vivax malaria prequalified by WHO and included in WHO Guidelines

Wed, 04 Dec 2024 09:29:00 GMT

Important steps to advance access to first single-dose malaria treatment

GSK’s fully liquid Menveo meningococcal vaccine approved by European Commission

Wed, 27 Nov 2024 13:13:58 GMT

Formulation supports simplification of vaccination process against invasive meningococcal disease (IMD).

Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma

Mon, 25 Nov 2024 07:04:12 GMT

Regulatory submission supported by phase III head-to-head DREAMM-7 and DREAMM-8 trials showing statistically significant efficacy.

Arexvy approval expanded to adults aged 50-59 at increased risk of severe RSV disease in Japan

Fri, 22 Nov 2024 18:46:04 GMT

First RSV vaccine approved in Japan to help protect 50-59 year olds at increased risk due to certain underlying health conditions.

Statement: GSK continues to show strong leadership in its Access to Medicines Index ranking

Tue, 19 Nov 2024 13:16:33 GMT

GSK is pleased to rank 2nd in the Access to Medicine Index (ATMI) in its ninth wave.

Linerixibat shows positive Phase III results in cholestatic pruritus (relentless itch) in primary biliary cholangitis (PBC)

Tue, 19 Nov 2024 06:07:45 GMT

Primary endpoint met with a statistically significant improvement in itch over 24 weeks compared with placebo

Blenrep shows overall survival benefit in head-to-head DREAMM-7 phase III trial for relapsed/refractory multiple myeloma

Thu, 14 Nov 2024 06:04:13 GMT

Full data to be presented at 2024 American Society of Hematology Annual Meeting in December.

GSK highlights key data from hepatology portfolio at the AASLD’s The Liver Meeting® 2024, emphasising patient impact in areas of high unmet need

Wed, 13 Nov 2024 13:55:21 GMT

New data shows potential for sequential therapy of bepirovirsen after daplusiran/tomligisiran to further increase functional cure rates.

New GSK-sponsored survey reveals unique gaps in care and support facing patients with gynaecologic cancers

Tue, 12 Nov 2024 13:00:55 GMT

GSK’s Your Cancer Is Our Challenge will raise awareness of barriers and inspire future solutions to address them, beyond treatment.

GSK on track to deliver 2024 outlooks with further good progress made in R&D

Wed, 30 Oct 2024 07:00:00 GMT

Q3 2024 performance highlights

GSK enters agreement to acquire CMG1A46 from Chimagen Biosciences to expand immunology pipeline

Tue, 29 Oct 2024 10:50:50 GMT

Agreement reinforces GSK’s portfolio in the treatment of lupus and underlying drivers of autoimmune disease

New data for Arexvy, GSK’s respiratory syncytial virus vaccine, show potential to help protect a broader group of adults at increased risk for RSV disease

Thu, 24 Oct 2024 12:33:51 GMT

Single dose of vaccine elicited robust immune response with acceptable safety profile in adults aged 18-49 at increased risk for RSV-LRTD.

GSK and Cambridge University announce new five-year collaboration in kidney and respiratory disease

Mon, 21 Oct 2024 14:35:44 GMT

GSK is investing more than £50 million in the CG-TIC to further accelerate research and development in kidney and respiratory diseases.

ViiV Healthcare shows more than 99% effectiveness in real-world studies for Apretude (cabotegravir long-acting), the only approved long-acting HIV PrEP, in data presented at IDWeek 2024

Wed, 16 Oct 2024 10:41:08 GMT

Studies from OPERA and Trio cohorts provide further real-world evidence.

Gepotidacin accepted for priority review by US FDA for treatment of uncomplicated urinary tract infections in female adults and adolescents

Wed, 16 Oct 2024 07:00:50 GMT

Gepotidacin could be the first in a new class of oral antibiotic treatment for uUTIs in over 20 years.

GSK announces positive phase III results from ANCHOR trials for depemokimab in chronic rhinosinusitis with nasal polyps

Mon, 14 Oct 2024 06:21:26 GMT

Depemokimab is an ultra-long-acting biologic administered once every six months

GSK and ViiV Healthcare to showcase advances across industry-leading infectious disease portfolio at IDWeek 2024

Thu, 10 Oct 2024 15:15:20 GMT

60 abstracts to be presented across broad and growing portfolio of vaccines and medicines aimed at getting ahead of infectious disease.

Statement: Zantac (ranitidine) litigation – settlement agreements reached

Wed, 09 Oct 2024 16:26:09 GMT

GSK to resolve 93% (approximately 80,000 cases) of U.S. state court Zantac product liability cases for up to $2.2 billion.

GSK presents positive data for Arexvy, its respiratory syncytial virus (RSV) vaccine, indicating protection over three RSV seasons

Tue, 08 Oct 2024 16:26:09 GMT

GSK’s RSV vaccine is the only RSV vaccine with efficacy and safety data available through 3 full seasons.

ViiV Healthcare to triple annual supply of long-acting HIV PrEP for low- and middle-income countries

Mon, 07 Oct 2024 10:26:45 GMT

At least two million doses of long-acting cabotegravir for PrEP to be made available in 2025-2026.

GSK’s Menveo meningococcal vaccine in new single-vial, fully liquid presentation receives positive European CHMP opinion

Tue, 24 Sep 2024 15:22:53 GMT

Marketing authorisation in EU expected by November 2024.

Statement: Zantac (ranitidine) litigation – Russell and Hughes cases

Wed, 18 Sep 2024 14:17:01 GMT

GSK confirmed it has reached two confidential settlements in cases filed in California State Court with Mr. John Russell and Annette Hughes.

Blenrep (belantamab mafodotin) combinations in relapsed/refractory multiple myeloma accepted for regulatory review in Japan

Tue, 17 Sep 2024 07:00:09 GMT

Regulatory submission supported by phase III head-to-head DREAMM-7 and DREAMM-8 trials.

Blenrep (belantamab mafodotin) in combination receives Breakthrough Therapy Designation in China for treatment of relapsed/refractory multiple myeloma

Fri, 13 Sep 2024 07:00:16 GMT

Granted based on results from phase III head-to-head DREAMM-7 trial.

GSK announces positive headline data from phase II seasonal influenza mRNA vaccine programme

Thu, 12 Sep 2024 06:09:08 GMT

Data support progression to phase III clinical trials.

GSK provides update on phase I/II therapeutic herpes simplex virus (HSV) vaccine trial

Wed, 11 Sep 2024 16:00:20 GMT

Results show that GSK3943104 did not meet the study’s primary efficacy objective.

Statement: Zantac (ranitidine) litigation – Dixon case

Wed, 11 Sep 2024 14:17:00 GMT

GSK confirmed it has reached a settlement with Mr. Isaac Dixon, resolving the prostate cancer case filed in Illinois State Court.

Depemokimab late-breaking data presented at ERS show a 54% reduction in severe asthma exacerbations

Mon, 09 Sep 2024 14:30:08 GMT

SWIFT-1 and SWIFT-2 phase III data show depemokimab delivered statistically significant and clinically meaningful reduction in exacerbations

GSK announces positive results from phase III trial of Nucala (mepolizumab) in COPD

Fri, 06 Sep 2024 08:03:28 GMT

GSK announces positive headline results of MATINEE, the phase III clinical trial evaluating Nucala (mepolizumab) in adults with COPD.

GSK aims to redefine the future of respiratory medicine at the European Respiratory Society International Congress

Tue, 03 Sep 2024 07:00:24 GMT

Presenting 56 abstracts to advance scientific understanding and support ambition to improve the lives of people with respiratory conditions

European Commission approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk

Thu, 29 Aug 2024 07:00:37 GMT

Authorisation helps protect this population for the first time ahead of this RSV season

GSK’s Nucala (mepolizumab) approved in Japan for treatment of adults with chronic rhinosinusitis with nasal polyps

Wed, 28 Aug 2024 07:00:01 GMT

Nucala is the first and only biologic in Japan with a four-weekly dosing schedule for this condition

Bepirovirsen granted SENKU designation in Japan for chronic hepatitis B

Wed, 28 Aug 2024 07:00:01 GMT

Designation expedites review of bepirovirsen as a potential treatment for people living with chronic hepatitis B (CHB)

Statement: Zantac (ranitidine) litigation – Delaware Supreme Court to review Superior Court’s Daubert decision

Tue, 27 Aug 2024 14:17:01 GMT

Zantac (ranitidine) litigation – Delaware Supreme Court to review Superior Court’s Daubert decision

GSK receives US FDA Breakthrough Therapy Designation for its B7-H3-targeted antibody-drug conjugate in relapsed or refractory extensive-stage small-cell lung cancer

Tue, 20 Aug 2024 09:14:39 GMT

Regulatory designation based on promising early clinical evidence observed with GSK5764227 in this tumour type

Statement: Zantac (ranitidine) litigation – Florida State Court Daubert Ruling in Wilson case

Thu, 15 Aug 2024 16:38:44 GMT

Zantac (ranitidine) litigation – Florida State Court Daubert Ruling in Wilson case

Statement: Zantac (ranitidine) litigation – Joiner case

Mon, 05 Aug 2024 17:57:20 GMT

Jury in Joiner case in Illinois state court finds GSK not liable for plaintiff’s colorectal cancer

US FDA expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immuno-oncology-based treatment to show an overall survival benefit

Thu, 01 Aug 2024 07:00:00 GMT

Jemperli approval now includes MMRp/MSS tumours, which represent majority of endometrial cancer cases.

GSK delivers continued strong performance and upgrades 2024 guidance

Wed, 31 Jul 2024 07:00:00 GMT

Q2 2024 performance highlights

GSK presents new data at the Alzheimer's Association International Conference 2024

Tue, 30 Jul 2024 11:07:16 GMT

ZOSTER-122 retrospective study presented during Featured Research Session on shingles and dementia risk

Arexvy, GSK’s Respiratory Syncytial Virus (RSV) vaccine, receives positive European Medicines Agency CHMP opinion for adults aged 50-59 at increased risk for RSV disease

Mon, 29 Jul 2024 14:43:36 GMT

If approved, this will be the first vaccine in the EU for adults aged 50-59 who are at increased risk of RSV disease.

Statement: Zantac (ranitidine) litigation – Kimbrow case

Mon, 29 Jul 2024 00:24:00 GMT

GSK has reached a confidential settlement with Ronald Kimbrow resolving the case he filed in Illinois state court.

GSK and Flagship Pioneering partner to discover novel medicines and vaccines

Mon, 29 Jul 2024 00:06:00 GMT

Collaboration brings together GSK disease area expertise and development capability with Flagship portfolio of 40+ bioplatform companies

ViiV Healthcare premieres early data showing antiviral activity against integrase resistance from its investigational, third-generation integrase inhibitor

Tue, 23 Jul 2024 10:45:44 GMT

Data, along with results from a phase I study, are the first public presentation of VH4524184.

ViiV Healthcare announces positive data demonstrating 2-drug regimen Dovato is as effective as 3-drug regimen Biktarvy for maintenance therapy of HIV-1

Tue, 23 Jul 2024 10:39:40 GMT

Largest head-to-head randomised clinical trial between DTG/3TC and BIC/FTC/TAF showed DTG/3TC demonstrated non-inferior efficacy

ViiV Healthcare announces positive new data for Apretude use during pregnancy at AIDS 2024

Tue, 23 Jul 2024 10:32:34 GMT

Open label extension show maternal and pregnancy outcomes with Apretude exposure were comparable to those with no cabotegravir exposure.

Blenrep (belantamab mafodotin) combinations in multiple myeloma application accepted for review by the European Medicines Agency

Fri, 19 Jul 2024 06:08:23 GMT

Regulatory submission supported by phase III head-to-head DREAMM-7 and DREAMM-8 trials

ViiV Healthcare to announce data from largest head-to-head randomised clinical trial for 2-drug regimen Dovato against 3-drug regimen Biktarvy at AIDS 2024

Mon, 15 Jul 2024 09:06:55 GMT

The presentation is one of 25 abstracts evaluating the company’s portfolio of marketed HIV treatment and prevention options.

Brazil and Thailand become first malaria-endemic countries to launch new single-dose radical cure medicine to prevent the relapse of Plasmodium vivax malaria

Fri, 05 Jul 2024 09:00:23 GMT

Launch of single-dose tafenoquine, co-administered with chloroquine, is another step closer to global elimination of malaria.

GSK and CureVac to restructure collaboration into new licensing agreement

Wed, 03 Jul 2024 17:02:17 GMT

GSK acquires full rights to develop, manufacture and commercialise globally mRNA candidate vaccines for influenza and COVID-19.

Statement: Zantac (ranitidine) litigation – Gross case

Fri, 28 Jun 2024 12:38:48 GMT

GSK has reached a confidential settlement with Martin Gross resolving the case he filed

Statement: US Centers for Disease Control and Prevention’s Advisory Committee on Immunisation Practices updates recommendations on adult RSV vaccines ahead of the next season

Wed, 26 Jun 2024 19:29:19 GMT

GSK today announced that the US CDC ACIP voted in favour of recommending the routine use of RSV vaccines in all adults aged 75 and above.

Jemperli (dostarlimab) plus chemotherapy application accepted for review by the European Medicines Agency to expand use to all patients with primary advanced or recurrent endometrial cancer

Mon, 24 Jun 2024 06:16:26 GMT

Regulatory submission supported by statistically significant and clinically meaningful progression-free and overall survival data

GSK’s Omjjara (momelotinib) approved in Japan for treatment of myelofibrosis

Mon, 24 Jun 2024 06:01:14 GMT

Omjjara approved for use in both newly diagnosed or previously treated myelofibrosis patients.

Statement: Zantac (ranitidine) litigation – Kasza case

Mon, 10 Jun 2024 18:03:48 GMT

GSK welcomes the plaintiff's voluntary dismissal of Zantac case (Kasza) in Illinois.

Statement: Zantac (ranitidine) litigation – GSK starts process for appeal of recent Delaware Daubert decision

Mon, 10 Jun 2024 16:34:32 GMT

GSK confirms that the Company has taken the first step to seek appeal of the recent Daubert ruling, made by the Delaware Superior Court.

US FDA approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk

Fri, 07 Jun 2024 13:01:49 GMT

Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes.

GSK accelerates oligonucleotide platform and pipeline medicines with acquisition of Elsie Biotechnologies

Thu, 06 Jun 2024 11:54:25 GMT

Oligonucleotides are a unique modality with potential to address hard-to-treat diseases with high unmet need

Jemperli (dostarlimab) trial continues to show unprecedented results with no evidence of disease in 100% of patients with locally advanced mismatch repair deficient (dMMR) rectal cancer

Mon, 03 Jun 2024 13:00:04 GMT

Updated analysis from Memorial Sloan Kettering Cancer Center presented at ASCO 2024.

Blenrep combination reduced the risk of disease progression or death by nearly 50% versus standard of care combination in relapsed/refractory multiple myeloma

Sun, 02 Jun 2024 15:46:40 GMT

DREAMM-8 phase III trial showed statistically significant and clinically meaningful improvement.

Statement: Zantac (ranitidine) litigation – Delaware State Court Daubert Ruling

Sat, 01 Jun 2024 09:38:36 GMT

GSK disagrees with ruling by the Delaware State Court and will immediately seek an appeal.

Statement: Zantac (ranitidine) litigation - Valadez and Williams cases

Thu, 23 May 2024 13:44:13 GMT

Jury in Valadez case in Illinois state court finds GSK not liable for plaintiff’s colorectal cancer

New data at ASCO showcases the transformational potential of GSK's oncology portfolio

Thu, 23 May 2024 13:19:38 GMT

Pivotal data will be shared from the DREAMM-8 and DREAMM-7 phase III trials.

GSK announces positive results from phase III severe asthma trials of depemokimab

Tue, 21 May 2024 06:33:29 GMT

Primary endpoints met in SWIFT-1 and SWIFT-2 trials with statistically significant reduction in exacerbations over 52 weeks vs. placebo

GSK to become a founding partner of Fleming Initiative to fight antimicrobial resistance (AMR)

Thu, 16 May 2024 00:01:00 GMT

GSK pledges to support the Fleming Initiative - an innovative and collaborative approach to develop new AMR interventions.

GSK makes a strong start to 2024 with improving outlook for the year

Wed, 01 May 2024 07:00:00 GMT

Q1 2024 performance highlights

US FDA accepts for priority review GSK’s application for an expanded indication of Jemperli (dostarlimab) plus chemotherapy to include all adult patients with primary advanced or recurrent endometrial cancer

Wed, 24 Apr 2024 07:00:00 GMT

Application supported by statistically significant and clinically meaningful progression-free and overall survival data from RUBY trial

EAGLE-1 phase III data show potential for gepotidacin as a new oral treatment option for uncomplicated urogenital gonorrhoea (GC) amid growing resistance to existing treatments

Wed, 17 Apr 2024 07:02:00 GMT

GSK has announced positive results from the pivotal EAGLE-1 phase III trial for gepotidacin.

New long-term data show Shingrix continues to provide high protection against shingles in adults aged 50 and over for more than a decade

Wed, 17 Apr 2024 07:00:33 GMT

End-of-trial data show 79.7% efficacy in participants aged 50 years and over, six to 11 years after vaccination.

GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA

Tue, 16 Apr 2024 20:34:46 GMT

Prescription Drug User Fee Act action date set by FDA for 14 February 2025.

Positive RUBY phase III data show potential for Jemperli (dostarlimab) combinations in more patients with primary advanced or recurrent endometrial cancer

Sat, 16 Mar 2024 09:43:06 GMT

Only immuno-oncology combination to show statistically significant and clinically meaningful overall survival in overall population.

GSK announces positive results from DREAMM-8 phase III trial for Blenrep versus standard of care combination in relapsed/refractory multiple myeloma

Thu, 07 Mar 2024 05:34:15 GMT

Trial unblinded early at an interim analysis based on Independent Data Monitoring Committee recommendation

ViiV Healthcare announces interim data at CROI indicating superior efficacy of long-acting injectable HIV treatment Cabenuva (cabotegravir + rilpivirine) compared to daily oral therapy in individuals living with HIV who have adherence challenges

Wed, 06 Mar 2024 13:14:01 GMT

The data were presented by the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections network at CROI.

ViiV Healthcare presents phase I clinical trial findings of a cabotegravir long-acting injectable investigational formulation allowing at least four months between doses

Mon, 04 Mar 2024 12:32:24 GMT

GSK announced the company’s first step towards delivering ultra long-acting injectable HIV treatment.

GSK announces Dr Jeannie Lee to join the Board as Non-Executive Director

Thu, 29 Feb 2024 06:53:49 GMT

GSK plc (LSE/NYSE: GSK) has today announced that Dr Jeannie Lee has been appointed to the Board of the Company as a Non-Executive Director.

Statement: Zantac (ranitidine) litigation

Thu, 29 Feb 2024 06:21:29 GMT

GSK plc (LSE/NYSE: GSK) today confirmed it has reached a confidential settlement with Boyd/Steenvoord.

ViiV Healthcare to present data for its next generation of ultra long-acting treatments for HIV

Wed, 28 Feb 2024 12:32:24 GMT

Key abstracts to be presented at CROI 2024 by ViiV Healthcare and its study partners.

GSK announces positive headline results from EAGLE-1 phase III trial for gepotidacin in uncomplicated urogenital gonorrhoea (GC)

Mon, 26 Feb 2024 06:16:11 GMT

EAGLE-1 trial met its primary efficacy endpoint.

LATITUDE phase III interim trial data indicates ViiV Healthcare’s long-acting injectable HIV treatment Cabenuva (cabotegravir + rilpivirine) has superior efficacy compared to daily therapy in individuals living with HIV who have adherence challenges

Wed, 21 Feb 2024 18:25:12 GMT

Full data set to be presented at an upcoming scientific conference.

GSK completes acquisition of Aiolos Bio

Thu, 15 Feb 2024 06:15:59 GMT

GSK has completed the acquisition of Aiolos Bio, a clinical-stage biopharmaceutical company.

GSK receives US FDA Fast Track designation for bepirovirsen in chronic hepatitis B

Mon, 12 Feb 2024 06:26:44 GMT

Designation underscores the unmet need for medicines that can achieve functional cure in patients with chronic hepatitis B (CHB)

GSK’s RSV vaccine, Arexvy, accepted under Priority Review in US for the prevention of RSV disease in adults aged 50-59 at increased risk

Tue, 06 Feb 2024 14:39:50 GMT

GSK is the first company to file for regulatory approval to extend RSV vaccination to adults aged 50-59 at increased risk.

GSK’s regulatory application for Shingrix for the prevention of shingles in at-risk adults aged 18 and over accepted for review by China National Medical Products Administration

Tue, 06 Feb 2024 11:07:34 GMT

Shingrix already approved in China for adults aged 50 years and over.

DREAMM-7 phase III trial shows Blenrep combination nearly tripled median progression-free survival versus standard of care combination in patients with relapsed/refractory multiple myeloma

Mon, 05 Feb 2024 16:36:20 GMT

Results from an interim analysis of the DREAMM-7 phase III head-to-head trial.

Statement: Zantac (ranitidine) litigation

Thu, 01 Feb 2024 07:01:27 GMT

GSK today confirmed it has reached a confidential settlement with David Browne, resolving the case he filed in California state court.

GSK delivers strong 2023 performance and upgrades growth outlooks

Wed, 31 Jan 2024 07:00:00 GMT

FY 2023 performance highlights

GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the European Medicines Agency for the prevention of RSV disease in adults aged 50-59 at increased risk

Mon, 29 Jan 2024 19:19:25 GMT

Application supported by positive results of a Phase III study showing immune response and acceptable tolerability profile.

European Commission authorises GSK’s Omjjara (momelotinib)

Mon, 29 Jan 2024 05:45:31 GMT

First medicine in the EU specifically indicated for splenomegaly or symptoms in adult myelofibrosis patients with moderate to severe anaemia

Nucala (mepolizumab) approved in China for use in severe asthma with an eosinophilic phenotype

Wed, 10 Jan 2024 07:02:56 GMT

Mepolizumab is the first targeted IL-5 biologic available in China as an add-on maintenance treatment for severe eosinophilic asthma.

GSK enters agreement to acquire Aiolos Bio

Tue, 09 Jan 2024 06:33:03 GMT

Acquisition expands GSK’s respiratory pipeline adding AIO-001, a phase II-ready, long-acting antibody.

GSK enters exclusive license agreement with Hansoh for HS-20093

Wed, 20 Dec 2023 12:00:09 GMT

Hansoh’s HS-20093 builds on GSK’s oncology portfolio of clinical-stage antibody-drug conjugates.

Jemperli (dostarlimab) plus Zejula (niraparib) combination significantly improved progression-free survival in primary advanced or recurrent endometrial cancer in RUBY Part 2 Phase III trial

Mon, 18 Dec 2023 05:46:38 GMT

Results reinforce development approach of using Jemperli as a backbone in immuno-oncology-based combination therapies

Japan’s Ministry of Health, Labour and Welfare accepts Arexvy (RSV vaccine) regulatory application to prevent RSV disease in adults aged 50-59 at increased risk

Tue, 12 Dec 2023 05:57:29 GMT

Submission supported by positive results of a Phase III study showing immune response and safety in adults aged 50-59.

GSK’s Jemperli (dostarlimab) plus chemotherapy approved as the first and only frontline immuno-oncology treatment in the European Union for dMMR/MSI-H primary advanced or recurrent endometrial cancer

Mon, 11 Dec 2023 14:51:56 GMT

European Commission converts previous conditional approval to full approval as monotherapy for second-line dMMR/MSI-H endometrial cancer.

New global analysis across five cities shows inequities in adult immunisation uptake, signalling need to redesign local and national policy interventions

Wed, 06 Dec 2023 16:38:31 GMT

Findings to be presented at the Global Coalition on Aging’s Silver Economy Forum 2023.

New global survey finds widespread misunderstandings about shingles despite its lifetime prevalence

Thu, 30 Nov 2023 08:31:21 GMT

A new GSK survey shows a large number of adults do not understand how shingles may be triggered.

GSK announces positive results from DREAMM-7 head-to-head phase III trial for Blenrep in relapsed/refractory multiple myeloma

Mon, 27 Nov 2023 06:36:54 GMT

Blenrep plus BorDex showed statistically significant progression-free survival (PFS) benefit versus daratumumab plus BorDex.

GSK announces major step towards sustainability ambitions with advancement of low carbon Ventolin programme to Phase III trials

Tue, 21 Nov 2023 08:00:35 GMT

Next-generation propellant technology has the potential to reduce greenhouse gas emissions from Ventolin (salbutamol) inhaler.

GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia

Mon, 13 Nov 2023 17:23:12 GMT

Decision on EU marketing authorisation expected for momelotinib by early 2024.

Strong year-to-date and Q3 performance drives upgrade to full-year guidance

Wed, 01 Nov 2023 07:00:00 GMT

Q3 2023 performance highlights

GSK enters agreement to obtain exclusive license for JNJ-3989 to expand the development of bepirovirsen

Tue, 31 Oct 2023 10:36:20 GMT

GSK plc and Arrowhead Pharmaceuticals Inc. today announced that they have reached an agreement with Janssen Pharmaceuticals, Inc.

Phase III RUBY trial of Jemperli (dostarlimab) plus chemotherapy meets endpoint of overall survival in patients with primary advanced or recurrent endometrial cancer

Mon, 30 Oct 2023 06:32:06 GMT

Statistically significant and clinically meaningful overall survival benefit observed in the overall population in the trial.

GSK launches £6m programme to boost STEM career progression for young people from under-represented groups in the UK

Fri, 27 Oct 2023 08:00:00 GMT

GSK to invest £6m in STEM equity-focused initiatives in the UK over ten years to tackle barriers to entry in STEM careers.

ViiV Healthcare receives approval from China’s National Medical Products Administration (NMPA) for Vocabria (cabotegravir) used in combination with Rekambys (rilpivirine), the first and only complete long-acting HIV-1 injectable treatment

Thu, 26 Oct 2023 07:04:27 GMT

The complete long-acting regimen enables virologically suppressed people living with HIV in China to reduce treatment dosing days.

New data for Arexvy, GSK’s RSV vaccine, show potential to help protect adults aged 50 to 59 at increased risk for RSV disease

Wed, 25 Oct 2023 17:36:47 GMT

Preliminary results from phase III trial show primary endpoints met, with non-inferior immune responses observed in adults aged 50-59.

GSK enters exclusive license agreement with Hansoh for HS-20089

Fri, 20 Oct 2023 11:28:53 GMT

Hansoh’s HS-20089 complements GSK’s portfolio of gynaecologic cancer therapies.

ViiV Healthcare to present 23 abstracts from innovative HIV treatment and prevention portfolio at EACS 2023

Wed, 18 Oct 2023 09:58:58 GMT

Key data to be presented include long-term and real-world data, including long-acting and 2-drug regimens.

GSK highlights new data in non-small cell lung cancer and endometrial cancer at the European Society for Medical Oncology (ESMO) Congress 2023, reinforcing potential of Jemperli (dostarlimab) as a backbone immuno-oncology therapy

Tue, 17 Oct 2023 17:26:13 GMT

Late-breaking data from head-to-head PERLA trial shows favourable numerical trend in overall survival (OS) results

GSK receives positive CHMP opinion recommending approval of Jemperli (dostarlimab) plus chemotherapy as a new frontline treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer

Mon, 16 Oct 2023 09:58:24 GMT

Decision on EU marketing authorisation expected by the end of the year.

GSK presents scientific advances to improve patient outcomes at the American Association for the Study of Liver Diseases’ The Liver Meeting® 2023

Wed, 11 Oct 2023 10:53:02 GMT

New data from the B-Together phase IIb trial contribute to the development of a functional cure for people living with CHB.

Statement: Zantac (ranitidine) litigation

Wed, 11 Oct 2023 07:00:00 GMT

GSK today confirmed it has reached a confidential settlement in the Cantlay/Harper case filed in California state court.

GSK and ViiV Healthcare to present scientific advancements in their industry-leading infectious diseases portfolio at IDWeek 2023

Tue, 10 Oct 2023 10:43:45 GMT

First scientific presentation of RSV vaccine efficacy and safety data over two seasons.

GSK and Zhifei announce exclusive strategic vaccine partnership in China

Mon, 09 Oct 2023 17:57:53 GMT

Partnership will significantly extend availability of Shingrix in China with co-promotion to healthcare professionals.

GSK survey finds parents know less about meningitis compared to some other childhood diseases

Thu, 05 Oct 2023 18:00:17 GMT

New multi-country survey finds 93% of parents couldn’t identify all three of the most common meningitis symptoms.

GSK announces Wendy Becker to join the Board as Non-Executive Director

Wed, 27 Sep 2023 15:00:00 GMT

GSK has announced that Wendy Becker will join the Board of the Company as a Non-Executive Director with effect from 1 October 2023.

Japan’s Ministry of Health, Labour and Welfare approves GSK’s Arexvy, the country’s first respiratory syncytial virus (RSV) vaccine for older adults

Mon, 25 Sep 2023 06:59:59 GMT

Arexvy’s approval will help protect adults 60 years of age and older in Japan from RSV disease for the first time

European Commission authorises ViiV Healthcare’s Apretude (cabotegravir long-acting and tablets) for HIV prevention

Tue, 19 Sep 2023 14:59:57 GMT

Cabotegravir demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV in clinical trials.

Ojjaara (momelotinib) approved in the US as the first and only treatment indicated for myelofibrosis patients with anaemia

Fri, 15 Sep 2023 20:48:55 GMT

Ojjaara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor.

GSK and Save the Children renew award-winning partnership, with focus on ‘zero dose’ children who have never received a vaccine

Thu, 14 Sep 2023 08:00:17 GMT

GSK and Save the Children renew their 10-year partnership for a further five years.

GSK regulatory submission for momelotinib for the treatment of myelofibrosis accepted for review by Japanese regulator

Mon, 11 Sep 2023 07:00:00 GMT

Submission included data from trials addressing clinical manifestations of myelofibrosis - splenomegaly, constitutional symptoms and anaemia

GSK’s regulatory submission accepted for review by Japanese regulator for use of Nucala (mepolizumab) in adults with chronic rhinosinusitis with nasal polyps

Fri, 01 Sep 2023 06:55:44 GMT

If approved, Nucala would be first anti-interleukin-5 biologic available in Japan for treatment of adults with CRSwNP

New Shingrix data demonstrate 100% vaccine efficacy in the prevention of shingles in adults aged 50 and over in China

Wed, 23 Aug 2023 06:34:42 GMT

No cases of shingles (herpes zoster) reported among the participants who received Shingrix in the randomised clinical trial

New research published in Science highlights potential of a naturally occurring bacterium to help eradicate malaria

Thu, 03 Aug 2023 19:02:58 GMT

GSK scientists have discovered a strain of Delftia tsuruhatensis bacterium, that inhibits P. falciparum malaria parasites in mosquitoes.

Jemperli (dostarlimab) plus chemotherapy approved in the US as the first new frontline treatment option in decades for dMMR/MSI-H primary advanced or recurrent endometrial cancer

Mon, 31 Jul 2023 18:14:20 GMT

Jemperli is the only immuno-oncology treatment approved in a frontline setting for this patient population in combination with chemotherapy

Strong performance and momentum drive upgraded guidance

Wed, 26 Jul 2023 07:00:00 GMT

Q2 2023 performance highlights

ViiV Healthcare’s cabotegravir for HIV prevention receives positive CHMP opinion from European Medicines Agency

Mon, 24 Jul 2023 17:16:07 GMT

Cabotegravir is the first and only long-acting injectable option for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1

New analysis shows lost ground on adult immunisation during the pandemic with 100 million doses potentially missed

Wed, 19 Jul 2023 09:02:55 GMT

Despite successes in Covid-19 vaccination programmes, global uptake of some other adult vaccines fell during the same timeframe

Medicines and Healthcare products Regulatory Agency authorises GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults

Mon, 10 Jul 2023 08:21:20 GMT

Authorisation will help protect adults 60 years of age and older in the UK from RSV disease for the first time

GSK completes acquisition of BELLUS Health

Wed, 28 Jun 2023 16:19:30 GMT

BELLUS is a biopharmaceutical company working to better the lives of patients suffering from refractory chronic cough.

GSK receives US FDA Fast Track designation for investigational vaccine against gonorrhoea

Tue, 27 Jun 2023 06:02:50 GMT

Fast Track designation accelerates the vaccine candidate’s path to US FDA submission for the prevention of Neisseria gonorrhoeae infection

Japan’s Ministry of Health, Labour and Welfare approves Shingrix for the prevention of shingles in at-risk adults aged 18 and over

Mon, 26 Jun 2023 07:02:24 GMT

Approval expands the number of people who can be protected against shingles.

GSK receives positive CHMP opinion recommending authorisation of daprodustat for symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis

Mon, 26 Jun 2023 07:02:17 GMT

The positive CHMP opinion is based on data from three global phase III trials in dialysis patients from the ASCEND clinical trial programme.

Statement - Zantac (ranitidine) litigation

Fri, 23 Jun 2023 07:01:04 GMT

GSK today confirmed it has reached a confidential settlement with James Goetz.

US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices votes to recommend Arexvy for the prevention of RSV disease in adults aged 60 and older with shared clinical decision making

Thu, 22 Jun 2023 19:23:41 GMT

Committee recommendations mean over 55 million older adults in the US could have access to RSV vaccination for the first time

GSK shares positive data for Arexvy, its respiratory syncytial virus (RSV) older adult vaccine, indicating protection over two RSV seasons

Wed, 21 Jun 2023 06:37:50 GMT

Results from the ongoing AReSVi-006 phase III trial show vaccine efficacy over two full seasons

GSK announces extension of FDA review period for momelotinib

Fri, 16 Jun 2023 06:16:21 GMT

GSK is confident in the momelotinib NDA and looks forward to working with the FDA as they finalise their review.

European Commission authorises GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults

Wed, 07 Jun 2023 16:28:39 GMT

Authorisation will help protect adults 60 years of age and older in 30 European countries from RSV disease for the first time

GSK receives US FDA file acceptance for Jemperli (dostarlimab) plus chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial cancer

Tue, 06 Jun 2023 07:04:03 GMT

Submission accepted for Priority Review

GSK presents pivotal data at ESPID confirming effectiveness of its 5-in-1 meningococcal ABCWY vaccine candidate, with demonstrated coverage against a panel of 110 MenB strains

Fri, 12 May 2023 07:57:05 GMT

GSK today presented preliminary positive results from the phase III trial

Statement: Zantac (ranitidine) litigation

Fri, 12 May 2023 06:53:22 GMT

GSK welcomes the decision of the British Columbia Supreme Court in Dussiaume v. Sandoz Canada Inc. 2023 BCSC 795

US FDA approves GSK’s Arexvy, the world’s first respiratory syncytial virus (RSV) vaccine for older adults

Wed, 03 May 2023 16:31:05 GMT

Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time

GSK’s respiratory syncytial virus older adult vaccine candidate gains positive European Medicines Agency CHMP opinion

Thu, 27 Apr 2023 16:34:48 GMT

Positive opinion advances GSK’s goal to provide the first vaccine to help protect older adults from respiratory syncytial virus disease

GSK momentum continues with strong start to 2023

Wed, 26 Apr 2023 07:00:00 GMT

Q1 2023 performance highlights

European Medicines Agency validates marketing authorisation application for Jemperli (dostarlimab) plus chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial cancer

Tue, 25 Apr 2023 07:01:26 GMT

Regulatory submission based on pivotal data from Part 1 of the RUBY phase III trial

GSK reaches agreement to acquire late-stage biopharmaceutical company BELLUS Health

Tue, 18 Apr 2023 08:19:22 GMT

Acquisition further strengthens specialty medicines and respiratory pipeline.

Gepotidacin’s positive phase III data shows potential to be the first in a new class of oral antibiotics for uncomplicated urinary tract infections in over 20 years

Sat, 15 Apr 2023 10:38:48 GMT

Gepotidacin is a late-stage antibiotic in development in GSK’s growing infectious diseases portfolio

GSK and SCYNEXIS announce an exclusive agreement to commercialise and further develop Brexafemme (ibrexafungerp), a novel, first-in-class medicine to treat fungal infection

Thu, 30 Mar 2023 12:00:00 GMT

Brexafemme complements GSK’s industry-leading infectious disease portfolio with an FDA approved treatment for vulvovaginal candidiasis.

Medicines Patent Pool signs sublicences with Aurobindo, Cipla and Viatris to produce generic versions of ViiV Healthcare’s innovative long-acting HIV prevention medicine

Thu, 30 Mar 2023 07:00:42 GMT

Licences should enable potentially millions of people living in areas most impacted by HIV to access innovative prevention medicine.

Phase III RUBY clinical trial demonstrates potential of Jemperli (dostarlimab) plus chemotherapy to redefine the treatment of primary advanced or recurrent endometrial cancer versus chemotherapy alone

Mon, 27 Mar 2023 17:00:48 GMT

Interim results from Part 1 of the RUBY clinical trial in primary advanced or recurrent endometrial cancer.

Statement: Zantac (ranitidine) litigation

Fri, 24 Mar 2023 10:00:00 GMT

In response to the Sargon ruling by the California state court in respect of the Goetz case, GSK plc issued the following statement.

China National Medical Products Administration accepts regulatory submission for Nucala (mepolizumab) in severe eosinophilic asthma

Tue, 14 Mar 2023 11:25:40 GMT

The China National Medical Products Administration (NMPA) has accepted for review a new drug application for Nucala (mepolizumab)

GSK announces positive pivotal phase III data for 5-in-1 Meningococcal ABCWY vaccine candidate

Tue, 14 Mar 2023 06:08:26 GMT

MenABCWY combination vaccine candidate met all its primary endpoints of the pivotal phase III clinical trial

US FDA Advisory Committee votes to support effectiveness and safety of GSK’s respiratory syncytial virus older adult vaccine candidate

Wed, 01 Mar 2023 15:17:05 GMT

Committee votes unanimously that the data support the effectiveness of the vaccine and 10-2 that the data support the safety of the vaccine

ViiV Healthcare announces positive data demonstrating long-acting injectable Cabenuva (cabotegravir, rilpivirine) is as effective as daily oral Biktarvy (BIC/FTC/TAF) for the treatment of HIV-1

Thu, 23 Feb 2023 06:57:48 GMT

ViiV Healthcare announced positive 12-month findings from the SOLAR study.

Landmark New England Journal of Medicine publication reinforces potential of GSK’s respiratory syncytial virus older adult vaccine candidate

Wed, 15 Feb 2023 13:58:48 GMT

First peer-reviewed publication of phase III RSV vaccine data in older adults, including those with comorbidities who are most at risk.

ViiV Healthcare to present first head-to-head data for long-acting HIV treatment Cabenuva against daily oral Biktarvy at CROI 2023

Tue, 14 Feb 2023 14:00:00 GMT

Other key data to be presented include new HIV prevention findings for long-acting cabotegravir and predictors of response to N6LS

US FDA grants regular approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer

Fri, 10 Feb 2023 07:48:47 GMT

Conversion from accelerated to regular (full) approval based on long-term outcomes from the GARNET phase I trial

US FDA Advisory Committee votes in support of trials designed to evaluate Jemperli (dostarlimab-gxly) as a potential treatment for mismatch repair-deficient/microsatellite instability-high locally advanced rectal cancer

Thu, 09 Feb 2023 23:22:03 GMT

In January 2023, the US FDA granted dostarlimab-gxly Fast Track designation for the treatment of dMMR/MSI-H locally advanced rectal cancer.

GSK announces results from 17-year retrospective study on US clinical trial diversity

Mon, 06 Feb 2023 12:00:55 GMT

Study examined clinical trial diversity across 495 GSK trials involving over 100,000 participants.

Jesduvroq (daprodustat) approved by US FDA for anaemia of chronic kidney disease in adults on dialysis

Wed, 01 Feb 2023 13:57:25 GMT

Jesduvroq is the only oral HIF-PHI approved in the US, offering adults on dialysis with anaemia of CKD a new oral treatment option

GSK delivers strong 2022 performance with full year sales of £29.3 billion +19% AER, +13% CER; Total EPS 371.4p >100% Adjusted EPS of 139.7p +27% AER, +15% CER from continuing operations

Wed, 01 Feb 2023 07:00:00 GMT

Step change in commercial execution drives strong sales growth across Specialty Medicines and Vaccines

Benlysta granted Orphan Drug Designation by US FDA for the potential treatment of systemic sclerosis

Wed, 01 Feb 2023 02:37:35 GMT

GSK plans to initiate a phase II/III trial for systemic sclerosis associated interstitial lung disease (SSc-ILD) in the first half of 2023.

VidPrevtyn Beta COVID-19 booster vaccine, developed by Sanofi and GSK, approved for use in Great Britain

Wed, 21 Dec 2022 15:45:54 GMT

SARS-CoV-2 spike protein vaccine is the first and only protein-based variant COVID-19 booster vaccine approved in Great Britain and the EU

GSK and Wave Life Sciences announce collaboration to drive discovery and development of oligonucleotide therapeutics focusing on novel genetic targets

Tue, 13 Dec 2022 09:27:31 GMT

A strategic collaboration to advance oligonucleotide therapeutics, including Wave’s preclinical RNA editing programme

GSK announces new global headquarters in central London

Mon, 12 Dec 2022 13:00:00 GMT

GSK today announced that its new global headquarters will be in central London. The company will move to the new headquarters in 2024.

New data at ASH underscore the potential for durable, clinically important responses with momelotinib for myelofibrosis patients

Sun, 11 Dec 2022 17:15:28 GMT

GSK today announced new 48-week data from the MOMENTUM phase III trial...

PERLA phase II trial of Jemperli (dostarlimab) plus chemotherapy shows positive results in first-line metastatic non-squamous non-small cell lung cancer

Wed, 07 Dec 2022 17:45:25 GMT

PERLA is the largest global head-to-head trial of PD-1 inhibitors in this patient population

Statement: Zantac (ranitidine) litigation

Wed, 07 Dec 2022 06:18:45 GMT

MDL Court has dismissed all cases alleging the five remaining cancers in the MDL

Jemperli (dostarlimab) RUBY phase III trial met its primary endpoint in a planned interim analysis in patients with primary advanced or recurrent endometrial cancer

Fri, 02 Dec 2022 18:42:20 GMT

Regulatory submissions based on the trial results are planned for the first half of 2023.

European Medicines Agency accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

Fri, 02 Dec 2022 07:07:59 GMT

Application includes data from key phase III trials, including the pivotal MOMENTUM trial.

New global survey reveals opportunities to address organ damage risk with people living with lupus earlier in the course of their disease

Tue, 29 Nov 2022 17:04:17 GMT

Survey examined healthcare professional approaches to preventing organ damage

GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorisation

Tue, 22 Nov 2022 06:28:21 GMT

GSK has initiated the process for withdrawal of the US marketing authorisation for Blenrep (belantamab mafodotin-blmf)

GSK tops Access to Medicine Index (ATMI) for eighth consecutive time

Tue, 15 Nov 2022 13:00:00 GMT

Company also announces £100 million investment over next ten years to support access initiatives in lower income countries

GSK announces positive Phase IIa study results for a new first-in-class candidate medicine for patients with tuberculosis

Mon, 14 Nov 2022 11:03:30 GMT

Results demonstrate the potential for this asset to be a component of simpler TB treatment regimens in the future.

GSK provides an update on Zejula (niraparib) US prescribing information

Fri, 11 Nov 2022 07:00:45 GMT

Zejula is an oral, once-daily PARP inhibitor currently being evaluated in multiple pivotal trials.

Positive data for bepirovirsen from B-Clear phase IIb trial presented at American Association for the Study of Liver Diseases’ Meeting with simultaneous publication in the New England Journal of Medicine

Tue, 08 Nov 2022 14:58:15 GMT

Phase III trial evaluating bepirovirsen to start in H1 2023.

GSK provides update on DREAMM-3 phase III trial for Blenrep in relapsed/refractory multiple myeloma

Mon, 07 Nov 2022 06:25:10 GMT

DREAMM-3 did not meet its primary endpoint of progression-free survival (PFS)

EAGLE-2 and EAGLE-3 phase III trials for gepotidacin stopped early for efficacy following pre-planned interim analysis by Independent Data Monitoring Committee

Thu, 03 Nov 2022 07:02:29 GMT

Gepotidacin could be the first new novel oral antibiotic treatment for uncomplicated urinary tract infections in over 20 years

GSK delivers strong Q3 2022 sales of £7.8 billion +18% AER, +9% CER and Total EPS 255.9p +>100% AER, +>100% CER; Adjusted EPS of 46.9p +25% AER, +11% CER

Wed, 02 Nov 2022 07:00:00 GMT

Strong commercial execution drives continued sales growth across Specialty Medicines, Vaccines and General Medicines

GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA

Wed, 02 Nov 2022 07:00:00 GMT

The US FDA has accepted a Biologics License Application and granted Priority Review for its RSV older adult vaccine candidate.

European Medicines Agency validates ViiV Healthcare’s marketing authorisation application for cabotegravir long-acting injectable for HIV Prevention

Fri, 28 Oct 2022 07:00:17 GMT

The marketing application is based on results from the HPTN 083 and 084 phase IIb/III studies.

GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment

Fri, 28 Oct 2022 07:00:00 GMT

The vaccine was well tolerated with a favourable safety profile.

GSK provides update on ContRAst phase III programme for otilimab in the treatment of moderate to severe rheumatoid arthritis

Thu, 27 Oct 2022 07:00:00 GMT

Full results from the ContRAst phase III programme will be submitted for publication in 2023.

GSK reports outcome from US FDA Advisory Committee meeting on daprodustat for anaemia of CKD

Thu, 27 Oct 2022 00:27:58 GMT

Daprodustat was studied in the ASCEND phase III clinical trial programme.

ViiV Healthcare presents positive proof-of-concept findings for N6LS, an investigational, broadly neutralising antibody (bNAb) offering a potential new approach for the treatment of HIV

Tue, 25 Oct 2022 15:00:00 GMT

Data from the BANNER study show antiviral efficacy, safety, and tolerability of N6LS, supporting its continued study in phase IIb

GSK regulatory submission accepted by Japanese regulator for respiratory syncytial virus older adult vaccine candidate

Fri, 21 Oct 2022 07:00:00 GMT

The proposed indication is for adults aged 60 years and above to prevent lower respiratory tract diseases (LRTD) caused by RSV.

New data show Shingrix can provide at least 10 years of protection against shingles in adults aged 50 years and over

Wed, 19 Oct 2022 13:00:00 GMT

The ZOSTER-049 extension study shows that Shingrix can provide at least a decade of protection against shingles after initial vaccination

GSK announces expanded collaboration with Tempus in precision medicine to accelerate R&D

Tue, 18 Oct 2022 06:25:21 GMT

GSK will work together with Tempus to improve clinical trial design, speed up enrolment and identify drug targets.

US FDA approves Menveo in a new single-vial presentation to help prevent disease caused by meningococcal bacteria serogroups A, C, Y, and W

Mon, 17 Oct 2022 07:00:00 GMT

The Menveo one-vial presentation now comes in a ready to use single vial giving healthcare providers a more convenient option.

GSK’s older adult respiratory syncytial virus (RSV) vaccine candidate shows 94.1% reduction in severe RSV disease and overall vaccine efficacy of 82.6% in pivotal trial

Thu, 13 Oct 2022 06:22:40 GMT

Data showed overall vaccine efficacy against RSV-lower respiratory tract disease in adults aged 60 years and above

GSK to present updates on its industry-leading infectious disease portfolio at IDWeek 2022

Wed, 12 Oct 2022 13:00:00 GMT

GSK will share updates on its industry-leading infectious disease pipeline and portfolio with 33 abstracts accepted for IDWeek 2022.

US FDA approves BOOSTRIX for immunisation during pregnancy for the prevention of whooping cough in newborn infants

Mon, 10 Oct 2022 07:00:00 GMT

The US FDA has approved Boostrix for immunisation during the third trimester of pregnancy to help prevent pertussis (whooping cough).

GSK announces positive headline results from PERLA, the phase II trial of Jemperli (dostarlimab) plus chemotherapy in patients with metastatic non-squamous non-small cell lung cancer

Wed, 05 Oct 2022 07:00:00 GMT

The PERLA phase II trial is the largest global head-to-head trial of programmed death receptor-1 (PD-1) inhibitors in this population.

Iain Mackay, Chief Financial Officer, to retire from GSK, Julie Brown appointed as successor

Mon, 26 Sep 2022 07:00:00 GMT

The Board has selected Ms Julie Brown, currently Chief Operating and Financial Officer, Burberry Group plc, as successor to Iain Mackay.

Oncologic Drugs Advisory Committee to review Zejula overall survival data from the NOVA phase III trial in recurrent ovarian cancer

Thu, 22 Sep 2022 14:00:00 GMT

The US FDA will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss overall survival data from the Nova trial

GSK and Spero Therapeutics announce exclusive licence agreement for tebipenem HBr, a late-stage antibiotic that may treat complicated urinary tract infections

Thu, 22 Sep 2022 07:00:00 GMT

GSK has entered into an exclusive license agreement with Spero Therapeutics for tebipenem pivoxil HBr.

GSK and Microsoft, in collaboration with the Centre for Health and Disease Studies, launch disease surveillance project in Nepal

Wed, 21 Sep 2022 12:00:00 GMT

New partnership combines expertise across Biopharma and Tech sectors.

GSK launches Sustainable Procurement Programme for suppliers

Tue, 20 Sep 2022 12:00:00 GMT

From 2023, the company will require and support suppliers to take action on sustainability commitments.

Zejula (niraparib) shows durable and sustained long-term progression-free survival benefit in the PRIMA study of first-line platinum-responsive advanced ovarian cancer

Fri, 09 Sep 2022 13:00:00 GMT

GSK today announced long-term data from the phase III PRIMA study

GSK announces update on US FDA regulatory review of daprodustat in anaemia of chronic kidney disease

Tue, 06 Sep 2022 13:00:00 GMT

GSK today announced that the US FDA will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review daprodustat

WHO grants prequalification to GSK’s Mosquirix – the first and only approved malaria vaccine

Tue, 06 Sep 2022 12:00:10 GMT

An important step for rolling out the vaccine to children living in regions with moderate to high transmission.

GSK to highlight the latest advances in cancer research from across its portfolio and pipeline at ESMO

Thu, 01 Sep 2022 07:00:00 GMT

GSK will present new findings from across its diverse oncology portfolio and pipeline at the congress.

GSK Board changes

Wed, 24 Aug 2022 06:57:22 GMT

Elizabeth (Liz) McKee Anderson to join the Board as Non-Executive Director

US FDA accepts new drug application for GSK’s momelotinib for the treatment of myelofibrosis

Wed, 17 Aug 2022 07:00:00 GMT

Regulatory submission included data from the pivotal MOMENTUM phase III clinical trial

Statement: Zantac (ranitidine) U.S. litigation

Tue, 16 Aug 2022 18:05:56 GMT

Statement regarding U.S. Zantac (ranitidine) litigation

GSK completes acquisition of Affinivax, Inc.

Tue, 16 Aug 2022 01:20:09 GMT

GSK today announced it has completed the acquisition of Affinivax, Inc, a clinical-stage biopharmaceutical company based in Cambridge.

Statement: Zantac (ranitidine) litigation

Thu, 11 Aug 2022 14:45:26 GMT

Response to recent speculative commentary regarding U.S. Zantac litigation

GSK Announces Offer to Repurchase Exchangeable Senior Notes Due 2023

Wed, 03 Aug 2022 01:36:01 GMT

GSK Finance (No.3) plc, is offering to repurchase for cash any and all of its outstanding Exchangeable Senior Notes due 2023.

ViiV Healthcare and the Medicines Patent Pool sign new voluntary licensing agreement to expand access to innovative long-acting HIV prevention medicine

Thu, 28 Jul 2022 09:48:06 GMT

Selected generic manufacturers will have the opportunity to develop, manufacture and supply generic versions of cabotegravir LA for PrEP

ViiV Healthcare announces new data at AIDS 2022 from unblinded phase of HPTN 084 study in women in sub Saharan Africa showing continued superior efficacy of injectable cabotegravir long-acting for PrEP over daily, oral TDF/FTC tablets

Thu, 28 Jul 2022 09:27:56 GMT

Findings show that cabotegravir LA for PrEP continued to demonstrate superior efficacy in the prevention of new HIV infections among women

GSK signs agreement to support pandemic preparedness in Europe

Thu, 28 Jul 2022 06:00:00 GMT

GSK will supply Adjupanrix to 12 participating European countries.

GSK delivers strong Q2 2022 sales of £6.9 billion +19% at AER, +13% at CER and Total EPS* from continuing operations** 17.5p -42% AER, -58% CER; Adjusted EPS of 34.7p +23% AER, +6% CER

Wed, 27 Jul 2022 06:46:37 GMT

Strong commercial execution across Specialty Medicines, Vaccines and General Medicines drives double-digit sales growth

ViiV Healthcare to present new data from innovative HIV treatment and prevention portfolio at AIDS 2022

Mon, 25 Jul 2022 12:00:00 GMT

Data to be presented include long-term and real-world data from portfolio of medicines

Board and Committee changes

Fri, 22 Jul 2022 16:00:00 GMT

Changes to GSK Board and Committees

Completion of GSK Share Consolidation

Mon, 18 Jul 2022 15:54:10 GMT

The consolidation of GSK shares will become effective at 8.00 a.m. tomorrow

Completion of the demerger of Haleon and share consolidation of GSK

Mon, 18 Jul 2022 07:00:00 GMT

Completion of the demerger of Haleon and share consolidation of GSK

GSK gathers global experts to discuss role of vaccines in protecting people and the planet

Thu, 07 Jul 2022 14:41:09 GMT

'Palio’ meeting to address growing threat to human health from infectious disease and its links to nature loss and climate change.

Result of General Meeting

Wed, 06 Jul 2022 14:30:07 GMT

At a General Meeting on Wednesday 6 July 2022 both resolutions set out in the Notice of General Meeting were duly passed by shareholders.

GSK completes acquisition of Sierra Oncology

Fri, 01 Jul 2022 15:19:34 GMT

GSK announced it has completed the acquisition of Sierra Oncology, a California-based biopharmaceutical company.

GSK selects Target the Future grant recipient in innovation challenge supporting multiple myeloma community

Wed, 29 Jun 2022 15:54:06 GMT

GSK today announced the first recipient of the Target the Future Think Tank Challenge.

Japan’s Ministry of Health, Labour and Welfare accepts Shingrix regulatory submission to prevent shingles in at-risk adults aged 18 years and older

Tue, 28 Jun 2022 15:41:25 GMT

Shingrix was initially approved in 2018 by the Japanese MHLW to prevent shingles in adults aged 50 years or older

GSK presents promising new data for bepirovirsen, an investigational treatment for chronic hepatitis B

Sat, 25 Jun 2022 12:36:56 GMT

GSK today announced interim results from the B-Clear phase IIb trial at the EASL International Liver Congress.

GSK announces £1 billion R&D investment over ten years to get ahead of infectious diseases in lower-income countries

Thu, 23 Jun 2022 10:35:37 GMT

GSK announced £1bn investment over ten years to accelerate R&D dedicated to infectious diseases

GSK to present new data from the B-Clear phase IIb trial for bepirovirsen in chronic hepatitis B at the International Liver Congress 2022

Wed, 15 Jun 2022 15:25:51 GMT

GSK will present 12 abstracts at the European Association for the Study of the Liver’s International Liver Congress 2022.

GSK announces positive pivotal phase III data for its respiratory syncytial virus (RSV) vaccine candidate for older adults

Fri, 10 Jun 2022 18:14:28 GMT

GSK today announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 phase III trial.

GSK announces US FDA approval of Priorix for the prevention of measles, mumps and rubella in individuals 12 months of age and older

Mon, 06 Jun 2022 18:10:21 GMT

Priorix becomes an additional source of measles, mumps and rubella vaccine for US patients

Update: Proposed demerger of the Consumer Healthcare business from GSK to form Haleon

Wed, 01 Jun 2022 18:00:27 GMT

The proposed Demerger is the most significant corporate change for GSK in the last 20 years

GSK publishes Prospectus and Circular for proposed demerger of its Consumer Healthcare business to form Haleon

Wed, 01 Jun 2022 14:22:57 GMT

The Circular is available at www.gsk.com/demerger and the Prospectus is available at www.haleon.com

GSK to acquire clinical-stage biopharmaceutical company Affinivax, Inc.

Tue, 31 May 2022 17:53:51 GMT

Supports development of a strong portfolio of innovative vaccines and specialty medicines

ViiV Healthcare announces marketing approval by Japan’s Ministry of Health, Labour and Welfare for Vocabria (cabotegravir) used in combination with Rekambys (rilpivirine)

Tue, 31 May 2022 17:24:42 GMT

Long-acting treatment enables people living with HIV to reduce the days they receive treatment.

GSK announces further appointments to Designate Haleon Board

Mon, 30 May 2022 16:58:35 GMT

Demerger and listing of Haleon expected in July 2022

China approves Cervarix two-dose vaccine schedule for girls aged 9 to 14 against certain types of cancer-causing human papillomavirus

Fri, 27 May 2022 17:38:58 GMT

China’s National Medical Products Administration has approved a two-dose vaccine schedule for Cervarix in girls aged between 9 to 14 years.

ViiV  Healthcare commits to grant voluntary licence for patents relating to cabotegravir long-acting for PrEP to Medicines Patent Pool

Fri, 27 May 2022 10:57:00 GMT

ViiV Healthcare and MPP are actively negotiating voluntary licensing terms to help widen access to innovative HIV prevention measure

GSK unveils latest research advances demonstrating strength of its portfolio and pipeline at ASCO and EHA

Thu, 26 May 2022 11:49:45 GMT

GSK plc will present 25 abstracts at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

GSK announces Dr Vishal Sikka to join the Board as Non-Executive Director

Wed, 04 May 2022 10:00:00 GMT

GSK has announced that Dr Vishal Sikka, founder and CEO of Vianai Systems, will join the Board of the Company as a Non-Executive Director.

SK bioscience and GSK’s adjuvanted COVID-19 vaccine candidate meets coprimary objectives in a phase III study; Biologics License Application submitted for SKYCovione™(GBP510/GSK adjuvant) in South Korea

Fri, 29 Apr 2022 08:24:03 GMT

SK submits license application to MFDS to support vaccine sovereignty in South Korea

GSK delivers strong Q1 2022 sales of £9.8 billion, +32% AER, +32% CER; Total EPS 35.9p +67% AER, +66% CER and Adjusted EPS 32.8p +43% AER, +43% CER

Wed, 27 Apr 2022 12:00:00 GMT

Sales growth across Pharmaceuticals, Vaccines and Consumer Healthcare driven by strong commercial execution and underlying demand

US Food and Drug Administration accepts New Drug Application for daprodustat

Tue, 19 Apr 2022 06:33:32 GMT

US FDA regulatory submission acceptance is the third major regulatory milestone for daprodustat

GSK reaches agreement to acquire late-stage biopharmaceutical company Sierra Oncology for $1.9bn

Wed, 13 Apr 2022 06:35:13 GMT

Myelofibrosis is a fatal cancer of the bone marrow impacting the normal production of blood cells.

ViiV Healthcare announces US FDA approval of Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV

Wed, 30 Mar 2022 14:06:29 GMT

According to UNAIDS, approximately 1.7 million children globally were living with HIV in 2020.

ViiV Healthcare announces label update for its long-acting HIV treatment, Cabenuva (cabotegravir, rilpivirine), to be initiated with or without an oral lead-in period

Thu, 24 Mar 2022 13:49:51 GMT

US FDA approval of updated label streamlines the initiation process for the first and only complete long-acting HIV treatment.

GSK to demonstrate its commitment to improving outcomes for patients with gynaecologic cancer at the 2022 SGO Annual Meeting

Tue, 15 Mar 2022 11:47:57 GMT

The meeting will take place in Phoenix, Arizona, and virtually from 18-21 March 2022

GSK announces appointments to Designate Haleon Board

Tue, 15 Mar 2022 10:00:00 GMT

GlaxoSmithKline plc (GSK) (LSE/NYSE: GSK) today announced the appointment of six directors to the designate Board of Haleon.

European Medicines Agency (EMA) accepts marketing authorisation application for daprodustat

Tue, 01 Mar 2022 07:00:55 GMT

The EMA has validated the MAA for daprodustat, for the treatment of patients with anaemia of chronic kidney disease.

GSK introduces Haleon to investors

Mon, 28 Feb 2022 10:45:43 GMT

Global leader in consumer health set to be a newly independent company

GSK provides further update on phase III RSV maternal vaccine candidate programme

Mon, 28 Feb 2022 06:42:41 GMT

Further to the voluntary pause shared on February 18, the Company has decided to stop enrolment and vaccination in trials

Medicago and GSK announce the approval by Health Canada of COVIFENZ®, an adjuvanted plant-based COVID-19 vaccine

Thu, 24 Feb 2022 15:02:38 GMT

A vaccine manufactured in plants and developed in Canada

Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine

Wed, 23 Feb 2022 09:58:13 GMT

Sanofi and GSK today announce that they intend to submit data from both their booster and Phase 3 efficacy trials

GSK announces independent Consumer Healthcare company is to be called Haleon

Tue, 22 Feb 2022 13:52:45 GMT

Haleon will be a new world-leader in consumer health with an exceptional portfolio of category-leading brands.

GSK provides update on phase III RSV maternal vaccine candidate programme

Fri, 18 Feb 2022 06:41:34 GMT

GSK gives update on RSV maternal vaccine candidate

China’s National Medical Products Administration approves Benlysta (belimumab) for adult patients with active lupus nephritis

Thu, 10 Feb 2022 08:42:33 GMT

First and only biologic approved in China for both systemic lupus erythematosus and lupus nephritis

GSK delivers FY 2021 reported sales of £34 billion, stable at AER, +5% CER; Total EPS 87.6p -24% AER, -13% CER and Adjusted EPS of 113.2p -2% AER, +9% CER

Wed, 09 Feb 2022 15:05:33 GMT

GSK delivers FY 2021 reported sales of £34 billion, stable at AER, +5% CER.

ViiV Healthcare to present new long-term findings from its innovative 2-drug and long-acting HIV medicines portfolio at CROI 2022

Mon, 07 Feb 2022 11:55:29 GMT

ViiV Healthcare to present new long-term findings at CROI 2022

GSK announces settlement between ViiV Healthcare and Gilead Sciences, Inc. resolving litigation relating to Biktarvy and ViiV’s dolutegravir patents and entry into a patent licence agreement

Tue, 01 Feb 2022 15:46:59 GMT

Gilead will make an upfront payment of $1.25 billion to ViiV Healthcare in the first quarter of 2022

ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for use every two months, expanding the label of the first and only complete long-acting HIV treatment

Tue, 01 Feb 2022 13:09:31 GMT

Cabenuva is now approved for administration as few as six times a year for virologically suppressed adults living with HIV.

Tony Wood appointed Chief Scientific Officer designate, GSK

Wed, 19 Jan 2022 02:01:12 GMT

Tony Wood appointed Chief Scientific Officer designate, GSK

Update - GSK Consumer Healthcare

Sat, 15 Jan 2022 15:57:25 GMT

GlaxoSmithKline (GSK) plc today confirms it has received three unsolicited, conditional and non-binding proposals from Unilever plc

GSK and Vir Biotechnology announce United States government agreement to purchase additional supply of sotrovimab, authorised for the early treatment of COVID-19

Tue, 11 Jan 2022 11:44:48 GMT

600,000 additional doses to be supplied to the US Government for distribution in Q1 2022

ViiV Healthcare announces US FDA approval of Apretude (cabotegravir extended-release injectable suspension), the first and only long-acting injectable option for HIV prevention

Mon, 20 Dec 2021 16:58:30 GMT

ViiV Healthcare announces US FDA approval of Apretude

GSK announces Sir Dave Lewis appointed Non-Executive Chair Designate of independent Consumer Healthcare company

Mon, 20 Dec 2021 01:20:42 GMT

GSK announces Sir Dave Lewis appointed Non-Executive Chair Designate of independent Consumer Healthcare company

Xevudy (sotrovimab) granted marketing authorisation by the European Commission for the early treatment of COVID-19

Fri, 17 Dec 2021 12:47:17 GMT

GSK and Vir are committed to the ongoing evaluation of sotrovimab as the COVID-19 landscape continues to evolve

GSK and Sanofi announce positive preliminary booster data for their COVID-19 vaccine candidate and continuation of phase III trial per independent Monitoring Board recommendation

Wed, 15 Dec 2021 06:12:37 GMT

Companies intend to file booster data with regulatory authorities following the phase III results

New data presented at ASH 2021 highlight potential of Blenrep (belantamab mafodotin-blmf) in combination with standard of care therapies in earlier lines of multiple myeloma treatment

Mon, 13 Dec 2021 13:00:19 GMT

GSK announced new data from the DREAMM-9 phase I trial and two GSK collaborative studies investigating the potential use of Blenrep.

Medicago and GSK announce positive Phase 3 efficacy and safety results for adjuvanted plant-based COVID-19 vaccine candidate

Tue, 07 Dec 2021 11:56:09 GMT

Primary endpoints and secondary endpoints for which data are available were met in trial dominated by COVID-19 variants

Preclinical studies demonstrate sotrovimab retains activity against the full combination of mutations in the spike protein of the Omicron SARS-CoV-2 variant

Tue, 07 Dec 2021 06:31:42 GMT

New preclinical findings generated through in vitro testing of sotrovimab against the complete pseudo-virus, updated to bioRxiv

GSK welcomes Gavi decision to fund the roll out of malaria vaccines for children

Thu, 02 Dec 2021 17:42:55 GMT

Gavi to provide funding for procurement and introduction of malaria vaccines into child immunisation programmes in Gavi eligible countries.

MHRA grants conditional marketing authorisation1 for COVID-19 treatment Xevudy (sotrovimab)

Thu, 02 Dec 2021 13:49:41 GMT

Conditional marketing authorisation has been granted for Great Britain and is based on Phase III data

GSK and the University of Oxford launch new Oxford-GSK Institute to harness advanced technology and unravel mechanisms of disease

Thu, 02 Dec 2021 07:42:06 GMT

The institute aims to deepen understanding of complex diseases such as Alzheimer’s and Parkinson’s, and increase drug discovery.

Preclinical data demonstrate sotrovimab retains activity against key Omicron mutations, new SARS-CoV-2 variant

Thu, 02 Dec 2021 06:46:52 GMT

Data to be confirmed by further in vitro pseudo-virus testing

GSK unveils Target the Future, a global, multi-year programme to help address key challenges affecting the multiple myeloma community

Wed, 01 Dec 2021 11:33:36 GMT

$100,000 grant to be awarded to best idea submitted to Target the Future Think Tank Challenge

GSK appoints Phil Dormitzer M.D., Ph.D., as Global Head of Vaccines R&D

Tue, 30 Nov 2021 12:43:44 GMT

Phil Dormitzer M.D., Ph.D., will join the company as Global Head of Vaccines R&D on 3 December 2021

GSK showcases progress from the DREAMM clinical trial programme in multiple myeloma at the 2021 ASH Annual Meeting

Thu, 18 Nov 2021 13:30:18 GMT

11 abstracts on Blenrep will be presented at the upcoming American Society of Hematology (ASH) Annual Meeting and Exposition.

GSK and Vir Biotechnology announce United States government agreements to purchase sotrovimab, a COVID-19 treatment

Wed, 17 Nov 2021 11:38:01 GMT

US government contracts for approximately $1 billion (USD) now in place to purchase sotrovimab, further expanding access nationwide

European Commission approves Nucala (mepolizumab) in three additional eosinophil-driven diseases

Wed, 17 Nov 2021 06:39:47 GMT

Mepolizumab is now the only treatment approved in Europe for use in four eosinophil-driven diseases

Primary endpoint met in COMET-TAIL Phase III trial evaluating intramuscular administration of sotrovimab for early treatment of COVID-19

Fri, 12 Nov 2021 12:00:44 GMT

Phase III IM administration data for sotrovimab.

GSK announces positive Phase III efficacy and safety data for daprodustat in patients with anaemia due to chronic kidney disease

Fri, 05 Nov 2021 16:57:22 GMT

Pivotal trials in non-dialysis and dialysis populations published simultaneously in the New England Journal of Medicine

ViiV Healthcare presents positive interim data showing Vocabria (cabotegravir) and Rekambys (rilpivirine) can be implemented successfully in a variety of European healthcare settings

Thu, 28 Oct 2021 08:00:00 GMT

The CARISEL study showed most people living with HIV who started treatment felt positive about the long-acting regimen

GSK delivers strong Q3 sales of £9.1 billion +5% AER, +10% CER Total EPS 23.3p -7% AER, +3% CER; Adjusted EPS 36.6p +3% AER, +10% CER 2021 full year EPS guidance improved

Wed, 27 Oct 2021 12:00:00 GMT

Sales growth across Pharmaceuticals, Vaccines and Consumer Healthcare driven by strong commercial execution and underlying demand

GSK announces Dr Harry (Hal) C. Dietz MD to join the Board as Non-Executive Director

Wed, 27 Oct 2021 09:04:15 GMT

Appointment further strengthens Board scientific capabilities, including in genetics which is central to GSK’s R&D approach

GSK Consumer Healthcare solidifies commitment to pharmacists with 3-year Pharmacist Support Programme

Tue, 26 Oct 2021 09:14:13 GMT

Helping global pharmacy teams play a critical role in improving public health in the age of self-care.

US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices votes unanimously to recommend Shingrix for immunocompromised adults aged 19 and up

Wed, 20 Oct 2021 18:27:28 GMT

US CDC and Prevention’s Advisory Committee votes unanimously to recommend Shingrix for immunocompromised adults aged 19 & up

Less talk, more action: New report sponsored by ViiV Healthcare provides roadmap to achieve health equity by 2040

Wed, 20 Oct 2021 13:39:58 GMT

The report offers actions to overcome the barriers that have blocked progress in achieving health equity across HIV, STIs, & COVID-19

GSK to showcase significant scientific advances in renal care at the American Society of Nephrology Kidney Week 2021

Mon, 18 Oct 2021 17:50:23 GMT

Data from all five Phase 3 trials of the ASCEND programme for the investigational medicine daprodustat will be presented at the meeting.

GSK unveils plan for UK headquarters of new Consumer Healthcare company

Mon, 11 Oct 2021 12:03:24 GMT

New UK-listed Consumer Healthcare company to build new global campus and innovation centre in Weybridge, UK

GSK welcomes WHO recommendation for broad roll-out of its RTS,S/AS01e (RTS,S) malaria vaccine

Wed, 06 Oct 2021 16:21:30 GMT

The vaccine is the result of over 30 years of research led by GSK, with PATH and other partners.

ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV

Mon, 04 Oct 2021 08:37:56 GMT

Paediatric HIV remains a global issue, with children disproportionately affected by the HIV epidemic.

ViiV Healthcare presents three-year switch data for Dovato (dolutegravir/lamivudine) confirming long-term, non-inferior efficacy with no virologic failure versus continuation of TAF-based regimens of at least three drugs

Wed, 29 Sep 2021 07:48:14 GMT

The Phase 3 TANGO study is the 3rd trial to provide long-term evidence for Dovato reinforcing its use as a viable switch for people with HIV

FDA grants Priority Review to ViiV Healthcare’s New Drug Application for cabotegravir long-acting for prevention of HIV

Tue, 28 Sep 2021 11:00:00 GMT

Final FDA decision anticipated by 23 January 2022; if approved, cabotegravir would be the first long-acting therapy for HIV PrEP

ViiV Healthcare announces exclusive license agreement with Shionogi to develop third-generation HIV integrase inhibitor with potential for ultra long-acting dosing intervals

Tue, 28 Sep 2021 10:17:21 GMT

S-365598 aims to build on the success of dolutegravir & cabotegravir with potential to anchor the next-gen pipeline of HIV therapies

Changing attitudes to vaccination after the COVID-19 pandemic could increase adult vaccination rates, improving health outcomes over the longer term

Wed, 22 Sep 2021 08:09:56 GMT

Survey shows that people 50 years of age and older value good health and improved quality of life

ViiV Healthcare to present key data that provides further support for the use of 2-drug regimens, including long-term efficacy, alongside new insights into living with HIV at IDWeek 2021

Wed, 22 Sep 2021 08:00:00 GMT

ViiV Healthcare announce the presentation of 13 abstracts from its portfolio of pipeline prevention options.

GSK announces major renewable energy investment and low carbon inhaler programme alongside Life Sciences sector Race to Zero ‘breakthrough’ at NYC Climate Week

Mon, 20 Sep 2021 09:56:39 GMT

Company announces £50m investment in renewable energy and carbon reduction at major UK and US manufacturing sites

GSK receives CHMP positive opinions recommending approval of Nucala (mepolizumab) in three additional eosinophil-driven diseases

Fri, 17 Sep 2021 13:21:37 GMT

Eosinophil-driven diseases are inflammatory conditions associated with elevated levels of eosinophils, a type of white blood cell.

GSK to highlight continued progress in oncology pipeline and portfolio with data presented at ESMO

Thu, 09 Sep 2021 08:43:40 GMT

The data reflects our commitment to strengthening our oncology pipeline across immuno-oncology, synthetic lethality & oncology cell therapy

GSK Consumer Healthcare leads oral care industry with launch of its first carbon neutral toothbrush

Mon, 06 Sep 2021 08:00:42 GMT

73% of consumers say they would definitely change their consumption habits to reduce their environmental impact.

SK bioscience and GSK start Phase 3 trial of adjuvanted COVID-19 vaccine candidate

Tue, 31 Aug 2021 06:39:59 GMT

Advance to Phase 3 follows positive interim Phase 1/2 immunogenicity and safety data

GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours

Tue, 17 Aug 2021 20:56:07 GMT

GARNET study demonstrated objective response rate of 41.6% across dMMR solid tumours

Second-Generation mRNA COVID-19 Vaccine Candidate, CV2CoV, Demonstrates Improved Immune Response and Protection in Preclinical Study

Mon, 16 Aug 2021 11:50:11 GMT

Preclinical study provides evidence for strongly improved immune responses with second-generation mRNA backbone

GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps

Thu, 29 Jul 2021 14:10:58 GMT

Fourth indication for mepolizumab in the US for eosinophil-driven diseases.

GSK delivers strong Q2 sales of £8.1 billion, +6% AER, +15% CER Total EPS 27.9p -39% AER, -28% CER; Adjusted EPS 28.1p +46% AER +71% CER

Wed, 28 Jul 2021 12:06:30 GMT

Sales growth driven by strong commercial execution and favourable prior year comparison

GSK and Vir Biotechnology announce Joint Procurement Agreement with European Commission for COVID-19 treatment, sotrovimab

Wed, 28 Jul 2021 11:13:44 GMT

GlaxoSmithKline plc and Vir Biotechnology, Inc. announce the supply of 220,000 doses of sotrovimab for adults and adolescents with COVID-19.

Shingrix approved in the US for prevention of shingles in immunocompromised adults

Mon, 26 Jul 2021 14:25:34 GMT

Immunocompromised individuals are at greater risk of shingles and associated complications than immunocompetent individuals

Brian McNamara appointed CEO Designate of new independent Consumer Healthcare company

Thu, 22 Jul 2021 14:45:00 GMT

Brian McNamara, the CEO of GSK Consumer Healthcare, has been appointed as CEO Designate of the new Consumer Healthcare company.

ViiV Healthcare presents data from second Dovato (dolutegravir/lamivudine) switch study confirming non-inferior efficacy and no virologic failure versus a broad range of regimens of at least 3 drugs

Sat, 17 Jul 2021 11:04:43 GMT

ViiV Healthcare today presented 48-week data from the SALSA study at the International AIDS Society Conference 2021

ViiV Healthcare study shows new long-acting HIV regimen Cabenuva (cabotegravir/rilpivirine) can be successfully implemented in broad range of US healthcare practices, even during COVID-19

Sat, 17 Jul 2021 10:53:45 GMT

ViiV Healthcare today presented positive findings from the CUSTOMIZE trial

ViiV Healthcare to present new data from diverse portfolio and pipeline of 2-drug and long-acting regimens for HIV treatment and prevention at IAS 2021

Sat, 17 Jul 2021 10:36:28 GMT

Data to be presented underscore the commitment to developing innovative treatment and prevention options

GSK announces positive headline results from five Phase 3 studies of daprodustat for patients with anaemia due to chronic kidney disease

Fri, 16 Jul 2021 11:31:37 GMT

Full results to be presented at a medical meeting later this year

GSK unveils plan for one of Europe’s largest life science campuses in Stevenage

Fri, 16 Jul 2021 07:00:00 GMT

Plan aims to unlock up to £400 million of new private investment and create up to 5,000 new highly-skilled jobs over next decade.

New study shows more needs to be done to raise public awareness on the impact of good oral health habits on overall health

Thu, 15 Jul 2021 15:45:00 GMT

A new study by Ipsos and GSK Consumer Healthcare reveals the need to improve public awareness of the benefits of good oral health.

GSK and Alector announce global collaboration in immuno-neurology for two clinical stage first-in-class monoclonal antibodies for neurodegenerative diseases

Fri, 02 Jul 2021 11:57:30 GMT

GSK and Alector to co-develop progranulin-elevating monoclonal antibodies, AL001 and AL101, for a range of neurodegenerative diseases

Elliott Advisors (UK) letter to GSK

Fri, 02 Jul 2021 10:42:02 GMT

The Board of GSK notes the letter issued by Elliott Advisors (UK) Limited (“Elliott”) on 1 July

New GSK to deliver step-change in growth and performance over next ten years driven by high-quality Vaccines and Specialty Medicines portfolio and late-stage pipeline

Wed, 23 Jun 2021 05:39:43 GMT

New GSK to positively impact health of >2.5 billion people next 10 years

ViiV Healthcare and Halozyme enter global collaboration and license agreement for ENHANZE® drug delivery technology to enable development of “ultra long-acting” medicines for HIV

Tue, 22 Jun 2021 16:32:27 GMT

Halozyme’s technology provides more “shots on goal” to create ultra long-acting HIV medicines with dosing intervals of 3 months or longer

GSK and Vir Biotechnology announce continuing progress of the COMET clinical development programme for sotrovimab

Mon, 21 Jun 2021 12:00:24 GMT

U.S. National Institutes of Health (NIH) COVID-19 Treatment Guidelines updated to recommend use of sotrovimab.

GSK and iTeos Therapeutics announce development and commercialisation collaboration for EOS-448, an anti-TIGIT monoclonal antibody, enabling novel next-generation immuno-oncology combinations

Mon, 14 Jun 2021 11:16:42 GMT

GSK now has the leading portfolio of antibodies targeting the CD226 axis - a key target for next-generation immuno-oncology therapies

GSK to showcase scientific advances and progress in oncology at ASCO and EHA

Tue, 01 Jun 2021 08:33:31 GMT

GSK will showcase innovative approaches to oncology R&D and cutting-edge science at the upcoming ASCO and EHA meetings.

Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate

Thu, 27 May 2021 06:03:17 GMT

Pending positive Phase 3 outcomes and regulatory reviews, the vaccine could be approved in Q4 2021

GSK and Vir Biotechnology announce sotrovimab (VIR-7831) receives Emergency Use Authorization from the US FDA for treatment of mild-to-moderate COVID-19 in high-risk adults and paediatric patients

Wed, 26 May 2021 18:18:33 GMT

GSK and Vir Biotechnology announce sotrovimab (VIR-7831) receives Emergency Use Authorization from the US FDA

GSK announced as a Principal Partner of COP26 UN Climate Change Conference

Wed, 26 May 2021 09:35:39 GMT

As Principal Partner, GSK will drive action on climate, nature and health targets in support of COP26 ambitions.

EMA issues positive scientific opinion on GSK and Vir Biotechnology’s sotrovimab for the early treatment of COVID-19

Fri, 21 May 2021 12:52:14 GMT

Opinion based on the EMA’s CHMP review of available data on sotrovimab (previously VIR-7831) for the early treatment of COVID-19.

GSK announces sale of stake in Innoviva Inc

Thu, 20 May 2021 14:45:00 GMT

Shares to be sold back to Innoviva at $12.25 per share

Medicago and GSK announce positive interim Phase 2 results for adjuvanted COVID-19 vaccine candidate

Tue, 18 May 2021 06:00:55 GMT

Neutralizing antibody responses were ten times higher than in people recovering from COVID-19.

Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial

Mon, 17 May 2021 06:30:12 GMT

Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups.

GSK Consumer Healthcare commits to make over a billion toothpaste tubes recyclable by 2025 as part of its ongoing sustainability journey

Thu, 13 May 2021 07:33:43 GMT

GSKCH’s initiatives support GSK’s company wide commitment to achieve a net zero impact on climate and a positive impact on nature by 2030.

GSK and Vir Biotechnology announce the start of the EMA rolling review of VIR-7831 (sotrovimab) for the early treatment of COVID-19

Fri, 07 May 2021 10:32:14 GMT

Review will support a formal Marketing Authorisation Application.

European Commission approves Benlysta for adult patients with active lupus nephritis

Wed, 05 May 2021 08:35:25 GMT

First and only biologic approved for both systemic lupus erythematosus and lupus nephritis

ViiV Healthcare initiates rolling submission of new drug application with US FDA for long-acting cabotegravir for prevention of HIV

Tue, 04 May 2021 10:45:04 GMT

If approved, cabotegravir would be the first, long-acting therapy for HIV PrEP

GSK delivers Q1 sales of £7.4 billion -18% AER, -15% CER Total EPS 21.5p, -32% AER, -25% CER; Adjusted EPS 22.9p -39% AER, -33% CER

Wed, 28 Apr 2021 11:17:59 GMT

Q1 performance reflects expected year-on-year impact and disruption from COVID-19

European Commission approves GSK’s JEMPERLI (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer

Fri, 23 Apr 2021 08:04:37 GMT

The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe.

FDA grants accelerated approval for GSK’s JEMPERLI (dostarlimab-gxly) for women with recurrent or advanced dMMR endometrial cancer

Thu, 22 Apr 2021 14:35:22 GMT

FDA grants accelerated approval for GSK’s JEMPERLI (dostarlimab-gxly) for women with recurrent or advanced dMMR endometrial cancer

GSK and Vir Biotechnology announce EMA review of dual-action monoclonal antibody VIR-7831 for the early treatment of COVID-19

Thu, 15 Apr 2021 14:53:38 GMT

GSK and Vir continue discussions with global regulators to make VIR-7831 available to patients with COVID-19.

GSK provides update on feladilimab, an investigational inducible T cell co-stimulatory (ICOS) agonist

Wed, 14 Apr 2021 16:50:12 GMT

GSK provides update on feladilimab, an investigational inducible T cell co-stimulatory (ICOS) agonist

GSK announces Dr Anne Beal to join the Board as Non-Executive Director

Tue, 06 Apr 2021 14:30:00 GMT

GlaxoSmithKline plc (LSE/NYSE: GSK) today announces that Dr Anne Beal will join the Board of the Company as a Non-Executive Director.

GSK to support manufacture of Novavax’ COVID-19 vaccine

Mon, 29 Mar 2021 17:00:16 GMT

GSK to support manufacture of up to 60 million doses of Novavax’ COVID-19 vaccine.

Lilly, Vir Biotechnology and GSK announce positive topline data from the phase 2 BLAZE-4 trial evaluating bamlanivimab with VIR-7831 in low-risk adults with COVID-19

Mon, 29 Mar 2021 13:30:02 GMT

In combination, the 2 monoclonal antibodies demonstrated 70% relative reduction in persistent high viral load at day 7 compared to placebo.

GSK and Vir Biotechnology announce submission of Emergency Use Authorization request to FDA for VIR-7831 for the early treatment of COVID-19

Fri, 26 Mar 2021 12:08:12 GMT

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE trial.

GSK receives CHMP positive opinion recommending approval of Benlysta for adult patients with active lupus nephritis

Fri, 26 Mar 2021 11:42:10 GMT

This CHMP opinion follows the recent label expansion by the US FDA to include lupus nephritis

Moncef Slaoui Departs Galvani Bioelectronics Board of Directors

Wed, 24 Mar 2021 12:04:57 GMT

Moncef Slaoui has been terminated as Chair of the Galvani Board of Directors, effective immediately.

Half of parents surveyed either cancelled or delayed their child’s scheduled meningitis vaccination during the COVID-19 pandemic – GSK survey shows [1]

Wed, 24 Mar 2021 07:57:40 GMT

The Ipsos survey on behalf of GSK offers insight into the pandemic's impact on meningitis vaccinations over the last 12 months.

GSK to highlight scientific research in ovarian and endometrial cancer at SGO 2021 Annual Meeting on Women’s Cancer

Fri, 19 Mar 2021 12:42:41 GMT

This research builds on the body of evidence supporting poly (ADP-ribose) polymerase (PARP) inhibitor use for maintenance treatment.

Back to the dentist – new study highlights urgent need to tackle oral healthcare habits post COVID-19

Thu, 18 Mar 2021 12:12:49 GMT

Due to restrictions and aims to reduce COVID-19 transmission, 30% of respondents had visited a dentist less frequently during the pandemic.

GSK starts the first phase 3 study with a long-acting anti-IL-5 treatment for patients with severe asthma

Thu, 18 Mar 2021 07:37:47 GMT

GSK '294 is a distinct, new biologic entity and has been engineered for high affinity and long-acting suppression of IL-5 function

Medicago and GSK start Phase 3 trial of adjuvanted COVID-19 vaccine candidate

Tue, 16 Mar 2021 11:00:00 GMT

Medicago/GSK announce Ph 3 trial start of Medicago’s plant-derived COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant.

Vir Biotechnology and GSK announce VIR-7831 reduces hospitalisation and risk of death in early treatment of adults with COVID-19

Wed, 10 Mar 2021 20:34:02 GMT

Vir Biotechnology and GSK announce VIR-7831 reduces hospitalisation and risk of death in early treatment of adults with COVID-19

ViiV Healthcare presents positive proof-of-concept findings for GSK3640254, a novel, investigational maturation inhibitor for the treatment of HIV

Tue, 09 Mar 2021 16:37:51 GMT

Maturation inhibitors are a class of antiretroviral medicines that target the late stage of the HIV viral life cycle.

ViiV Healthcare presents data for long-acting cabotegravir and rilpivirine for the treatment of HIV showing continued virologic suppression to 96 weeks

Sat, 06 Mar 2021 19:10:24 GMT

Long-term efficacy and safety data from phase IIIb ATLAS-2M study reinforce therapeutic potential of long-acting cabotegravir & rilpivirine

GSK makes landmark pricing agreement for rotavirus vaccine, Rotarix, for use with children living in humanitarian crises

Thu, 04 Mar 2021 13:23:14 GMT

GSK has committed to supply its rotavirus vaccine, Rotarix, through the Humanitarian Mechanism.

Vir Biotechnology and GSK provide update on NIH-sponsored ACTIV-3 trial evaluating VIR-7831 in hospitalised adults with COVID-19

Wed, 03 Mar 2021 14:00:47 GMT

The DSMB has recommended that the VIR-7831 arm of the trial be closed to enrolment while the data mature.

ViiV Healthcare to present new data on long-acting regimens for HIV prevention and treatment, alongside pipeline advances at CROI 2021

Tue, 02 Mar 2021 11:59:55 GMT

16 sponsored abstracts from our diverse portfolio of innovative pipeline and licensed HIV treatment and prevention options will be presented

GSK receives CHMP positive opinion recommending approval of dostarlimab for women with recurrent or advanced endometrial cancer

Fri, 26 Feb 2021 12:32:24 GMT

This positive CHMP opinion brings us closer to providing dostarlimab as a new treatment option to women with endometrial cancer in Europe

GSK announces results evaluating its investigational monoclonal antibody, otilimab, for the treatment of hospitalised adult patients with COVID-19

Thu, 25 Feb 2021 12:00:00 GMT

GSK today announce results from the phase 2 proof of concept OSCAR study with otilimab, an investigational anti-GM-CSF monoclonal antibody.

Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate

Mon, 22 Feb 2021 10:45:30 GMT

New Phase 2 study assesses potential for refined antigen formulation to achieve optimal immune response, including in older adults.

GSK and Vir Biotechnology expand coronavirus collaboration to advance new therapeutics for influenza and other respiratory viruses

Wed, 17 Feb 2021 12:00:00 GMT

Companies to combine expertise in immunology and infectious diseases to accelerate development of promising new therapeutics for influenza.

GSK announces gender and diversity aspirational targets to increase representation at senior levels

Wed, 17 Feb 2021 08:30:00 GMT

Aspirational targets to increase ethnically diverse senior leadership in the US and UK.

GSK starts Phase III RSV candidate vaccine programme for older adults

Tue, 16 Feb 2021 17:52:50 GMT

Positive Phase I/II results established the robust immunogenicity of the vaccine candidate in the target population

GSK to sell Cephalosporin antibiotics business to Sandoz

Thu, 11 Feb 2021 12:00:00 GMT

GSK has announced it has reached an agreement with Sandoz, a Novartis division, to sell its Cephalosporin antibiotics business.

ViiV Healthcare receives Marketing Authorisation for Rukobia (fostemsavir), a first-in-class attachment inhibitor in combination with other antiretrovirals for the treatment of adults with multidrug-resistant HIV

Mon, 08 Feb 2021 11:16:39 GMT

Fostemsavir addresses a critical need for those with little to no treatment options left who are at risk of further disease progression

GSK delivers FY 2020 reported sales of £34 billion, +1% AER, +3% CER and Adjusted EPS of 115.9p, -6% AER, -4% CER, in line with guidance; Total EPS 115.5p, +23% AER

Wed, 03 Feb 2021 11:43:54 GMT

Strong growth of new and specialty products; on track to deliver two exciting new companies

GSK and CureVac to develop next generation mRNA COVID-19 vaccines

Wed, 03 Feb 2021 07:00:00 GMT

Companies aim to develop a multi-valent candidate vaccine to address emerging variants for pandemic and endemic use.

GSK, PATH, and Bharat Biotech sign product transfer agreement to help ensure long-term supply of RTS,S/AS01E malaria vaccine

Wed, 27 Jan 2021 12:05:02 GMT

The agreement recognises the track record and expertise of BBIL in developing and supplying vaccines against infectious diseases.

Lilly, Vir Biotechnology and GSK announce first patient dosed in expanded BLAZE-4 trial evaluating bamlanivimab (LY-CoV555) with VIR-7831 (GSK4182136) for COVID-19

Wed, 27 Jan 2021 11:45:52 GMT

Collaboration to evaluate a combination of two COVID-19 therapies in low-risk patients with mild to moderate COVID-19.

GSK ranks 1st in the 2021 Access to Medicine Index with leading R&D pipeline for priority diseases

Tue, 26 Jan 2021 11:30:39 GMT

Ranking reflects GSK leadership through access to its medicines and vaccines for people around the world.

ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment

Thu, 21 Jan 2021 21:34:21 GMT

The approval is based on the pivotal phase III ATLAS and FLAIR studies that included more than 1,100 patients from 16 countries.

GSK and Novartis announce collaboration to support scientific research into genetic diversity in Africa

Tue, 19 Jan 2021 05:18:59 GMT

Combined funding commitment of GBP 2.8 million (USD 3.6 million) over five years.

GSK presents positive efficacy data of dostarlimab in mismatch repair-deficient (dMMR) solid cancers at ASCO Gastrointestinal Cancers Symposium

Sat, 16 Jan 2021 13:08:40 GMT

Data from GARNET cohort F shows a 38.7% objective response rate with dostarlimab in patients with dMMR advanced solid cancers

ViiV Healthcare receives EU Marketing Authorisation for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe

Wed, 13 Jan 2021 08:48:12 GMT

The EU Marketing Authorisation follows the US Food and Drug Administration (FDA) approval of Tivicay PD in 2020.

Vir Biotechnology and GSK announce NHS-supported AGILE study to evaluate VIR-7832 in the early treatment of COVID-19

Tue, 12 Jan 2021 07:12:46 GMT

Second monoclonal antibody from Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

GSK, MMV filing for Kozenis (tafenoquine) in paediatric populations with Plasmodium vivax malaria accepted by Australian Therapeutic Goods Administration

Fri, 08 Jan 2021 11:22:13 GMT

The application includes data for a new, 50 mg tablet that can be dispersed in water and which was developed to facilitate use in children.

ViiV Healthcare announces the Marketing Authorisation of the first complete long-acting injectable HIV treatment in Europe

Mon, 21 Dec 2020 12:41:07 GMT

New treatment can enable people living with HIV to reduce the days they receive treatment from 365 to 12 or 6 per year

GSK and Ahren Announce Co-Led Series A Investment in Adrestia, and Multi-Project Discovery Collaboration with Each of the Five Projects Eligible To Receive Up To $230M (£172M) in Post Option Milestones

Fri, 18 Dec 2020 07:41:43 GMT

The multi-year collaboration agreement seeks to discover novel drug targets across a number of therapeutic areas

FDA approves GSK’s BENLYSTA as the first medicine for adult patients with active lupus nephritis in the US

Thu, 17 Dec 2020 12:41:31 GMT

Approval builds on nearly 10 years of experience in lupus

Vir Biotechnology and GSK announce start of NIH-sponsored ACTIV-3 trial evaluating VIR-7831 in hospitalised adults with COVID-19

Thu, 17 Dec 2020 11:48:22 GMT

Global Phase 3 trial will investigate the safety and efficacy of VIR-7831 in hospitalised adults with COVID-19

ViiV Healthcare announces positive CHMP opinion for Rukobia (fostemsavir), a first-in-class attachment inhibitor for the treatment of adults with multidrug-resistant HIV with few treatment options available

Fri, 11 Dec 2020 10:42:51 GMT

Fostemsavir addresses a critical unmet need in HIV care for those with little to no treatment options left.

Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine programme to improve immune response in the elderly

Fri, 11 Dec 2020 05:21:03 GMT

Phase 1/2 interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years

FDA accepts GSK’s filing of Nucala (mepolizumab) for use in chronic rhinosinusitis with nasal polyps

Tue, 08 Dec 2020 11:45:52 GMT

If approved, Nucala would be the only treatment approved in the US for use in four eosinophil-driven diseases.

GSK starts phase 3 study of RSV maternal candidate vaccine

Mon, 23 Nov 2020 17:40:10 GMT

RSV is a leading cause of respiratory infections such as bronchiolitis and viral pneumonia in infants.

GSK and MMV present positive data on treatment for Plasmodium vivax malaria in children from 6 months up to 15 years of age

Thu, 19 Nov 2020 22:14:25 GMT

The results of the TEACH study were presented during the American Society of Tropical Medicine & Hygiene 2020 virtual annual meeting.

ViiV Healthcare receives FDA Breakthrough Therapy Designation for investigational, long-acting cabotegravir for HIV prevention

Tue, 17 Nov 2020 18:00:26 GMT

This is intended to facilitate the development and expedite the review of drugs that address serious or life-threatening medical conditions.

GSK presents Phase 2b data on linerixibat for the treatment of cholestatic pruritus in primary biliary cholangitis (PBC)

Fri, 13 Nov 2020 14:26:37 GMT

The Phase 2b GLIMMER study was presented today at The Liver Meeting® 2020.

ViiV Healthcare announces CHMP positive opinion for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe

Fri, 13 Nov 2020 13:16:35 GMT

This CHMP positive opinion paves the way to expand the use of dolutegravir in a younger population.

Medicago and GSK announce start of Phase 2/3 clinical trials of adjuvanted COVID-19 vaccine candidate

Thu, 12 Nov 2020 10:33:29 GMT

Based on the positive Phase 1 results, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant.

GSK highlights progress from the BLENREP (belantamab mafodotin-blmf) development programme in multiple myeloma at ASH Annual Meeting

Wed, 11 Nov 2020 11:18:15 GMT

Studies presented will demonstrate belantamab mafodotin's potential in combination with standard therapies in earlier lines of treatment.

ViiV Healthcare announces investigational injectable cabotegravir is superior to oral standard of care for HIV prevention in women

Mon, 09 Nov 2020 17:37:31 GMT

The study showed cabotegravir was 89% more effective than daily oral FTC/TDF for pre-exposure prophylaxis (PrEP).

GSK sets new environmental goals of net zero impact on climate and net positive impact on nature by 2030

Tue, 03 Nov 2020 07:58:32 GMT

The new goals support GSK's aim to create long-term value for shareholders and meet the needs of society.

GSK Nucala (mepolizumab) filings accepted by European Medicines Agency for three additional eosinophil-driven diseases

Thu, 29 Oct 2020 07:39:54 GMT

If approved in the EU, Nucala would be the only treatment indicated for four eosinophil-driven diseases.

European Commission approves Zejula (niraparib) as first-line monotherapy maintenance treatment in advanced ovarian cancer

Thu, 29 Oct 2020 06:41:59 GMT

The European Commission has approved Zejula as first-line monotherapy maintenance treatment for adult patients with advanced ovarian cancer.

GSK delivers resilient performance, strong commercial execution and further strategic progress in Q3

Wed, 28 Oct 2020 11:42:13 GMT

GSK delivers resilient performance, strong commercial execution and further strategic progress in Q3

Sanofi and GSK to support COVAX with 200 million doses of adjuvanted, recombinant protein-based COVID-19 vaccine

Wed, 28 Oct 2020 05:57:45 GMT

COVAX Facility is led by Gavi and aims to secure successful and equitable access to COVID-19 vaccines worldwide.

ViiV Healthcare presents continued positive findings from first-ever implementation science study on integrating an investigational once-monthly injectable HIV treatment into US healthcare practices

Thu, 22 Oct 2020 21:04:07 GMT

These findings build on recently presented healthcare provider and clinical staff survey perspectives.

ViiV Healthcare presents positive new findings from two studies of its investigational, long-acting regimen of cabotegravir and rilpivirine, including five-year data showing long-term durability, efficacy, safety, and tolerability

Thu, 22 Oct 2020 07:50:25 GMT

Positive new findings from two studies of the investigational, long-acting regimen of cabotegravir and rilpivirine for treatment of HIV.

ViiV Healthcare announces analysis showing no antiretroviral therapy interruptions due to COVID-19 across its clinical development programme for investigational, long-acting cabotegravir and rilpivirine

Wed, 21 Oct 2020 07:13:27 GMT

ViiV Healthcare announces analysis showing no antiretroviral therapy interruptions due to COVID-19

GSK presents positive clinical data on maternal and older adults RSV candidate vaccines

Wed, 21 Oct 2020 06:29:29 GMT

Phase I/II data presented at ID Week show the two FDA fast-tracked candidate vaccines trigger robust immune response and are well-tolerated

ViiV Healthcare receives positive CHMP opinion for long-acting regimen for the treatment of HIV

Fri, 16 Oct 2020 10:37:30 GMT

Long-acting regimen is based on co-administration of cabotegravir and rilpivirine injections once-monthly or once every 2-months

ViiV Healthcare presents long-term switch data for Dovato demonstrating non-inferior efficacy in adults with HIV-1 and zero cases of virologic failure versus continuation of a 3-drug TAF-based regimen

Thu, 08 Oct 2020 10:51:30 GMT

The TANGO 96-week data presented at HIV Glasgow 2020 also confirm Dovato’s well-established safety and tolerability profile

Vir Biotechnology and GSK announce global expansion to Phase 3 of COMET-ICE study evaluating VIR-7831 for the treatment of COVID-19

Tue, 06 Oct 2020 13:22:25 GMT

Initial Phase 3 results may be available as early as the end of 2020; complete results are anticipated in January 2021.

ViiV Healthcare announces dolutegravir plus lamivudine three-year data confirming long-term viral suppression non-inferior to a 3-drug regimen for treatment-naïve adults with HIV-1

Mon, 05 Oct 2020 11:01:26 GMT

ViiV Healthcare present their three-year results from the phase III GEMINI 1 & 2 studies at the HIV Glasgow 2020 congress

ViiV Healthcare to present long-term safety and efficacy data for 2-drug regimen Dovato (dolutegravir/lamivudine) alongside other key research advances at the HIV Glasgow 2020 congress

Wed, 30 Sep 2020 08:36:01 GMT

Data presented will reinforce the potential to shift the treatment paradigm to 2-drug regimens (2DRs) for people living with HIV

ViiV Healthcare announces start of implementation science study to identify and evaluate approaches to integrating its investigational, every-two-month, injectable HIV treatment in European healthcare practices

Mon, 28 Sep 2020 16:24:27 GMT

ViiV Healthcare work with clinical staff at 18 diverse practice sites across different healthcare systems in France, Spain, Belgium, Germany

FDA approves Nucala as the first and only biologic treatment for Hypereosinophilic Syndrome (HES)

Fri, 25 Sep 2020 14:38:04 GMT

Third US indication for Nucala demonstrates GSK’s commitment to finding new ways to help patients with eosinophil-driven diseases

Sanofi and GSK sign agreements with the Government of Canada to supply up to 72 million doses of adjuvanted COVID-19 vaccine

Tue, 22 Sep 2020 17:49:44 GMT

Agreements relate to vaccine candidate using Sanofi’s recombinant protein-based technology and GSK’s pandemic adjuvant.

GSK receives CHMP positive opinion recommending approval of Zejula (niraparib) as first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer

Fri, 18 Sep 2020 13:16:12 GMT

This opinion follows the expansion of Zejula’s indication in the US with approval by the US Food and Drug Administration earlier this year.

Sanofi and GSK confirm agreement with European Union to supply up to 300 million doses of adjuvanted COVID-19 vaccine

Fri, 18 Sep 2020 11:02:49 GMT

This confirmation follows the announcement on 31 July of advanced discussions between the companies and the EC.

GSK highlights scientific advances across its growing oncology portfolio at ESMO Virtual Congress 2020

Tue, 15 Sep 2020 08:00:00 GMT

New data from the GARNET study to be presented as a late-breaking abstract

FDA approves Trelegy Ellipta as the first once-daily single inhaler triple therapy for the treatment of both asthma and COPD in the US

Wed, 09 Sep 2020 14:50:30 GMT

New asthma indication for Trelegy Ellipta introduces an important option for patients to the current treatment paradigm

Sanofi and GSK initiate Phase 1/2 clinical trial of COVID-19 adjuvanted recombinant protein-based vaccine candidate

Thu, 03 Sep 2020 06:08:22 GMT

Over 400 participants being enrolled in Phase 1/2 study.

Vir Biotechnology and GSK start phase 2/3 study of COVID-19 antibody treatment

Mon, 31 Aug 2020 08:28:15 GMT

Phase 2/3 study will investigate the safety and efficacy of antibody treatment in preventing hospitalisation due to COVID-19.

GSK presents promising phase 2a data for chronic hepatitis B treatment

Fri, 28 Aug 2020 07:51:54 GMT

Chronic hepatitis B is a major global health problem that occurs when the body’s immune system is unable to fight off the virus.

European Commission approves BLENREP (belantamab mafodotin) for the treatment of patients with relapsed and refractory multiple myeloma

Wed, 26 Aug 2020 22:43:43 GMT

BLENREP is a first-in-class humanised anti-BCMA treatment for patients whose disease has progressed despite the current standard of care.

GSK announces first participant vaccinated in phase 3 clinical trials of its 5-in-1, meningitis ABCWY vaccine candidate

Wed, 19 Aug 2020 09:48:43 GMT

The trial will evaluate safety, tolerability and immunogenicity of GSK’s MenABCWY vaccine candidate compared to Bexsero and Menveo.

FDA approves GSK’s BLENREP (belantamab mafodotin-blmf) for the treatment of patients with relapsed or refractory multiple myeloma

Thu, 06 Aug 2020 01:10:09 GMT

BLENREP is the fifth major medicine approval for GSK in 2020

Sanofi and GSK in advanced discussions with European Union to supply up to 300 million doses of COVID-19 vaccine

Fri, 31 Jul 2020 19:56:19 GMT

Discussions relate to vaccine candidate using Sanofi’s recombinant protein-based technology combined with GSK’s pandemic adjuvant system

Sanofi and GSK to supply European Union with up to 300 million doses of COVID-19 vaccine

Fri, 31 Jul 2020 18:19:23 GMT

The agreement relates to vaccine candidate using Sanofi’s recombinant protein-based technology combined with GSK’s pandemic adjuvant system.

Sanofi and GSK selected for Operation Warp Speed to supply United States Government with 100 million doses of COVID-19 vaccine

Fri, 31 Jul 2020 12:06:10 GMT

Promising COVID-19 vaccine candidate, developed by Sanofi in partnership with GSK, selected by U.S. government’s Operation Warp Speed.

GSK delivers Q2 sales of £7.6 billion -2% AER, -3% CER (Pro-forma -10% CER*)

Wed, 29 Jul 2020 12:00:00 GMT

GSK delivers Q2 sales of £7.6 billion -2% AER, -3% CER (Pro-forma -10% CER*)

Sanofi and GSK agree with the UK government to supply up to 60 million doses of COVID-19 vaccine

Wed, 29 Jul 2020 06:00:00 GMT

Agreement relates to vaccine candidate using Sanofi’s recombinant protein-based technology combined with GSK’s pandemic adjuvant system.

GSK receives positive CHMP opinion recommending approval of belantamab mafodotin for the treatment of relapsed and refractory multiple myeloma

Fri, 24 Jul 2020 09:16:42 GMT

If approved, it will be the second major regulatory milestone for GSK’s oncology portfolio this year.

COVID-19 prompts increased focus on self-care, with Europeans taking their health more seriously to relieve pressure on healthcare systems

Mon, 20 Jul 2020 09:30:00 GMT

New research shared by GSK Consumer Healthcare and IPSOS

GSK and CureVac announce strategic mRNA technology collaboration

Mon, 20 Jul 2020 07:00:00 GMT

Companies to collaborate on mRNA vaccine and monoclonal antibody research programmes in infectious diseases

GSK announces FDA advisory committee votes in favour of positive benefit/risk profile for belantamab mafodotin for patients with relapsed/refractory multiple myeloma

Tue, 14 Jul 2020 16:31:28 GMT

FDA ODAC voted 12-0 in favour of the demonstrated benefit of monotherapy treatment with belantamab mafodotin

ViiV Healthcare announces superior efficacy of investigational, long-acting injectable formulation of cabotegravir dosed every two months over daily oral PrEP

Tue, 07 Jul 2020 13:30:34 GMT

ViiV Healthcare announces superior efficacy of investigational, long-acting injectable formulation of cabotegravir

GSK and Medicago announce collaboration to develop a novel adjuvanted COVID-19 candidate vaccine

Tue, 07 Jul 2020 12:49:28 GMT

GSK and Medicago announce collaboration to develop a novel adjuvanted COVID-19 candidate vaccine.

ViiV Healthcare presents positive data from first-ever implementation research study on how best to integrate an investigational once-monthly injectable HIV treatment in US healthcare practices

Sat, 04 Jul 2020 08:00:00 GMT

Findings presented showed healthcare providers perceived implementation of the treatment as feasible and appropriate for people with HIV.

ViiV Healthcare announces US FDA approval for Rukobia (fostemsavir), a first-in-class treatment for HIV in adults with few treatment options available

Thu, 02 Jul 2020 16:06:42 GMT

ViiV today announced that the US FDA has approved Rukobia (fostemsavir), 600 mg extended-release tablets.

ViiV Healthcare to present new data on long-acting regimens for HIV prevention and treatment, alongside extensive insights into the evolving needs of people living with HIV at 23rd International AIDS Conference (AIDS 2020: Virtual)

Thu, 02 Jul 2020 08:04:44 GMT

ViiV Healthcare will present over 20 abstracts during next week at the 23rd International AIDS Conference (AIDS 2020: Virtual), 6-10 July.

GSK receives first regulatory approval for Duvroq (daprodustat) in Japan for patients with anaemia due to chronic kidney disease

Mon, 29 Jun 2020 08:00:16 GMT

Approval marks a significant step in GSK’s global efforts to help patients with anaemia due to chronic kidney disease (CKD).

GSK announces FDA Advisory Committee meeting to review belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma

Fri, 19 Jun 2020 15:35:00 GMT

GSK announces FDA Advisory Committee meeting to review belantamab mafodotin

GSK COVID-19 vaccine development collaboration with Clover Biopharmaceuticals begins clinical trials

Fri, 19 Jun 2020 08:00:11 GMT

Clover Biopharmaceuticals initiates phase 1 study using GSK pandemic adjuvant in combination with COVID-19 vaccine candidate SCB-2019

GSK prices $280,336,000 Senior Notes Due 2023 Exchangeable into Theravance Biopharma Ordinary Shares

Thu, 18 Jun 2020 11:00:00 GMT

GSK prices $280,336,000 Senior Notes Due 2023 Exchangeable into Theravance Biopharma Ordinary Shares

GSK announces Proposed Unregistered Offering of Senior Notes Exchangeable into Theravance Biopharma Ordinary Shares

Wed, 17 Jun 2020 11:00:35 GMT

GSK announces Proposed Unregistered Offering of Senior Notes Exchangeable into Theravance Biopharma Ordinary Shares

IDEAYA and GSK Announce a Broad Partnership in Synthetic Lethality, an Emerging Field in Precision Medicine Oncology

Tue, 16 Jun 2020 09:51:41 GMT

IDEAYA and GSK Announce a Broad Partnership in Synthetic Lethality, an Emerging Field in Precision Medicine Oncology

ViiV Healthcare announces US FDA approval of the first-ever dispersible tablet formulation of dolutegravir, Tivicay PD, a once-daily treatment for children living with HIV

Fri, 12 Jun 2020 13:43:33 GMT

ViiV Healthcare announces US FDA approval of the first-ever dispersible tablet formulation of dolutegravir.

GSK announces new data presentations from the DREAMM programme exploring investigational belantamab mafodotin in patients with relapsed/refractory multiple myeloma

Thu, 04 Jun 2020 12:00:26 GMT

16 presentations, including new analyses from the pivotal DREAMM-2 study and initial results from the DREAMM-4 study

GSK announces intention to produce 1 billion doses of pandemic vaccine adjuvant in 2021 to support multiple COVID-19 vaccine collaborations

Thu, 28 May 2020 07:00:31 GMT

Announcement follows completion of global manufacturing review and decision to invest in expanded manufacturing capacity

DREAMM-2 and DREAMM-6 data at ASCO reinforce the potential of GSK’s investigational belantamab mafodotin in patients with relapsed/refractory multiple myeloma

Wed, 27 May 2020 14:00:05 GMT

13-month update on the DREAMM-2 study shows median overall survival of 13.7 months and median duration of response of 11 months

FDA grants priority review of Nucala for patients with Hypereosinophilic Syndrome (HES)

Wed, 27 May 2020 08:30:23 GMT

An approval would give Nucala a third indication in an eosinophil-driven disease

GSK partners with Samsung Biologics to secure additional manufacturing capacity for innovative biopharmaceutical portfolio

Thu, 21 May 2020 20:22:50 GMT

Samsung Biologics will provide GSK with additional capacity for large-scale biopharmaceutical product manufacturing.

GSK highlights scientific innovation and advances in its growing oncology portfolio at ASCO 2020

Wed, 20 May 2020 14:00:06 GMT

26 abstracts across 8 tumour types, advancing GSK’s goal of maximising outcomes for patients

Global HIV prevention study to stop early after ViiV Healthcare’s long-acting injectable formulation of cabotegravir dosed every two months shows higher efficacy than daily oral PrEP

Mon, 18 May 2020 06:06:20 GMT

Interim analysis of the HIV Prevention Trials Network (HPTN) 083 study.

FDA approves Zejula (niraparib) as the only once-daily PARP inhibitor in first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer regardless of biomarker status

Wed, 29 Apr 2020 20:19:25 GMT

Zejula is the only oral monotherapy available as first-line maintenance treatment for women regardless of BRCA mutational status

GSK delivers strong Q1: sales £9.1 billion +19% AER, +19% CER (Proforma +10% CER*)

Wed, 29 Apr 2020 12:00:40 GMT

GSK delivers strong Q1: sales £9.1 billion +19% AER, +19% CER (Proforma +10% CER*)

GSK presents new data from the GARNET study demonstrating potential of dostarlimab to treat a subset of women with recurrent or advanced endometrial cancer

Thu, 23 Apr 2020 20:00:41 GMT

Data accepted as a late-breaking abstract and presented as a webinar as part of the Society of Gynecologic Oncology 2020 virtual congress

Sanofi and GSK to join forces in unprecedented vaccine collaboration to fight COVID-19

Tue, 14 Apr 2020 12:00:53 GMT

Companies to combine innovative technologies to develop an adjuvanted COVID-19 vaccine.

GSK and Vir Biotechnology enter collaboration to find coronavirus solutions

Mon, 06 Apr 2020 13:00:01 GMT

Companies will combine their unique scientific and technical expertise to combat COVID-19 and potential future coronavirus outbreaks.

FDA approves Zejula (niraparib) as the only once-daily PARP inhibitor in first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer regardless of biomarker status

Fri, 03 Apr 2020 13:44:48 GMT

Zejula is the only monotherapy available for women who do not have a BRCA mutation.

Nucala (mepolizumab) is the first anti-IL5 biologic to report positive phase 3 results in patients with nasal polyps

Fri, 03 Apr 2020 09:00:23 GMT

Pivotal data support regulatory filing for additional eosinophil-driven disease

GSK completes divestment of Horlicks and other Consumer Healthcare nutrition products in India and certain other markets

Wed, 01 Apr 2020 13:00:04 GMT

GSK today announced the completion of its divestment of Horlicks and other Consumer Healthcare nutrition products in India to Unilever.

Zejula (niraparib) is the first and only once-daily PARP inhibitor FDA-approved as a first-line monotherapy maintenance treatment for women with advanced ovarian cancer regardless of biomarker status

Mon, 30 Mar 2020 13:41:43 GMT

GlaxoSmithKline plc today announced the U.S. FDA approved the company’s supplemental New Drug Application (sNDA) of Zejula (niraparib).

GSK appoints Charles Bancroft to the Board as a Non-Executive Director

Fri, 20 Mar 2020 14:00:02 GMT

GlaxoSmithKline plc today announced that Charles Bancroft will join the Board of the Company as a Non-Executive Director on 1 May 2020.

ViiV Healthcare announces first global regulatory approval of CABENUVA; the first complete, long-acting, regimen for the treatment of HIV

Fri, 20 Mar 2020 13:00:56 GMT

ViiV Healthcare, today announced that Health Canada has approved CABENUVA.

ViiV Healthcare presents positive long-term data from phase III study demonstrating efficacy and safety of cabotegravir and rilpivirine, its investigational, long-acting, injectable treatment regimen in adults living with HIV-1

Mon, 09 Mar 2020 18:30:02 GMT

ViiV Healthcare presents positive long-term data from phase III study

ViiV Healthcare presents positive 48-week data from phase III study showing every-two-month regimen of investigational long-acting, injectable cabotegravir and rilpivirine has similar efficacy to once-monthly dosing

Mon, 09 Mar 2020 14:15:01 GMT

ViiV Healthcare presents positive 48-week data from phase III study

ViiV Healthcare and UNC-Chapel Hill announce five-year renewal of innovative HIV cure partnership

Mon, 09 Mar 2020 14:00:03 GMT

ViiV Healthcare and UNC-Chapel Hill announce five-year renewal of innovative HIV cure partnership

GSK receives EC approval for the sale of ThermaCare

Thu, 05 Mar 2020 12:18:44 GMT

GSK receives EC approval for the sale of ThermaCare

FDA approves GSK’s Advil Dual Action with Acetaminophen for over-the-counter use in the United States

Mon, 02 Mar 2020 19:34:58 GMT

First combination of ibuprofen and acetaminophen for pain relief to be available OTC in 2020

GSK filing accepted by European Medicines Agency for Trelegy Ellipta use in adult patients with asthma

Thu, 27 Feb 2020 14:30:05 GMT

GSK filing accepted by European Medicines Agency for Trelegy Ellipta use in adult patients with asthma

First-of-its-kind global collaboration launched to develop transformative treatment regimens for tuberculosis

Thu, 27 Feb 2020 13:00:56 GMT

First-of-its-kind global collaboration launched to develop transformative treatment regimens for tuberculosis

European Medicines Agency accepts submission of GSK’s Marketing Authorisation Application for Zejula (niraparib) in first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer

Thu, 27 Feb 2020 13:00:12 GMT

Submission based on data from the Phase III PRIMA clinical study.

U.S. FDA accepts GSK’s sNDA application for Zejula (niraparib) for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer

Mon, 24 Feb 2020 14:00:05 GMT

U.S. FDA accepts GSK’s sNDA application for Zejula (niraparib)

Clover and GSK announce research collaboration to evaluate coronavirus (COVID-19) vaccine candidate with pandemic adjuvant system

Mon, 24 Feb 2020 08:00:42 GMT

Clover and GSK Announce Research Collaboration to Evaluate Coronavirus (COVID-19) Vaccine Candidate with Pandemic Adjuvant System

FDA approves GSK’s Voltaren Arthritis Pain for over-the-counter use in the United States

Mon, 17 Feb 2020 12:30:15 GMT

U.S. Food and Drug Administration (FDA) has approved Voltaren Arthritis Pain as an over-the-counter (OTC) product.

GSK delivers 2019 sales of £33.8 billion +10% AER, +8% CER (Pro-forma +4% CER*)

Wed, 05 Feb 2020 12:00:35 GMT

Total EPS 93.9p; +27% AER; +23% CER; Adjusted EPS 123.9p +4% AER, +1% CER

CEPI and GSK announce collaboration to strengthen the global effort to develop a vaccine for the 2019-nCoV virus

Mon, 03 Feb 2020 23:00:08 GMT

GSK to make adjuvant technology available to support rapid development of candidate vaccines

GSK announces European Medicines Agency (EMA) accepted marketing authorisation application for belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma

Mon, 03 Feb 2020 09:00:01 GMT

Belantamab mafodotin accepted for accelerated assessment by the EMA’s Committee for Human Medicinal Products (CHMP)

GSK licenses tuberculosis vaccine candidate to the Bill & Melinda Gates Medical Research Institute for continued development

Mon, 27 Jan 2020 13:00:26 GMT

GSK announced that it has licensed its M72/AS01E3 tuberculosis disease (TB) vaccine.

World’s first meningitis B national infant vaccination programme shows 75% drop in cases over three years

Thu, 23 Jan 2020 08:00:02 GMT

New England Journal of Medicine also publishes results of Australian carriage study with Bexsero

US Food and Drug Administration (FDA) grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma

Tue, 21 Jan 2020 14:00:32 GMT

Belantamab mafodotin has potential to be the first anti-BCMA treatment available to patients

Dovato (dolutegravir/lamivudine), the once-daily, single-pill, 2-drug regimen for the treatment of HIV-1 infection, granted marketing approval by Japan Ministry of Health, Labour and Welfare

Wed, 15 Jan 2020 09:00:23 GMT

ViiV Healthcare, the global specialist HIV company announced that it has obtained approval of Dovato.

ViiV Healthcare submits regulatory application to the European Medicines Agency for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available

Fri, 10 Jan 2020 12:00:46 GMT

ViiV Healthcare submits regulatory application to the European Medicines Agency for fostemsavir.

Deborah Waterhouse, CEO of ViiV Healthcare, to join GSK Corporate Executive Team (CET)

Wed, 08 Jan 2020 14:40:14 GMT

GlaxoSmithKline plc today announced that Deborah Waterhouse, CEO of ViiV Healthcare, will join GSK’s Corporate Executive Team

GSK completes divestment of rabies and tick-borne encephalitis vaccines to Bavarian Nordic

Tue, 31 Dec 2019 11:42:43 GMT

GlaxoSmithKline plc today announced the completion of the divestment of Rabipur (tradename Rabavert in the US) to Bavarian Nordic.

ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV

Sat, 21 Dec 2019 08:26:45 GMT

ViiV Healthcare received a CRL from the FDA regarding its application for cabotegravir and rilpivirine.

GSK announces positive headline results in phase 3 study of Benlysta in patients with lupus nephritis

Wed, 18 Dec 2019 13:26:13 GMT

BLISS-LN achieves primary endpoint and all major secondary endpoints. On-track for regulatory submission during the first half of 2020.

Pivotal DREAMM-2 study demonstrated a clinically meaningful overall response rate with belantamab mafodotin (GSK2857916) for patients with relapsed/refractory multiple myeloma

Mon, 16 Dec 2019 18:23:41 GMT

Today announced treatment with the investigational single-agent belantamab mafodotin.

GSK Consumer Healthcare nutritional products divestment

Fri, 13 Dec 2019 10:20:46 GMT

GSK Consumer Healthcare nutritional products divestment

ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir (DTG) for children living with HIV

Fri, 13 Dec 2019 10:05:00 GMT

If approved, DTG will be the first integrase inhibitor available as a dispersible tablet for children living with HIV.

ViiV Healthcare submits New Drug Application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available

Thu, 05 Dec 2019 12:00:00 GMT

ViiV Healthcare completed submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA).

ViiV Healthcare announces exclusive licensing agreement with the National Institutes of Health for investigational “bNAb” with potential for long-acting HIV treatment and prevention

Thu, 21 Nov 2019 14:00:05 GMT

ViiV Healthcare announces exclusive licensing agreement with the National Institutes of Health for investigational “bNAb”.

Nucala (mepolizumab) is the first treatment to show a significant reduction in flares for patients with Hypereosinophilic Syndrome (HES)

Wed, 13 Nov 2019 08:00:01 GMT

Positive data from a pivotal study supports new regulatory filing in HES

EACS 2019: ViiV Healthcare to present 17 abstracts from its portfolio addressing the diverse needs of people living with HIV

Wed, 06 Nov 2019 08:00:31 GMT

Data presentations expand understanding of ViiV Healthcare’s pipeline for heavily treatment-experienced populations.

GSK delivers sales of £9.4 billion +16% AER, +11% CER (Pro-forma +6% CER*)

Wed, 30 Oct 2019 12:00:00 GMT

GSK delivers sales of £9.4 b +16% AER, +11% CER (Pro-forma +6% CER*) Total EPS 31.4p +9% AER, -1% CER; Adjusted EPS 38.6p +9% AER, +1% CER

Intravenous Benlysta is the first biologic treatment to be approved for children with lupus in Europe

Tue, 29 Oct 2019 16:00:24 GMT

European Commission has made a decision to extend to children five years and older, the existing adult indication for intravenous Benlysta

GSK candidate vaccine demonstrates sustained level of protection against active pulmonary tuberculosis

Tue, 29 Oct 2019 06:00:05 GMT

Analysis of phase IIb study published in the New England Journal of Medicine, presented at the 50th Union World Conference on Lung Health.

GSK starts a phase III clinical programme for a potential first-in-class antibiotic, gepotidacin

Mon, 28 Oct 2019 09:00:00 GMT

First in a new chemical class of antibiotic with a mechanism of action distinct from any currently approved antibiotic.

GSK agrees to divest rabies and tick-borne encephalitis vaccines to Bavarian Nordic

Mon, 21 Oct 2019 08:00:00 GMT

GSK to receive upfront payment of approximately EUR301 million and milestone payments for a total consideration of up to EUR955 million

Global Fund Replenishment - 2019 media statement

Thu, 10 Oct 2019 10:43:07 GMT

The Global Fund, world's largest financier of 3 of the deadliest diseases worldwide, AIDS, TB, and malaria, has helped save 27 million lives

GSK and Lyell Immunopharma join forces to develop the next generation of cancer cell therapies

Tue, 08 Oct 2019 14:30:00 GMT

Collaboration will combine Lyell’s technologies with GSK’s pipeline of cell therapies and manufacturing capability

GSK submits filing to FDA for Trelegy Ellipta use in patients with asthma

Wed, 02 Oct 2019 14:00:56 GMT

Trelegy Ellipta was approved in the US in September 2017 for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).

IDWeek 2019: ViiV Healthcare to present 20 abstracts from its innovative R&D portfolio with focus on 2-drug and long-acting regimens and mental health impact of HIV

Wed, 02 Oct 2019 09:30:43 GMT

Presentations include six-year data for the investigational regimen of cabotegravir and rilpivirine.

Nucala significantly reduces exacerbations in first global prospective real-world study of a biologic in severe eosinophilic asthma

Mon, 30 Sep 2019 10:30:23 GMT

Results from interim analysis of REALITI-A study presented at ERS conference

Phase 3 PRIMA trial of Zejula® (niraparib) is the first study to show a PARP inhibitor significantly improves PFS, regardless of biomarker status, when given as monotherapy in women with first-line platinum responsive advanced ovarian cancer

Sat, 28 Sep 2019 15:32:17 GMT

Niraparib treatment resulted in a 38% reduction in the risk of disease progression or death in the study population compared to placebo.

GSK presents new data showing promising anti-tumour activity with GSK3359609, an ICOS receptor agonist, in combination with pembrolizumab in head and neck squamous cell carcinoma (HNSCC)

Sat, 28 Sep 2019 07:45:29 GMT

Data presented at ESMO 2019 support phase II/III registrational trial with pembrolizumab in first-line recurrent/metastatic HNSCC.

Real-world effectiveness evidence among GSK data presented at ERS 2019

Mon, 23 Sep 2019 09:00:00 GMT

GlaxoSmithKline will for the first time share data on the effectiveness of mepolizumab in severe eosinophilic asthma patients

GSK receives positive CHMP opinion for intravenous Benlysta in children with lupus aged five years and above

Fri, 20 Sep 2019 12:00:54 GMT

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion

Nucala is the first biologic approved in the US for six to 11-year-old children with severe eosinophilic asthma

Thu, 12 Sep 2019 14:30:27 GMT

The US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for use in children as young as six years old.

GSK to present data from its innovative oncology portfolio at ESMO Congress 2019

Tue, 10 Sep 2019 13:00:31 GMT

GSK announced that data from its growing oncology pipeline will be presented at the European Society for Medical Oncology Congress.

GSK announces positive headline results from the pivotal DREAMM-2 study for multiple myeloma

Fri, 23 Aug 2019 06:54:28 GMT

Belantamab mafodotin (GSK2857916) on track for regulatory submission by the end of 2019

ViiV Healthcare reports positive phase III study results of investigational, long-acting, injectable HIV-treatment regimen administered every two months

Thu, 22 Aug 2019 06:59:13 GMT

ATLAS-2M study met its primary endpoint.

GSK submits first regulatory application for daprodustat in Japan for patients with renal anaemia due to chronic kidney disease

Wed, 21 Aug 2019 08:00:28 GMT

GSK announced, submission of JNDA for daprodustat, an oral HIF-PHI, for the treatment of renal anaemia due to CKD.

GSK announces leadership changes in the US

Mon, 12 Aug 2019 10:07:56 GMT

Jack Bailey, President US Pharmaceuticals has decided to step down from his role at the end of the year, succeeded by Maya Martinez-Davis.

GSK grants exclusive technology license for clinical-stage Ebola vaccines to Sabin Vaccine Institute

Tue, 06 Aug 2019 12:00:54 GMT

Transfer from GSK and partnership with NIAID will enable Sabin to advance development of the candidate vaccines

Nucala receives EU approval for self-administration by patients with severe eosinophilic asthma

Thu, 01 Aug 2019 15:04:08 GMT

96% of patients in studies preferred self-administration at home over being treated in clinic

GSK completes transaction with Pfizer to form new world-leading Consumer Healthcare Joint Venture

Thu, 01 Aug 2019 06:27:27 GMT

GSK today announced that it has completed its transaction with Pfizer to combine their consumer healthcare businesses into a Joint Venture.

Five years on, 3.9 million people in the developing world have access to HIV treatment dolutegravir, thanks to access-oriented voluntary licensing agreements

Tue, 30 Jul 2019 09:35:48 GMT

Innovative licensing agreements continue to provide access to dolutegravir in an unprecedented timeframe

ViiV Healthcare submits regulatory application to European Medicines Agency for investigational cabotegravir to be used in combination with rilpivirine as the first monthly, injectable treatment for HIV

Mon, 29 Jul 2019 07:02:49 GMT

The marketing application is based on phase III ATLAS and FLAIR trials in which the regimen showed similar efficacy to daily, 3-drug one.

ViiV Healthcare presents GEMINI 1 & 2 studies through Week 96 showing 2-drug regimen of dolutegravir plus lamivudine continues to demonstrate high efficacy rates and no cases of treatment emergent resistance

Wed, 24 Jul 2019 16:00:56 GMT

ViiV - GEMINI 1 & 2 studies through Week 96 showing 2-drug regimen of dolutegravir & lamivudine continues to demonstrate high efficacy rates

ViiV Healthcare announces positive Week 48 results in first study to evaluate treatment switch from TAF-containing regimen with three or more drugs to 2-drug regimen of dolutegravir/lamivudine for HIV-1 infection

Wed, 24 Jul 2019 16:00:46 GMT

International AIDS Society Conference on HIV Science demonstrate non-inferior efficacy of Dovato▼ in virally suppressed adults with HIV

GSK delivers sales and earnings growth in Q2 2019

Wed, 24 Jul 2019 14:00:38 GMT

Total EPS 19.5p, +>100% AER, +>100% CER; Adjusted EPS 30.5p +9% AER, +4% CER

GlaxoSmithKline plc appoints Jonathan Symonds as Non-Executive Chairman of the Board of Directors

Wed, 24 Jul 2019 10:00:33 GMT

GlaxoSmithKline plc appoints Jonathan Symonds as Non-Executive Chairman of the Board of Directors

ViiV Healthcare presents positive 96-week data from phase III study of investigational fostemsavir in heavily treatment-experienced patients with HIV at IAS 2019

Mon, 22 Jul 2019 17:00:56 GMT

Week 96 data from the BRIGHTE study of fostemsavir continue to show improvement in virologic suppression and immunologic response

IAS 2019: ViiV Healthcare showcasing innovation in HIV science

Mon, 15 Jul 2019 14:00:47 GMT

challenging the current treatment paradigm and investigating new options to meet the evolving needs of people living with HIV

GSK announces positive headline results in Phase 3 PRIMA study of ZEJULA (niraparib) for patients with ovarian cancer in the first line maintenance setting

Mon, 15 Jul 2019 07:00:14 GMT

Niraparib demonstrates significant improvement in progression free survival for women regardless of their biomarker status

ViiV Healthcare announces phase III study meets primary endpoint, demonstrating the ability to control HIV-1 with a 2-drug regimen of dolutegravir plus lamivudine in virally suppressed patients switching from a TAF-containing, 3-drug regimen

Wed, 10 Jul 2019 07:01:37 GMT

Week 48 results from the TANGO study will be presented this month at 10th International AIDS Society Conference on HIV Science (IAS 2019).

GSK welcomes the UK trial of subscription-style payment system for pharma companies to incentivise creation of new antibiotics

Tue, 09 Jul 2019 12:00:09 GMT

GSK welcomes the UK trial of subscription-style payment system for pharma companies to incentivise creation of new antibiotics

ViiV Healthcare announces start of first-ever study to identify and evaluate approaches to implementing its once-monthly injectable HIV treatment in clinical practice

Mon, 08 Jul 2019 17:17:47 GMT

The long-acting injectable regimen has been granted Priority Review status by the FDA, with a target approval date set for December 29, 2019

GSK announces phase III start for its anti GM-CSF antibody, otilimab, in patients with rheumatoid arthritis (RA)

Wed, 03 Jul 2019 11:03:43 GMT

First phase III programme in RA to include comparisons with current treatments across all studies in a range of RA patients.

ViiV Healthcare receives EU Marketing Authorisation for Dovato (dolutegravir/lamivudine), a new once-daily, single-pill, two-drug regimen for the treatment of HIV-1 infection

Wed, 03 Jul 2019 09:01:10 GMT

Dovato achieved non-inferior efficacy compared to a dolutegravir-based, three-drug regimen through 48 weeks.

U.S. Food and Drug Administration accepts GSK’s application for ZEJULA (niraparib) in late stage ovarian cancer with priority review

Mon, 24 Jun 2019 12:00:00 GMT

TESARO, submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for ZEJULA (niraparib).

GSK joins forces with the University of California to advance genomic research and improve drug discovery

Thu, 13 Jun 2019 11:15:29 GMT

New ‘Laboratory for Genomics Research’ unites CRISPR pioneers with industry expertise to help unravel mysteries of the human genome

GSK announces data on anti-BCMA antibody-drug conjugate in patients with relapsed/refractory multiple myeloma to be presented at European Hematology Association (EHA) Congress

Wed, 12 Jun 2019 12:10:32 GMT

GSK today announced new data on belantamab mafodotin will be presented at the 24th Congress of the European Hematology Association.

Nucala (mepolizumab) gains FDA approval for two new self-administration options

Thu, 06 Jun 2019 15:10:46 GMT

GSK today announced that the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab)

Nucala (mepolizumab) receives positive CHMP opinion for new self-administration options

Tue, 04 Jun 2019 08:00:24 GMT

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion.

GSK announces approval of Shingrix in China for prevention of shingles in adults aged 50 and over

Thu, 23 May 2019 16:00:00 GMT

Shingrix is a recombinant subunit adjuvanted vaccine given intramuscularly in two doses.

GSK changes sales representative incentive programme

Thu, 23 May 2019 14:00:00 GMT

We are announcing changes to our incentive programme for sales representatives in certain countries.

GSK’s strong science prominent at ATS 2019

Thu, 16 May 2019 11:20:39 GMT

More than 70 GSK abstracts presented

Update on Consumer Healthcare Joint Venture with Pfizer

Wed, 08 May 2019 18:40:36 GMT

The transaction between GSK and Pfizer Inc to create a Consumer Healthcare Joint Venture, was approved at a General Meeting held by GSK.

Phase III CAPTAIN study of Trelegy Ellipta in patients with asthma meets primary endpoint

Thu, 02 May 2019 16:46:02 GMT

Phase III CAPTAIN study of Trelegy Ellipta in patients with asthma meets primary endpoint

GSK delivers sales of £7.7 billion +6% AER, +5% CER

Wed, 01 May 2019 12:00:00 GMT

Total EPS 16.8p, +50% AER, +42% CER; Adjusted EPS 30.1p, +22% AER, +18% CER

ViiV Healthcare submits New Drug Application to US FDA for the first monthly, injectable, two-drug regimen of cabotegravir and rilpivirine for treatment of HIV

Mon, 29 Apr 2019 12:17:49 GMT

If approved, cabotegravir and rilpivirine would be the first-ever long-acting, injectable treatment regimen for adults living with HIV.

ViiV Healthcare announces CHMP Positive Opinion for Dovato® (dolutegravir/lamivudine) as a once-daily, single-pill, two-drug regimen for the treatment of HIV infection

Fri, 26 Apr 2019 16:04:52 GMT

Recommendation based on GEMINI 1 & 2 studies which demonstrated non-inferior efficacy.

GSK receives US approval of Benlysta for intravenous use in children with lupus aged five years and above

Fri, 26 Apr 2019 14:49:53 GMT

FDA approval marks the first medicine in the US approved for children with systemic lupus erythematosus (SLE)

US FDA approves ViiV Healthcare’s Dovato (dolutegravir/lamivudine), the first, once-daily, single-tablet, two-drug regimen for treatment-naïve HIV-1 adults

Mon, 08 Apr 2019 21:15:30 GMT

Dovato strengthens ViiV Healthcare’s industry-leading portfolio of innovative treatment approaches for people living with HIV.

ViiV Healthcare announces Juluca (dolutegravir/rilpivirine) maintains HIV viral suppression at 148-weeks

Wed, 03 Apr 2019 10:07:06 GMT

SWORD studies demonstrate long-term durable efficacy and tolerability of Juluca for treatment of virologically suppressed adults with HIV

GSK publishes product sales reporting changes and the impact of IFRS 16 ‘Leases’

Thu, 28 Mar 2019 22:48:21 GMT

GSK, financial reporting under regular review to ensure that it remains current and in line with developing best practice within industry.

GSK announces further positive data from DREAMM-1 study of anti-BCMA antibody-drug conjugate in patients with relapsed/refractory multiple myeloma

Thu, 21 Mar 2019 11:41:35 GMT

Median progression-free survival extends to twelve months.

Data from GARNET study indicates robust activity of dostarlimab in patients with advanced or recurrent endometrial cancer

Tue, 19 Mar 2019 16:21:02 GMT

TESARO announced the presentation of data from the Phase 1/2 GARNET study

ViiV Healthcare presents positive, 48-week data from two pivotal phase III studies showing long-acting, injectable two-drug regimen of cabotegravir and rilpivirine has similar efficacy to daily, three-drug oral treatment in adults living with HIV-1 infection

Thu, 07 Mar 2019 12:17:33 GMT

Comprehensive data from ATLAS and FLAIR studies presented today at the 2019 Conference on Retroviruses and Opportunistic Infections

GSK receives a positive CHMP opinion for intravenous zanamivir for the treatment of complicated influenza

Fri, 01 Mar 2019 09:27:43 GMT

Positive opinion by CHMP for intravenous zanamivir for the treatment of complicated and potentially life-threatening influenza A or B virus

GSK delivers sales, earnings and cash flow growth in 2018

Wed, 06 Feb 2019 12:00:00 GMT

Total EPS 73.7p, +>100% AER, +>100% CER; Adjusted EPS 119.4p +7% AER, +12% CER

GSK and Merck KGaA, Darmstadt, Germany announce global alliance to jointly develop and commercialise M7824, a novel immunotherapy with potential in multiple difficult-to-treat cancers

Tue, 05 Feb 2019 12:01:03 GMT

GlaxoSmithKline plc (LSE/NYSE: GSK) and Merck KGaA, Darmstadt, Germany announced that they have entered into a global strategic alliance

GSK completes acquisition of TESARO, an oncology focused biopharmaceutical company

Tue, 22 Jan 2019 13:59:14 GMT

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that it has successfully completed the acquisition of TESARO, Inc.

GSK announces succession plan to appoint new Chairman

Mon, 21 Jan 2019 09:27:30 GMT

GSK announces that Sir Philip Hampton has informed the Board of his intention to step down as non-executive Chairman.

Two positive phase III studies of tafenoquine for the radical cure of Plasmodium vivax malaria published in The New England Journal of Medicine

Wed, 16 Jan 2019 12:31:50 GMT

GSK and Medicines for Malaria Venture announced the publication of positive results from two phase III studies of single-dose tafenoquine

GlaxoSmithKline plc and Pfizer Inc to form new world-leading Consumer Healthcare Joint Venture

Wed, 19 Dec 2018 07:00:00 GMT

GSK plc has reached agreement with Pfizer Inc to combine their consumer health businesses into a new world-leading Joint Venture.

GSK reaches agreement to acquire TESARO, an oncology focused biopharmaceutical company

Mon, 03 Dec 2018 10:16:12 GMT

GSK & TSRO announced that the Companies have entered into a definitive agreement pursuant to which GSK will acquire TESARO.

GSK to divest Horlicks and other Consumer Healthcare nutrition products to Unilever

Mon, 03 Dec 2018 08:24:28 GMT

GlaxoSmithKline plc (LSE/NYSE: GSK) announces the divestment of Horlicks and other consumer healthcare nutrition brands to Unilever plc.

Juluca (dolutegravir/rilpivirine), the first single pill, 2-drug regimen, for the maintenance treatment of HIV, granted marketing approval by Japan Ministry of Health, Labour and Welfare

Mon, 26 Nov 2018 10:39:33 GMT

The Ministry of Health, Labour and Welfare has approved Juluca Combination Tablets for the maintenance treatment of (HIV-1) infection.

GSK and Kyowa Hakko Kirin sign strategic commercialisation deal in Japan for daprodustat, a potential new oral treatment for anaemia associated with chronic kidney disease

Thu, 22 Nov 2018 07:10:15 GMT

Announcing a strategic collaboration for the future commercialisation of daprodustat in Japan.

Access to Medicine Index 2018 media statement

Tue, 20 Nov 2018 13:23:30 GMT

GSK media statement on the results of the Access to Medicine Index 2018

GSK submits US regulatory filing to expand the use of Nucala in children with severe eosinophilic asthma

Mon, 19 Nov 2018 12:06:31 GMT

Supplemental Biologics License Application filed indication for the use of Nucala as an add-on treatment for severe eosinophilic asthma.

ViiV Healthcare receives CHMP Positive Opinion for Tivicay EU label update with GEMINI study data for the 2-drug regimen of Tivicay + lamivudine

Fri, 16 Nov 2018 15:45:23 GMT

Committee for Medicinal Products for Human Use has adopted a Positive Opinion on a Type II variation regulatory application for Tivicay

Once-daily Trelegy Ellipta gains expanded COPD indication in Europe

Fri, 09 Nov 2018 08:00:11 GMT

Once-daily Trelegy Ellipta now available for COPD patients requiring a step up from dual bronchodilation

Statement: GSK supports GOLD committee’s efforts to further personalise COPD management

Thu, 08 Nov 2018 12:21:04 GMT

Welcoming the updated Global Initiative for Chronic Obstructive Lung Disease (GOLD) Strategy.

ViiV Healthcare announces positive phase 3 results from the BRIGHTE study of fostemsavir at 48 weeks in heavily treatment-experienced patients with HIV

Wed, 31 Oct 2018 14:02:19 GMT

BRIGHTE study highlights ViiV Healthcare’s commitment to developing innovative medicines for all people living with HIV

GSK delivers Q3 sales of £8.1 billion, +3% AER, +6% CER

Wed, 31 Oct 2018 12:00:00 GMT

Total EPS 28.8p, +16% AER, +23% CER; Adjusted EPS 35.5p, +10% AER, + 14% CER

ViiV Healthcare reports positive 48-week results for second phase III study for novel, long-acting, injectable HIV-treatment regimen

Tue, 30 Oct 2018 14:30:11 GMT

FLAIR study meets primary endpoint

ViiV Healthcare presents three-year data for investigational long-acting injectable, two-drug HIV regimen

Mon, 29 Oct 2018 10:10:35 GMT

LATTE-2 study shows high rates of virologic response & long-term durability with long-acting, injectable, two-drug regimen over 160 weeks.

GSK announces positive phase 3 results for daprodustat in patients with anaemia associated with chronic kidney disease

Mon, 29 Oct 2018 09:34:13 GMT

Second of three pivotal studies intended to support regulatory filing in Japan in 2019

GSK presents new efficacy and safety data of an anti GM-CSF antibody in patients with rheumatoid arthritis

Sun, 21 Oct 2018 09:38:47 GMT

Marked patient benefit observed in phase II study supports further clinical development of GSK3196165 for RA.

ViiV Healthcare submits New Drug Application to US FDA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV

Thu, 18 Oct 2018 15:43:52 GMT

Priority review voucher used with NDA submission with anticipated target action date of six months.

GSK updates policy for working with healthcare professionals

Tue, 02 Oct 2018 11:28:19 GMT

We are updating our policy on working with healthcare professionals (HCPs).

Positive results from Harmony Outcomes study of albiglutide published in The Lancet

Tue, 02 Oct 2018 11:09:19 GMT

GSK & DCRI announced publication of positive results from the Harmony Outcomes study which assessed CV safety and efficacy of albiglutide.

GSK candidate vaccine helps prevent active pulmonary tuberculosis in HIV negative adults in phase II study

Tue, 25 Sep 2018 17:18:28 GMT

Positive impact of innovative vaccine technology in clinical trial conducted in tuberculosis endemic regions

GSK and Tres Cantos Open Lab Foundation announce additional £5m funding for open innovation research in diseases impacting the developing world

Fri, 21 Sep 2018 14:09:12 GMT

Additional £5m in GSK funding to support the Foundation’s research and development programmes in diseases of the developing world.

Trelegy Ellipta receives positive CHMP opinion supporting expanded COPD indication in Europe

Fri, 21 Sep 2018 11:44:21 GMT

European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion supporting use of Trelegy Ellipta

Kozenis (tafenoquine) approved by the Australian Therapeutic Goods Administration for the radical cure of P. vivax malaria

Fri, 21 Sep 2018 09:15:15 GMT

Approval marks a major step in global eradication efforts and will support registrations in malaria-endemic countries

ViiV Healthcare submits regulatory application to European Medicines Agency for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV

Fri, 14 Sep 2018 08:52:14 GMT

ViiV announced submission of MAA to EMA for a single-tablet, two-drug regimen of DTG and 3TC for the treatment of HIV-1 infection.

GSK data presented at ERS further supports its industry-leading respiratory medicines portfolio

Mon, 10 Sep 2018 10:00:48 GMT

GSK will profile the growing evidence base that supports its broad respiratory medicines portfolio at ERS congress in Paris, France, 09/18.

GSK announces results of indirect treatment comparisons of Nucala to benralizumab and reslizumab for severe eosinophilic asthma

Mon, 10 Sep 2018 08:00:11 GMT

Nucala demonstrated greater reduction in exacerbations and improved asthma control.

GSK receives complete response letter from US FDA for use of mepolizumab in COPD patients

Fri, 07 Sep 2018 16:49:38 GMT

GlaxoSmithKline plc(LSE/NYSE: GSK) today received a complete response letter (CRL) from the US FDA regarding its application for mepolizumab

European Commission approves Nucala (mepolizumab) for the treatment of children with severe asthma

Thu, 30 Aug 2018 07:59:42 GMT

First anti-IL-5 biologic treatment for paediatric patients with severe eosinophilic asthma in Europe

ViiV Healthcare reports positive 48-week results for first pivotal, phase III study for novel, long-acting, injectable HIV-treatment regimen

Wed, 15 Aug 2018 07:05:28 GMT

ATLAS study meets primary endpoint, showing similar efficacy of a once-a-month, investigational, injectable two-drug regimen

Iain Mackay appointed GSK Chief Financial Officer

Tue, 07 Aug 2018 07:04:12 GMT

GSK today announced that Iain Mackay has been appointed GSK’s next CFO.

CHMP recommend Nucala (mepolizumab) for the treatment of severe eosinophilic asthma paediatric patients in Europe

Fri, 27 Jul 2018 14:56:53 GMT

GSK announced, EMA's CHMP is recommending Nucala as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients.

GSK reports on outcome of the FDA Advisory Committee on mepolizumab for the treatment of COPD patients on maximum inhaled therapy

Wed, 25 Jul 2018 16:38:28 GMT

Advisory Committee provide non-binding recommendation for consideration by the FDA

GSK and 23andMe sign agreement to leverage genetic insights for the development of novel medicines

Wed, 25 Jul 2018 06:25:27 GMT

Multi-year collaboration to identify novel drug targets, tackle new subsets of disease and enable rapid progression of clinical programmes

GSK delivers improvements in sales, margins and cash flow in Q2 2018

Wed, 25 Jul 2018 06:00:00 GMT

Total EPS 9.0p, >100% AER, >100% CER; Adjusted EPS 28.1p, +3% AER, +10% CER

GSK and Adaptimmune complete transition of NY-ESO SPEAR T-cell therapy programme to GSK

Tue, 24 Jul 2018 13:45:59 GMT

GlaxoSmithKline plc and Adaptimmune Therapeutics plc, announced the transition of the development programme for GSK3377794 to GSK.

ViiV Healthcare announces SWORD 100-week data for Juluca (dolutegravir/rilpivirine) at AIDS 2018

Tue, 24 Jul 2018 09:38:16 GMT

Juluca, the first 2-drug regimen, once daily, single pill regimen, maintains viral suppression through 100 weeks.

ViiV Healthcare presents phase III data at AIDS 2018 from landmark GEMINI studies showing two-drug regimen of dolutegravir and lamivudine has similar efficacy to a three-drug regimen in treatment naïve HIV patients, with no emergence of resistance

Tue, 24 Jul 2018 09:24:08 GMT

GEMINI 1 & 2 studies meet primary endpoint, showing two-drug regimen to be effective across high and low viral loads.

US FDA approves Krintafel (tafenoquine) for the radical cure of P. vivax malaria

Fri, 20 Jul 2018 17:15:45 GMT

US FDA approves Krintafel (tafenoquine) for the radical cure of P. vivax malaria

ViiV Healthcare shares data from landmark 2-drug regimen trials at AIDS 2018

Wed, 18 Jul 2018 17:27:09 GMT

ViiV, specialist HIV company will be presenting over 20 abstracts, including GEMINI 1 & 2 trials, at the AIDS 2018 in Amsterdam.

US FDA Advisory Committee endorses the effectiveness and safety of single-dose tafenoquine for the radical cure of P. vivax malaria

Thu, 12 Jul 2018 16:37:20 GMT

There is substantial evidence of the effectiveness and adequate evidence of the safety of single-dose tafenoquine

James Ford appointed GSK General Counsel

Thu, 12 Jul 2018 13:50:39 GMT

James Ford, currently SVP and General Counsel for Global Pharma, will succeed Dan Troy as General Counsel, GSK.

Roivant subsidiary Dermavant Sciences signs agreement with GSK to purchase rights to tapinarof

Thu, 12 Jul 2018 10:53:43 GMT

GSK today announced that Dermavant Sciences, a subsidiary of Roivant Sciences, has agreed to purchase the rights to tapinarof.

Infants may now be protected against Meningitis B with fewer doses, adding flexibility to vaccination schedules

Wed, 27 Jun 2018 10:00:12 GMT

Healthcare professionals now have more options to help protect infants from invasive meningococcal disease (IMD) caused by serogroup B

ViiV Healthcare reports landmark phase III studies for dolutegravir and lamivudine, demonstrating the ability to control HIV with a two-drug regimen in treatment naïve patients

Thu, 14 Jun 2018 06:53:59 GMT

GEMINI 1&2 studies meet primary endpoint, demonstrating similar efficacy of two-drug regimen compared to standard three-drug regimen

GSK presents new results showing low rates of organ damage with long term use of Benlysta

Wed, 13 Jun 2018 13:50:49 GMT

Results showing low rates of organ damage progression in patients with active systemic lupus erythematosus treated with Benlysta

GSK announces changes to Vaccines and Global Manufacturing & Supply leadership

Tue, 12 Jun 2018 13:16:51 GMT

Luc Debruyne, President, Vaccines, is to leave GSK at the end of the year.

GSK completes Consumer Healthcare buyout

Fri, 01 Jun 2018 14:12:46 GMT

GSK has completed the buyout of Novartis’ 36.5% stake in its Consumer Healthcare Joint Venture for $13 billion (£9.3 billion*).

GSK submits regulatory application in Japan for once-daily single inhaler triple therapy FF/UMEC/VI for patients with COPD

Tue, 29 May 2018 08:38:27 GMT

GlaxoSmithKline plc and Innoviva, Inc. today announced the submission of a regulatory application to the Japanese Ministry of Health,

ViiV Healthcare receives EU marketing authorisation for Juluca (dolutegravir/rilpivirine), the first 2-drug regimen, once-daily, single-pill for the treatment of HIV

Mon, 21 May 2018 12:40:16 GMT

Juluca maintains viral suppression with two drugs in the smallest single pill regimen

GSK receives US approval of Arnuity Ellipta for use in children from 5 years old who suffer from asthma

Mon, 21 May 2018 11:42:07 GMT

GSK today announced it has received approval from the US Food and Drug Administration (FDA) for the use of Arnuity Ellipta

Nucala (mepolizumab) study reports long-term safety data, consistent exacerbation reduction and improved asthma control

Mon, 21 May 2018 08:00:00 GMT

New study showed one third of patients had no exacerbations on long-term treatment with Nucala.

GSK’s industry-leading respiratory research and scientific innovation showcased at ATS conference

Wed, 16 May 2018 10:36:36 GMT

GlaxoSmithKline plc (GSK) will present at the American Thoracic Society (ATS) conference in San Diego, USA, 19-23 May 2018.

Simon Dingemans, Chief Financial Officer, to retire from GSK

Wed, 09 May 2018 12:20:55 GMT

Simon Dingemans, Chief Financial Officer, GSK, has informed the Board of his intention to retire from the Company in May 2019.

GSK delivers Q1 sales of £7.2 billion, -2% AER, +4% CER

Wed, 25 Apr 2018 12:00:00 GMT

Total EPS 11.2p, -48% AER, -33% CER; Adjusted EPS 24.6p, -2% AER, +11% CER

Once-daily Trelegy Ellipta gains expanded indication in the US for the treatment of patients with COPD

Tue, 24 Apr 2018 17:40:16 GMT

Expanded indication approved for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’)

Landmark IMPACT study published in NEJM shows significant benefits of Trelegy Ellipta for patients with COPD

Wed, 18 Apr 2018 14:10:18 GMT

Once-daily single inhaler triple therapy superior to Relvar/Breo Ellipta and Anoro Ellipta across multiple endpoints

GSK appoints Kevin Sin as new SVP and Head of Worldwide Business Development for R&D

Wed, 18 Apr 2018 14:00:00 GMT

Kevin Sin appointed as Senior Vice President and Head of Worldwide Business Development for Pharmaceuticals Research & Development.

GSK signs strategic agreement to transfer rare disease gene therapy portfolio to Orchard Therapeutics

Thu, 12 Apr 2018 17:51:17 GMT

Agreement strengthens Orchard’s position as a global leader in gene therapy for rare diseases.

GSK reaches agreement with Novartis to acquire full ownership of Consumer Healthcare Business

Tue, 27 Mar 2018 05:59:33 GMT

GSK reaches agreement with Novartis to acquire full ownership of Consumer Healthcare Business

ViiV Healthcare gains CHMP positive opinion for Juluca (dolutegravir/rilpivirine) in Europe

Fri, 23 Mar 2018 11:18:13 GMT

ViiV Healthcare announced that the European Committee for Medicinal Products for Human Use issued a Positive Opinion for Juluca.

Shingrix approved in Europe and Japan for the prevention of shingles in adults aged 50 and over

Fri, 23 Mar 2018 07:17:12 GMT

GSK announced the EC has approved Shingrix for the prevention of shingles & PHN in adults aged 50 years or older.

GSK update regarding Pfizer Inc. Consumer Healthcare

Fri, 23 Mar 2018 06:53:10 GMT

GlaxoSmithKline plc (LSE/NYSE: GSK) today confirms it has withdrawn from the process relating to Pfizer’s Consumer Healthcare business.

GSK starts phase III study of Benlysta and rituximab combination in systemic lupus erythematosus

Tue, 20 Mar 2018 11:09:24 GMT

GSK today announced the start of a phase III study investigating Benlysta (belimumab)

GSK announces positive EU approval for labelling update to Relvar Ellipta in patients with asthma

Thu, 08 Mar 2018 09:27:33 GMT

GSK & INVA announced that the EC has approved a label update for the use of once daily Relvar Ellipta (fluticasone furoate/vilanterol,FF/VI)

New clinical data demonstrate high vaccine efficacy of Fluarix Tetra (Influenza Vaccine) in children 6-35 months of age

Tue, 06 Mar 2018 10:43:52 GMT

New data published in The Lancet from a Phase III clinical trial with Fluarix Tetra which prevented influenza in children 6 to 35 months

ViiV Healthcare announces positive new dolutegravir data for the treatment of people living with HIV co-infected with tuberculosis

Mon, 05 Mar 2018 17:45:20 GMT

INSPIRING study results contribute to extensive body of evidence for dolutegravir

Nucala (mepolizumab) improved asthma control in patients uncontrolled on Xolair (omalizumab)

Mon, 05 Mar 2018 11:30:40 GMT

Positive clinical study outcomes observed for severe eosinophilic asthma patients uncontrolled on omalizumab

GSK receives European approval for expanded indication for Fluarix Tetra (Influenza Vaccine) for ages six months and older

Thu, 15 Feb 2018 10:49:56 GMT

GSK announced the expanded indication for Fluarix Tetra has been approved in Europe.

GSK submits landmark IMPACT data to European Medicines Agency to support expanded label for Trelegy Ellipta

Wed, 14 Feb 2018 09:21:42 GMT

GlaxoSmithKline plc and Innoviva, Inc. announce submission of landmark IMPACT data to the European Medicines Agency

ViiV Healthcare launches eighth phase III study in two-drug regimen programme for HIV-1 treatment

Thu, 08 Feb 2018 10:22:42 GMT

TANGO will seek to enrol approximately 550 adults with HIV-1, from clinical trial sites in North America, Europe, Australia, and Japan.

ViiV Healthcare files patent infringement litigation against Gilead Sciences Inc. over bictegravir

Wed, 07 Feb 2018 15:56:42 GMT

ViiV Healthcare announces it has filed patent infringement litigation against Gilead Sciences Inc.

GSK delivers improvements in sales, margins and cash flow in 2017

Wed, 07 Feb 2018 12:00:01 GMT

Total EPS 31.4p, +67% AER, +36% CER; Adjusted EPS 111.8p, +11% AER, +4% CER

GSK’s meningitis B vaccine Bexsero receives Breakthrough Therapy Designation from US FDA for prevention of Invasive Meningococcal Disease in children 2-10 years of age

Wed, 07 Feb 2018 09:17:55 GMT

GlaxoSmithKline plc announced that it has received Breakthrough Therapy Designation from the U.S. FDA for its meningitis B vaccine Bexsero

GSK’s Shingrix receives positive opinion from the CHMP in Europe for the prevention of shingles in adults aged 50 and over

Fri, 26 Jan 2018 12:42:24 GMT

Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses, with a two-to-six month interval between doses.

GSK announces CHMP positive opinion for labelling update to Relvar Ellipta in patients with asthma

Fri, 26 Jan 2018 09:11:45 GMT

A positive CHMP opinion is one of the final steps before marketing authorisation is updated by the European Commission.

GSK responds to the AMR Benchmark

Tue, 23 Jan 2018 16:27:42 GMT

New AMR Benchmark provides useful analysis of industry’s contribution to addressing the public health threat of antimicrobial resistance.

FDA approves US label update on ICS/LABA combinations in asthma, based on review of safety data

Thu, 21 Dec 2017 09:13:22 GMT

Boxed warning removed from ICS/LABA combination products, including BREO ELLIPTA, ADVAIR DISKUS and ADVAIR HFA.

GSK submits regulatory application for single-dose tafenoquine for the treatment of Plasmodium vivax malaria to Australia’s Therapeutic Goods Administration

Thu, 14 Dec 2017 10:04:19 GMT

Innovative science drives progress in developing medicines for infectious diseases.

GSK achieves approval for Nucala (mepolizumab) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) for adults in the US

Tue, 12 Dec 2017 16:07:20 GMT

First targeted treatment approved for this rare eosinophil-driven disease

GSK presents promising new data for priority BCMA asset from its emerging Oncology pipeline at 59th ASH meeting

Mon, 11 Dec 2017 15:01:11 GMT

Data from dose expansion phase of DREAMM-1 study

New data supports the safety and efficacy of GSK’s Shingrix in preventing shingles in autologous haematopoietic stem cell transplant patients

Wed, 06 Dec 2017 07:17:11 GMT

GSK announced new data from a Phase III clinical study

GSK welcomes launch of the UK Government’s Life Sciences Sector Deal

Wed, 06 Dec 2017 07:02:07 GMT

New £40 million GSK investment in genomic research

ViiV Healthcare announces start of phase III study of long-acting cabotegravir for HIV prevention in women

Thu, 30 Nov 2017 00:00:00 GMT

The HPTN 084 study will evaluate injections given every two months

GSK submits US regulatory application for single-dose tafenoquine for Plasmodium vivax malaria

Tue, 28 Nov 2017 00:00:00 GMT

Regulatory milestone affirms GSK's strong commitment and scientific capabilities to fighting infectious diseases

GSK responds to UK Industrial Strategy

Mon, 27 Nov 2017 00:00:00 GMT

Read our response to the UK Industrial Strategy White Paper.

ViiV Healthcare starts third phase III HIV treatment study investigating long-acting two-drug regimen of cabotegravir plus rilpivirine

Mon, 27 Nov 2017 00:00:00 GMT

ViiV announced start of phase III study with a two-drug regimen of long-acting, injectable cabotegravir & rilpivirine in adults with HIV-1.

GSK submits landmark IMPACT data to US regulatory authority to support expanded label for Trelegy Ellipta

Thu, 23 Nov 2017 00:00:00 GMT

GSK submits landmark IMPACT data to US regulatory authority to support expanded label for Trelegy Ellipta

Juluca® (dolutegravir and rilpivirine) approved in US as first 2-drug regimen, once-daily, single pill - a complete regimen for the maintenance treatment of virologically suppressed HIV-1 infection

Tue, 21 Nov 2017 00:00:00 GMT

ViiV announced the FDA has approved Juluca®, complete regimen for the maintenance treatment of HIV-1 infection in virologically suppressed..

Trelegy Ellipta once-daily single inhaler triple therapy gains marketing authorisation in Europe for the treatment of COPD

Thu, 16 Nov 2017 00:00:00 GMT

GlaxoSmithKline plc and Innoviva, Inc. today announced that the European Commission has granted marketing authorisation for Trelegy Ellipta

GSK receives European marketing authorisation for self-injectable formulation of Benlysta for the treatment of systemic lupus erythematosus

Mon, 13 Nov 2017 00:00:00 GMT

The approval is for a single-dose prefilled syringe and a single-dose prefilled pen presentation, administered as a once weekly

Dr Hal Barron appointed Chief Scientific Officer and President, Research & Development, GSK

Wed, 08 Nov 2017 00:00:00 GMT

Dr Hal Barron appointed Chief Scientific Officer and President, Research & Development, GSK

First long-term efficacy analysis on the effect of GSK’s Benlysta on rate of organ damage progression in SLE versus standard therapy alone

Wed, 08 Nov 2017 00:00:00 GMT

GSK announced results of the first study assessing levels of organ damage in patients with active systemic lupus erythematosus (SLE)

Patrick Vallance, President, R&D, GSK to become UK Government's Chief Scientific Adviser

Wed, 08 Nov 2017 00:00:00 GMT

Patrick Vallance, President, R&D, GSK to become UK Government’s Chief Scientific Adviser

GSK submits US regulatory application for mepolizumab in eosinophilic chronic obstructive pulmonary disease (COPD)

Tue, 07 Nov 2017 00:00:00 GMT

GlaxoSmithKline plc today announced the submission of a supplemental Biologics License Application (sBLA) to the United States FDA

New multi-country survey reveals need for improved awareness around long-term impact and appropriate use of corticosteroids in SLE management

Mon, 06 Nov 2017 00:00:00 GMT

EnABLE highlight opportunity for increased awareness on appropriate corticosteroid use and a more proactive approach to management of SLE.

GSK’s investigational BCMA antibody-drug conjugate receives Breakthrough Therapy Designation from US FDA for relapsed and refractory multiple myeloma

Thu, 02 Nov 2017 00:00:00 GMT

GlaxoSmithKline plc (LSE/NYSE: GSK) announced it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration

GSK study demonstrates superiority of Anoro Ellipta to Stiolto Respimat in improving lung function in chronic obstructive pulmonary disease

Wed, 01 Nov 2017 00:00:00 GMT

GSK plc and Innoviva, Inc. announced positive data from a study

ViiV Healthcare announces positive phase 3 results from the BRIGHTE study of fostemsavir in heavily treatment-experienced patients with HIV

Fri, 27 Oct 2017 00:00:00 GMT

ViiV Healthcare announced results from phase III BRIGHTE study of fostemsavir

Public-private consortium aims to cut preclinical cancer drug discovery from six years to just one

Fri, 27 Oct 2017 00:00:00 GMT

Lawrence Livermore National Laboratory, Frederick National Laboratory for Cancer Research, GSK, and University of California San Francisco

CDC’s Advisory Committee on Immunization Practices recommends Shingrix as the preferred vaccine for the prevention of shingles for adults aged 50 and up

Wed, 25 Oct 2017 00:00:00 GMT

Committee recommends immunization for up to 62 million additional adults in the US

GSK delivers Q3 sales of £7.8 billion, +4% AER, +2% CER

Wed, 25 Oct 2017 00:00:00 GMT

Total EPS 24.8p, +49% AER, +46% CER; Adjusted EPS 32.5p, +3% AER, flat CER

Shingrix approved in the US for prevention of shingles in adults aged 50 and over

Mon, 23 Oct 2017 00:00:00 GMT

Pooled clinical trial results showed > 90 percent efficacy across all age groups

GSK receives World Health Organization Prequalification for Synflorix pneumococcal vaccine four-dose vial

Wed, 18 Oct 2017 00:00:00 GMT

WHO awarded prequalification for the new four-dose vial presentation of Synflorix pneumococcal vaccine targeting GAVI supported countries.

GSK announces first approval of Shingrix in Canada

Fri, 13 Oct 2017 00:00:00 GMT

The only shingles vaccine to achieve ≥90% efficacy in adults aged 50 and over

GSK receives approval for Benlysta in Japan for the treatment of systemic lupus erythematosus

Wed, 27 Sep 2017 00:00:00 GMT

GSK announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Benlysta (belimumab)

GSK and Innoviva report positive headline results from IMPACT study showing single inhaler triple therapy Trelegy Ellipta reduced COPD exacerbations

Wed, 20 Sep 2017 00:00:00 GMT

Trelegy Ellipta met study primary endpoint

Trelegy Ellipta approved as the first once-daily single inhaler triple therapy for the treatment of appropriate patients with COPD in the US

Mon, 18 Sep 2017 00:00:00 GMT

GlaxoSmithKline plc and Innoviva, Inc. announced the US Food and Drug Administration has approved once-daily, single inhaler triple therapy

Trelegy Ellipta once-daily single inhaler triple therapy receives positive opinion from the CHMP in Europe for appropriate patients with COPD

Fri, 15 Sep 2017 00:00:00 GMT

EMA CHMP issues positive opinion for Trelegy Ellipta.

GSK receives CHMP positive opinion for self-injectable formulation of Benlysta for systemic lupus erythematosus

Fri, 15 Sep 2017 00:00:00 GMT

GSK today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion

FDA Advisory Committee votes unanimously for Shingrix (HZ/su) in the US for prevention of herpes zoster (shingles) in adults ages 50 and over

Wed, 13 Sep 2017 00:00:00 GMT

The data supports the efficacy and safety of Shingrix for the prevention of herpes zoster (shingles) in adults ages 50 and over.

GSK announces phase III results published in NEJM of mepolizumab in patients with eosinophilic COPD at risk of exacerbations

Tue, 12 Sep 2017 00:00:00 GMT

GlaxoSmithKline plc announced the results from the phase III studies for mepolizumab in chronic obstructive pulmonary disease (COPD).

Positive results from pioneering Salford Lung Study in asthma published in The Lancet, and presented at European Respiratory Congress

Mon, 11 Sep 2017 00:00:00 GMT

Relvar Ellipta was superior to usual care treatment in improving asthma control for patients in Salford Lung Study.

GSK exercises option on phase I/II NY-ESO T-cell therapy (GSK3377794)

Thu, 07 Sep 2017 00:00:00 GMT

Today GSK announced that it has exercised the option to obtain an exclusive global license from Adaptimmune

GSK presents respiratory data from pipeline to clinical practice at ERS

Mon, 04 Sep 2017 00:00:00 GMT

45 abstracts will be shared about current and future treatments for patients with respiratory diseases

GSK responds to UK Life Sciences Industrial Strategy

Wed, 30 Aug 2017 00:00:00 GMT

Read our response to the UK Life Sciences Industrial Strategy.

GSK delivers further progress in Q2 and sets out new priorities for the Group

Wed, 26 Jul 2017 00:00:00 GMT

Q2 was another quarter of progress for GSK with Group sales up 3% to £7.3 billion and Adjusted EPS of 27.2p.

ViiV Healthcare announces superior efficacy of dolutegravir versus lopinavir/ritonavir in second-line HIV treatment in resource-limited settings

Tue, 25 Jul 2017 00:00:00 GMT

ViiV, specialist HIV company, majority owned by GSK, Pfizer & Shionogi announced positive interim results from DAWNING.

Karenann Terrell appointed Chief Digital & Technology Officer, GSK

Tue, 25 Jul 2017 00:00:00 GMT

GSK today announced that Karenann Terrell has been appointed Chief Digital & Technology Officer

Switching to a dolutegravir regimen from a boosted protease inhibitor regimen maintained viral suppression and improved lipid fractions in patients with HIV and high cardiovascular risk

Tue, 25 Jul 2017 00:00:00 GMT

ViiV Healthcare and NEAT-ID announced results from the NEAT 022 study of more than 400 patients with HIV and high cardiovascular risk

Phase II study results showed comparable viral suppression rates at 96 weeks for a two-drug regimen of long-acting cabotegravir and rilpivirine and a three-drug regimen in patients with HIV

Mon, 24 Jul 2017 00:00:00 GMT

LATTE-2 study results published in The Lancet and presented at International AIDS Society Meeting

GSK submits US regulatory filing of Arnuity Ellipta in children with asthma

Mon, 24 Jul 2017 00:00:00 GMT

The sNDA is seeking approval for a dose of 50mcg once-daily, delivered using the Ellipta inhaler in this group of patients.

GSK announces Board and Committee changes

Fri, 21 Jul 2017 00:00:00 GMT

GSK - Dr Laurie Glimcher has been appointed to Board of the Company, Non-Executive Director and a Scientific and Medical Expert.

GSK submits EU filing for extended use of Relvar Ellipta in patients with controlled asthma on an ICS/LABA combination

Fri, 21 Jul 2017 00:00:00 GMT

GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced a submission to the European Medicines Agency (EMA).

GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus

Fri, 21 Jul 2017 00:00:00 GMT

GSK announced today that the US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Benlysta

ViiV Healthcare shares data from its innovative portfolio with HIV community at IAS 2017

Thu, 20 Jul 2017 00:00:00 GMT

ViiV Healthcare shares data from its innovative portfolio with HIV community at IAS 2017

GSK updates on UK manufacturing network

Wed, 19 Jul 2017 00:00:00 GMT

GSK today set out several announcements made by the company to improve the efficiency and competitiveness of its manufacturing network.

GSK announces US regulatory submission for mepolizumab in Eosinophilic Granulomatosis with Polyangiitis (EGPA)

Wed, 28 Jun 2017 00:00:00 GMT

GSK plc announced the submission of a supplemental Biologics License Application (sBLA) to the United States Food and Drug Administration

GSK starts phase III study with mepolizumab in patients with nasal polyps

Tue, 27 Jun 2017 00:00:00 GMT

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the start of a phase III study with mepolizumab, an interleukin 5 (IL-5) antagonist

GSK receives CHMP positive opinion for Synflorix pneumococcal vaccine four-dose vial

Tue, 27 Jun 2017 00:00:00 GMT

New presentation designed to significantly reduce storage requirements in developing countries.

GSK presents positive results from Phase III revaccination study of its candidate shingles vaccine Shingrix at CDC’s Advisory Meeting

Wed, 21 Jun 2017 00:00:00 GMT

Study conducted in individuals who had previously received current standard of care

GSK announces results from 10-year continuation study showing sustained disease control with Benlysta (belimumab) in SLE

Fri, 16 Jun 2017 00:00:00 GMT

Benlysta is a biologic medicine specifically developed and approved for SLE

GSK and MMV announce positive headline phase III results showing single-dose tafenoquine reduces risk of relapse in patients with Plasmodium vivax malaria

Mon, 12 Jun 2017 00:00:00 GMT

GSK and Medicines for Malaria Venture (MMV) today announced positive results from two phase III studies of tafenoquine

Four innovations to tackle under-five deaths win US$1 million Healthcare Innovation Award from GSK and Save the Children

Mon, 05 Jun 2017 00:00:00 GMT

Organisations in Pakistan, Colombia, India and Nigeria recognised for innovations helping the hardest-to-reach children HIA (award).

ViiV Healthcare

Thu, 01 Jun 2017 00:00:00 GMT

ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines

Thu, 01 Jun 2017 00:00:00 GMT

ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines

GSK presents data at ATS on treatment effect of Nucala (mepolizumab) in severe asthma according to blood eosinophil level

Mon, 22 May 2017 00:00:00 GMT

GlaxoSmithKline plc (LSE/NYSE:GSK) today presented data from a post-hoc analysis of the phase IIIb MUSCA study

GSK announces NEJM publication of positive phase III study investigating mepolizumab in patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA)

Wed, 17 May 2017 00:00:00 GMT

GSK announces NEJM publication of phase III study investigating mepolizumab in patients with EGPA

GSK announces headline phase III results of mepolizumab in patients with severe chronic obstructive pulmonary disease

Wed, 10 May 2017 00:00:00 GMT

GSK plc (LSE/NYSE:GSK) announced preliminary results of two pivotal phase III studies evaluating the efficacy and safety of mepolizumab

Relvar Ellipta significantly improved asthma control in Salford Lung Study patients compared with their usual care

Fri, 05 May 2017 00:00:00 GMT

Endpoint: patients initiated with Relvar Ellipta had twice the odds of achieving improvement in asthma control than patients in usual care.

GSK delivers another quarter of continued progress

Wed, 26 Apr 2017 00:00:00 GMT

GSK Q1 sales of £7.4 billion, +19% AER, + 5% CER Total EPS of 21.4p >100% AER, >100% CER; Adjusted EPS of 25.0p, +31% AER, +9% CER

GSK announces regulatory submission in Japan of its candidate vaccine for prevention of shingles

Tue, 18 Apr 2017 00:00:00 GMT

Follows regulatory submissions in US, EU and Canada

Togo becomes first country in Africa to validate the elimination of lymphatic filariasis as a public health problem

Tue, 18 Apr 2017 00:00:00 GMT

LF, commonly known as elephantiasis, is a debilitating disease caused by a parasite transmitted to humans through the bites of mosquitoes.

GSK makes change to financial reporting framework

Tue, 11 Apr 2017 00:00:00 GMT

GSK keeps its financial reporting framework under regular review to ensure that it remains current.

GSK starts phase III study with mepolizumab in patients with severe hypereosinophilic syndrome

Fri, 31 Mar 2017 00:00:00 GMT

GSK starts phase III study with mepolizumab in patients with severe hypereosinophilic syndrome

GSK announces new scholarships to recognise retiring CEO Sir Andrew Witty’s contribution to global health

Wed, 29 Mar 2017 00:00:00 GMT

GSK today announced a new partnership with the London School of Hygiene & Tropical Medicine

UK Biobank, GSK and Regeneron announce largest gene sequencing initiative on world’s most detailed health database to improve drug discovery and disease diagnosis

Thu, 23 Mar 2017 00:00:00 GMT

Groundbreaking UK/US initiative will deliver first data within a year

GSK’s MUSCA study shows Nucala® (mepolizumab) significantly improves quality of life and lung function in severe asthma patients with an eosinophilic phenotype

Mon, 06 Mar 2017 00:00:00 GMT

MUSCA study shows asthma patients achieved improvements in their health-related quality of life and lung function with Nucala® (mepolizumab)

GSK confirms closure of agreement to divest anaesthesia portfolio to Aspen

Wed, 01 Mar 2017 00:00:00 GMT

GSK announced the closure of agreement with Aspen aligned with GSK’s strategy of simplification through focusing on core therapeutic areas.

Positive results for Relvar® Ellipta® lung function study in patients with well-controlled asthma

Thu, 23 Feb 2017 00:00:00 GMT

Positive headline results from a non-inferiority lung function study.

ViiV Healthcare announces detailed positive phase III results for investigational two-drug regimen of dolutegravir and rilpivirine for HIV treatment

Mon, 13 Feb 2017 00:00:00 GMT

Headline results were announced in December 2016 and detailed study results are being presented at the annual Conference

Results announcement for the fourth quarter 2016

Wed, 08 Feb 2017 00:00:00 GMT

View full Q4 2016 Results (PDF)

Abbas Hussain to leave GSK

Thu, 19 Jan 2017 00:00:00 GMT

Abbas Hussain, President, Global Pharmaceuticals has decided to leave the company.

Luke Miels appointed President, Global Pharmaceuticals, GSK

Thu, 19 Jan 2017 00:00:00 GMT

Luke Miels has been appointed President, Global Pharmaceuticals, GSK.

GSK confirms closure of agreement to divest non-core assets to Aspen

Tue, 03 Jan 2017 00:00:00 GMT

GlaxoSmithKline today announced the closure of one of its series of agreements with Aspen Pharmacare Holdings Limited (JSE: APN)

ViiV Healthcare announces start of phase III study evaluating long-acting cabotegravir for HIV prevention

Tue, 20 Dec 2016 00:00:00 GMT

First injectable to be studied for efficacy in pre-exposure prophylaxis

GSK announces Board changes

Mon, 19 Dec 2016 00:00:00 GMT

The creation of a new Board committee and a number of changes to the membership of the Board and its committees

ViiV Healthcare announces positive results from first phase III studies of two-drug HIV treatment regimen

Mon, 19 Dec 2016 00:00:00 GMT

First phase III studies to show efficacy of two-drug regimen as maintenance therapy

GSK starts phase III study of once-daily closed triple combination therapy FF/UMEC/VI in patients with asthma

Mon, 19 Dec 2016 00:00:00 GMT

The start of a phase III study investigating the effects of once-daily closed triple combination therapy (FF/UMEC/VI).

ViiV Healthcare Announces CHMP positive opinion to lower the age and weight limit for Tivicay® (dolutegravir) in children and adolescents living with HIV in Europe

Fri, 16 Dec 2016 00:00:00 GMT

The CHMP has adopted a positive opinion to reduce the weight and age limit for the treatment of HIV with Tivicay.

GSK submits regulatory application in Japan for belimumab in systemic lupus erythematosus

Tue, 13 Dec 2016 00:00:00 GMT

Belimumab is a human monoclonal antibody that selectively targets B-lymphocyte stimulator an important factor in the survival of B cells.

GSK opens new global vaccines R&D center in Rockville, MD, USA

Tue, 13 Dec 2016 00:00:00 GMT

New state-of-the-art facility will house 450 scientists and support staff, creating up to 200 new jobs.

Dominique Limet to step down as CEO of ViiV Healthcare; Deborah Waterhouse to succeed him

Mon, 05 Dec 2016 00:00:00 GMT

After seven years as CEO of ViiV Healthcare, Dr Dominique Limet will step down at the end of March 2017.

Relvar® Ellipta® 100/25 mcg gains approval in Japan for use in patients with COPD

Fri, 02 Dec 2016 00:00:00 GMT

Relvar is a combination of the inhaled corticosteroid, fluticasone furoate, and the long-acting beta2 agonist, vilanterol ‘VI’.

GSK files EU regulatory submission for once-daily closed triple combination therapy FF/UMEC/VI for patients with COPD

Fri, 02 Dec 2016 00:00:00 GMT

The filing by GSK of a regulatory submission closed triple combination therapy FF/UMEC/VI 100/62.5/25 mcg for patients with COPD.

GSK announces EU regulatory submission of candidate vaccine for prevention of shingles - Follows regulatory submissions in US and Canada

Fri, 25 Nov 2016 00:00:00 GMT

Tthe regulatory submission of a MMA to the EMA seeking approval for ShingrixTM.

GSK starts phase III programme with daprodustat for anaemia associated with chronic kidney disease

Thu, 24 Nov 2016 00:00:00 GMT

The start of a phase III development programme investigating daprodustat as a treatment for anaemia associated with CKD.

GSK announces phase lll study of mepolizumab meets co-primary endpoints and all secondary endpoints in patients with eosinophilic granulomatosis with polyangiitis

Wed, 23 Nov 2016 00:00:00 GMT

Both co-primary endpoints and all secondary endpoints were met in a pivotal phase III study.

GSK files regulatory submission in US for once-daily closed triple combination therapy FF/UMEC/VI for patients with COPD

Mon, 21 Nov 2016 00:00:00 GMT

COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both.

GSK receives FDA approval for expanded indication for FluLaval® Quadrivalent (Influenza Vaccine) for infants 6 months and older

Fri, 18 Nov 2016 00:00:00 GMT

An approval from the US Food and Drug Administration’s (FDA) Center

ViiV Healthcare launches phase III programme to evaluate a long-acting, injectable HIV treatment regimen

Fri, 18 Nov 2016 00:00:00 GMT

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders

GSK announces new data from phase III studies of sirukumab in adult patients with moderately to severely active rheumatoid arthritis

Wed, 16 Nov 2016 00:00:00 GMT

Sirukumab is being co-developed as part of a collaboration with Janssen Biologics (Ireland) [Janssen].

GSK’s Benlysta® (belimumab) shows sustained benefits in patients with SLE

Wed, 16 Nov 2016 00:00:00 GMT

GSK today announced results from a 7-year safety and efficacy continuation study for Benlysta® (belimumab).

GSK leads Access to Medicine Index 2016

Mon, 14 Nov 2016 00:00:00 GMT

GSK has today been ranked first in the Access to Medicine Index for the fifth consecutive time.

GSK announces positive results in fourth consecutive pivotal trial of Benlysta® (belimumab) in SLE

Sun, 13 Nov 2016 00:00:00 GMT

Data in Japan, China and South Korea will form basis of new regulatory submissions for Benlysta

GSK statement in response to New York Times article on China

Wed, 02 Nov 2016 00:00:00 GMT

These matters relating to our operations in China were deeply disappointing to GSK.

GSK presents new data for shingles candidate vaccine at IDWeek scientific conference

Thu, 27 Oct 2016 00:00:00 GMT

GSK today announced new data for its shingles candidate vaccine ShingrixTM.

Results Announcement for the third quarter 2016

Wed, 26 Oct 2016 00:00:00 GMT

GSK delivers sales growth, improved cash flow and sustained pipeline progression in Q3.

GSK announces US regulatory submission of candidate vaccine for prevention of shingles

Mon, 24 Oct 2016 00:00:00 GMT

Regulatory submissions in the EU and Canada remain on track for 2016

New data published for GSK’s Nucala investigating hospitalisation reduction in severe asthma patients with an eosinophilic phenotype

Fri, 07 Oct 2016 00:00:00 GMT

The risk of hospitalisations or emergency room visits caused by asthma attacks was halved (51% reduction p<0.001) in severe asthma patients

GlaxoSmithKline plc appoints Brian McNamara as CEO of GSK Consumer Healthcare

Thu, 29 Sep 2016 00:00:00 GMT

Brian join GSK’s Corporate Executive Team and will continue as a member of the Board of the Consumer Healthcare Joint Venture with Novartis.

GlaxoSmithKline completes sale of remaining Aspen shares

Thu, 29 Sep 2016 00:00:00 GMT

GSK has agreed to the sale of 28.2 million ordinary shares in Aspen Pharmacare Holdings Ltd ("Aspen") at a price of ZAR 300 per share.

GlaxoSmithKline announces intention to sell remaining holding in Aspen

Wed, 28 Sep 2016 00:00:00 GMT

GSK intends to sell its remaining stake in Aspen Pharmacare Holdings Ltd ("Aspen").

GSK announces US regulatory submission for sirukumab in rheumatoid arthritis

Fri, 23 Sep 2016 00:00:00 GMT

Sirukumab is being co-developed for RA as part of a collaboration with Janssen Biologics (Ireland) [Janssen], an affiliate of JBI.

GSK announces regulatory submissions for subcutaneous formulation of Benlysta® (belimumab) for patients with systemic lupus disease

Fri, 23 Sep 2016 00:00:00 GMT

It has filed regulatory submissions in the US and Europe for Benlysta® (belimumab) for approval.

Emma Walmsley to succeed Andrew Witty as Chief Executive Officer of GlaxoSmithKline

Tue, 20 Sep 2016 00:00:00 GMT

Emma Walmsley, currently CEO of GSK’s Consumer Healthcare division, is appointed GSK CEO Designate and will succeed Andrew Witty as GSK CEO.

GSK sets out further steps to address emerging global health security challenges

Mon, 19 Sep 2016 00:00:00 GMT

GSK will set out a series of steps to further address emerging global health challenges

GSK’s candidate shingles vaccine shows high efficacy against shingles and its complications in adults aged 70 years and over in phase III study published in NEJM

Wed, 14 Sep 2016 00:00:00 GMT

GSK on track to file regulatory applications in 2016

GSK announces EU regulatory submission for sirukumab in rheumatoid arthritis

Mon, 12 Sep 2016 00:00:00 GMT

Sirukumab is being co-developed for RA as part of a collaboration with Janssen Biologics (Ireland) [Janssen].

GSK divests non-core assets to Aspen

Mon, 12 Sep 2016 00:00:00 GMT

A series of agreements Between Aspen and GSK through focusing on core therapeutic areas

GSK presents positive results from phase III FULFIL study of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in COPD at ERS International Congress

Tue, 06 Sep 2016 00:00:00 GMT

Improvements in lung function and health-related quality of life supported by statistically significant reductions in exacerbations

‘Real world’ data shows 83 percent effectiveness for Bexsero® in infants in first year of UK national meningitis B immunisation programme

Mon, 05 Sep 2016 00:00:00 GMT

Cases of meningitis B halved after ten months

GSK announce positive results from the COPD Salford Lung Study published in the NEJM and presented at European Respiratory Congress

Sun, 04 Sep 2016 00:00:00 GMT

The results from the pioneering Salford Lung Study (SLS) have been published in the New England Journal of Medicine (NEJM).

NEJM publishes results of GSK’s long-term LABA safety study of Advair® Diskus® in children aged 4-11 years with asthma

Thu, 01 Sep 2016 00:00:00 GMT

Headline results reported in March, demonstrated that the study had achieved its primary endpoint.

GSK’s continued commitment to innovative respiratory research demonstrated in European Respiratory Society congress data presentations

Sat, 27 Aug 2016 00:00:00 GMT

More than 30 abstracts from the company will be featured at the meeting.

ViiV Healthcare launches phase III programme evaluating a two-drug regimen combining dolutegravir and lamivudine for HIV-1 treatment

Tue, 16 Aug 2016 00:00:00 GMT

HIV care is a long-term prospect for those living with the disease, requiring life-long adherence to treatment.

GSK and Verily to establish Galvani Bioelectronics – a new company dedicated to the development of bioelectronic medicines

Mon, 01 Aug 2016 00:00:00 GMT

GSK will hold a 55% equity interest in the new jointly owned company and Verily will hold 45%.

GSK in-licenses anti-IL-33R monoclonal antibody for severe asthma from Janssen

Wed, 27 Jul 2016 00:00:00 GMT

Agreement further strengthens respiratory pipeline of targeted biological therapies

Results announcement for the second quarter 2016 and half-yearly financial report for the half-year 2016

Wed, 27 Jul 2016 00:00:00 GMT

GSK delivers further progress against strategy with strong Q2 performance

GSK announces significant new investment in UK manufacturing network

Wed, 27 Jul 2016 00:00:00 GMT

GSK today announced £275 million of new investments at three of its manufacturing sites in the UK

ARIA study shows superior efficacy of Triumeq® for treatment-naïve women living with HIV

Mon, 18 Jul 2016 00:00:00 GMT

ViiV Healthcare today presented 48-week data from the phase IIIb, open-label, international, multi-centre ARIA study

GSK and Save the Children call for developing country innovations to enter $1 million award

Thu, 07 Jul 2016 00:00:00 GMT

GSK and Save the Children today launched their fourth annual $1 million Healthcare Innovation Award.

Update on GSK’s response to the Zika virus disease outbreak

Thu, 07 Jul 2016 00:00:00 GMT

Since the outbreak of Zika virus disease began in the Americas late last year, GSK has been assessing how we can best help to respond.

GSK announces start of phase I oncology study with its ICOS agonist antibody

Thu, 30 Jun 2016 00:00:00 GMT

The start of a phase I clinical trial with GSK3359609, an investigational inducibile T-cell costimulator (ICOS) agonist antibody

FULFIL study shows superiority of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in improving lung function and health-related quality of life in COPD patients

Mon, 20 Jun 2016 00:00:00 GMT

FULFIL - Lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy

Executive Director Change

Tue, 14 Jun 2016 00:00:00 GMT

Dr Moncef Slaoui, Chairman, Vaccines, has indicated to the Board his intention to retire from the Company in 2017.

ViiV Healthcare announces FDA approval to lower the weight limit for dolutegravir in children and adolescents living with HIV

Fri, 10 Jun 2016 00:00:00 GMT

The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for dolutegravir 10mg and 25mg oral tablets.

New Phase III data shows greater treatment response with GSK’s Benlysta® (belimumab) vs placebo in patients with highly active SLE

Wed, 08 Jun 2016 00:00:00 GMT

BLISS-SC builds on an extensive clinical trial programme for belimumab, which is the largest clinical programme in SLE to date.

GSK announces phase III study of sirukumab meets both co-primary endpoints in patients with rheumatoid arthritis

Wed, 08 Jun 2016 00:00:00 GMT

The results from the positive SIRROUND-D study are being presented at the Annual European Congress of Rheumatology (EULAR 2016) in London.

ViiV Healthcare announces public tender agreement with Botswana Ministry of Health for dolutegravir

Fri, 03 Jun 2016 00:00:00 GMT

Agreement supports the first ‘Treat All’ programme for HIV in sub-Saharan Africa, where 70% of people with HIV live

Regulatory update on US filing plans for closed triple combination therapy FF/UMEC/VI in patients with COPD

Thu, 02 Jun 2016 00:00:00 GMT

Acceleration of filing of US New Drug Application now expected by end of 2016

Board and Committee changes

Fri, 27 May 2016 00:00:00 GMT

Dr Vivienne Cox, CBE, has been appointed to the Board of the Company as a Non-Executive Director with effect from 1 July 2016.

StrimvelisTM receives European marketing authorisation to treat very rare disease, ADA-SCID

Fri, 27 May 2016 00:00:00 GMT

GSK, Fondazione Telethon and Ospedale San Raffaele gain approval to provide life-saving gene therapy to patients.

GSK, Fondazione Telethon and Ospedale San Raffaele announce publication of pivotal safety and efficacy of gene therapy for children with ADA-SCID

Wed, 25 May 2016 00:00:00 GMT

GSK today announced the publication in BLOOD of the long-term safety and efficacy data from an analysis of 18 children with ADA-SCID

Salford Lung Study results show COPD patients treated with Relvar® Ellipta® achieve superior reduction in exacerbations compared with ‘usual care’

Tue, 24 May 2016 00:00:00 GMT

Pioneering GSK study provides important new data on the effectiveness of Relvar Ellipta (FF/VI) when used in everyday clinical practice.

GSK presents new data from Breo® Ellipta® SUMMIT study in patients with COPD at ATS Conference

Wed, 18 May 2016 00:00:00 GMT

GSK presents new data at the American Thoracic Society Conference from two pre-specified analyses from the Study

GSK presents efficacy data for Anoro® Ellipta® in COPD patients who remained symptomatic on tiotropium

Wed, 18 May 2016 00:00:00 GMT

GSK and Innoviva, Inc. announce results from data presented at the American Thoracic Society 2016 conference

GSK’s Bexsero®▼achieves primary and secondary endpoints with reduced 3-dose schedule (2+1) in safety and immunogenicity study in infants and children

Fri, 13 May 2016 00:00:00 GMT

GSK today presented new data for its meningococcal group B vaccine, Bexsero®,1 [Meningococcal group B Vaccine (rDNA, component, adsorbed)]

European agency endorses antiseptic gel, developed through GSK and Save the Children partnership, for newborn umbilical cord infections in developing countries

Fri, 29 Apr 2016 00:00:00 GMT

Milestone for GSK and Save the Children partnership and its mission to help save the lives of children in the world’s poorest communities

Results announcement for the first quarter 2016

Wed, 27 Apr 2016 00:00:00 GMT

GSK delivers Q1 performance of £6.2 b (+8% CER), core EPS 19.8p (+8% CER); dividend of 19p 2016 core EPS growth expected to be 10-12% CER

GSK statement on pneumococcal vaccine pricing

Wed, 27 Apr 2016 00:00:00 GMT

For many years we have been working hard, in partnership with others, to develop vaccines against infectious diseases

ViiV Healthcare extends Medicines Patent Pool licence agreement for dolutegravir to cover all lower middle-income countries

Mon, 25 Apr 2016 00:00:00 GMT

Follows announcement by majority shareholder GSK to expand graduated approach to patents and intellectual property (IP)

GSK announces start of a phase II study to evaluate an anti GM-CSF antibody for inflammatory hand osteoarthritis

Mon, 18 Apr 2016 00:00:00 GMT

Phase II study evaluates efficacy and safety of an investigational anti-granulocyte macrophage colony-stimulating factor monoclonal antibody

GSK opens new state of the art respiratory manufacturing facility in Ware, UK

Mon, 18 Apr 2016 00:00:00 GMT

GSK today opens a £56 million state of the art manufacturing facility, creating 150 new jobs in the UK,

GSK receives positive CHMP opinion in Europe for Strimvelis™, the first gene therapy to treat very rare disease, ADA-SCID

Fri, 01 Apr 2016 00:00:00 GMT

GSK announces a positive opinion recommending marketing authorisation for Strimvelis

GSK expands graduated approach to patents and intellectual property to widen access to medicines in the world’s poorest countries

Thu, 31 Mar 2016 00:00:00 GMT

GSK has a deep commitment to improving healthcare by developing innovative new medicines and widening access to them around the world.

GSK receives marketing authorisation for Nucala® (mepolizumab) in Japan

Tue, 29 Mar 2016 00:00:00 GMT

The Japanese Ministry of Health, Labour and Welfare has granted approval for Nucala® (mepolizumab) as a treatment for bronchial asthma.

Sir Andrew Witty to retire from GSK in March 2017

Thu, 17 Mar 2016 00:00:00 GMT

GSK plc today announced that Sir Andrew Witty, CEO, has indicated to the Board his intention to retire from the company in early 2017

GlaxoSmithKline plc (the “Company”) Directorate changes

Thu, 17 Mar 2016 00:00:00 GMT

Sir Deryck Maughan, Dr Stephanie Burns, Dr Daniel Podolsky and Hans Wijers will not stand for re-election to the Board at GSK’s AGM

GSK’s Advair® Diskus® achieves primary endpoint in LABA safety study of children aged 4-11 years with asthma

Thu, 17 Mar 2016 00:00:00 GMT

GSK today announced results from the paediatric ‘LABA’ (long acting beta2-agonist) safety study.

GSK and Miltenyi Biotec establish cell and gene therapy collaboration

Wed, 16 Mar 2016 00:00:00 GMT

Collaboration includes discovery programme for CAR-T cell-based oncology therapies

GSK presents data at AAAAI on efficacy of Nucala® (mepolizumab) in severe asthma patients stratified by eosinophil levels

Mon, 07 Mar 2016 00:00:00 GMT

GSK today presented results at the American Academy of Allergy, Asthma & Immunology annual meeting from a post-hoc study

NEJM publishes results of GSK’s long-term LABA safety study of Advair ® Diskus® in adults and adolescents with asthma

Sun, 06 Mar 2016 00:00:00 GMT

GSK today announced publication of results from the ‘LABA’ (long acting beta2-agonist) safety study, AUSTRI (SAS115359)

GSK presents new data on the long-term efficacy & safety of Nucala® for the treatment of severe asthma with an eosinophilic phenotype

Sat, 05 Mar 2016 00:00:00 GMT

GSK today presented new safety and efficacy data for Nucala® (mepolizumab)

GSK names winners of 2015 Discovery Fast Track Challenge

Fri, 04 Mar 2016 00:00:00 GMT

Six winning proposals were selected from 378 entries submitted from 21 countries across Europe and North America

New long-term organ damage analysis published for GSK’s Benlysta® (belimumab)

Thu, 03 Mar 2016 00:00:00 GMT

Patients with SLE are at risk of irreversible organ damage which will accrue over time and is associated with increased risk of death1.

ViiV Healthcare announces first phase II HIV prevention study results for investigational long-acting injectable cabotegravir

Wed, 24 Feb 2016 00:00:00 GMT

Results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.

ViiV Healthcare announces phase II study results for first two drug, long-acting injectable regimen for HIV-1 treatment

Tue, 23 Feb 2016 00:00:00 GMT

32 week maintenance data presented at CROI showed comparable viral suppression rates between injectable regimen and three drug oral regimen

Four inspiring innovations which help reduce child deaths in developing countries share $1 million prize from GSK and Save the Children

Tue, 23 Feb 2016 00:00:00 GMT

Healthcare Innovation Award is a major initiative within five-year partnership to help save one million children’s lives

GSK’s global HIV business ViiV Healthcare completes transactions to acquire Bristol-Myers Squibb’s R&D HIV assets

Mon, 22 Feb 2016 00:00:00 GMT

ViiV Healthcare has completed two previously announced transactions with Bristol-Myers Squibb

Results announcement for the fourth quarter 2015

Wed, 03 Feb 2016 00:00:00 GMT

GSK delivers further progress with 2015 sales of £24 billion (+6%), core EPS 75.7p (-15%) and total EPS 174.3p, +>100% CER 2016

GSK announces US regulatory submission seeking expanded indication for FluLaval® Quadrivalent (Influenza Vaccine) for infants 6 mos+

Tue, 02 Feb 2016 00:00:00 GMT

This vaccine is currently approved for active immunisation against influenza A subtype viruses and type B viruses

GSK and Adaptimmune expand strategic immunotherapy collaboration

Tue, 02 Feb 2016 00:00:00 GMT

GSK and Adaptimmune Therapeutics have expanded the terms of their strategic collaboration agreement

Global pharmaceutical industry calls on governments to work with them to beat the rising threat of drug resistance

Thu, 21 Jan 2016 00:00:00 GMT

Governments and industry called on to work in parallel in taking comprehensive action against drug-resistant infections

ViiV Healthcare to progress collaboration with Janssen to develop the first long-acting, two drug injectable regimen for treatment of HIV-1 infection

Thu, 07 Jan 2016 00:00:00 GMT

ViiV Healthcare, Pfizer Inc. and Shionogi Limited with Janssen for cabotegravir and rilpivirine for the treatment of HIV-1 infection.

GSK appoints Dr Jesse Goodman to the Board as a Non-Executive Director

Wed, 23 Dec 2015 00:00:00 GMT

Dr Jesse Goodman has been appointed to the Board of the Company as a Non-Executive Director and Scientific and Medical Expert

GSK completes divestment of rights to ofatumumab for auto-immune indications to Novartis

Mon, 21 Dec 2015 00:00:00 GMT

GSK announced completion of its divesting of rights to ofatumumab for auto-immune indications to Novartis Pharma following reg. approval.

GSK’s global HIV business ViiV Healthcare to acquire Bristol-Myers Squibb’s R&D HIV assets

Fri, 18 Dec 2015 07:00:00 GMT

Two transactions further strengthen HIV pipeline and outlook

GSK receives positive top-line results from sirukumab phase III programme supporting regulatory filings for rheumatoid arthritis in 2016

Wed, 16 Dec 2015 14:00:00 GMT

GSK today announced it has received positive top-line results from the phase III programme investigating sirukumab

Comic Relief and GSK form five-year partnership to fight malaria and strengthen health systems

Tue, 15 Dec 2015 08:00:00 GMT

A five-year partnership to fight malaria and improve health in five countries has today been launched by Comic Relief and GSK.

GSK receives European marketing authorisation for Nucala® (mepolizumab) in 31 countries

Wed, 02 Dec 2015 00:00:00 GMT

GSK announced that EMA has granted marketing authorisation for Nucala® as an add-on treatment for severe refractory eosinophilic asthma

GSK announces start of phase III study of sirukumab in Giant Cell Arteritis

Wed, 25 Nov 2015 00:00:00 GMT

GSK announced that dosing has commenced in a phase III study evaluating sirukumab.

GSK receives European marketing authorisation to expand indication for Volibris® in treatment of pulmonary arterial hypertension

Tue, 24 Nov 2015 00:00:00 GMT

GSK today announced that the European Commission has approved a variation to expand the current therapeutic indication for Volibris®

GSK announces positive results from phase III BLISS-SC study of Benlysta® (belimumab) administered subcutaneously in patients with systemic lupus erythematosus

Sat, 07 Nov 2015 00:00:00 GMT

GSK announces positive results from phase III BLISS-SC study of Benlysta® (belimumab) in patients with systemic lupus erythematosus

GSK’s Nucala® (mepolizumab) receives approval from US FDA

Wed, 04 Nov 2015 00:00:00 GMT

First anti-IL5 treatment for adults and adolescents with severe asthma with an eosinophilic phenotype

ViiV Healthcare announces positive headline results from a study of two drug injectable regimen for HIV maintenance therapy

Tue, 03 Nov 2015 12:00:00 GMT

ViiV ,Pfizer and Shionogi today announced that the Phase IIb study LATTE 2 (NCT02120352) met its primary endpoint at 32 weeks

GSK and Merck to study immunotherapy combination as potential cancer treatment

Tue, 03 Nov 2015 12:00:00 GMT

Phase I human study to evaluate GSK’s OX40 agonist GSK3174998 as monotherapy and in combination with Merck’s anti-PD-1 therapy, Keytruda®

GSK profiles innovative R&D portfolio to investors

Tue, 03 Nov 2015 11:55:00 GMT

40 potential new medicines and vaccines offer opportunity to drive long-term performance and deliver new benefits to patients and consumers

Results announcement for the third quarter 2015

Wed, 28 Oct 2015 12:00:00 GMT

Q3 sees continued progress in execution of Group strategy Sales of £6.1 billion (+11% CER) and core EPS of 23.0p (-13% CER)

GSK’s candidate shingles vaccine demonstrates 90% efficacy against shingles in people 70 years of age and over

Tue, 27 Oct 2015 10:55:00 GMT

GSK today announced that the second pivotal phase III study of its candidate vaccine Shingrix™ successfully met its primary objective

GSK provides update on LATITUDE-TIMI 60 (losmapimod cardiovascular study)

Tue, 27 Oct 2015 10:45:00 GMT

GSK announced that its losmapimod phase III study, review of data from part A,3,503 patients did not indicate efficacy against larger part B

GSK’s Advair® Diskus® achieves primary endpoint in LABA safety study of patients with asthma

Tue, 27 Oct 2015 00:00:00 GMT

GlaxoSmithKline plc (GSK) today announced results from the ‘LABA’ (long acting beta2-agonist) safety study, AUSTRI (SAS115359).

GSK receives CHMP positive opinion to expand indication for Volibris® in pulmonary arterial hypertension

Fri, 23 Oct 2015 00:00:00 GMT

GSK receives CHMP positive opinion to expand indication for Volibris® in pulmonary arterial hypertension

GSK announces positive new data comparing Incruse® Ellipta® to tiotropium and glycopyrronium in patients with COPD

Tue, 20 Oct 2015 00:00:00 GMT

GSK announced positive results from comparing umeclidinium to two available bronchodilator treatments when used by patients with COPD.

GSK submits regulatory application for chlorhexidine gel for the prevention of umbilical cord infections in newborn babies

Mon, 12 Oct 2015 00:00:00 GMT

GSK announced it's submitted an application to EMA for antiseptic chlorhexidine gel for the prevention omphalitis in newborn babies.

GSK presents post-hoc analysis of Anoro® Ellipta® data assessing markers of COPD deterioration compared to tiotropium or placebo using a novel composite endpoint

Sun, 27 Sep 2015 00:00:00 GMT

GSK and THRX today announced data presented by GSK at the European Respiratory Society (ERS) International Congress (poster PA1001)

Regulatory update: GSK and Theravance announce intention to file Relvar® Ellipta® for COPD in Japan

Thu, 24 Sep 2015 00:00:00 GMT

GSK and THRX announced intention to file sJNDA for Relvar® Ellipta® for the treatment of COPD with the Japanese authority during the Q12016.

GSK receives positive CHMP opinion in Europe for novel anti-IL5 biological Nucala (mepolizumab) for the treatment of patients with severe refractory eosinophilic asthma

Thu, 24 Sep 2015 00:00:00 GMT

GSK today announced that the CHMP of EMA issued a positive opinion recommending marketing authorisation for mepolizumab

New Phase IIIb/IV data show switching to once-daily Triumeq® maintains HIV viral suppression

Wed, 23 Sep 2015 00:00:00 GMT

ViiV Healthcare today announced 24-week data from the Phase IIIb/IV STRIIVING study

GSK starts build of its largest Indian tablet manufacturing pharmaceutical factory in Vemgal, Karnataka

Tue, 08 Sep 2015 00:00:00 GMT

Hon’ble Chief Minister of Karnataka, Shri Siddaramaiah lays the foundation stone of the new pharmaceutical factory

GSK and Theravance announce results from the SUMMIT COPD CV Survival Study

Tue, 08 Sep 2015 00:00:00 GMT

GSK and THRX announced initial results from study for Relvar®Breo® Ellipta® 100/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’).

GSK announces NEJM publication of Phase 3b/4 study of ambrisentan and tadalafil as first-line combination treatment in patients with pulmonary arterial hypertension

Wed, 26 Aug 2015 00:00:00 GMT

GSK today announced publication of first-line combination therapy of ambrisentan and tadalafil in treatment-naïve patients with PAH.

GSK to divest ofatumumab for auto-immune indications to Novartis for up to $1 billion plus royalties

Fri, 21 Aug 2015 06:30:00 GMT

GSK announced an agreement with Novartis Pharma to divest its rights in ofatumumab for auto-immune indications, incl. multiple sclerosis.

Results Announcement for the second quarter 2015

Wed, 29 Jul 2015 12:00:00 GMT

GSK delivers Q2 Group sales of £5.9 billion +7% CER and core EPS of 17.3p (flat CER) in first full quarter of performance since transaction

GSK’s Synflorix™ receives CHMP positive opinion for major label extension

Mon, 27 Jul 2015 00:00:00 GMT

GSK announced that the CHMP of EMA has issued a positive opinion for the expansion of the SynflorixTM European label

GSK’s malaria candidate vaccine, Mosquirix™ (RTS,S), receives positive opinion from European regulators for the prevention of malaria in young children in sub-Saharan Africa

Fri, 24 Jul 2015 06:00:00 GMT

GSK announced that the CHMP of EMA has adopted a positive scientific opinion for its malaria candidate vaccine Mosquirix.

GSK and Save the Children launch 2015 call for developing country healthcare innovations to reduce child deaths

Wed, 15 Jul 2015 00:00:00 GMT

GSK and Save the Children announce the launch of their third annual $1 million Healthcare Innovation Award.

GSK and the Francis Crick Institute join forces in collaboration to forge new scientific discoveries

Tue, 14 Jul 2015 08:00:00 GMT

The Francis Crick Institute and GSK to partner on an innovation collaboration exploring new avenues of medical research and drug discovery

Regulatory update on divestment of Nimenrix and Mencevax

Mon, 22 Jun 2015 00:00:00 GMT

GSK is divesting its meningitis vaccines Nimenrix and Mencevax to Pfizer Ireland Pharmaceuticals (a subsidiary of Pfizer Inc).

GSK to create independent research institute with goal of radically changing and improving medicines development

Tue, 16 Jun 2015 00:00:00 GMT

Seattle-based Altius Institute for Biomedical Sciences to pioneer new understanding of cell “operating systems”

GSK announces outcome of US FDA Advisory Committee recommending approval of mepolizumab for the treatment of adults with severe asthma

Thu, 11 Jun 2015 00:00:00 GMT

GSK announced outcome regarding the BLA for mepolizumab as an add-on maintenance treatment for severe asthma with eosinophilic inflammation.

GSK submits Japan regulatory application for mepolizumab in severe eosinophilic asthma

Fri, 22 May 2015 00:00:00 GMT

GSK announced application to the Japanese MHLW for mepolizumab as add-on maintenance treatment for patients with severe eosinophilic asthma

GSK to support training of frontline health workers across Ghana, Kenya and Nigeria

Fri, 22 May 2015 00:00:00 GMT

GSK is to support the training of more than 9,000 health workers in Ghana, Kenya and Nigeria over the next three years.

GSK presents data at ATS on the role of blood eosinophil levels as a potential biomarker in the treatment of COPD

Tue, 19 May 2015 00:00:00 GMT

GSK presented data on the role of blood eosinophils as a potential biomarker to determine responsiveness to treatment with ICS

GSK’s ECLIPSE study shows association between improving health status and reduced morbidity and mortality in patients with COPD

Mon, 18 May 2015 00:00:00 GMT

keeping stable health status in patients with COPD significantly reduces the likelihood of exacerbation, hospital admission and dying.

GSK responds to latest report from the O’Neill Review on antibiotic resistance

Thu, 14 May 2015 00:00:00 GMT

It is essential that we find new ways to increase antibiotics R&D and create a future pipeline of new treatments.

GSK and UNC-Chapel Hill announce novel partnership to accelerate search for HIV cure

Sun, 10 May 2015 00:00:00 GMT

Unique collaboration will create HIV Cure center and a new company to bring together academic and pharmaceutical research scientists

GlaxoSmithKline plc announces Board and Committee changes

Thu, 07 May 2015 00:00:00 GMT

GSK today announces that Manvinder Singh (Vindi) Banga will join GSK’s Board as a Non-Executive Director on 1 September 2015.

ViiV Healthcare begins phase III programme with dolutegravir/rilpivirine combination for HIV maintenance therapy

Wed, 06 May 2015 00:00:00 GMT

ViiV announced the start of a phase III clinical trial for the safety and efficacy of dolutegravir&rilpivirine for adult patients with HIV.

Results announcement for the first quarter 2015

Wed, 06 May 2015 00:00:00 GMT

GSK reports Q1 sales of £5.6 billion; Core EPS of 17.3p (-16%) CER

GSK, Fondazione Telethon and Ospedale San Raffaele announce EU regulatory submission for gene therapy to treat rare disease ADA-SCID

Tue, 05 May 2015 00:00:00 GMT

Today announced the submission of a marketing application to the EMA for a gene therapy (GSK2696273) to treat patients with a rare disease

FDA approves BREO® ELLIPTA® for the treatment of adults with asthma in the US

Thu, 30 Apr 2015 00:00:00 GMT

GSK and THRX announced approved once-daily treatment of asthma in patients aged 18+ BreoEllipta is not for the relief of acute bronchospasm.

GSK candidate vaccine for the prevention of shingles demonstrates overall efficacy of 97.2 which does not diminish in the age groups studied

Tue, 28 Apr 2015 00:00:00 GMT

Shingles is a significant public health burden, more than 90% of adults aged 50 years and over are at risk.

Malaria vaccine candidate has demonstrated efficacy over 3-4 years of follow-up

Fri, 24 Apr 2015 00:00:00 GMT

Final results from a large-scale Phase III trial of the RTS,S malaria vaccine candidate published today in The Lancet.

GSK to establish global vaccines R&D centre in the US

Thu, 02 Apr 2015 00:00:00 GMT

New hub based in Rockville, MD expands GSK’s global vaccines R&D footprint

GSK statement on meningitis vaccination in the UK

Sun, 29 Mar 2015 00:00:00 GMT

GSK reached an agreement with the UK’s Department of Health that will enable babies to receive its meningitis B vaccine through the NHS

GSK receives approval for Encruse® Ellipta® in Japan for the treatment of COPD

Thu, 26 Mar 2015 00:00:00 GMT

Two further GSK products, Duac® Combination Gel and Synflorix™, also gain approval in Japan.

GSK’s 2015 Discovery Fast Track Challenge seeks early drug discovery partnerships with academics in Europe, Canada and US

Tue, 24 Mar 2015 00:00:00 GMT

GSK is encouraging scientists to submit their novel early drug discovery research proposals into its Discovery Fast Track Challenge

GSK and Theravance announce outcome of US FDA Advisory Committee on BREO® ELLIPTA® in asthma

Thu, 19 Mar 2015 00:00:00 GMT

GSK and THRX announced the outcome of the joint meeting for a once-daily inhaled treatment for asthma in patients aged 12 years and older.

GSK announces start of phase III programme to evaluate retosiban for spontaneous preterm labour

Tue, 17 Mar 2015 01:00:00 GMT

GSK today announced the start of a phase III programme to evaluate the efficacy of retosiban, an investigational oxytocin antagonist.

GSK becomes partner in new global fund to accelerate dementia research

Tue, 17 Mar 2015 00:00:00 GMT

Company makes $25m (approx £17m) investment in first-of-its-kind venture capital fund focused on dementia

GSK transaction

Fri, 13 Mar 2015 00:00:00 GMT

Exclusively intended for persons who are not residents of the United States and who are not physically present in the United States.

GSK transaction launch

Thu, 12 Mar 2015 00:00:00 GMT

Exclusively intended for persons who are not residents of the United States and who are not physically present in the United States

GSK announces major new commitment to Asia

Tue, 10 Mar 2015 00:00:00 GMT

GlaxoSmithKline (GSK) is strengthening its presence in Singapore by establishing a new global headquarters for Asia

GSK completes major three-part transaction with Novartis

Mon, 02 Mar 2015 00:00:00 GMT

GSK has acquired Novartis’s global Vaccines business (excluding influenza vaccines) for an initial cash consideration of $5.25 billion

GlaxoSmithKline plc announces changes to its Board

Thu, 26 Feb 2015 00:00:00 GMT

GSK today announces that Sir Christopher Gent will step down as Chairman of GSK at the Company’s Annual General Meeting on 7 May 2015

Update on three-part transaction with Novartis

Wed, 25 Feb 2015 00:00:00 GMT

GSK today announces good progress on obtaining clearances and approvals to enable completion of its three-part transaction with Novartis

GSK strengthens early stage vaccine pipeline with acquisition of GlycoVaxyn AG

Wed, 11 Feb 2015 00:00:00 GMT

GSK today announced that it has acquired GlycoVaxyn AG, a specialist vaccine biopharmaceutical company based in Switzerland.

GSK and Theravance announce start of phase III lung function study with ‘closed’ triple combination treatment FF/UMEC/VI for COPD

Mon, 09 Feb 2015 00:00:00 GMT

GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the start of a second global phase III study

GSK announces positive overall survival results from phase III COMBI-d study of dabrafenib (Tafinlar™) and trametinib (Mekinist™) combination

Fri, 06 Feb 2015 00:00:00 GMT

GSK today announced overall survival results from COMBI-d which demonstrate a statistically significant reduction in the risk of death

GSK announces EU regulatory submission seeking additional indication for eltrombopag (Revolade™)

Fri, 06 Feb 2015 00:00:00 GMT

GSK today announced the submission to the European Medicines Agency of a variation to the Marketing Authorisation for eltrombopag (Revolade)

Results announcement for the fourth quarter 2014

Wed, 04 Feb 2015 00:00:00 GMT

GSK delivers 2014 core EPS of 95.4p (-1% CER excluding divestments) and dividend of 80 pence per share (+3%)

Four initiatives from across Africa win share of global US$1 million Healthcare Innovation Award

Thu, 29 Jan 2015 00:00:00 GMT

Organisations from South Africa, Zambia, Kenya and Uganda and Save the Children for innovations proven to help reduce deaths in under-fives

Regulatory update on three-part transaction with Novartis

Wed, 28 Jan 2015 00:00:00 GMT

GlaxoSmithKline plc (GSK) has today received clearance from the European Commission of its proposed three-part transaction with Novartis

GSK statement on Oxford University phase I trial results of an Ebola candidate vaccine

Wed, 28 Jan 2015 00:00:00 GMT

Results from a phase I trial published by Oxford University show that a GSK/NIH Ebola vaccine demonstrated an acceptable safety profile

Board Committee change

Tue, 27 Jan 2015 00:00:00 GMT

GSK announces that Sir Philip Hampton has been appointed Chairman of the Nominations Committee (the “Committee”) with effect from today

GSK extends its price-freeze commitment to ten years for countries graduating from Gavi support

Mon, 26 Jan 2015 00:00:00 GMT

New extended price freeze enables countries that graduate from Gavi support to continue to pay the same discounted price for GSK vaccines

Major milestone for GSK/NIH candidate Ebola vaccine as first doses shipped to Liberia for use in phase III clinical trial

Fri, 23 Jan 2015 00:00:00 GMT

Healthcare workers among those to be vaccinated in large-scale trial involving up to 30,000 people due to start in the coming weeks

GSK ‘confronts COPD’ to deliver new insights from across the globe to promote improved management of chronic lung disease

Thu, 22 Jan 2015 00:00:00 GMT

Data published today suggests, that long-term health outlook for patients with chronic obstructive pulmonary disease (COPD) has improved.

GSK announces US regulatory submission seeking additional indication for eltrombopag (Promacta™)

Mon, 22 Dec 2014 00:00:00 GMT

GSK announced the submission of sNDA to the US Food and Drug Administration for eltrombopag (Promacta™)

Pivotal phase III study of GSK shingles candidate vaccine meets its primary endpoint

Thu, 18 Dec 2014 00:00:00 GMT

GSK announced a phase III study to assess the efficacy of HZ/su, investigational vaccine for shingles, has met its primary endpoint.

New European consortium formed to help further advance development of a GSK/NIH Ebola candidate vaccine

Tue, 16 Dec 2014 00:00:00 GMT

Consortium includes GSK and research partners from Oxford, Centre Hospitalier Universitaire Vaudois in Lausanne and the Bernhard-Nocht

GSK announces EU regulatory submission seeking extended indication for ambrisentan (Volibris®) in pulmonary arterial hypertension

Thu, 11 Dec 2014 00:00:00 GMT

GSK announced that it has filed a regulatory submission to the EMA for a variation to the Marketing Authorisation for ambrisentan(Volibris®)

GSK statement on Established Products Portfolio

Thu, 04 Dec 2014 00:00:00 GMT

GSK started a process to consider the divestment of certain North American and European brands in its Established Products Portfolio.

GSK names winners of 2014 Discovery Fast Track Challenge

Mon, 01 Dec 2014 00:00:00 GMT

GSK announced the winners of its second Discovery Fast Track Challenge for academic researchers & drug discovery scientists at GSK

GSK statement on first phase 1 trial results of a candidate Ebola vaccine

Wed, 26 Nov 2014 00:00:00 GMT

Results from phase 1 trial published in NEJM show that GSK/NIH Ebola candidate vaccine was well-tolerated in the 20 healthy adult volunteers

Regulatory update on transaction with Novartis

Wed, 26 Nov 2014 00:00:00 GMT

GSK providing AN update relating to the major three-part transaction with Novartis AG (the Original Announcement).

Publication of Circular and Notice of General Meeting relating to the proposed major transaction with Novartis

Mon, 24 Nov 2014 00:00:00 GMT

GSK announced a major conditional transaction with Novartis involving its Consumer Healthcare, Vaccines and Oncology businesses

GSK leads Access to Medicine Index 2014

Mon, 17 Nov 2014 00:00:00 GMT

The Access to Medicines Index published today has ranked GSK top for the fourth consecutive time.

New England Journal of Medicine publishes positive results from COMBI-v study of trametinib (Mekinist™) and dabrafenib (Tafinlar™) combination

Sun, 16 Nov 2014 00:00:00 GMT

Results published in NEJM show that treatment with trametinib (Mekinist™) & Tafinlar™ improved OS compared to vemurafenib monotherapy

GSK launches first call for proposals for research in to non-communicable diseases in sub-Saharan Africa

Fri, 14 Nov 2014 00:00:00 GMT

GSK launched first call for proposals for its Africa NCD Open Lab, to support much-needed scientific research into NCDs in Africa.

GSK announces EU regulatory submission seeking additional indication for eltrombopag (Revolade™) (1)

Wed, 12 Nov 2014 00:00:00 GMT

GSK announced submission to EMA for eltrombopag (Revolade™) for the treatment of patients with SAA who have insufficient response to IST.

GSK announces regulatory submissions for mepolizumab in severe eosinophilic asthma

Wed, 05 Nov 2014 00:00:00 GMT

GSK announced that it has filed regulatory submissions in the USA and Europe for mepolizumab for patients with severe eosinophilic asthma

Results announcement for the third quarter 2014

Wed, 22 Oct 2014 00:00:00 GMT

GSK announces Q3 core EPS of 27.9p +5% CER excluding divestments and dividend of 19 pence per share

GSK update on current development status of the GSK/NIH Ebola vaccine candidate

Sat, 18 Oct 2014 00:00:00 GMT

GSK is working WHO to accelerate development of our investigational Ebola vaccine and to ramp up production as quickly as possible

Data published on Anoro® Ellipta® demonstrate improved lung function compared to tiotropium

Fri, 17 Oct 2014 00:00:00 GMT

Respiratory Medicine has published positive results from a third lung function study comparing the efficacy and safety of Anoro® Ellipta®.

Stiefel, a GSK company, announces start of phase III study of subcutaneous ofatumumab for pemphigus vulgaris

Tue, 07 Oct 2014 00:00:00 GMT

Stiefel, announced phase III study to evaluate the efficacy and safety of subcutaneous ofatumumab in patients with pemphigus vulgaris

GSK appoints Mr Urs Rohner to its Board as a Non-Executive Director

Fri, 03 Oct 2014 00:00:00 GMT

GSK today announced the appointment of Mr Urs Rohner to its Board as a Non-Executive Director, effective 1 January 2015.

GSK commits further funding to advance bioelectronics research with creation of 5 million Innovation Challenge Fund

Tue, 30 Sep 2014 00:00:00 GMT

GSK announced, $5 million ICF to encourage and advance collaborative research as part of its effort to develop bioelectronic medicines.

GSK announces overall survival results from phase III BREAK-3 study of Tafinlar® (dabrafenib) in patients with BRAF V600E-mutant metastatic melanoma

Mon, 29 Sep 2014 00:00:00 GMT

GSK updated results for Tafinlar® from a planned analysis of the phase III BREAK-3 study in 250 patients with BRAFV600E metastatic melanoma.

GlaxoSmithKline plc appoints Sir Philip Hampton to the Board of Directors

Thu, 25 Sep 2014 00:00:00 GMT

GSK announced that Sir Philip Hampton will join the Board of the company as Non-Executive Director from 1 January 2015

International collaboration to develop inhaled form of oxytocin to manage bleeding after childbirth in developing countries

Thu, 25 Sep 2014 00:00:00 GMT

GSK, Monash University, McCall MacBain Foundation, Grand Challenges Canada and Planet Wheeler Foundation join forces

GSK China Investigation Outcome

Fri, 19 Sep 2014 00:00:00 GMT

GlaxoSmithKline plc (GSK) announced that China ruled that GSK China Investment Co. Ltd has, according to Chinese law been found guilty

GSK joins with research councils in UK and South Africa to tackle non-communicable diseases in Africa

Tue, 09 Sep 2014 00:00:00 GMT

GSK announced a £5m collaboration with UK and SAMRC, to support much-needed research into NCDs in Africa, part of GSK Open Lab initiative.

GSK data presented at ERS demonstrate potential of blood eosinophil levels to help inform COPD treatment decisions

Mon, 08 Sep 2014 00:00:00 GMT

GSK presented data at ERS Congress showing blood eosinophil levels may help predict patients with COPD when receiving an ICS regimen.

New England Journal of Medicine and ERS publish positive results from GSK phase III studies of mepolizumab in patients with severe eosinophilic asthma

Mon, 08 Sep 2014 00:00:00 GMT

NEJM presented at ERS data from Phase III asthma studies of mepolizumab, an investigational IL-5 antagonist monoclonal antibody.

GSK announces first-line combination of ambrisentan and tadalafil reduces risk of clinical failure compared to monotherapy in pulmonary arterial hypertension outcomes study

Mon, 08 Sep 2014 00:00:00 GMT

GSK announced, phase IIIb/IV study to investigate combination therapy of ambrisentan and tadalafil in treatment naïve patients...

GSK, GOLD and the COPD Foundation announce formation of a new external expert Governance Board for the COPD Assessment Test (CAT)

Mon, 08 Sep 2014 00:00:00 GMT

At the ERS International Congress in Germany, GSK, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) ...

ViiV Healthcare receives EU marketing authorisation for Triumeq® (dolutegravir/abacavir/lamivudine), a new once-daily single-pill regimen for the treatment of HIV

Wed, 03 Sep 2014 00:00:00 GMT

ViiV announced, the EC has granted marketing authorisation for Triumeq® for the treatment of HIV in those aged 12+ and weighing 40kg+.

Ebola vaccine trials fast-tracked by international consortium

Thu, 28 Aug 2014 00:00:00 GMT

Unprecedented international consortium assembled to accelerate collaborative multi-site trials of candidate Ebola vaccine

GSK's Promacta® (eltrombopag) receives FDA approval of an additional indication

Tue, 26 Aug 2014 00:00:00 GMT

New first-in-class treatment option for this previously treated SAA patient population

ViiV Healthcare receives FDA approval for Triumeq® (abacavir, dolutegravir and lamivudine), a new single-pill regimen for the treatment of HIV-1 infection

Fri, 22 Aug 2014 00:00:00 GMT

ViiV announced that the FDA has approved Triumeq® (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg), treatment of HIV-1 infection.

GSK receives FDA approval for Arnuity™ Ellipta® (fluticasone furoate) in the USA for the treatment of asthma

Wed, 20 Aug 2014 00:00:00 GMT

GSK announced that the FDA has approved Arnuity™ Ellipta® for treatment of asthma in patients aged 12 years and older.

GSK and Genmab announce positive interim result for phase III study of ofatumumab as maintenance therapy for relapsed CLL

Thu, 31 Jul 2014 00:00:00 GMT

GSK & GEN announced that an Independent Data Monitoring Committee (IDMC) interim analysis of a phase III study, PROLONG (OMB 112517)

FDA approves Flonase allergy relief for sale over-the-counter in the United States

Thu, 24 Jul 2014 00:00:00 GMT

No. 1 prescribed allergy treatment ingredient1 to be available OTC

GSK announces EU regulatory submission for malaria vaccine candidate RTS,S

Thu, 24 Jul 2014 00:00:00 GMT

GSK announced today that it has submitted a regulatory application to the EMA for its malaria vaccine candidate, RTS,S.

Results announcement for the second quarter 2014

Wed, 23 Jul 2014 00:00:00 GMT

GSK delivers Q2 2014 turnover £5.6 billion (-4%) and core EPS 19.1p (-12%) on ex-divestment basis (both CER). Q2 dividend 19p (+6%).

ViiV Healthcare presents phase III data

Tue, 22 Jul 2014 00:00:00 GMT

An investigational two drug-regimen of maraviroc with DRV/r showed inferior efficacy compared to emtricitabine/tenofovir with DRV/r.

Trametinib (Mekinist™) and dabrafenib (Tafinlar™) combination demonstrated overall survival benefit compared to vemurafenib; phase III BRAF V600-mutant metastatic melanoma study stopped early

Thu, 17 Jul 2014 00:00:00 GMT

GSK announced that the IDMC recommended COMBI-v phase III study of Mekinist™, in combination with Tafinlar™ be stopped early.

GSK and Theravance announce initiation of phase III programme with fixed dose triple combination treatment FF/UMEC/VI in patients with COPD

Wed, 16 Jul 2014 00:00:00 GMT

GSK and Theravance, Inc. today announced the start of a global phase III study, known as IMPACT.

Anoro® Ellipta® (umeclidinium/vilanterol) gains approval in Japan for the treatment of COPD

Fri, 04 Jul 2014 00:00:00 GMT

GSK & THRX announced that JMHLW has approved Anoro® Ellipta® (umeclidinium/vilanterol) for the relief of various symptoms with COPD

GSK receives EU marketing authorisation for Mekinist™ (trametinib) for patients with unresectable or metastatic melanoma with a BRAF V600 mutation

Fri, 04 Jul 2014 00:00:00 GMT

GSK announced, the EC has granted marketing authorisation for trametinib as treatment of patients with unresectable/metastatic melanoma

GSK and Genmab receive EU authorisation for Arzerra

Thu, 03 Jul 2014 00:00:00 GMT

GSK & GEN announced today that the EC has granted marketing authorisation for a new indication for the use of Arzerra™ (ofatumumab)...

GSK statement in response to recent media coverage related to our China business

Thu, 03 Jul 2014 00:00:00 GMT

Following media coverage, GSK has issued the below statement.

GSK statement on UK Government-initiated review of antibiotic resistance

Wed, 02 Jul 2014 00:00:00 GMT

We welcome today’s announcement of a review to explore the economic issues surrounding antimicrobial resistance.

GSK and Save the Children offer $1 million award for healthcare innovations in developing countries that reduce child deaths

Mon, 30 Jun 2014 00:00:00 GMT

GSK and Save the Children today announced the launch of their second annual $1 million Healthcare Innovation Award.

GSK and Theravance announce submission to US regulatory authorities for fluticasone furoate/vilanterol in asthma

Mon, 30 Jun 2014 00:00:00 GMT

GSK and THRX announced the submission of a new drug application for asthma in patients aged 12 years and older, brand name Breo® Ellipta®.

GSK statement on recent media coverage related to our China business

Mon, 30 Jun 2014 00:00:00 GMT

Following media coverage this weekend, GSK has issued the following statement.

GSK and Genmab announce top-line results from a Phase III study of ofatumumab versus physicians’ choice for bulky fludarabine-refractory CLL

Fri, 27 Jun 2014 00:00:00 GMT

GSK & GEN announced today that the Phase III study of ofatumumab (Arzerra™) did not meet its primary endpoint of PFS.

Triumeq® (dolutegravir/abacavir/lamivudine) single-tablet regimen receives positive CHMP opinion in Europe for the treatment of HIV

Fri, 27 Jun 2014 00:00:00 GMT

ViiV Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion.

GSK announces the start of a phase III study with eltrombopag in patients with myelodysplastic syndromes

Wed, 25 Jun 2014 00:00:00 GMT

GSK announced the start of a Phase III study to evaluate effects of eltrombopag with azacitidine versus placebo in patients with MDS.

GSK presents new data for once-weekly Tanzeum/Eperzan (albiglutide) showing blood glucose lowering up to three years in type 2 diabetes

Sat, 14 Jun 2014 00:00:00 GMT

Data from four randomised phase III studies show that patients on albiglutide, continued to show blood glucose lowering at three years.

GSK announces results of Phase III PETIT2 study of eltrombopag (Promacta™/Revolade™) in paediatric patients with chronic immune thrombocytopenia

Fri, 13 Jun 2014 00:00:00 GMT

GSK announced the results from the Phase III PETIT2 study evaluating efficacy of eltrombopag vs. placebo in paediatric patients with cITP

ViiV Healthcare announces new collaboration with Janssen to investigate single-tablet regimen for maintenance treatment of HIV-1

Thu, 12 Jun 2014 00:00:00 GMT

ViiV announced they have entered into an agreement with Janssen for the development and commercialisation of Tivicay® Edurant®.

GSK and Theravance announce positive data from two studies evaluating the efficacy and safety of Incruse™ Ellipta® when added to Relvar®/Breo® Ellipta® in patients with COPD

Wed, 11 Jun 2014 00:00:00 GMT

GSK and THRX today announced positive results from two phase III studies.

GSK announces start of phase III cardiovascular outcomes study with losmapimod in patients with acute coronary syndrome

Thu, 05 Jun 2014 00:00:00 GMT

GSK today announced the start of a pivotal phase III study to evaluate the effects of losmapimod in patients presenting with ACS.

GSK announces Phase III ALTTO results for anti-HER2 therapy combination in the adjuvant breast cancer treatment setting

Sun, 01 Jun 2014 00:00:00 GMT

GSK today announced that the Phase III study of two anti-HER2 agents, lapatinib (Tykerb™/Tyverb™) and trastuzumab.

Serious Fraud Office Investigation

Tue, 27 May 2014 00:00:00 GMT

GSK has today been informed by UK's SFO that it has opened a formal criminal investigation into the Group’s commercial practices.

GSK and Genmab receive FDA approval for Arzerra® (ofatumumab)

Fri, 23 May 2014 00:00:00 GMT

GSK and Genmab announced today that CHMP of the European Medicines Agency (EMA) has issued a positive opinion recommending a variation.

GSK announces regulatory submission for umeclidinium monotherapy for COPD in Japan

Fri, 23 May 2014 00:00:00 GMT

GSK announced the submission of a regulatory application to the JMHLW for UMEC, a LAMA, administered using the Ellipta™ dry powder inhaler.

GSK announces new commitment to improve access to vaccines with 5-year price freeze for countries graduating from GAVI Alliance support

Tue, 20 May 2014 00:00:00 GMT

GSK announced today that it will freeze the prices of its vaccines for 5 years for countries that graduate from GAVI Alliance support.

GSK presents positive data at ATS 2014 from study evaluating efficacy and safety of Incruse™ Ellipta® added to Advair® Diskus® in patients with COPD

Mon, 19 May 2014 00:00:00 GMT

GlaxoSmithKline plc (LSE:GSK) today presented data at the American Thoracic Society (ATS) from a late-stage clinical study.

motherapy for the treatment of relapsed or refractory diffuse large b-cell lymphoma

Mon, 19 May 2014 00:00:00 GMT

GSK & GEN announced that the Phase III study ORCHARRD of Arzerra™ or rituximab plus chemotherapy for DLBCL did not meet its primary endpoint

GSK comment: China investigation

Wed, 14 May 2014 00:00:00 GMT

Following media coverage today related to the investigation being conducted by the Chinese authorities into GSK China Ltd...

GSK announces phase III study with darapladib did not meet primary endpoint in patients following an acute coronary syndrome

Tue, 13 May 2014 00:00:00 GMT

GSK announced headline results from its second phase III study with darapladib evaluating efficacy in adults with acute coronary syndrome.

Anoro® (umeclidinium/vilanterol) gains marketing authorisation in Europe for the treatment of COPD

Thu, 08 May 2014 00:00:00 GMT

GSK & THRX announced that the European Commission has granted marketing authorisation for Anoro to relieve symptoms in patients with COPD.

GSK receives approval for Incruse™ Ellipta® (umeclidinium) in the US for the treatment of COPD

Wed, 30 Apr 2014 00:00:00 GMT

GSK announced that the FDA has approved umeclidinium as treatment of airflow obstruction in patients with COPD.

Results announcement for the first quarter 2014

Wed, 30 Apr 2014 00:00:00 GMT

Q1 turnover £5.6 billion, -2% (CER) on an ex-divestment* basis.

GSK announces start of phase III programme for mepolizumab in patients with COPD

Tue, 29 Apr 2014 00:00:00 GMT

GSK announced the start of a phase III programme to evaluate the efficacy and safety of mepolizumab for adults with COPD.

GSK and MMV announce start of phase III programme of tafenoquine for Plasmodium vivax malaria

Mon, 28 Apr 2014 00:00:00 GMT

GSK and Medicines for Malaria Venture (MMV) today announced the start of a phase III global programme.

GSK receives EU marketing authorisation for Incruse (umeclidinium) for the treatment of COPD

Mon, 28 Apr 2014 00:00:00 GMT

GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the European Commission has granted marketing authorisation for Incruse®

GSK receives positive CHMP opinion for Mekinist™ (trametinib) in metastatic melanoma with a BRAF V600 mutation

Fri, 25 Apr 2014 00:00:00 GMT

(LSE/NYSE: GSK) today announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on Mekinist™

GSK and Theravance announce phase III study of fluticasone furoate/vilanterol in COPD commenced to support potential future filing in Japan

Tue, 22 Apr 2014 00:00:00 GMT

GSK and THRX today announced the start of a Phase III efficacy and study of a combination treatment of the inhaled corticosteroid (ICS).

GSK plc announces major three-part transaction with Novartis to drive sustainable sales growth, improve long-term earnings and deliver increasing returns to shareholders

Tue, 22 Apr 2014 00:00:00 GMT

GSK announces a major conditional transaction with Novartis AG involving its Consumer Healthcare, Vaccines and Oncology businesses

GSK and Genmab receive FDA approval for Arzerra

Thu, 17 Apr 2014 00:00:00 GMT

GSK & GEN announced today that the FDA has approved a sBLA for Arzerra® (ofatumumab) for CLL

GSK announces approval in Canada for Incruse Ellipta (umeclidinium) as a treatment for COPD

Thu, 17 Apr 2014 00:00:00 GMT

GSK announced that Incruse™Ellipta™ has received market authorisation in Canada for bronchodilator airflow obstruction in patients with COPD

GSK statement on media reports

Wed, 16 Apr 2014 00:00:00 GMT

There has been recent publicity on cases of alleged misconduct by GSK employees in a number of countries.

GSK receives US approval for once-weekly type 2 diabetes treatment, Tanzeum™ (albiglutide)

Tue, 15 Apr 2014 00:00:00 GMT

GSK today announced that the FDA has approved TanzeumTM (albiglutide) for injection, as a once-weekly treatment for type 2 diabetes.

GSK statement on BBC Panorama programme

Mon, 14 Apr 2014 00:00:00 GMT

GSK issued the following statement in response to claims by BBC Panorama related to GSK in Poland, to be broadcast on Monday April 14 2014

Update on phase III clinical trial of investigational MAGE-A3 antigen-specific cancer immunotherapeutic in non-small cell lung cancer

Wed, 02 Apr 2014 00:00:00 GMT

GSK announced its decision to stop the Phase III trial of MAGE-A3ii cancer immunotherapeuticiii in non-small cell lung cancer patients.

Results from phase III patient preference study of GSK’s Votrient® (pazopanib) vs. Sutent® (sunitinib) in advanced renal cell carcinoma published in Journal of Clinical Oncology

Tue, 01 Apr 2014 00:00:00 GMT

Data from the first patient preference study in advanced renal cell carcinoma have been published in the Journal of Clinical Oncology.

ViiV Healthcare announces new initiatives to improve access to dolutegravir: licence to the Medicines Patent Pool

Tue, 01 Apr 2014 00:00:00 GMT

ViiV announced new collaborations to increase access to its HIV medicine, dolutegravir ( Tivicay®), just after approval by EMA & FDA.

GSK announces new strategic investments in Africa to increase access to medicines, build capacity and deliver sustainable growth

Mon, 31 Mar 2014 00:00:00 GMT

GSK today announced a series of investments in sub-Saharan Africa designed to address pressing needs and contribute to long-term growth.

Regulatory update: Votrient® (pazopanib) as maintenance therapy for advanced ovarian cancer in the EU

Mon, 31 Mar 2014 00:00:00 GMT

GSK today announced that it has withdrawn application to EMA for a variation to the Marketing Authorisation for Votrient® (pazopanib).

GSK presents data from Phase III STABILITY study of darapladib in patients with chronic coronary heart disease

Sun, 30 Mar 2014 00:00:00 GMT

GSK presented data from the pivotal Phase III STABILITY study of darapladib at the American College of Cardiology 63rd Annual Session

GSK acquires full ownership of its Indonesian Consumer Healthcare business

Fri, 28 Mar 2014 00:00:00 GMT

GSK has acquired full ownership of its Indonesian Consumer Healthcare business

Where do you start when developing a new medicine?

Thu, 27 Mar 2014 00:00:00 GMT

Initiative between GSK, EMBL-EBI and Sanger Institute is using ‘big data’ & genome sequencing improving chances for discovering new drugs.

GSK receives European authorisation for once-weekly type 2 diabetes treatment, Eperzan® (albiglutide)

Wed, 26 Mar 2014 00:00:00 GMT

GSK announced that the EC has granted marketing authorisation for its once-weekly diabetes treatment, Eperzan® (albiglutide).

Regulatory update: combined use of Mekinist™ (trametinib) and Tafinlar® (dabrafenib) in Europe

Wed, 26 Mar 2014 00:00:00 GMT

GSK today announced that it has withdrawn its MAA to EMA for the use of Mekinist (trametinib) in combination with Tafinlar (dabrafenib).

GSK publishes historical quarterly restated financial information

Fri, 21 Mar 2014 00:00:00 GMT

GSK will adopt a revised presentation for the analysis of its Pharmaceuticals and Vaccines turnover by segment, product and therapeutic area

Investigational MAGE-A3 antigen-specific cancer immunotherapeutic does not meet first co-primary endpoints in MAGRIT, a phase III non-small cell lung cancer clinical trial

Thu, 20 Mar 2014 00:00:00 GMT

GSK announced that the MAGRITi phase III trial of MAGE-A3 cancer immunotherapeuticii in NSCLC patients did not meet its primary endpoint.

GSK and Theravance announce positive results from studies comparing ANORO™ ELLIPTA™ with SERETIDE® DISKUS® and ADVAIR® DISKUS® in patients with COPD

Fri, 14 Mar 2014 00:00:00 GMT

GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced positive results from three phase III studies.

Patient recruitment completes in landmark RELVAR®/ BREO® ELLIPTA® Study to Understand Mortality and MorbidITy (SUMMIT) in COPD

Thu, 13 Mar 2014 00:00:00 GMT

GSK & THRX announced that recruitment of patients into the study known as SUMMIT, has completed enrolment.

GSK announces positive results from phase III studies for mepolizumab in severe eosinophilic asthma

Wed, 12 Mar 2014 00:00:00 GMT

GSK announced that, pivotal phase III study of mepolizumab, an investigational IL-5 antagonist monoclonal antibody, met its primary endpoint

GSK increases stake in Indian Pharmaceuticals subsidiary to 75 per cent after Open Offer

Mon, 10 Mar 2014 00:00:00 GMT

GSK announced that, it has successfully increased its stake in its publicly-listed pharmaceuticals subsidiary in India.

GSK announces submission to U.S. regulatory authorities for Promacta™ (eltrombopag) for severe aplastic anaemia

Fri, 28 Feb 2014 00:00:00 GMT

GSK announced the submission of a supplemental New Drug Application (sNDA) to the U.S. FDA for Promacta™ (eltrombopag).

GSK kicks off 2014 Discovery Fast Track Challenge for academic drug hunters in Europe, Canada and USA

Tue, 25 Feb 2014 00:00:00 GMT

GSK is inviting academic scientists to enter their most innovative drug research proposals into its 2014 Discovery Fast Track Challenge.

Anoro® (umeclidinium / vilanterol) receives positive opinion from the CHMP in Europe for the treatment of COPD

Thu, 20 Feb 2014 00:00:00 GMT

GSK & THRX announced that CHMP of EMA has issued a positive opinion recommending marketing authorisation for UMEC/VI ,brand name Anoro®

GSK receives positive CHMP opinion for Incruse® (umeclidinium) for the treatment of COPD

Thu, 20 Feb 2014 00:00:00 GMT

GSK announced that EMA's CHMP is recommending marketing authorisation for umeclidinium, treatment to relieve symptoms in patients with COPD.

GSK announces start of Phase lll study for mepolizumab in patients with Eosinophilic Granulomatosis with Polyangiitis

Fri, 14 Feb 2014 00:00:00 GMT

GSK today announced the start of a Phase III study to evaluate the efficacy and safety of mepolizumab, an investigational IL-5 antagonist.

Results announcement for fourth quarter 2013

Wed, 05 Feb 2014 00:00:00 GMT

GSK announces core EPS of 112.2p and dividend of 78p.

GSK gains FDA Breakthrough Therapy designation for Promacta®/Revolade® (eltrombopag) for severe aplastic anaemia

Mon, 03 Feb 2014 00:00:00 GMT

GSK announced that the U.S. FDA has granted Breakthrough Therapy designation for Promacta®/Revolade® (eltrombopag).

GSK announces headline results for Phase III study of the combination of Tafinlar® (dabrafenib) and Mekinist® (trametinib) in metastatic melanoma

Fri, 24 Jan 2014 00:00:00 GMT

GSK announced that a Phase III study of the combination of Tafinlar® (dabrafenib) and Mekinist® (trametinib) met its primary endpoint of PFS

GSK receives positive opinion from the CHMP in Europe for once-weekly EperzanTM (albiglutide) for the treatment of type 2 diabetes

Fri, 24 Jan 2014 00:00:00 GMT

GlaxoSmithKline plc today announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion albiglutide

ViiV Healthcare’s new HIV medicine TivicayTM (dolutegravir) is approved in Europe

Tue, 21 Jan 2014 00:00:00 GMT

ViiV Healthcare today announced that the European Commission has approved TivicayTM (dolutegravir).

Prosensa regains rights to drisapersen from GSK and retains rights to all other programmes for the treatment of Duchenne muscular dystrophy (DMD)

Mon, 13 Jan 2014 00:00:00 GMT

Prosensa Holding N.V. (NASDAQ: RNA) and GlaxoSmithKline (GSK) today announced that Prosensa has regained all rights from GSK to drisapersen.

Tafinlar® receives FDA Breakthrough Therapy designation for non-small cell lung cancer with BRAF mutation

Mon, 13 Jan 2014 00:00:00 GMT

GSK announced today that the U.S. FDA has granted Breakthrough Therapy designation for Tafinlar® (dabrafenib).

GSK gains accelerated FDA approval for combination use of Mekinist® (trametinib) and Tafinlar® (dabrafenib)

Thu, 09 Jan 2014 00:00:00 GMT

GSK announced today that the FDA has approved Mekinist® (trametinib) for use with Tafinlar® (dabrafenib) for the treatment melanoma

GSK adds detailed clinical trial data to multi-sponsor request system as part of continued commitment to data transparency

Thu, 02 Jan 2014 00:00:00 GMT

GSK added its anonymised patient-level data from the online request system it launched in May 2013 to a new multi-sponsor request system.

GSK completes divestment of thrombosis brands and related manufacturing site to Aspen

Tue, 31 Dec 2013 00:00:00 GMT

GlaxoSmithKline (GSK) today completed the previously announced divestment of its thrombosis brands, ArixtraTM and FraxiparineTM.

GSK completes divestment of Lucozade and Ribena to Suntory

Tue, 31 Dec 2013 00:00:00 GMT

GSK today completed the previously announced divestment of its nutritional drinks brands Lucozade and Ribena.

GSK Cervarix® two-dose schedule receives European marketing authorisation

Fri, 20 Dec 2013 00:00:00 GMT

GSK announced today that the European Commission has granted marketing authorisation for its cervical cancer vaccine Cervarix.

GSK and MMV announce FDA Breakthrough Therapy designation for tafenoquine for Plasmodium vivax malaria

Fri, 20 Dec 2013 00:00:00 GMT

GSK and Medicines for Malaria Venture (MMV) announced today that the FDA has granted Breakthrough Therapy designation for tafenoquine.

Update on Patent Ruling on ViiV Healthcare's EPZICOM® and TRIZIVIR®

Wed, 18 Dec 2013 00:00:00 GMT

Update on Patent Ruling on ViiV Healthcare's EPZICOM® and TRIZIVIR®

GSK announces 1 million innovation prize for bioelectronics research

Wed, 18 Dec 2013 00:00:00 GMT

GSK is announcing today a $1 million dollar prize for innovation in the emerging area of bioelectronics research.

ANORO™ ELLIPTA™ approved as first once-daily dual bronchodilator for the treatment of COPD in the US

Wed, 18 Dec 2013 00:00:00 GMT

GlaxoSmithKline plc and Theravance, Inc. today announced that the US Food and Drug Administration (FDA) has approved ANORO ELLIPTA.

GSK announces changes to its global sales and marketing practices to further ensure patient interests come first

Tue, 17 Dec 2013 00:00:00 GMT

GSK today set out plans to evolve the way it sells and markets its products to healthcare professionals.

GSK and Genmab Receive Priority Review from FDA for Arzerra® (ofatumumab) as 1st Line Treatment for Chronic Lymphocytic Leukaemia (CLL)

Tue, 17 Dec 2013 00:00:00 GMT

GSK and Genmab Receive Priority Review from FDA for Arzerra® (ofatumumab) as 1st Line Treatment for Chronic Lymphocytic Leukaemia (CLL)

GSK initiates voluntary open offer to increase stake in its pharmaceuticals subsidiary in India

Mon, 16 Dec 2013 00:00:00 GMT

GSK today announced a Voluntary Open Offer to increase its stake in its publicly-listed pharmaceuticals subsidiary in India.

GSK announces £200 million investment in UK advanced manufacturing and science

Wed, 11 Dec 2013 00:00:00 GMT

GSK announced a series of investments totalling approx £200million for new medicines and to create a centre for pharmaceutical manufacturing

Update regarding 2010 Nature Medicine study

Fri, 06 Dec 2013 00:00:00 GMT

A GSK research paper published in 2010 that was found earlier this year to contain incorrect data has now been retracted by Nature Medicine.

GSK and Theravance announce positive results from pivotal phase III study for fluticasone furoate/vilanterol in asthma

Fri, 06 Dec 2013 00:00:00 GMT

GSK & THRX announced positive results from a phase III efficacy and safety study of fluticasone furoate “FF”/vilanterol “VI”.

Synflorix™ receives European marketing authorisation for additional pneumonia indication

Thu, 05 Dec 2013 00:00:00 GMT

GSK today announced that the European Commission (EC) has granted marketing authorisation for an additional indication for Synflorix™

GSK launches global consortium with six renowned cancer research centres

Thu, 05 Dec 2013 00:00:00 GMT

GSK announced today the formation of the Oncology Clinical and Translational Consortium (OCTC)

Regulatory Update - GSK receives positive CHMP opinion for Cervarix™ two-dose schedule

Thu, 28 Nov 2013 00:00:00 GMT

CHMP is recommending marketing authorisation for a 2-dose schedule in 9-14yo girls for GSK's cervical cancer vaccine, Cervarix™.

H5N1 vaccine approved by the U.S. FDA as pandemic influenza preparedness measure

Mon, 25 Nov 2013 00:00:00 GMT

GSK announced FDA has approved its pandemic Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted for the immunisation of adults 18+.

GSK Responds to FDA Decision on Avandia (rosiglitazone)

Mon, 25 Nov 2013 00:00:00 GMT

GSK announced the FDA has eased restrictions on patient access to Avandia (rosiglitazone), following an committee review in June 2013.

Tivicay® (dolutegravir) receives positive CHMP opinion in Europe for the treatment of HIV

Fri, 22 Nov 2013 00:00:00 GMT

ViiV announced that the CHMP of EMA has issued a positive opinion recommending marketing authorisation for Tivicay® (dolutegravir).

GSK and Amicus Therapeutics announce revised Fabry agreement

Wed, 20 Nov 2013 00:00:00 GMT

GSK & Amicus announced that Amicus has obtained global rights to develop chaperone migalastat HCl as monotherapy for Fabry disease.

RELVAR® ELLIPTA® receives European marketing authorisation for the treatment of asthma and COPD

Mon, 18 Nov 2013 00:00:00 GMT

GSK & THRX announced today that the European Commission has granted marketing authorisation for RELVAR® ELLIPTA®.

Five inspirational organisations from Malawi, Bangladesh, Mali, Kenya, and Colombia recognised by GSK and Save the Children

Thu, 14 Nov 2013 00:00:00 GMT

A simple low-cost device that helps newborn babies to breathe has been awarded $1million in the first GSK and Save the Children Award

GSK announces top-line results from pivotal Phase III study of darapladib in chronic coronary heart disease

Tue, 12 Nov 2013 00:00:00 GMT

Study did not meet the primary endpoint measure.

GSK names inaugural winners in unique competition for academic drug hunters

Wed, 06 Nov 2013 00:00:00 GMT

GSK announced selection of eight winners in its first Discovery Fast Track competition.

GSK announces new apprentice and graduate engineering opportunities in the UK during Tomorrow’s Engineers Week

Tue, 05 Nov 2013 00:00:00 GMT

GSK today announced the recruitment of 140 new apprentices over the next two years in the UK - of which a third will be in engineering.

GSK announces data to support Cervarix® two-dose schedule for the prevention of cervical cancer in 9-14 year old girls

Mon, 04 Nov 2013 00:00:00 GMT

GSK today announced the results of a Phase III study of its HPV vaccine, Cervarix.

New partnership between GSK and the Bill & Melinda Gates Foundation to accelerate research into vaccines for global health needs

Tue, 29 Oct 2013 00:00:00 GMT

GSK & BMGF announced the launch of initiative that will endeavour to make vaccines more resistant to heat, reducing need for refrigeration.

GSK to create a new Centre of Excellence for Sustainable Chemistry in Brazil

Fri, 25 Oct 2013 00:00:00 GMT

GSK announced it's formed new collaboration with FAPESP to create a new Centre of Excellence for Sustainable Chemistry in Brazil.

ViiV Healthcare announces European regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV

Fri, 25 Oct 2013 00:00:00 GMT

ViiV announced submission in EU for STR combining dolutegravir (DTG), abacavir (ABC) and lamivudine (3TC) for treatment of people with HIV.

Synflorix™ receives positive opinion from the CHMP in Europe for additional pneumonia indication

Fri, 25 Oct 2013 00:00:00 GMT

GSK announced that CHMP has issued a positive opinion for Synflorix™, a paediatric pneumococcal conjugate vaccine.

GSK announces US regulatory submission for fluticasone furoate monotherapy for asthma

Wed, 23 Oct 2013 00:00:00 GMT

GSK announced the submission of a New Drug Application in the US for ICS treatment, FF administered using the ELLIPTA™ dry powder inhaler.

Results announcement for the third quarter 2013

Wed, 23 Oct 2013 00:00:00 GMT

GSK announces Q3 core EPS growth of 16% and dividend of 19p

ViiV Healthcare announces US regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV

Tue, 22 Oct 2013 00:00:00 GMT

ViiV announced submission application in the US for STR combining dolutegravir, abacavir and lamivudine for treatment of people with HIV-1.

Regulatory update – GSK and Genmab announce submission to US regulatory authorities for Arzerra® (ofatumumab) as 1st line treatment of Chronic Lymphocytic Leukaemia (CLL)

Fri, 18 Oct 2013 00:00:00 GMT

GSK and Genmab A/S announced today the submission of a supplemental Biologics License Application to the US Food and Drug Administration

Malaria vaccine candidate reduces disease over 18 months of follow-up in late-stage study of more than 15,000 infants and young children

Tue, 08 Oct 2013 00:00:00 GMT

Results from a large-scale Phase III trial, presented today in Durban, show that the most clinically advanced malaria vaccine candidate.

Regulatory update – GSK and Genmab announce European submission to regulatory authorities for Arzerra® (ofatumumab) as 1st line treatment of Chronic Lymphocytic Leukaemia (CLL)

Fri, 04 Oct 2013 00:00:00 GMT

GSK & Genmab A/S announced submission of Marketing Authorisation for Arzerra in combination with alkylator-based therapy, for CLL patients

GlaxoSmithKline reaches agreement with Aspen to divest thrombosis brands and related manufacturing site for £0.7 billion

Mon, 30 Sep 2013 00:00:00 GMT

Divestment supports strategic focus and delivery of pipeline.

GSK and Barclays form partnership to increase access to healthcare and promote economic development in Zambia

Fri, 27 Sep 2013 00:00:00 GMT

GSK & Barclays have formed partnership which aims to increase affordable healthcare for people in Zambia, improving economic conditions

GSK receives marketing authorisation from the European Commission for additional Revolade™

Tue, 24 Sep 2013 00:00:00 GMT

GSK announced that the EC has granted Revolade™ as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection.

RELVAR™ ELLIPTA™ gains approval in Japan for the treatment of asthma

Fri, 20 Sep 2013 00:00:00 GMT

GSK & THRX announced that JMHLW has approved RELVAR™ ELLIPTA™ for the treatment of bronchial asthma.

GSK and Prosensa announce primary endpoint not met in Phase III study of drisapersen in patients with Duchenne Muscular Dystrophy

Fri, 20 Sep 2013 00:00:00 GMT

GSK & Prosensa announced that Phase III clinical study of drisapersen, treatment for DMD did not meet the primary endpoint.

GSK signs a multi-year agreement with BARDA to supply the US government with anthrax treatment

Thu, 19 Sep 2013 00:00:00 GMT

GlaxoSmithKline (GSK) plc today announced a new four year contract with the Biomedical Advanced Research and Development Authority (BARDA).

RELVAR™ ELLIPTA™ receives positive opinion from the CHMP in Europe for the treatment of asthma and COPD

Thu, 19 Sep 2013 00:00:00 GMT

GSK and Theravance, Inc. has issued a positive opinion for fluticasone furoate/vilanterol under the proposed brand name RELVAR™ ELLIPTA™.

GSK receives Priority Review from FDA for dabrafenib/trametinib combination in metastatic melanoma

Mon, 16 Sep 2013 00:00:00 GMT

GSK announced that the FDA has granted Priority Review designation to the use of Tafinlar® & Mekinist® for the treatment of melanoma

GSK statement in response to patent ruling reversal on Lovaza

Fri, 13 Sep 2013 00:00:00 GMT

the Court of Appeals for the Federal Circuit has ruled against Pronova Biopharma Norge AS in its patent litigation regarding Lovaza®

FDA grants GSK and Genmab’s Arzerra® (ofatumumab) Breakthrough Therapy designation for previously untreated chronic lymphocytic leukaemia

Fri, 13 Sep 2013 00:00:00 GMT

GSK & Genmab A/S announced today that FDA has granted Breakthrough Therapy designation for Arzerra® (ofatumumab) with chlorambucil for CLL

ViiV Healthcare Presents Positive Data from Phase IIIb/IV Study of Dolutegravir vs Darunavir in Treatment-Naïve Adults with HIV-1

Thu, 12 Sep 2013 00:00:00 GMT

ViiV Healthcare today announced initial results from the Phase IIIb/IV FLAMINGO (ING114915) study.

FDA Advisory Committee recommends approval in US of umeclidinium/vilanterol for the treatment of COPD

Tue, 10 Sep 2013 00:00:00 GMT

GSK & THRX announced that the PADAC voted 11/2 Yes/No for the efficacy & safety of umeclidinium/ vilanterol, treatment of COPD

GSK reaches agreement to divest Lucozade and Ribena for £1.35 billion

Mon, 09 Sep 2013 00:00:00 GMT

GSK today announced it has reached agreement to sell its nutritional drinks brands Lucozade and Ribena to Suntory Beverage & Food Ltd.

The investigational MAGE-A3 antigen-specific cancer immunotherapeutic does not meet first co-primary endpoint in Phase III melanoma clinical trial

Thu, 05 Sep 2013 00:00:00 GMT

In line with IDMC unanimous recommendation, GSK will continue the DERMA trial until the second co-primary endpoint is assessed.

GSK receives marketing authorisation from the European Commission for Tafinlar™

Mon, 02 Sep 2013 00:00:00 GMT

GSK announced today that the European Commission has granted marketing authorisation for Tafinlar™ (dabrafenib).

GSK announces phase III study of vercirnon in patients with moderate-to-severe Crohn’s disease did not meet its primary endpoint

Fri, 23 Aug 2013 00:00:00 GMT

GSK announced Phase III studies, investigating vercirnon in patients with Crohn's disease did not achieve the primary endpoint

GSK receives marketing authorisation from the European Commission for additional indication: Tyverb™ (lapatinib)

Wed, 14 Aug 2013 00:00:00 GMT

GSK announced today that the EC has granted an additional indication for Tyverb™ (lapatinib) to be used in combination with trastuzumab.

ViiV Healthcare announces U.S. approval of Tivicay® (dolutegravir) for the treatment of HIV-1

Tue, 13 Aug 2013 00:00:00 GMT

ViiV Healthcare is pleased to announce today that the U.S. Food and Drug Administration (FDA) has approved Tivicay® (dolutegravir)

GSK launches 50 million venture capital fund to invest in pioneering bioelectronic medicines and technologies

Thu, 08 Aug 2013 00:00:00 GMT

GSK launch of Action Potential Venture, a $50 million strategic venture that will invest in companies that pioneer bioelectronic medicines

Regulatory Update - GSK announces EU submission seeking additional indication for Votrient® as maintenance therapy for advanced ovarian cancer

Wed, 07 Aug 2013 00:00:00 GMT

GSK today announced submission to the European Medicines Agency of a variation to the Marketing Authorisation for Votrient® (pazopanib)

Regulatory update – GSK announces EU submission for Cervarix® two dose schedule

Wed, 07 Aug 2013 00:00:00 GMT

GSK announced, submission of a regulatory application in the EU for two dosing schedule in 9-14yo girls for its cervical cancer vaccine.

Regulatory update: albiglutide US PDUFA date extended by three months

Fri, 02 Aug 2013 00:00:00 GMT

GSK announced that PDUFA goal date for albiglutide, treatment for adult patients with type 2 diabetes, has been extended by three months.

GSK adds to its commitment to GAVI Alliance to help protect millions more children against infectious diseases

Mon, 29 Jul 2013 00:00:00 GMT

Extension of Synflorix vaccine supply agreement will help protect an additional 80 million children in the world's poorest countries.

GSK receives positive CHMP opinion for REVOLADE in thrombocytopenia associated with chronic hepatitis C infection

Fri, 26 Jul 2013 00:00:00 GMT

GSK announced a positive opinion from EMA's CHMP recommending marketing authorisation for Revolade™ (eltrombopag).

Results announcement for the second quarter 2013

Wed, 24 Jul 2013 00:00:00 GMT

GSK announces Q2 core EPS growth of 4% and dividend of 18p

GSK statement regarding recent meeting with Chinese authorities

Mon, 22 Jul 2013 00:00:00 GMT

with the Chinese Ministry of Public Security GSK Abbas Hussain, President International - made the following statement.

Update on GSK Consumer Nigeria plc Scheme of Arrangement

Mon, 22 Jul 2013 00:00:00 GMT

GSK announced shareholders document dated 24 June 2013, where it was proposed to increase ownership in GSK Nigeria to 75%, will be withdrawn

GSK response to China investigation

Mon, 15 Jul 2013 00:00:00 GMT

In response to the investigations by government authorities in China regarding our business in the country, GSK has issued a statement.

Regulatory update: fluticasone furoate/vilanterol submission in Japan

Fri, 12 Jul 2013 00:00:00 GMT

GSK & THRX announce application for FF and vilanterol in patients with COPD has been withdrawn from the Japanese New Drug Application (JNDA)

Regulatory update – GSK announces US submission for dabrafenib/trametinib combination in metastatic melanoma

Tue, 09 Jul 2013 00:00:00 GMT

GSK today announced submission of NDAs to the FDA for use of dabrafenib, a BRAF inhibitor, in combination with trametinib, a MEK inhibitor.

Regulatory Update - GSK receives positive CHMP opinions for Tafinlar® (dabrafenib) and Tyverb® (lapatinib)

Fri, 28 Jun 2013 00:00:00 GMT

GSK announces that the European Medicines Agency's CHMP is recommending marketing authorisation for two cancer drugs.

GSK and Save the Children launch $1 million award to discover new healthcare innovations for reducing child deaths

Thu, 27 Jun 2013 00:00:00 GMT

The Healthcare Innovation Award is the first joint initiative announced following the partnership between GSK and Save the Children

GlaxoSmithKline’s drisapersen (previously GSK2402968/PRO051) to receive Food and Drug Administration Breakthrough Therapy designation

Thu, 27 Jun 2013 00:00:00 GMT

Breakthrough Therapy designation is one of several programmes created by the FDA to expedite the development and review of drugs.

GSK announces data from five Phase III studies of albiglutide, an investigational once-weekly treatment for type 2 diabetes

Mon, 24 Jun 2013 00:00:00 GMT

Data from five long-term Phase III studies comparing albiglutide to placebo presented at the American Diabetes Association Meeting

GSK receives offer for its thrombosis brands and related manufacturing site

Tue, 18 Jun 2013 00:00:00 GMT

GSK has today received an offer for its thrombosis brands and NDB site from Aspen Global Incorporated and Aspen Pharmacare Holdings Limited.

GSK statement regarding 2010 Nature Medicine study

Mon, 10 Jun 2013 00:00:00 GMT

GSK and Nature Medicine aware of allegations of misrepresentation of data in research paper written by scientists at GSK's China centre

GSK statement in response to FDA Advisory Committee’s vote on availability of Avandia (rosiglitazone)

Thu, 06 Jun 2013 00:00:00 GMT

GSK confirmed that FDA voted to continue to make Avandia (rosiglitazone) available to appropriate patients.

GSK announces Phase III data for TYKERB/TYVERB® (lapatinib) in combination with chemotherapy for advanced HER2-positive gastric cancer

Mon, 03 Jun 2013 00:00:00 GMT

GSK announced study of lapatinib with chemotherapy in patients with HER2-positive advanced gastric cancer did not meet the primary endpoint

GSK announces late-stage clinical data for VOTRIENT® (pazopanib) following chemotherapy in women with advanced epithelial ovarian cancer

Sat, 01 Jun 2013 00:00:00 GMT

GSK announced its Phase III trial of VOTRIENT met primary objective of a statistically significant improvement in PFS compared to placebo.

GSK strengthens vaccines business with acquisition of Okairos

Wed, 29 May 2013 00:00:00 GMT

GSK announced it's acquired Okairos, a specialist developer of vaccine platform technologies for €250 million (approx. £215/$325 million)

GSK and Genmab announce positive top-line results from pivotal trial of ARZERRA® (ofatumumab) combined with chlorambucil in previously untreated chronic lymphocytic leukaemia

Wed, 29 May 2013 00:00:00 GMT

GSK & Genmab announce phase III study of ARZERRA® with chlorambucil versus chlorambucil in patients with CLL met its primary endpoint.

Two new GSK oral oncology treatments, BRAF-inhibitor Tafinlar® (dabrafenib) capsules and the first MEK-inhibitor Mekinist™ (trametinib) tablets, approved by FDA as single-agent therapies

Wed, 29 May 2013 00:00:00 GMT

GSK announced today that the FDA has approved both TAFINLAR® (dabrafenib) and MEKINIST™ (trametinib).

Grant to Help Coordinate Campaign to Train One Million Community Health Workers in sub-Saharan Africa

Fri, 24 May 2013 00:00:00 GMT

In an effort to expand health services in sub-Saharan Africa, GSK will donate $750,000 to One Million Community Health Workers Campaign.

GlaxoSmithKline awarded up to $200 million by U.S. government to develop new antibiotics

Wed, 22 May 2013 00:00:00 GMT

GSK & BARDA have agreed to support the development of several antibiotics to fight antibiotic resistance and bioterrorism.

BREO™ ELLIPTA™ gains US approval for the treatment of COPD

Fri, 10 May 2013 00:00:00 GMT

GSK & THRX announced that the FDA has approved BREO™ ELLIPTA™ as treatment in patients with COPD, including chronic bronchitis/emphysema.

GSK enters new commitment with the GAVI Alliance to supply cervical cancer vaccine for girls in the world’s poorest countries

Thu, 09 May 2013 00:00:00 GMT

GSK announced a commitment to GAVI Alliance to supply its cervical cancer vaccine to help protect girls in the world's poorest countries.

GSK and Save the Children form unique partnership to save the lives of one million children

Thu, 09 May 2013 00:00:00 GMT

A new partnership to save the lives of a million of the poorest children in the world has been launched by GSK and Save the Children.

GSK gives update on plans to share detailed clinical trial data as part of its commitment to transparency

Tue, 07 May 2013 00:00:00 GMT

GSK today announced progress on its commitment to share more detailed data from its clinical trials.

Funding boost for GSK’s open innovation research into diseases affecting the developing world

Fri, 03 May 2013 00:00:00 GMT

GSK announced a funding of up to £5m from the Wellcome Trust to support discovering and developing new treatments for diseases

Regulatory update: Trametinib US PDUFA date extended to 3 September 2013

Wed, 01 May 2013 00:00:00 GMT

GSK today announced that the US Prescription Drug User Fee Act (PDUFA) goal date for trametinib.

GSK announces regulatory submission for umeclidinium monotherapy in US

Tue, 30 Apr 2013 00:00:00 GMT

GSK announced the submission of a regulatory application in the US for umeclidinium bromide (UMEC), for patients COPD.

GlaxoSmithKline and Impax Pharmaceuticals terminate their collaboration on IPX066

Mon, 29 Apr 2013 00:00:00 GMT

GSK & Impax announced that they are terminating their collaboration for the development of IPX066 outside the United States and Taiwan.

GSK announces regulatory submission for umeclidinium monotherapy in European Union

Fri, 26 Apr 2013 00:00:00 GMT

GSK announced the submission of a regulatory application to the EU for umeclidinium bromide (UMEC), for patients with COPD.

Results announcement for the first quarter 2013

Wed, 24 Apr 2013 00:00:00 GMT

GSK delivers Q1 2013 core EPS of 26.9p and dividend of 18p

GSK and Theravance announce regulatory submission for ANORO™ ELLIPTA™ (UMEC/VI) in Japan

Mon, 22 Apr 2013 00:00:00 GMT

GSK & THRX announced the submission of a regulatory application to the JMHLW for the LAMA/LABA medicine, UMEC/VI for patients COPD.

GSK statement in response to OFT Statement of Objections

Fri, 19 Apr 2013 00:00:00 GMT

GSK supports fair competition and we very strongly believe that we acted within the law, as the holder of valid patents for paroxetine

FDA Advisory Committee recommends approval of BREO(TM) ELLIPTA(TM) for the treatment of COPD

Wed, 17 Apr 2013 00:00:00 GMT

GSK & THRX announced that PADAC voted that the efficacy and safety data evidence to support approval of BREO™ ELLIPTA™

GSK announces first four-strain seasonal influenza vaccine granted marketing authorisation in Germany and the UK

Wed, 03 Apr 2013 00:00:00 GMT

GSK has announced the marketing authorisation of its quadrivalent (four-strain) influenza vaccine in Germany and the UK.

GlaxoSmithKline announces start of phase III study of Benlysta® (belimumab ) in patients with vasculitis

Wed, 03 Apr 2013 00:00:00 GMT

GSK announced the start of a Phase III study to evaluate Benlysta® (belimumab) in patients with ANCA - a condition involving inflammation

Regulatory update: GlaxoSmithKline receives complete response from FDA for candidate pandemic H5N1 adjuvanted influenza vaccine

Mon, 25 Mar 2013 00:00:00 GMT

GSK announced today that it has received a Complete Response letter from the FDA .

GSK publishes 2012 Corporate Responsibility report

Wed, 20 Mar 2013 00:00:00 GMT

Report sets out 23 forward-looking commitments to help measure future performance

$500,000 Endowment Gift from The GlaxoSmithKline Foundation Expands Program to Help Patients with Cancer and their Families at The Children’s Hospital of Philadelphia

Mon, 18 Mar 2013 00:00:00 GMT

The Children’s Hospital of Philadelphia is proud to announce a $500,000 gift from the GSK Foundation.

Young scientists challenged by GSK and McLaren to help drive science behind Formula 1™

Wed, 13 Mar 2013 00:00:00 GMT

GSK and the McLaren Group announce new science education initiative to inspire young people into science and engineering careers

Regulatory update – GSK announces regulatory submission for albiglutide in Europe

Thu, 07 Mar 2013 00:00:00 GMT

GSK today announced the submission of a MAA for albiglutide, with the proprietary name EPERZAN, to the European Medicines Agency (EMA).

ViiV Healthcare presents data from Phase III study of dolutegravir vs raltegravir in treatment-experienced adults with HIV-1

Wed, 06 Mar 2013 00:00:00 GMT

ViiV present 24-week interim results from Phase III SAILING study at the 20th Conference on Retroviruses and Opportunistic Infections (CROI)

ViiV Healthcare announces a voluntary licence agreement with the Medicines Patent Pool to increase access to HIV medicines for children

Wed, 27 Feb 2013 00:00:00 GMT

Agreement brings the number of voluntary licences granted by ViiV Healthcare to 14.

GSK and Theravance announce FDA acceptance of New Drug Application (NDA) submission in the US for ANORO ELLIPTATM for COPD

Tue, 19 Feb 2013 00:00:00 GMT

GSK & THRX announced NDA for LAMA/LABA combination medicine, UMEC/VI, for patients with COPD has been accepted by the FDA.

ViiV Healthcare announces FDA priority review designation for dolutegravir as a potential treatment for HIV infection

Fri, 15 Feb 2013 00:00:00 GMT

ViiV announced that the FDA has granted a priority review designation to dolutegravir submitted for the treatment of HIV infection.

Regulatory update – GSK announces European submission for MEK monotherapy and BRAF/MEK combination therapy in metastatic melanoma

Thu, 07 Feb 2013 00:00:00 GMT

GSK announced submission of a Marketing Authorisation Application to EMA for MEK with BRAF for the treatment of adult patients with melanoma

Results announcement for the fourth quarter 2012

Wed, 06 Feb 2013 00:00:00 GMT

GSK delivers 2012 core EPS of 112.7p and returns £6.3bn to shareholders

GSK increases stake in its publicly-listed Consumer Healthcare subsidiary in India to 72.5 per cent

Tue, 05 Feb 2013 00:00:00 GMT

GSK announced it has successfully increased its publicly-listed Consumer Healthcare subsidiary in India, from 43.2% to 72.5%

GSK announces support for AllTrials campaign for clinical data transparency

Tue, 05 Feb 2013 00:00:00 GMT

Campaign calls for full disclosure of clinical trial results and clinical study reports to help drive scientific understanding.

GlaxoSmithKline starts Phase III study to test combined BRAF/MEK inhibition in patients with BRAF positive melanoma following surgery

Fri, 01 Feb 2013 00:00:00 GMT

GSK today announced the start of COMBI-AD, a Phase III study evaluating the combination of dabrafenib, its BRAF inhibitor and trametinib.

GSK response to news article in The Guardian on UK legal proceedings related to Avandia (rosiglitazone)

Wed, 30 Jan 2013 00:00:00 GMT

Responding to an article in The Guardian legal proceedings related to our type 2 diabetes medicine Avandia (rosiglitazone),

GSK and Biological E. announce joint venture to develop combination vaccine for India and other developing countries

Mon, 28 Jan 2013 00:00:00 GMT

GSK & Biological E. announced an agreement for development of a paediatric vaccine to help protect children in India from polio

GSK appoints Hans Wijers to its Board as a Non-Executive Director

Thu, 24 Jan 2013 00:00:00 GMT

GSK announced the appointment of Hans Wijers to its Board as a Non-Executive Director, effective 1st April 2013.

GSK signs up to UK Government’s Public Health Responsibility Deal

Tue, 22 Jan 2013 00:00:00 GMT

Pledge to reduce the sugar and calorie content of Lucozade Energy and Ribena products.

Regulatory update – GSK announces submission of albiglutide BLA to the US FDA for the treatment of type 2 diabetes

Mon, 14 Jan 2013 00:00:00 GMT

GSK announced a regulatory submission to the FDA for albiglutide, an investigational treatment for adult patients with type 2 diabetes.

GSK and Theravance announce regulatory submission for ANORO™ (UMEC/VI) in Europe

Wed, 09 Jan 2013 00:00:00 GMT

GSK & THRX announced submission of regulatory application in the EU for the LAMA/LABA combination medicine for patients with COPD

GSK and Theravance announce regulatory submission for UMEC/VI (LAMA/LABA) in the US

Tue, 18 Dec 2012 00:00:00 GMT

GSK & THRX announced submission of regulatory application in US for LAMA/LABA combination medicine, UMEC/VI, for patients with COPD.

FDA Approves GlaxoSmithKline’s four-strain seasonal influenza vaccine for use in the US

Mon, 17 Dec 2012 00:00:00 GMT

GSK announced ,FDA has approved FLUARIX QUADRIVALENT Influenza Vaccine for the immunisation of patients to help prevent seasonal influenza

Results from five phase III studies presented for GSK’s two candidate quadrivalent influenza vaccines

Mon, 22 Oct 2012 00:00:00 GMT

GSK announced results from five Phase III studies investigating two candidate quadrivalent influenza vaccines. presented in Spain & US.

GSK announces further initiatives to advance openness and collaboration to help tackle global health challenges

Thu, 11 Oct 2012 00:00:00 GMT

GSK CEO Sir Andrew Witty will outline new steps to build on progress resulting from open innovation approach to R&D.

Millions of children in Pakistan to be protected against pneumococcal disease with GSK’s Synflorix

Tue, 09 Oct 2012 00:00:00 GMT

GSK & GAVI Alliance pneumococcal vaccine, SynflorixTM, is to be introduced into the national immunisation programme in Pakistan.

Shionogi-ViiV Healthcare announces completion of initial clinical registration package for dolutegravir in HIV

Thu, 04 Oct 2012 00:00:00 GMT

Shionogi-ViiV announced phase III data required for initial regulatory filings of dolutegravir in adults infected with HIV are in house.

GSK and Theravance announce FDA acceptance of FF/VI New Drug Application (NDA) submission in the US for COPD

Wed, 26 Sep 2012 00:00:00 GMT

GSK & THRX announced New Drug Application for vilanterol for patients with COPD, has been accepted by the FDA meaning it's ready for review.

GlaxoSmithKline plc announces changes to its Board and Committees

Wed, 26 Sep 2012 00:00:00 GMT

GlaxoSmithKline plc today announces the following changes to its Board and Committee structure.

Regulatory Update: GSK announces submission for a new indication for Synflorix™ in Europe

Mon, 17 Sep 2012 00:00:00 GMT

GSK submitted a regulatory application in EU seeking approval of Synflorix, a Streptococcus pneumococcal vaccine for infants and children.

GSK to acquire five million shares in Response Genetics for US$1.10 per share in cash

Thu, 13 Sep 2012 00:00:00 GMT

GSK announces that it has acquired 5Mil newly issued shares of Response Genetics Inc. common stock at a price of US$1.10 per share in cash.

GSK and Theravance announce completion of the Phase III programme for once-daily LAMA/LABA (UMEC/VI) in COPD

Fri, 24 Aug 2012 00:00:00 GMT

GSK & THRX announced completion of phase III programme of LAMA/LABA involving approx. 6,000 patients with COPD.

GSK announces start of Phase III programme of sirukumab in rheumatoid arthritis

Thu, 23 Aug 2012 00:00:00 GMT

GSK & Janssen announced, Phase III programme evaluating sirukumab, (IL)-6 monoclonal antibody in the treatment of RA, has commenced dosing.

GlaxoSmithKline reaches agreement to divest majority of Classic Brands in Australia for £172m

Wed, 15 Aug 2012 00:00:00 GMT

GSK announced it's reached agreement to divest majority of its Classic Brands in Australia to Aspen for approximately £172 million in cash.

European Commission grants marketing authorisation for pazopanib (Votrient®) in the treatment of certain advanced soft tissue sarcoma subtypes

Tue, 07 Aug 2012 00:00:00 GMT

GSK announced today the EC has granted pazopanib marketing authorisation for the treatment of aSTS who have received prior chemotherapy.

Regulatory update – GSK announces submissions in the EU and US for dabrafenib and trametinib

Fri, 03 Aug 2012 00:00:00 GMT

GSK announced submissions in EU & US related to single-agent use of dabrafenib & trametinib to treat BRAF V600 mutation metastatic melanoma.

GSK completes acquisition of Human Genome Sciences

Fri, 03 Aug 2012 00:00:00 GMT

GSK announced it has completed acquisition of HGS for US$3.6 billion equity. outstanding shares acquired for US$14.25 per share in cash.

GSK announces acquisition of 79% of Human Genome Sciences shares; commences subsequent offering period

Mon, 30 Jul 2012 00:00:00 GMT

GlaxoSmithKline plc (LSE: GSK) today announced the results of its initial tender offer for all outstanding shares of Human Genome Sciences.

Maximuscle powers Vodafone McLaren Mercedes drivers through the 2012 Formula 1™ season

Fri, 27 Jul 2012 00:00:00 GMT

Leading sports nutrition brand continues its presence with on-car logos in Hungary

Results announcement for the second quarter 2012

Wed, 25 Jul 2012 00:00:00 GMT

GSK delivers Q2 core EPS of 26.4p and dividend of 17p

GSK pre-broadcast statement on BBC Panorama: “The truth about Sports Products”, 19 July 2012

Thu, 19 Jul 2012 00:00:00 GMT

GSK issued statement in anticipation of BBC Panorama programme. The truth about sports products, scheduled to be aired this evening.

GlaxoSmithKline and Amicus Therapeutics expand Fabry disease collaboration

Tue, 17 Jul 2012 00:00:00 GMT

GSK & FOLD announced an expansion of their collaboration to develop the investigational pharmacological migalastat HCl for Fabry disease.

GlaxoSmithKline celebrates its role in supporting the biggest anti-doping operation in the history of the Olympic Games

Mon, 16 Jul 2012 00:00:00 GMT

GSK, Official Laboratory Services Provider for the London 2012 Olympic and Paralympic Games celebrating with anti-doping science campaign.

GSK to acquire Human Genome Sciences for US$14.25 per share in cash

Mon, 16 Jul 2012 00:00:00 GMT

GSK & HGS announced they have entered into a definitive agreement under which GSK will acquire HGS for US$14.25 per share in cash.

US Regulatory Update – Tykerb® (lapatinib)

Thu, 12 Jul 2012 00:00:00 GMT

GSK announced it has withdrawn a sNDA to the FDA for lapatinib with trastuzumab for HER2 (ErbB2)-positive metastatic breast cancer

Shionogi-ViiV Healthcare announces positive initial data from phase III study of dolutegravir-based regimen vs Atripla in HIV

Wed, 11 Jul 2012 00:00:00 GMT

Shionogi-ViiV announced results received from Phase III SINGLE study of dolutegravir in treatment-naive adults with HIV-1.

GSK announces positive data from Harmony 8 and completion of clinical registration package for albiglutide in type 2 diabetes

Wed, 11 Jul 2012 00:00:00 GMT

GSK announced data have been received from Phase III Harmony 8 study of cardiovascular safety conducted across the albiglutide programme.

GlaxoSmithKline concludes previously announced agreement in principle to resolve multiple investigations with US Government and numerous states

Mon, 02 Jul 2012 00:00:00 GMT

GSKannounced it has reached an agreement with the US Government, to conclude the Companys ongoing Federal government investigations.

GSK sets 20 July for expiration of tender offer to acquire Human Genome Sciences

Fri, 29 Jun 2012 00:00:00 GMT

GSK announced it has extended its tender offer to acquire all of the outstanding shares of HGSI for US$13.00 per share 5pm NY 20/07/12

GSK continues with tender offer to acquire all outstanding shares of Human Genome Sciences

Fri, 15 Jun 2012 00:00:00 GMT

GSK confirmed receiving an invitation from HGS to participate in its strategic alternatives review process which started in April.

GSK receives FDA approval for MenHibrix

Thu, 14 Jun 2012 00:00:00 GMT

GSK plc announced today that the US FDA has approved the vaccine MenHibrix, Haemophilus b Tetanus Toxoid Conjugate Vaccine].

Stiefel signs worldwide acquisition and license agreement for Toctino®

Mon, 11 Jun 2012 00:00:00 GMT

Stiefel announced it has entered into a worldwide agreement to acquire Toctino (alitretinoin) from Basilea Pharmaceutica Ltd. (Basilea).

GSK announces new 52-week data from phase III study of once-weekly albiglutide in type 2 diabetes

Sat, 09 Jun 2012 00:00:00 GMT

Phase III study comparing albiglutide to Lispro, were presented today at the ADA Meeting in Philadelphia, USA.

GSK extends tender offer for all outstanding shares of Human Genome Sciences

Fri, 08 Jun 2012 00:00:00 GMT

GSK announced it has extended its tender offer to acquire all of the outstanding shares of HGS for US$13.00 per share 5:00pm NY 29/06/12

GSK and XenoPort receive FDA approval for Horizant® for postherpetic neuralgia

Thu, 07 Jun 2012 00:00:00 GMT

GSK & XNPT announced today that the FDA has approved Horizant, Extended-Release Tablets for the management of PHN in adults.

GSK announces expiration of Hart-Scott-Rodino waiting period for tender offer for HGS

Fri, 01 Jun 2012 00:00:00 GMT

GSK announced that the waiting period under the HSR Act, has expired with respect to GSK tender offer for all the outstanding shares of HGS

GSK and EPSRC announce creation of new Chair in Sustainable Chemistry at the University of Nottingham

Thu, 31 May 2012 00:00:00 GMT

GSK & EPSRC announced they will contribute to funding for a Chair in Sustainable Chemistry to be based at GSK's Carbon Neutral Laboratory

Regulatory Update – GSK announces submissions in the EU & US for new indications for Promacta®/Revolade®

Wed, 30 May 2012 00:00:00 GMT

GSK's submitted regulatory applications in the EU and US related to eltrombopag to increase platelet counts in patients with chronic hep C

GSK secures future of local playing fields with Fields in Trust as part of London 2012 legacy

Tue, 29 May 2012 00:00:00 GMT

GSK entered a partnership with FIT to secure the future of its Swyncombe Avenue Playing Fields, where hundreds of local people enjoy sport

GSK announces start of Phase III programme for combination of dabrafenib (GSK2118436) and trametinib (GSK1120212) in BRAF V600 mutation-positive metastatic cutaneous melanoma

Tue, 29 May 2012 00:00:00 GMT

The start of a Phase III programme evaluating the combination of dabrafenib, its BRAF inhibitor, and trametinib, its MEK inhibitor,

GlaxoSmithKline confirms US District Court ruling in Pronova BioPharma’s favour on Lovaza™ patents

Tue, 29 May 2012 00:00:00 GMT

GSK which has the marketing rights for Lovaza in the US and Puerto Rico, confirmed that U.S. District Judge Sue Lewis Robinson...

GSK receives positive opinion from European CHMP for pazopanib in the treatment of patients with certain advanced soft tissue sarcomas

Fri, 25 May 2012 00:00:00 GMT

GSK announced that the EMA CHMP has issued a positive opinion recommending marketing authorisation for Votrient for the treatment of STS.

Innovative public-private collaboration launches to tackle antibiotic research

Thu, 24 May 2012 00:00:00 GMT

GSK & AZN launch a pioneering approach to antibiotic research in Europe and address key barriers to the development of antibiotics.

Two overall winners announced at prestigious national award ceremony in London’s Science Museum

Fri, 18 May 2012 00:00:00 GMT

For the first time in its 15 year history the judges of the GSK IMPACT Awards could not choose one winner so instead awarded two prizes.

GSK statement on tender offer to acquire Human Genome Sciences

Thu, 17 May 2012 00:00:00 GMT

GSK commented on HGS Board of Directors decision to recommend against GSK's offer to acquire all outstanding shares of HGS for US$13.00

GlaxoSmithKline completes transaction to increase its ownership in Theravance

Wed, 16 May 2012 00:00:00 GMT

Approval by Theravance, Inc. stockholders at their Annual Meeting, GSKs acquisition of 10M shares of Theravance common stock has completed.

GlaxoSmithKline to fully acquire Cellzome for £61 million

Tue, 15 May 2012 00:00:00 GMT

GSK announced it has entered into an agreement to acquire shares in Cellzome, leader in the development of proteomics technologies for $99m

GSK statement on BBC Panorama broadcast: ‘the truth about tax’

Mon, 14 May 2012 00:00:00 GMT

GSK issued the following statement in response to the BBC Panorama programme related to Corporation Tax payments in the UK and Luxembourg

Stiefel receives US FDA approval of Fabior™ Foam, 0.1%

Fri, 11 May 2012 00:00:00 GMT

Stiefel, a GSK company, announced that the FDA has approved the New Drug Application for Fabior (tazarotene) Foam, 0.1%.

GSK commences tender offer to acquire Human Genome Sciences for US $13.00 per share in cash

Thu, 10 May 2012 00:00:00 GMT

GSK commenced its previously announced tender offer to acquire all of the outstanding shares of Human Genome Sciences for US$13.00 per share

GSK to commence tender offer to acquire Human Genome Sciences for US $13.00 per share in cash

Wed, 09 May 2012 00:00:00 GMT

GSK announced it won't participate in Human Genome Sciences strategic alternatives review process

James Shannon named GlaxoSmithKline Chief Medical Officer

Fri, 04 May 2012 00:00:00 GMT

James Shannon has been named GSK's Chief Medical Officer (CMO), effective 1/05, accountable for medical governance & patient safety

GlaxoSmithKline plc appoints two Non-Executive Directors to its Board

Thu, 03 May 2012 00:00:00 GMT

GSK announces that Ms. Lynn Elsenhans and Ms. Jing Ulrich will join Board with effect from 1 July 2012 as Non-Executive Directors.

GlaxoSmithKline and Yale University establish drug discovery collaboration to design potential new class of medicines

Tue, 01 May 2012 00:00:00 GMT

GSK and Yale established a drug discovery research collab to design a potential class of medicines that degrade disease-causing proteins.

GlaxoSmithKline receives European authorisation for Nimenrix™ (Meningococcal group A, C, W-135 and Y conjugate vaccine)

Fri, 27 Apr 2012 00:00:00 GMT

GSK announced today that the EC has granted marketing authorisation for Nimenrix for immunisation against invasive meningococcal disease

GSK and University of Nottingham collaborate to create Centre of Excellence for sustainable chemistry

Thu, 26 Apr 2012 00:00:00 GMT

GSK & University of Nottingham formalised a collaboration to establish a new laboratory to accommodate the Centre of Excellence

Children in Ghana to be vaccinated against diarrhoeal disease with the introduction of GSK’s Rotarix™ vaccine

Thu, 26 Apr 2012 00:00:00 GMT

GSK welcomes GAVI announcement that rotavirus vaccine, Rotarix, will be introduced into national vaccination programme in Ghana.

FDA approves Votrient® for treatment of patients with certain types of advanced soft tissue sarcoma

Thu, 26 Apr 2012 00:00:00 GMT

GSK announced the U.S. FDA has approved Votrient for the treatment of soft tissue sarcoma who have received prior chemotherapy.

Results announcement for the first quarter 2012

Wed, 25 Apr 2012 00:00:00 GMT

Sales growth of +2% CER Further R&D delivery, operational leverage returns to shareholders. Core EPS 27.3p (+7%), dividend up 6% to 17p

GlaxoSmithKline reaches agreement to divest non-core over-the-counter (OTC) brands in international markets for £164 million

Fri, 20 Apr 2012 00:00:00 GMT

GSK announced it's reached agreement to divest non-core OTC brands in its international markets to Aspen for 163;164 million in cash.

GSK confirms offer to acquire Human Genome Sciences for US$13.00 per share in cash

Thu, 19 Apr 2012 00:00:00 GMT

GSK confirms it made an offer to the Board of Directors of HGS on 11/04 proposing to acquire all of the outstanding shares for US$13.00

GSK provides update on corporate responsibility commitments in 2011 report

Wed, 11 Apr 2012 00:00:00 GMT

GSK published its Corporate Responsibility Report, reiterating commitments to operate responsibly & transparently

GSK receives further data from phase lll studies of albiglutide in type 2 diabetes

Tue, 03 Apr 2012 00:00:00 GMT

GSK today announced that topline results have been received from seven of the eight Harmony Phase III studies investigating albiglutide.

Shionogi-ViiV Healthcare announces initial data from pivotal phase III study of dolutegravir in HIV

Mon, 02 Apr 2012 00:00:00 GMT

SPRING-2 study meets primary endpoint of non-inferiority of dolutegravir compared to raltegravir over 48 weeks in treatment of HIV patients.

GlaxoSmithKline to increase its ownership in Theravance

Mon, 02 Apr 2012 00:00:00 GMT

GSK will acquire, 10,000,000 shares of Theravance common stock at a price of $21.2887 per share, for a total investment of $212,887,000.

GSK and Theravance announce completion of the Relovair™* registrational programme and topline results from Relovair™ vs. Advair® phase III studies in COPD

Fri, 23 Mar 2012 00:00:00 GMT

GSK & THNX announced study results for Relovair in patients with COPD evaluating the efficacy compared to placebo in treatment of asthma

GSK confirms significant investments in UK manufacturing: Ulverston in Cumbria selected as site of new biopharmaceutical factory

Thu, 22 Mar 2012 00:00:00 GMT

GSK today confirmed it will invest over 163m in the UK manufacturing sites to increase production of pharmaceutical products & vaccines

GSK announces positive vote from FDA panel for pazopanib in certain advanced soft tissue sarcomas

Tue, 20 Mar 2012 00:00:00 GMT

GSK announced the ODAC voted 11:2 in support a favourable benefit; risk assessment for use of Votrient in patients with soft tissue sarcoma.

GlaxoSmithKline provides further update on divestment of non-core over-the-counter (OTC) brands

Thu, 15 Mar 2012 00:00:00 GMT

GSK announced intention to divest Consumer Healthcare OTC products predominantly in the US & EU with aggregate sales of approx 163million.

GSK reinforces commitment to youth training with launch of new UK apprenticeship programme

Fri, 09 Mar 2012 00:00:00 GMT

GSK announced launch of a new apprenticeship scheme. The programme will sit alongside GSK's established schemes & is aimed at 16-24yo

Regulatory Update: GSK announces submissions for two influenza vaccines

Mon, 05 Mar 2012 00:00:00 GMT

GSK announced today that it has submitted regulatory files for two of its influenza vaccines currently in development.

Innovative UK research project to study the value medicines bring to patients in the real world

Fri, 02 Mar 2012 00:00:00 GMT

Unique collaboration to ensure medicines under development meet patient and healthcare system needs.

GSK and Daiichi Sankyo vaccines joint venture to become largest vaccines company in Japan

Thu, 01 Mar 2012 00:00:00 GMT

GSK announced that it has signed an agreement with Daiichi Sankyo Co., Ltd. to form JV expected to create #1 vaccines company in Japan.

GlaxoSmithKline receives positive opinion in Europe from the CHMP for Nimenrix®

Fri, 17 Feb 2012 00:00:00 GMT

GSK announced that EMA's CHMP is recommending marketing authorisation for Nimenrix for immunisation against meningococcal disease

EU and US Regulatory Update – Tykerb/Tyverb® (lapatinib)

Thu, 16 Feb 2012 00:00:00 GMT

GSK announced it has submitted regulatory applications in EU & US related to Tykerb/ Tyverb (lapatinib) to treat metastatic breast cancer.

GSK results announcement for Q4 and full year 2011

Tue, 07 Feb 2012 00:00:00 GMT

GSK delivers continued underlying sales growth*, R&D progress and improving financial returns to shareholders

GSK joins new global partnership to help defeat ten neglected tropical diseases by 2020

Mon, 30 Jan 2012 00:00:00 GMT

GSK announced it has joined other global pharma companies and organisations in a united effort to defeat neglected tropical diseases.

GSK announces changes to the Board

Fri, 27 Jan 2012 00:00:00 GMT

GSK announced at annual GM in 2013,that Sir Crispin Davis, Sir Robert Wilson and Mr Larry Culp will not stand for re-election to the Board.

GSK responds to the recent court ruling on the COMPAS study in Mendoza, Argentina

Wed, 11 Jan 2012 00:00:00 GMT

GSK respectfully disagrees with court ruling in favour of ANMAT on fine issued regarding conduct of the COMPAS study in Mendoza, Argentina

GSK and Theravance announce initial outcomes from pivotal Phase III studies for once-daily Relovair™* in COPD and asthma

Mon, 09 Jan 2012 00:00:00 GMT

GSK & THRX announced completion of phase III registration programme for Relovair in patients with COPD and in patients with asthma.

GlaxoSmithKline provides update on divestment of non-core over-the-counter (OTC) brands

Tue, 20 Dec 2011 00:00:00 GMT

Agreement reached to divest brands in USA and Canada to Prestige Brands Holdings, Inc. for £426m ($660m).

GSK extends pneumococcal vaccine agreement with GAVI Alliance

Thu, 15 Dec 2011 00:00:00 GMT

GSK & GAVI to help protect millions more children in the world's poorest countries from pneumococcal disease.

GlaxoSmithKline and Human Genome Sciences initiate phase III trial of belimumab (Benlysta®) administered subcutaneously in subjects with systemic lupus erythematosus

Thu, 15 Dec 2011 00:00:00 GMT

GSK & HGS announced dosing has been initiated in BLISS-SC, a new Phase III study of belimumab administered SC to adults with SLE.

GSK presents phase lll data for lapatinib at San Antonio breast cancer symposium

Thu, 08 Dec 2011 00:00:00 GMT

Improvement in disease-free survival does not reach statistical significance in study of Tykerb monotherapy in HER2 positive breast cancer.

GSK and Help for Heroes partner to support the rehabilitation of wounded servicemen and women in the UK

Wed, 07 Dec 2011 00:00:00 GMT

GSK & Help for Heroes announced new partnership to help injured British armed forces personnel successfully transition into civilian life.

GSK statement in response to the Prime Minister’s speech on life sciences

Mon, 05 Dec 2011 00:00:00 GMT

The Government's strategy for Life Sciences is an important step to make UK the best place in the world to locate pharmaceutical investment.

Regulatory Update: GlaxoSmithKline submits additional information for candidate meningococcal and Hib combination vaccine

Thu, 01 Dec 2011 00:00:00 GMT

GSK submitted information to the FDA supporting BLA for combination vaccine MenHibrix. submitted in response to Complete Response letter.

Reporting on a core earnings basis will begin with effect from Q1 2012

Thu, 01 Dec 2011 00:00:00 GMT

Go to the Presentations and webcasts page for the full announcement.

GSK welcomes GAVI Alliance decision to introduce vaccines against cervical cancer and rubella in the world’s poorest countries

Thu, 17 Nov 2011 00:00:00 GMT

GAVI Board to provide funding for cervical cancer immunisation programmes & rubella vaccination, across the world's poorest countries.

GlaxoSmithKline welcomes innovative knowledge-sharing collaboration to break deadlock in antibiotic discovery and development

Thu, 17 Nov 2011 00:00:00 GMT

GSK welcomes EC decision to promote collaborative research efforts to develop new antibiotics against growing threat from resistant bacteria

GSK receives initial data from the first completed phase lll study of albiglutide in type 2 diabetes

Wed, 16 Nov 2011 00:00:00 GMT

Head-to-head study primary end point did not meet non-inferiority, but results support progression towards registration

Data published in The Lancet Oncology support high efficacy previously demonstrated by Cervarix® (HPV 16 and 18 vaccine) against precancerous cervical lesions

Wed, 09 Nov 2011 00:00:00 GMT

Analysis in TheLancet reinforces findings that GSK's Cervarix, provided protection against CIN3+, above expected from a vaccine against HPV.

GSK presents phase III results for eltrombopag in hepatitis C virus related thrombocytopenia

Mon, 07 Nov 2011 00:00:00 GMT

Full results from ENABLE 1 & 2 presented at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases

GlaxoSmithKline reaches agreement in principle to resolve multiple investigations with US Government

Thu, 03 Nov 2011 00:00:00 GMT

GSK announced it's reached an agreement with US Gov to conclude the Company’s most significant ongoing Federal government investigations

GSK delivers strong Q3 performance with underlying sales growth of 6% and reported sales growth of 3%

Wed, 26 Oct 2011 00:00:00 GMT

Full details of GSK's results for the third quarter of 2011 can be found in the Investors section of GSK.com.

GSK joins WIPO Re:Search open innovation platform as part of its commitment to tackling diseases of the developing world

Wed, 26 Oct 2011 00:00:00 GMT

GSK joined WIPO Re:Search in innovation strategy to help accelerate the development of treatments of NTDs affecting over a billion each year

First results from ongoing Phase III trial show malaria vaccine candidate, RTS,S* reduces the risk of malaria by half in African children aged 5 to 17 months

Tue, 18 Oct 2011 00:00:00 GMT

Half the world's population at risk of malaria responsible for 800,000 deaths each year, most of whom children under 5 in sub-Saharan Africa

Regulatory Update: GlaxoSmithKline receives Complete Response letter from FDA for candidate meningococcal and Hib combination vaccine

Fri, 23 Sep 2011 00:00:00 GMT

GSK announced it's received a Complete Response letter from FDA for MenHibrix ,active immunization of infants 6 weeks through 15 months

Lucozade to help drive Vodafone McLaren Mercedes performance

Thu, 22 Sep 2011 00:00:00 GMT

Ahead of Singapore Grand Prix, Lucozade announces an innovative performance partnership with the Vodafone McLaren Mercedes Formula 1 team.

GlaxoSmithKline (GSK) and McLaren Group announce innovative strategic partnership

Thu, 15 Sep 2011 00:00:00 GMT

GSK announced it's formed a partnership with McLaren Group which will run initially until 2016 focusing on innovation and high-tech research

GlaxoSmithKline (GSK) commits $1 million in cervical cancer vaccine to new cooperative effort aimed at reducing deaths from women's cancers

Tue, 13 Sep 2011 00:00:00 GMT

GSK has committed $1 million in Cervarix, cervical cancer vaccine to the Pink Ribbon Red Ribbon partnership over the next five years.

GlaxoSmithKline and Amicus Therapeutics commence second phase III study of Amigal™ for Fabry disease

Mon, 12 Sep 2011 00:00:00 GMT

GlaxoSmithKline and Amicus Therapeutics commence second phase III study of Amigal™ for Fabry disease

GSK gives update on agreement with World Health Organization to support de-worming of school age children in endemic countries

Mon, 12 Sep 2011 00:00:00 GMT

First African countries, Togo and Rwanda, receive albendazole donations to scale-up school based de-worming programmes for children at risk.

Lapatinib clinical trial update

Fri, 09 Sep 2011 00:00:00 GMT

Review - Phase III study of lapatinib & trastuzumab in patients with HER2+ early stage breast cancer to continue trials without modification

Jens Eckstein named President of SR One, GSK’s venture healthcare group

Wed, 07 Sep 2011 00:00:00 GMT

Jens Eckstein has been named President of SR One, GSK's independent healthcare venture organisation, effective 1 October.

GlaxoSmithKline (GSK) shows sign of things to come at London 2012 Olympic and Paralympic Games

Wed, 07 Sep 2011 00:00:00 GMT

2012 provider, GSK, unveils sign celebrating its scientific contribution to the Games

GSK awarded contract by BARDA to support research on potential novel antibiotic

Tue, 06 Sep 2011 00:00:00 GMT

GSK & BARDA's contract to support the development of a potentially new antibiotic against hospital Gram negative and biothreat pathogens.

GSK takes minority stake in new spin out Autifony Therapeutics

Mon, 22 Aug 2011 00:00:00 GMT

GSK announced its wholly-owned subsidiary will receive 25.4% equity stake in Autifony Therapeutics Limited alongside other investors.

GSK and Impax announce positive topline results of ASCEND-PD Phase III study of IPX066 in Advanced Parkinson’s disease

Mon, 15 Aug 2011 00:00:00 GMT

IPX066 demonstrated statistically significant improvement over carbidopa-levodopa plus entacapone in reducing off time % during waking hours

GSK and Enigma Diagnostics announce collaboration on assay development and commercialisation of Enigma’s ML platform

Wed, 10 Aug 2011 00:00:00 GMT

GSK & Enigma announced agreements for the supply of Enigma ML system for respiratory tests for use on its real-time PCR technology platform.

Regulatory Update: GSK and XenoPort submit supplemental New Drug Application to FDA for Horizant™ in postherpetic neuralgia

Tue, 09 Aug 2011 00:00:00 GMT

GSK & XNPT announced sNDA submitted to FDA for approval of Horizant tablets for the management of PHN in adults.

Regulatory update – Stiefel, a GSK company, files NDA for tazarotene foam

Wed, 03 Aug 2011 00:00:00 GMT

Stiefel announced it's submitted a NDA to the FDA for tazarotene foam for the topical treatment of facial acne vulgaris in patients 12+.

GSK delivers strong Q2 performance with underlying sales growth* of 5%, increased pipeline visibility and dividend of 16p, up 7%

Tue, 26 Jul 2011 00:00:00 GMT

Full details of GSK's results for the second quarter of 2011 can be found in the

GlaxoSmithKline European regulatory update on Pandemrix™

Thu, 21 Jul 2011 00:00:00 GMT

GSK announced EMA's CHMP has recommended an update to the product label for the H1N1 influenza vaccine, Pandemrix.

GlaxoSmithKline and Human Genome Sciences receive European authorisation for Benlysta® (belimumab)

Thu, 14 Jul 2011 00:00:00 GMT

GSK & HSG announced, EC has granted marketing authorisation for Benlysta as therapy in patients with active autoantibody-positive SLE.

EU and US Regulatory Update - Votrient® (pazopanib)

Wed, 06 Jul 2011 00:00:00 GMT

GSK announced it's submitted a Marketing Authorisation Application to EMA for Votrient, the treatment of patients with advanced STR.

London 2012 partner, GlaxoSmithKline, shares scientific expertise with World Anti-Doping Agency to help fight against abuse of drugs in sport

Mon, 04 Jul 2011 00:00:00 GMT

GSK signed a long-term agreement with WADA helping create early detection methods for performance-enhancing medicines in sport.

GlaxoSmithKline receives new approval for Rotarix and significant new indication for Lamictal® (lamotrigine) in Japan

Fri, 01 Jul 2011 00:00:00 GMT

GSK rotavirus vaccine approved for use in babies Lamotrigine becomes the first treatment to be approved in Japan for adult bipolar disorder

GSK welcomes external scientists to diseases of the developing world research campus

Tue, 28 Jun 2011 00:00:00 GMT

GSK will provide support, expertise and facilities as part of our open innovation strategy to spur global collaboration in research

GSK statement on University of East Anglia study examining health impacts of anticholinergic medicines for over 65s

Fri, 24 Jun 2011 00:00:00 GMT

University of East Anglia published in JAGS, long term health impacts of anticholinergic medicines, group of drugs taken by older people.

GSK statement on agreements with State Attorneys General on former Cidra manufacturing facility

Thu, 23 Jun 2011 00:00:00 GMT

GSK agreed to pay $40.75 million as part of an agreement related to events during early 2000s at former manufacturing facility in Cidra

GSK to purchase Shenzhen Neptunus stake in previously formed joint venture for influenza vaccines in China

Tue, 14 Jun 2011 00:00:00 GMT

GSK entered into agreement to acquire the remaining 51% equity interest of Neptunus in JV company for a total cash consideration of $39m

GlaxoSmithKline and Valeant announce US FDA approval of Potiga™ (ezogabine)

Mon, 13 Jun 2011 00:00:00 GMT

GSK & VRX announced that the FDA has approved Potiga Tablets, a potassium channel opener, as treatment of partial-onset seizures in 18yo+.

Millions of children in the world’s poorest countries could receive vaccination against rotavirus diarrhoeal disease under new offer made by GSK to the GAVI Alliance

Mon, 06 Jun 2011 00:00:00 GMT

GSK announced it's made a new offer to supply Rotarix, to the GAVI Alliance at $2.50 per dose, a small fraction of developed world prices.

GlaxoSmithKline’s pazopanib improved progression free survival in adults with certain soft tissue sarcomas

Sat, 04 Jun 2011 00:00:00 GMT

PALETTE study presented at ASCO demonstrated improvement in the time to occurrence of tumour progression in patients on pazopanib vs placebo

GSK and Theravance announce results of two pivotal Phase III studies for Relovair in COPD

Thu, 02 Jun 2011 00:00:00 GMT

GSK and THRX announced the results of two pivotal 6-month efficacy and safety phase III studies of Relovair for patients with COPD.

GSK forms partnership with three leading NGOs to address shortage of frontline healthcare workers in Least Developed Countries LDCs

Tue, 24 May 2011 00:00:00 GMT

- Agreements signed with AMREF, CARE International UK and Save the Children as part of commitment to reinvest 20% of profits in LDCs

GlaxoSmithKline and Human Genome Sciences receive positive opinion in Europe from the CHMP for Benlysta® belimumab

Fri, 20 May 2011 00:00:00 GMT

GSK & HGS announced that EMA's CHMP issued a positive opinion, recommending marketing authorisation for Benlysta, a lupus therapy.

Young peoples health charity steps forward to claim top accolade and 35,000

Fri, 13 May 2011 00:00:00 GMT

Step Forward, has beaten more than 400 organisations from around the UK to be crowned the overall winner of this year's GSK IMPACT Awards

pharmaceutical industry and university create manchester collaborative centre for inflammation research

Thu, 12 May 2011 00:00:00 GMT

GSK, UofM & AZN announce creation of MCCIR, unique collaboration to establish a world-leading translational centre for inflammatory diseases

GSK Q1 performance demonstrates continued progress with delivery of underlying sales growth, cash generation and pipeline visibility

Wed, 27 Apr 2011 00:00:00 GMT

Reported sales -10%; underlying sales* +4% EPS before major restructuring* 32.2p (+9%); dividend 16p (+7%)

Regulatory update – GSK and Valeant respond to FDA on ezogabine

Mon, 18 Apr 2011 00:00:00 GMT

GSK & VRX submitted on 15/04/11 the response to the FDA Complete Response letter received on 30 November 2010 for the NDA for ezogabine.

GSK welcomes key agreement to support global preparedness against pandemic influenza

Mon, 18 Apr 2011 00:00:00 GMT

GSK welcomes agreement reached at OEWG coordinated by WHO on a Framework to support global preparedness for a future influenza pandemic.

GSK European regulatory update on Pandemrix™

Fri, 15 Apr 2011 00:00:00 GMT

EMA's CHMP recommends changes to Pandemrix, including prescribing advice based on increased risk of narcolepsy in children or adolescents

Regulatory Update - Tyverb® lapatinib

Fri, 15 Apr 2011 00:00:00 GMT

GSK submitted a MAA to EMA for lapatinib in with paclitaxel for the treatment of metastatic breast cancer with over-express HER2 (ErbB2).

GlaxoSmithKline announces non-core OTC products to be divested

Thu, 14 Apr 2011 00:00:00 GMT

GSK to divest non-core OTC brands as it focuses Consumer Healthcare business around fast-growing priority brands and the emerging markets.

Unique research alliance expands collaboration opportunities at state-of-the-art medical imaging centre

Tue, 12 Apr 2011 00:00:00 GMT

UK research community to have access to world-class medical imaging facilities in London with the signing of an agreement between MRC & GSK

GlaxoSmithKline and XenoPort receive FDA approval for Horizant™

Wed, 06 Apr 2011 00:00:00 GMT

GSK & XNPT announced that the FDA has approved Horizant for the treatment of moderate-to-severe primary Restless Legs Syndrome in adults.

GSK publishes payments for research consulting and advising by US healthcare professionals

Thu, 31 Mar 2011 00:00:00 GMT

GSK published a list of payments for clinical research studies led by U.S. healthcare professionals, for the discovering of new medicines.

GlaxoSmithKline confirms Pronova BioPharma reaches agreement with Apotex regarding Lovaza™ US patent litigation

Wed, 30 Mar 2011 00:00:00 GMT

GSK confirmed that Pronova entered into an agreement with Apotex to settle their patent litigation in the United States related to Lovaza.

GSK and Valeant receive European authorisation for Trobalt (retigabine)

Tue, 29 Mar 2011 00:00:00 GMT

GSK & VRX announced, EC has granted marketing authorisation for Trobalt (retigabine) as an add-on treatment of partial onset seizures.

GSK publishes 2010 Corporate Responsibility Report

Sun, 27 Mar 2011 00:00:00 GMT

In its CRR, GSK reiterated its commitment to building its business on strong values and ethical standards.

GSK statement on Avodart™ (dutasteride) for prostate cancer risk reduction

Wed, 23 Mar 2011 00:00:00 GMT

GSK announced it will no longer pursue global approval for the use of Avodart (dutasteride) to reduce the risk of prostate cancer.

GSK launches London 2012 initiative with King’s College London to inspire young people into science careers

Tue, 22 Mar 2011 00:00:00 GMT

Scientists in Sport programme designed to inspire young people published a study that 8/10 secondary school pupils are worried about work.

GSK supports recovery efforts to help those affected by the Japan earthquake

Fri, 18 Mar 2011 00:00:00 GMT

As a result of the Tohoku Kanto Earthquake and tsunami GSK is supporting the ongoing relief efforts and pharmaceutical donation needs.

GSK announces positive topline results of Phase lll study of IPX066 in advanced Parkinson’s disease

Mon, 14 Mar 2011 00:00:00 GMT

GSK announced results of the PD Phase III study by Impax Pharma, of IPX066 versus IR CD-LD patients experiencing motor fluctuations.

GlaxoSmithKline and Tolerx announce phase III DEFEND-1 study of otelixizumab in type 1 diabetes did not meet its primary endpoint

Fri, 11 Mar 2011 00:00:00 GMT

GSK and Tolerx announced Phase III DEFEND-1 study of otelixizumab did not meet the PFS at month 12 in patients with type 1 diabetes.

GlaxoSmithKline and Human Genome Sciences announce FDA approval of Benlysta® (belimumab) for the treatment of systemic lupus erythematosus

Wed, 09 Mar 2011 00:00:00 GMT

GSK & HGS announced that the FDA has approved Benlysta for the treatment of active, autoantibody-positive SLE who are receiving therapy.

GlaxoSmithKline plc appoints two Non-Executive Directors to its Board (1)

Fri, 04 Mar 2011 00:00:00 GMT

GSK announces, Ms. Judy Lewent and Ms. Stacey Cartwright have been appointed as Non-Executive Directors and will join the Board from 1/4/11.

Regulatory update: Nimenrix® (MenACWY vaccine)

Wed, 02 Mar 2011 00:00:00 GMT

GSK submitted a MAA to EMA for Nimenrix, active immunisation against meningococcal diseases caused by Neisseria meningitidis serogroups.

GSK outlines new plan to drive recruitment and attract graduate talent in the UK

Wed, 02 Mar 2011 00:00:00 GMT

GSK outlined new plans to encourage talented students graduating from UK universities to consider pursuing a career within the company.

Reward for charities bridging gaps in health care provision

Tue, 01 Mar 2011 00:00:00 GMT

Ten UK charities have each won £25,000 in recognition of their outstanding contribution to improving health care, part of GSK IMPACT Awards.

World’s first everyday fluoride toothpaste with NovaMin® technology that can repair sensitive teeth

Tue, 01 Mar 2011 00:00:00 GMT

GlaxoSmithKline Consumer Healthcare today announced a breakthrough in dental care with the launch of new Sensodyne Repair & Protect.

David Redfern appointed as new Chairman of ViiV Healthcare

Fri, 25 Feb 2011 00:00:00 GMT

GSK, ViiV & Pfizer announced the appointment of David Redfern as the new Chairman of the Board for ViiV Healthcare with effect from 1/4/11.

GSK European regulatory update on Pandemrix™ (1)

Fri, 18 Feb 2011 00:00:00 GMT

CHMP concludes that data are insufficient to establish a causal relationship between Pandemrix and narcolepsy.

First African country introduces GSK’s pneumococcal vaccine through innovative financing mechanism

Fri, 11 Feb 2011 00:00:00 GMT

GSK announced the incorporation of its pneumococcal vaccine into the Kenyan national immunisation programme.

GlaxoSmithKline moving to new building at Philadelphia Navy Yard

Tue, 08 Feb 2011 00:00:00 GMT

GSK & LRY announced they signed a 15.5-year lease for a new building to be developed by Liberty Property Trust and Synterra Partners.

GSK revises US Avandia label to include new restrictions on use

Mon, 07 Feb 2011 00:00:00 GMT

GSK announced revised US prescribing information and medication guides for all rosiglitazone-containing medicines.

GlaxoSmithKline and Human Genome Sciences announce publication of BLISS-52 phase lll study results for Benlysta® in The Lancet

Mon, 07 Feb 2011 00:00:00 GMT

GSK & HGS announced publication Benlysta in autoantibody-positive patients with active systemic lupus erythematosus (SLE) in The Lancet.

GSK results announcement for the fourth quarter

Thu, 03 Feb 2011 00:00:00 GMT

Strategic progress drives positive underlying sales growth, increasing pipeline potential and improved cash generation.

GSK and Theravance announce progression of LAMA/LABA combination treatment into Phase III development for COPD

Thu, 03 Feb 2011 00:00:00 GMT

GSK & THRX announced major milestones in two clinical development programmes focused on new treatments for patients with COPD.

GSK announces the sale of its entire shareholding in Quest Diagnostics

Tue, 01 Feb 2011 00:00:00 GMT

GSK announces that it has sold its entire holding of 30,755,151 shares of common stock in Quest Diagnostics Inc. (Quest).

Update on Pandemrix™ and interim Finnish report on narcolepsy

Tue, 01 Feb 2011 00:00:00 GMT

GSK is aware of today's interim report by the Finnish National narcolepsy committee on their investigation into reported cases in Finland.

GSK and Actelion discontinue clinical development of almorexant

Fri, 28 Jan 2011 00:00:00 GMT

GSK & ATLN announced the Phase III investigational dual orexin receptor antagonist, almorexant, has been discontinued.

GSK receives FDA Complete Response letter for Avodart for prostate cancer risk reduction supplemental indication

Wed, 26 Jan 2011 00:00:00 GMT

GSK received a Complete Response letter from the FDA for the sNDA for Avodart for reducing the risk of prostate cancer in men.

GlaxoSmithKline announces start of two phase III studies in advanced/metastatic melanoma

Mon, 24 Jan 2011 00:00:00 GMT

GSK announced the start of two global Phase III studies in advanced or metastatic melanoma patients with a BRAF V600 mutation.

Regulatory update - GSK and Valeant receive positive opinion in Europe from the CHMP for Trobalt (retigabine)

Fri, 21 Jan 2011 00:00:00 GMT

GSK & VRX announced EMA's CHMP has issued a positive opinion, recommending marketing authorisation for Trobalt, treatment of seizures.

GSK and Prosensa announce start of Phase III study of investigational Duchenne Muscular Dystrophy medication

Wed, 19 Jan 2011 00:00:00 GMT

GSK and Prosensa announced - first patient has commenced treatment in the Phase III study investigating GSK2402968 in ambulant boys with DMD

GlaxoSmithKline commences Phase III study of intravenous zanamivir for hospitalised patients with influenza

Wed, 19 Jan 2011 00:00:00 GMT

GSK announced, patient has received treatment in Phase III study of hospitalised patients with influenza comparing zanamivir & oseltamivir

GlaxoSmithKline announces Q4 2010 legal charge

Mon, 17 Jan 2011 00:00:00 GMT

GSK announces that it expects to record a legal charge for the fourth quarter of 2010 of £2.2 billion ($3.4 billion) after tax £1.8 billion.

GlaxoSmithKline and ChemoCentryx announce initiation of Phase III study of GSK’786, formerly Traficet-EN™, for the treatment of Crohn’s disease

Wed, 12 Jan 2011 00:00:00 GMT

GSK & ChemoCentryx announced, first patient with Crohn's disease has initiated treatment in study comparing Traficet-EN, to placebo.

GlaxoSmithKline and DENTSPLY International sign global agreement to create a portfolio of co-branded professional oral care products

Fri, 07 Jan 2011 00:00:00 GMT

GlaxoSmithKline and DENTSPLY International, announced an agreement to create a portfolio of co-branded oral care products.

GSK responds to 60 Minutes

Sat, 01 Jan 2011 00:00:00 GMT

GSK issued response regarding a 60' program on Jan 2 that focused on a manufacturing facility in Puerto Rico, formerly owned by the company.

GlaxoSmithKline and Theravance commence MABA Phase IIb COPD study

Mon, 20 Dec 2010 00:00:00 GMT

GSK & THRX announced, first patient has started treatment with GSK961081 in a Phase IIb study to evaluate efficacy in patients with COPD.

GlaxoSmithKline and Impax Pharmaceuticals enter global agreement to develop and commercialise a late stage compound for Parkinson’s Disease

Wed, 15 Dec 2010 00:00:00 GMT

GSK & Impax announced, agreement for the development of IPX066 outside the US & Taiwan, product for the treatment of PD in Phase III trials.

Andrew Witty appointed Lead Non-Executive Board Member for the Department for Business, Innovation and Skills (BIS)

Wed, 15 Dec 2010 00:00:00 GMT

UK Gov announced, Andrew Witty appointed as the Lead Non-Executive Board Member for the Department for Business, Innovation and Skills.

GSK to strengthen Nutritional Healthcare business with acquisition of Maxinutrition

Mon, 13 Dec 2010 00:00:00 GMT

GSK entered into an agreement for acquisition of Maxinutrition protein-enhanced functional nutrition manufacturer from Darwin Private Equity

Phase III study in HER2-positive advanced breast cancer shows overall survival benefit when Tykerb is combined with paclitaxel

Thu, 09 Dec 2010 00:00:00 GMT

Phase III study, women with untreated HER2+ metastatic breast cancer improved when treated with a combination of lapatinib & paclitaxel

Data from Tykerb investigational phase III studies in neo-adjuvant HER2-positive breast cancer presented at breast cancer symposium

Thu, 09 Dec 2010 00:00:00 GMT

Results from 2 Phase III studies examining Tykerb with trastuzumab in the neo-adjuvant setting of HER2+ breast cancer with chemotherapy

GSK signs agreement to acquire Nanjing MeiRui Pharmaceuticals in China

Mon, 06 Dec 2010 00:00:00 GMT

GSK in agreement to acquire MeiRui for approx $70 million. 90% of share capital is to be acquired from Pagoda, remaining 10 from Allergon.

GlaxoSmithKline and Human Genome Sciences announce FDA extension of Benlysta® PDUFA target date to 10th March 2011

Thu, 02 Dec 2010 00:00:00 GMT

GSK & HGS announced, FDA has extended the PDUFA target date for its priority review of BLA for Benlysta as a potential treatment for SLE.

Avodart reviewed by FDA advisory committee for prostate cancer risk reduction

Tue, 30 Nov 2010 00:00:00 GMT

GSK announced, results of FDA ODAC meeting to discuss sNDA for Avodart, reducing the risk of prostate cancer in men at risk of the disease

GSK and Valeant announce receipt of U.S. FDA Complete Response letter for ezogabine

Tue, 30 Nov 2010 00:00:00 GMT

GSK & VRX announced receipt of CRL from FDA for NDA for ezogabine*, a drug studied for the treatment of adults with partial-onset seizures.

Government patent box proposals ‘transform’ UK attractiveness for investment

Sun, 28 Nov 2010 00:00:00 GMT

GSK welcomes Gov proposals to establish a patent box, designed to encourage investment in R&D, by introducing a lower corporation tax.

GlaxoSmithKline to increase its shareholding in Theravance

Sun, 28 Nov 2010 00:00:00 GMT

GSK to increase shareholding in THRX through stock purchase of 5,750,000 shares for $22.50 per share, a total investment of $129,375,000.

GlaxoSmithKline and JSC Binnopharm enter vaccine production alliance in Russia

Thu, 25 Nov 2010 00:00:00 GMT

GSK and JSC Binnopharm today announced an alliance to enable the local secondary manufacture of a number of GSK vaccines in Russia.

Human Genome Sciences and GlaxoSmithKline announce vote of FDA advisory committee to recommend approval of Benlysta® for systemic lupus erythematosus

Mon, 15 Nov 2010 00:00:00 GMT

GSK & HGS announced, FDA has voted 13 to 2 to recommend BENLYSTA for the treatment of autoantibody-positive patients with active SLE.

New study findings show no benefit of prescription omega-3 fatty acids in prevention of recurrent symptomatic atrial fibrillation in affected patients

Sun, 14 Nov 2010 00:00:00 GMT

Findings from study show treatment with high-dose prescription omega-3 fatty acids did not reduce the recurrence of symptomatic AF.

GlaxoSmithKline and Fiocruz extend innovative collaboration to research and develop new medicines for neglected tropical diseases

Thu, 11 Nov 2010 00:00:00 GMT

GSK and Fiocruz have today announced a unique collaboration to research and develop new and innovative medicines to treat diseases.

GlaxoSmithKline receives approval in Japan for two medicines: Revolade and Xyzal

Thu, 28 Oct 2010 00:00:00 GMT

GSK announced that it has received approval in Japan from the Ministry of Health, Labour and Welfare for Revolade (eltrombopag).

GSK and Amicus Therapeutics enter exclusive worldwide agreement to develop and commercialise Amigal™ for Fabry disease

Thu, 28 Oct 2010 00:00:00 GMT

GSK and Amicus today announced a definitive agreement to develop and commercialise AmigalTM (migalastat HCl),

GSK completes previously reported settlement with U.S. Department of Justice regarding former manufacturing plant

Mon, 25 Oct 2010 00:00:00 GMT

GSK announced that it has finalised an agreement with the U.S. Attorneys Office for the District of Massachusetts and DOJ.

GSK announces Q3 results for 2010

Wed, 20 Oct 2010 00:00:00 GMT

Q3 EPS before major restructuring of 28.2p

GSK outlines approach to delivering advances in the treatment of rare diseases

Sun, 17 Oct 2010 00:00:00 GMT

Creating an environment that fosters innovation, intuition and scientific acumen to deliver breakthrough thinking and new medicines

GSK, Fondazione Telethon and Fondazione San Raffaele to collaborate on gene therapy for rare diseases

Sun, 17 Oct 2010 00:00:00 GMT

GSK, Fondazione Telethon and Fondazione San Raffaele today announced a new strategic alliance to research and develop novel treatments.

GSK increases support for WHO strategy to improve children’s health with new 5-year commitment to expand donations of albendazole medicine

Wed, 13 Oct 2010 00:00:00 GMT

At the launch of the World Health Organizations (WHO) first report on Neglected Tropical Diseases today.

GSK takes minority stake in newly formed Convergence Pharmaceuticals

Sun, 03 Oct 2010 00:00:00 GMT

GSK announced that it has taken an 18% minority equity stake in Convergence Pharmaceuticals Limited.

GSK provides update on Herpevac trial for women evaluating Simplirix™ (Herpes Simplex Vaccine)

Wed, 29 Sep 2010 00:00:00 GMT

GSK has made the decision not to pursue further worldwide development of Herpes Simplex Vaccine.

GlaxoSmithKline receives EU approval for a new therapeutic indication for Arixtra® (fondaparinux)

Wed, 29 Sep 2010 00:00:00 GMT

GSK confirmed today that the European Commission has granted an amendment of their marketing authorisation for their anti-clotting agent.

GSK regulatory update on Avandia following EMA and FDA reviews

Wed, 22 Sep 2010 00:00:00 GMT

GSK confirms that following a review of Avandia® (rosiglitazone maleate) by the EMA and the FDA.

GSK EU regulatory update on Pandemrix™

Wed, 22 Sep 2010 00:00:00 GMT

GSK confirmed that on behalf of the EMA, CHMP has concluded that the available data are insufficient to Pandemrix and narcolepsy.

GSK and Theravance announce combination ICS/LABA Phase II results in the Relovair™ development programme

Tue, 21 Sep 2010 00:00:00 GMT

Additional data presentations for fluticasone furoate and vilanterol trifenatate support the potential developmental combination treatment

GlaxoSmithKline and Genmab refocus development programme for ofatumumab in autoimmune indications

Wed, 15 Sep 2010 00:00:00 GMT

GSK and Genmab announced today plans to refocus the development programme of ofatumumab in autoimmune indications.

Three-year results from ECLIPSE study indicate that COPD patients may require prevention strategies to manage exacerbations, regardless of disease severity

Tue, 14 Sep 2010 00:00:00 GMT

Today the New England Journal of Medicine published results from ECLIPSE, an extensive research programme sponsored by GSK.

GSK and BJD collaborate on a new educational programme to reduce global burden of joint pain

Fri, 10 Sep 2010 00:00:00 GMT

BJD international initiative and GSK today announced the launch of the LIBERATE™ joint pain management programme.

Audio recording of meeting between GSK and Dr Nissen to discuss Avandia

Fri, 10 Sep 2010 00:00:00 GMT

Audio recording of meeting between GSK and Dr Nissen to discuss Avandia

GlaxoSmithKline and Genmab announce start of ofatumumab Phase III combination study in non-Hodgkin’s lymphoma

Tue, 07 Sep 2010 00:00:00 GMT

GSK and GEN announced today the start of a Phase III study in patients with indolent B-cell non-Hodgkin’s lymphoma (B-NHL).

GSK announces succession plan for Chief Financial Officer

Tue, 07 Sep 2010 00:00:00 GMT

GSK announces that Julian Heslop is to retire as Chief Financial Officer and Executive Director of the company at the end of March 2011.

Galapagos reaches agreement to acquire GlaxoSmithKline research centre in Zagreb, Croatia

Tue, 07 Sep 2010 00:00:00 GMT

R&D operations in Zagreb fulfil Galapagos; growing R&D capacity requirements

GSK signs agreement with Lonza to secure capacity and expertise in biological manufacturing to support ongoing development of GSK’s biopharmaceuticals portfolio

Tue, 07 Sep 2010 00:00:00 GMT

GSK and Lonza today announced that they have entered into a new agreement under which Lonza will support the ongoing development of GSK.

BBC Panorama – 6 September 2010

Sun, 05 Sep 2010 00:00:00 GMT

Patient safety is our first priority. We strongly refute any allegation that our actions have put patients at risk.

GlaxoSmithKline pre-broadcast statement: BBC Panorama, 6 September 2010

Sun, 05 Sep 2010 00:00:00 GMT

GSK today issued the statement in anticipation of the BBC programme, A risk worth taking which is scheduled to be aired this evening.

GlaxoSmithKline responds to British Medical Journal article regarding Avandia® (rosiglitazone)

Sun, 05 Sep 2010 00:00:00 GMT

GSK continues to work in the best interest of diabetes patients who face this chronic and serious disease.

Reports of narcolepsy in Europe following vaccination with Pandemrix™

Wed, 01 Sep 2010 00:00:00 GMT

GSK became aware of cases of narcolepsy following vaccination with the adjuvanted H1N1 pandemic vaccine Pandemrix.

GSK and Valeant announce new U.S. FDA PDUFA goal date for ezogabine

Sun, 29 Aug 2010 00:00:00 GMT

GSK and VRX announced today FDA has extended the PDUFA goal date for ezogabine* to 30 Nov 2010, the original goal date was 30 August 2010.

GSK commences Phase III clinical trials to develop herpes zoster vaccine for the prevention of shingles

Sun, 22 Aug 2010 00:00:00 GMT

GSK confirmed that the company has commenced the Phase III clinical trials programme of its candidate herpes zoster vaccine.

GlaxoSmithKline and Human Genome Sciences announce FDA priority review designation for Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus

Wed, 18 Aug 2010 00:00:00 GMT

GSK and Human Genome Sciences, Inc. today announced that the FDA has granted a priority review designation to Benlysta.

GSK and Genmab announce topline results from the concluded pivotal trial of Arzerra (ofatumumab) in fludarabine and alemtuzumab refractory chronic lymphocytic leukemia

Sun, 08 Aug 2010 00:00:00 GMT

GSK and GEN announced today top line results from the concluded pivotal trial.

Image of new antibiotic in action opens up new opportunities to combat antibacterial resistance

Tue, 03 Aug 2010 00:00:00 GMT

Pictures have been published showing how a type of experimental antibiotic can kill bacteria already resistant to existing treatments.

GSK exercises option on Anacor’s novel antibiotic for the treatment of gram-negative infections

Wed, 28 Jul 2010 00:00:00 GMT

GSK and Anacor Pharmaceuticals today announced that GSK has exercised its option to obtain an exclusive licence to develop.

GSK receives CHMP positive opinion for a new indication for Arixtra

Thu, 22 Jul 2010 00:00:00 GMT

GSK today announced that CHMP has issued a positive opinion for Arixtra (fondaparinux),an anti-clotting drug (antithrombotic).

GlaxoSmithKline statement in response to FDA announcement on TIDE trial

Tue, 20 Jul 2010 00:00:00 GMT

GSK confirmed that it will suspend enrollment of new patients in TIDE clinical trial at the request of FDA.

GSK announces Q2 results for 2010

Tue, 20 Jul 2010 00:00:00 GMT

Q2 EPS before major restructuring* 2.6p (29.3p excluding pre-announced legal charge)

GlaxoSmithKline legal update

Wed, 14 Jul 2010 00:00:00 GMT

GSK today announces that it expects to record a legal charge for the second quarter of 2010 of £1.57billion ($2.36 billion).

GlaxoSmithKline statement in response to FDA Advisory Committees’ vote on safety of Avandia® (rosiglitazone)

Tue, 13 Jul 2010 00:00:00 GMT

GSK confirmed that a joint advisory committee to the FDA voted to allow Avandia to remain on the market.

GlaxoSmithKline (GSK) responds to Senate Finance Committee letter of 12 July to FDA

Mon, 12 Jul 2010 00:00:00 GMT

The Senate Finance Committee (SFC) has released a small subset of the 14 million pages of documents provided to plaintiffs&apos.

Data support Avandia (rosiglitazone maleate) cardiovascular safety profile

Thu, 08 Jul 2010 00:00:00 GMT

The U.S. Food and Drug Administration (FDA) today posted a comprehensive review conducted by GlaxoSmithKline (GSK).

GSK EU regulatory update on Avandia (rosiglitazone)

Thu, 08 Jul 2010 00:00:00 GMT

GSK today confirmed that on behalf of EMA, the CHMP is to review the benefit/risk profile of Avandia (rosiglitazone).

GSK and EDB commit $35 million (USD) in funding to support research in green and sustainable manufacturing in Singapore

Thu, 01 Jul 2010 00:00:00 GMT

GSK and the Singapore EDB, the government agency responsible for economic growth and development.

GlaxoSmithKline and Genmab announce amendment to Ofatumumab agreement

Wed, 30 Jun 2010 00:00:00 GMT

GSK and GEN announced today an amendment to the ofatumumab co-development and commercialisation agreement.

GlaxoSmithKline creates a new operating unit dedicated to expanding access to medicines for people living in the world’s poorest countries

Wed, 30 Jun 2010 00:00:00 GMT

As part of its commitment to further transform the companys approach to diseases that disproportionately affect the world's poorest people.

GSK and Aptuit finalise agreement for Aptuit to acquire GSK’s research operations in Italy

Wed, 30 Jun 2010 00:00:00 GMT

Augments Aptuit's global, integrated scientific and operational capabilities and preserves scientific expertise at the centre

GlaxoSmithKline receives EU authorisation for a new therapeutic indication for Tyverb® (lapatinib)

Tue, 22 Jun 2010 00:00:00 GMT

GSK confirmed that EC has granted a variation to the conditional marketing authorisation for Tyverb in the EU for therapeutic indication.

GlaxoSmithKline enters agreement with Medivir for exclusive rights to cold sore treatment Xerclear™

Tue, 22 Jun 2010 00:00:00 GMT

GlaxoSmithKline (GSK) and Medivir (STO: MVIR-B) today announced an exclusive agreement for the commercialisation of cold sore treatment.

GlaxoSmithKline receives conditional marketing authorisation in the EU for Votrient® (pazopanib)

Mon, 14 Jun 2010 00:00:00 GMT

As part of these conditions, GSK will provide data from ongoing clinical studies.

FDA approves Jalyn™, a fixed-dose combination of dutasteride and tamsulosin, for symptomatic BPH in men with an enlarged prostate

Sun, 13 Jun 2010 00:00:00 GMT

BPH is one of the most common prostate disorders, affecting nearly half of all men 50 years of age or older in the U.S.

GlaxoSmithKline Receives Complete Response from FDA for Candidate Meningococcal and Hib Combination Vaccine

Thu, 10 Jun 2010 00:00:00 GMT

Meningococcal and Hib diseases are caused by potentially deadly bacteria that can lead to meningitis and other very serious complications.

GSK drives Latin America growth strategy with acquisition of Laboratorios Phoenix

Wed, 09 Jun 2010 00:00:00 GMT

GSK today announced that it has acquired Laboratorios Phoenix, a leading pharmaceutical business, a cash consideration of $253 million.

Regulatory update – BLA filed for Benlysta® (belimumab)

Wed, 09 Jun 2010 00:00:00 GMT

GSK announced today that Human Genome Sciences, Inc. (HGS) has submitted a Biologics License Application (BLA) to the U.S.

Regulatory update - Benlysta® (belimumab)

Sun, 06 Jun 2010 00:00:00 GMT

GSK announced today that it has submitted a MAA to the EMA, for Benlysta (belimumab) for reducing disease activity in adult patients.

GSK announces revised product labels for Serevent and Advair

Tue, 01 Jun 2010 00:00:00 GMT

The changes communicated by the FDA reflect class labeling for all LABA containing products and are specific to product labels in the U.S.

European Medicines Agency maintains position on the continued use of Rotarix™ (rotavirus vaccine)

Thu, 20 May 2010 00:00:00 GMT

GSK today confirmed that following a meeting of the Committee for Medicinal Products for Human Use (CHMP).

Viani (Seretide): German patent litigation update

Wed, 19 May 2010 00:00:00 GMT

GSK today confirmed that the Federal Patents Court in Munich, Germany, has ruled in patent litigation regarding GSKs product Viani.

New research identifies promising leads to follow in search for medicines to fight malaria

Tue, 18 May 2010 00:00:00 GMT

New research conducted by GSK was published in Nature1 identifying promising potential leads to develop new medicines to treat malaria.

FDA says Healthcare Providers can resume use of Rotarix (Rotavirus Vaccine, Live, Oral)

Thu, 13 May 2010 00:00:00 GMT

GSK announced that the Food and Drug Administration (FDA) has determined that U.S. healthcare practitioners can resume the use of Rotarix.

Patrick Vallance appointed to GSK executive leadership team

Mon, 10 May 2010 00:00:00 GMT

GSK announced the appointment of Patrick Vallance, Medicines Discovery and Development and as a member of the Corporate Executive Team.

GSK extends presence in Asia with new strategic alliance in South Korea

Mon, 10 May 2010 00:00:00 GMT

GSK today entered into a strategic alliance with Dong-A, the number one pharmaceutical and OTC Company in South Korea.

GSK Statement on FDA Advisory Committee meeting on Rotavirus vaccines

Fri, 07 May 2010 00:00:00 GMT

GlaxoSmithKline (NYSE: GSK) today participated in a U.S. Food and Drug Administration (FDA) advisory committee meeting.

GSK announces Q1 results for 2010

Tue, 27 Apr 2010 00:00:00 GMT

GSK delivers Q1 EPS of 30.7p +16% CER before major restructuring

GlaxoSmithKline and Human Genome Sciences announce topline 76-week results of phase 3 trial of Benlysta™ in systemic lupus erythematosus

Mon, 19 Apr 2010 00:00:00 GMT

GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) and today announced topline secondary endpoints from BLISS-76.

GlaxoSmithKline receives conditional marketing authorisation in the EU for Arzerra® (ofatumumab)

Sun, 18 Apr 2010 00:00:00 GMT

GSK and Genmab AS confirmed that EC has granted a conditional marketing authorisation for Arzerra for the treatment of refractory CLL.

GSK and Isis Pharmaceuticals collaborate on RNA therapeutics for rare and infectious diseases

Tue, 30 Mar 2010 00:00:00 GMT

GSK has right to license and commercialise compounds at clinical proof-of-concept

GSK receives European approval for Duodart®

Tue, 30 Mar 2010 00:00:00 GMT

The first fixed dose combination medicine for benign prostatic hyperplasia

GSK regulatory update – Avodart (dutasteride)

Sun, 28 Mar 2010 00:00:00 GMT

GSK announced today that it has re-submitted sNDA for Avodart (dutasteride) for prostate cancer risk reduction among men.

Updated GlaxoSmithKline statement on European regulatory guidance relating to manufacture of Rotarix (rotavirus vaccine)

Thu, 25 Mar 2010 00:00:00 GMT

GlaxoSmithKline (GSK) today confirmed that the European Medicines Agency (EMA) has maintained its position.

GlaxoSmithKline update: Government orders for pandemic H1N1 vaccine

Thu, 25 Mar 2010 00:00:00 GMT

GlaxoSmithKline has been working closely with governments around the world to respond to their pandemic needs.

GSK joins global vaccine alliance to help prevent millions of children from contracting pneumococcal disease in the world’s poorest countries

Mon, 22 Mar 2010 00:00:00 GMT

Unique finance mechanism ensures vaccinations will begin in 2010 - Up to 300 million doses to be supplied over ten years.

GSK announces succession plan for leadership of Consumer Healthcare business

Sun, 21 Mar 2010 00:00:00 GMT

Emma Walmsley appointed President, Consumer Healthcare Europe and President Designate, Worldwide Consumer Healthcare

GlaxoSmithKline statement on new information relating to manufacture of Rotarix (rotavirus vaccine)

Sun, 21 Mar 2010 00:00:00 GMT

GlaxoSmithKline (GSK) today confirmed that it has notified regulatory authorities of the presence of material from a virus called PCV-1.

GlaxoSmithKline announces Swiss approval of Duodart®

Sun, 21 Mar 2010 00:00:00 GMT

The first fixed dose combination medicine for benign prostatic hyperplasia

GlaxoSmithKline commences Relovair Phase III asthma programme

Thu, 18 Mar 2010 00:00:00 GMT

GlaxoSmithKline (GSK) announced today that the first asthma patient has commenced treatment with Relovair.

GSK publishes 2009 Corporate Responsibility Report

Mon, 15 Mar 2010 00:00:00 GMT

In its 2009 Corporate Responsibility Report published online today, GSK reiterated its commitment to running its business responsibly.

GlaxoSmithKline receives marketing authorisation in the EU for Revolade® (eltrombopag)

Thu, 11 Mar 2010 00:00:00 GMT

GlaxoSmithKline (GSK) confirmed today that the European Commission (EC) has granted marketing authorisation for Revolade.

GSK commences succession plan for management of vaccines business

Thu, 11 Mar 2010 00:00:00 GMT

GlaxoSmithKline (GSK) today announced management changes related to its Vaccines business as part of a planned succession strategy.

GSK CEO Andrew Witty dedicates albendazole facility in Nashik to WHO’s Global Programme to Eliminate LF

Sun, 07 Mar 2010 00:00:00 GMT

(GSK) CEO Andrew Witty today dedicated a new production facility at its Nashik site in India to the manufacture of albendazole.

GlaxoSmithKline responds to US Senate Committee on Finance report on Avandia

Tue, 23 Feb 2010 00:00:00 GMT

GSK responded to the released Senate Committee on Finance January 2010 Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia.

GSK rejects conclusions of Senate Committee on Finance Staff Report on Avandia

Fri, 19 Feb 2010 00:00:00 GMT

The Staff Report of the Senate Committee on Finance draws conclusions on the safety of Avandia (rosiglitazone).

GSK rejects conclusions reported in The New York Times story on Avandia

Fri, 19 Feb 2010 00:00:00 GMT

GlaxoSmithKline (GSK) rejects the conclusions about the safety of Avandia (rosiglitazone) reported in New York Times story.

GSK receives positive opinions in Europe for Tyverb® (lapatinib) and Votrient™ (pazopanib)

Thu, 18 Feb 2010 00:00:00 GMT

GSK announced today that CHMP has issued two positive opinions in the European Union for two of its cancer medicines.

GSK statement on FDA’s proposed label revisions for some asthma medicines

Wed, 17 Feb 2010 00:00:00 GMT

GSK is reviewing label changes proposed today by FDA for asthma medications containing long-acting beta-agonists (LABAs).

GSK Consumer Healthcare warns consumers of potential health risks associated with long-term excessive use of zinc-containing denture adhesives

Wed, 17 Feb 2010 00:00:00 GMT

Because the safety and health of our consumers is our primary concern.

GlaxoSmithKline and XenoPort receive FDA Complete Response letter for Horizant™ (GSK1838262/XP13512) for RLS

Tue, 16 Feb 2010 00:00:00 GMT

GSK and XNPT received a Complete Response letter from FDA regarding NDA for gabapentin enacarbil) Extended-Release Tablets.

GSK launches new specialist unit to research and develop medicines for rare diseases

Wed, 03 Feb 2010 00:00:00 GMT

GSK today announces the formation of a new standalone unit specialising in the development and commercialisation of medicines.

GSK announces appointment of Philippe Fauchet as President of GSK Japan

Wed, 03 Feb 2010 00:00:00 GMT

GSK today announces the appointment of Philippe Fauchet as President of GSK Japan.

Results announcement for the fourth quarter 2009

Wed, 03 Feb 2010 00:00:00 GMT

See the quarterly results page for more information

GSK’s Tykerb® receives accelerated approval for first-line combination treatment of hormone receptor positive, HER2+/ErbB2+ metastatic breast cancer

Thu, 28 Jan 2010 00:00:00 GMT

GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval.

Rotarix™ significantly reduced severe rotavirus gastroenteritis in African babies during their first year of life

Tue, 26 Jan 2010 00:00:00 GMT

NEJM today published the first study demonstrating that Rotarix, GSK rotavirus vaccine.

GSK announces ‘open innovation’ strategy to help deliver new and better medicines for people living in the world’s poorest countries

Tue, 19 Jan 2010 00:00:00 GMT

'Open Lab' established with $8m seed funding for new research

GSK contributes to Haiti relief efforts

Sun, 17 Jan 2010 00:00:00 GMT

In keeping with GSK's response to previous natural disasters, we have initiated a program of support for Haiti.

GSK exercises option to progress development of ChemoCentryx’s Traficet-EN for the treatment of inflammatory bowel diseases

Sun, 10 Jan 2010 00:00:00 GMT

GlaxoSmithKline(GSK) andChemoCentryx Inc. today announced that GSK has exercised its option to obtain an exclusive license.

Revolade (eltrombopag) receives positive opinion in Europe for chronic immune thrombocytopenic purpura

Thu, 17 Dec 2009 00:00:00 GMT

GSK announced today that CHMP has issued a positive opinion for Revolade.

GlaxoSmithKline and NanoBio announce OTC licensing agreement for cold sore treatment

Tue, 15 Dec 2009 00:00:00 GMT

Next advance in the treatment of cold sores - Strengthens a key OTC franchise

GSK publishes speaking, consulting fees paid to US healthcare professionals

Sun, 13 Dec 2009 00:00:00 GMT

Company progresses commitments to increase transparency

GSK study showed targeted therapy combination achieved 14 month overall survival in patients with advanced breast cancer

Thu, 10 Dec 2009 00:00:00 GMT

In a clinical study, women with an aggressive form of breast cancer experienced a median survival of 14 months when treated.

GSK and Intercell form strategic alliance to develop and commercialise innovative needle-free patch-based vaccines

Thu, 10 Dec 2009 00:00:00 GMT

GlaxoSmithKline Biologicals SA (GSK) and Intercell today announced an agreement to form a strategic alliance to accelerate the development.

Pre-Budget Report response - GSK comments on patent box

Wed, 09 Dec 2009 00:00:00 GMT

GSK welcomes the introduction of a new measure announced in the Pre-Budget Report to stimulate future investment in the UK.

GSK initiates second pivotal Phase III trial for investigational cardiovascular medication Darapladib

Wed, 09 Dec 2009 00:00:00 GMT

GSK today announced initiation of the second large-scale Phase III clinical trial to evaluate long-term treatment.

GSK Update: GSK’s Arepanrix™ H1N1 pandemic vaccine prequalified by the World Health Organization

Mon, 30 Nov 2009 00:00:00 GMT

First prequalification for an H1N1 pandemic vaccine

GSK completes extension of strategic collaboration with Aspen

Mon, 30 Nov 2009 00:00:00 GMT

GSK announced that yesterday it completed the extension of its strategic relationship with Aspen Pharmacare Holdings Limited (Aspen)

GlaxoSmithKline announced as Tier 3 Sponsor as London 2012 anti-doping plans confirmed

Sun, 29 Nov 2009 00:00:00 GMT

GSK becomes Laboratory Services Provider

Regulatory Update: GSK files Rotarix for prevention of rotavirus in Japan

Sun, 29 Nov 2009 00:00:00 GMT

GlaxoSmithKline (GSK) announced today that it has filed its vaccine for the prevention of rotavirus gastroenteritis.

GlaxoSmithKline and Gilead announce agreement to commercialise Viread® for chronic hepatitis B in key Asian countries

Mon, 23 Nov 2009 00:00:00 GMT

GlaxoSmithKline (GSK) and Gilead Sciences, Inc. (Nasdaq: GILD) today announced a licensing agreement to commercialise.

GSK Regulatory Update: Avodart

Sun, 22 Nov 2009 00:00:00 GMT

GSK expects to resubmit the file shortly. This action is not the result of new findings related to safety or efficacy.

Pandemic 2009 Influenza Update: Pandemrix™ data in children and adolescents from 3 to 17 years of age

Sun, 22 Nov 2009 00:00:00 GMT

GlaxoSmithKline (GSK) today announced that over 40 million doses of its adjuvanted pandemic H1N1 vaccine have been distributed to countries.

GSK and Nabi announce agreement for NicVAX®, a vaccine for nicotine addiction

Mon, 16 Nov 2009 00:00:00 GMT

GSK and Nabi announced an exclusive worldwide option and licensing agreement for a nicotine conjugate candidate vaccine.

Pandemic 2009 Influenza Update: US FDA approves GSK’s pandemic H1N1 vaccine

Mon, 09 Nov 2009 00:00:00 GMT

GSK today announced that FDA has approved a sBLA for its unadjuvanted influenza A (H1N1) pandemic vaccine.

GSK signs agreement with the WHO to donate 50 million doses of pandemic H1N1 vaccine for distribution to developing countries

Mon, 09 Nov 2009 00:00:00 GMT

GSK today announced that it has signed an agreement with WHO to donate 50 million doses of its influenza vaccine.

Pandemic 2009 Influenza Update: Pandemrix™ data on co-administration with annual seasonal influenza vaccine (Fluarix®)

Mon, 09 Nov 2009 00:00:00 GMT

The trial involves 168 adults aged over 60 years of age, and was designed to evaluate the tolerability and immunogenicity.

GlaxoSmithKline and XenoPort announce extension of GSK1838262 (XP13512) FDA review date to 9 February 2010

Thu, 05 Nov 2009 00:00:00 GMT

GSK and XNPT today announced that FDA has extended the original PDUFA goal date for its review of NDA for GSK to February 9, 2010.

World Health Organization Grants Prequalification for Global Use to GSK’s 10-Valent Synflorix™ Vaccine

Thu, 05 Nov 2009 00:00:00 GMT

First prequalification for pneumococcal disease vaccine, a threatening disease affecting many children; follows first World Pneumonia Day.

World’s largest malaria vaccine trial now underway in seven African countries

Mon, 02 Nov 2009 00:00:00 GMT

Pivotal testing of RTS,S is on track for target enrollment of 16,000 children

ViiV Healthcare launches: A new specialist HIV company dedicated to delivering advances in HIV treatment and care

Mon, 02 Nov 2009 00:00:00 GMT

CEO promises 'relentless pursuit' of new treatments

Retigabine Regulatory Update

Mon, 02 Nov 2009 00:00:00 GMT

on 30 October, they filed a New Drug Application with the FDA and MAA with EMEA for retigabine.

GlaxoSmithKline and Human Genome Sciences announce positive results in second of two phase 3 trials of Benlysta in systemic lupus erythematosus

Sun, 01 Nov 2009 00:00:00 GMT

Benlysta 10 mg/kg plus standard of care met its primary efficacy endpoint by achieving a statistically significant improvement.

Results announcement for the third quarter 2009

Wed, 28 Oct 2009 00:00:00 GMT

See the quarterly results page for more information.

Pandemic 2009 Influenza Update: Pandemrix™ data in an elderly population

Tue, 27 Oct 2009 00:00:00 GMT

GlaxoSmithKline (GSK) today announced that this week, approximately half a million people will have received its pandemic H1N1 vaccine.

GlaxoSmithKline and Theravance commence Phase III Horizon programme to develop a next-generation treatment for COPD

Tue, 27 Oct 2009 00:00:00 GMT

GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the first patient has commenced treatment.

GSK and Genmab receive accelerated approval for Arzerra™

Mon, 26 Oct 2009 00:00:00 GMT

Today, GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced the accelerated approval of Arzerra TM (ofatumumab).

Pandemic (H1N1) 2009 Influenza Update: Experience of GSK’s H1N1 adjuvanted vaccine, Pandemrix™, and preliminary paediatric results

Fri, 23 Oct 2009 00:00:00 GMT

GSK today announced that, to date, more than 150,000 people have received GSK pandemic H1N1 vaccine, Pandemrix.

GlaxoSmithKline and Human Genome Sciences announce full presentation at ACR of positive phase 3 study results for Benlysta in systemic lupus erythematosus

Mon, 19 Oct 2009 00:00:00 GMT

Benlysta (belimumab) significantly reduced SLE disease activity, disease flare rates and fatigue; delayed time-to-first SLE disease flare.

FDA approves GlaxoSmithKline’s Votrient™ for advanced renal cell cancer

Mon, 19 Oct 2009 00:00:00 GMT

GSK announced that FDA has approved Votrient to treat patients with advanced renal cell carcinoma (RCC).

FDA approves Cervarix, GlaxoSmithKline’s cervical cancer vaccine

Thu, 15 Oct 2009 00:00:00 GMT

GSK announced today that FDA has approved Cervarix[Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant].

Pandemic (H1N1) 2009 Influenza Update: Results from second clinical trial of GSK’s H1N1 adjuvanted vaccine confirm immune response and tolerability

Thu, 15 Oct 2009 00:00:00 GMT

GSK announced results from a second clinical trial of its pandemic (H1N1) adjuvanted vaccine.

GSK’s Cervarix® becomes the first cervical cancer vaccine to gain approval in Japan

Thu, 15 Oct 2009 00:00:00 GMT

Landmark approval paves the way for access to the vaccine for women in Japan

GlaxoSmithKline and Prosensa form alliance to fight Duchenne Muscular Dystrophy

Tue, 13 Oct 2009 00:00:00 GMT

GlaxoSmithKline plc (GSK) announced today that it has entered into a unique partnership with the UK Government.

GSK partners with UK Government and Wellcome Trust to stimulate innovation through the creation of a world-class science park

Tue, 13 Oct 2009 00:00:00 GMT

GSK announced today the U.S. Food and Drug Administration (FDA) has not yet completed the review of the Biologics License Application.

GSK’s Avodart® / tamsulosin combination showed benefits for men with prostate enlargement

Mon, 12 Oct 2009 00:00:00 GMT

GSK announced today that it has filed a sNDA for Avodart with the FDA for prostate cancer among men at increased of developing the disease.

GlaxoSmithKline and U.S. Patent and Trademark Office file a motion to dismiss litigation over Final Regulations

Thu, 08 Oct 2009 00:00:00 GMT

GSK and Prosensa, the Dutch based biopharmaceutical company focusing on RNA modulating therapeutics.

GlaxoSmithKline update: Government orders for pandemic (H1N1) 2009 vaccine

Tue, 06 Oct 2009 00:00:00 GMT

GSK is committed to supporting governments and health authorities around the world respond to the pandemic (H1N1) 2009 influenza strain.

GSK expands presence in China through strategic cooperation to form a joint venture on paediatric vaccines

Mon, 05 Oct 2009 00:00:00 GMT

GlaxoSmithKline (GSK) and Jiangsu Walvax Biotech Company today announced a cooperation agreement to form a long-term Joint Venture (JV)

Positive phase II results for GSK1838262 (XP13512) reported for subjects with post-herpetic neuralgia and a history of inadequate response to gabapentin

Mon, 05 Oct 2009 00:00:00 GMT

GSK & XNPT announced results from a Phase II clinical trial of gabapentin enacarbil in adult patients with neuropathic pain from PHN.

GlaxoSmithKline receives unanimous FDA Panel approval recommendation for Votrient™

Mon, 05 Oct 2009 00:00:00 GMT

the panel voted that the benefit-to-risk profile is acceptable for patients with advanced renal cell carcinoma (RCC).

Avodart (dutasteride) regulatory update

Thu, 01 Oct 2009 00:00:00 GMT

GSK filed a sNDA for Avodart with theFDA for prostate cancer risk reduction among men at increased risk of developing the disease.

Pandemic (H1N1) 2009 Influenza Update: GSK’s H1N1 ‘Pandemrix’ vaccine receives European Commission Approval

Wed, 30 Sep 2009 00:00:00 GMT

GlaxoSmithKline (GSK) confirmed today that the European Commission has granted marketing authorisation of GSK’s pandemic (H1N1).

GlaxoSmithKline update on FDA review of Cervarix

Tue, 29 Sep 2009 00:00:00 GMT

GSK announced the FDA has not yet completed the review of BLA for CERVARIX vaccine, review will continue beyond September 29, 2009.

Fatality reported in UK HPV vaccine immunisation programme

Mon, 28 Sep 2009 00:00:00 GMT

GSK notified of the death of 14 year old Natalie Morton, vaccinated in Coventry with Cervarix part of national HPV immunisation programme

GSK and UPCH to launch Lucozade across China

Sun, 27 Sep 2009 00:00:00 GMT

GSK announced an agreement with UPCH, one of the leading food and beverage companies in China, to launch GSK Lucozade drinks across China.

GSK provides update on regulatory filings for Zunrisa/Rezonic

Sun, 27 Sep 2009 00:00:00 GMT

GSK to discontinue casopitant, developed for chemotherapy-induced and post-operative nausea and vomiting.

Pandemic (H1N1) 2009 Influenza Update: GSK’s H1N1 ‘Pandemrix’ vaccine receives positive opinion from European Regulators

Thu, 24 Sep 2009 00:00:00 GMT

GSK announced EMA's CHMP has issued a positive opinion recommending approval of GSK's H1N1 adjuvanted vaccine Pandemrix.

Pandemic (H1N1) 2009 Influenza Update: Initial results from first clinical trial of GSK’s H1N1 adjuvanted vaccine

Mon, 14 Sep 2009 00:00:00 GMT

GlaxoSmithKline (GSK) today announced results from its first clinical trial assessing use of its pandemic (H1N1) adjuvanted vaccine.

Antiviral Activity of S/GSK1265744, a Once-Daily, Unboosted Integrase Inhibitor in Clinical Development, Evaluated in Phase 1-2a Study in Healthy and HIV-Infected Subjects

Sun, 13 Sep 2009 00:00:00 GMT

GSK announced results from Phase 1-2a study evaluating PK, safety and activity of its INI S/GSK1265744 in healthy HIV-infected patients.

FDA Advisory Committee makes favorable recommendation for Cervarix, GlaxoSmithKline’s candidate cervical cancer vaccine

Tue, 08 Sep 2009 00:00:00 GMT

GSK announced FDA voted that clinical data support the efficacy and safety of Cervarix, candidate cervical cancer vaccine, 12-1 & 11-1.

GlaxoSmithKline and Genmab announce results from a study of Arzerra in rituximab refractory follicular NHL

Sun, 16 Aug 2009 00:00:00 GMT

GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today top-line results from an international multi-center study of Arzerra.

GSK and Brazil’s Fiocruz form partnership for new R&D effort and increased vaccine access

Sun, 16 Aug 2009 00:00:00 GMT

GlaxoSmithKline plc (GSK) announced today that it has launched a unique partnership with Brazil’s Oswaldo Cruz Foundation (Fiocruz).

Pandemic (H1N1) 2009 influenza update

Thu, 13 Aug 2009 00:00:00 GMT

GSK issued an update on H1N1 influenza virus vaccine, it's commenced the clinical development programme for its adjuvanted pandemic vaccine.

Shionogi-GlaxoSmithKline Pharmaceuticals acknowledges position of the European AIDS Treatment Group

Thu, 13 Aug 2009 00:00:00 GMT

GSK, EATG & DDC of ATAC announce plans to revise inclusion criteria for Study ING112276, in antiretroviral therapy-naïve patients.

GlaxoSmithKline and Genmab announce top-line results for ofatumumab in rheumatoid arthritis

Tue, 28 Jul 2009 00:00:00 GMT

GSK & GEN announced results from a Phase III study of ofatumumab, treatment of RA in patients with no response to methotrexate.

Regulatory update: mepolizumab for the treatment of hypereosinophilic syndrome (HES)

Tue, 28 Jul 2009 00:00:00 GMT

GSK has notified EMA of decision to withdraw MAA in the EU for mepolizumab for the treatment of hypereosinophilic syndrome (HES).

Amgen to collaborate with GSK to commercialize denosumab in Europe for postmenopausal osteoporosis (PMO)

Sun, 26 Jul 2009 00:00:00 GMT

Amgen to retain full rights for denosumab in the United States and Canada and for oncology indications in Europe.

GlaxoSmithKline completes acquisition of Stiefel

Tue, 21 Jul 2009 00:00:00 GMT

GSK creates new world-leading specialist dermatology business with revenues of approximately $1.5 billion

Results announcement for the second quarter 2009

Tue, 21 Jul 2009 00:00:00 GMT

See the quarterly results page for more information

GSK and Enigma Diagnostics announce commercial partnership to develop point-of-care influenza diagnostics

Mon, 20 Jul 2009 00:00:00 GMT

GSK & Enigma have signed agreements to develop and supply influenza tests to identify virus strains using its real-time PCR technology.

Antiviral activity of S/GSK1349572, the only once-daily, unboosted integrase inhibitor in clinical development, evaluated in phase 2 study

Mon, 20 Jul 2009 00:00:00 GMT

GSK announced results from Phase 2a study evaluating antiviral activity of INI, S/GSK1349572, results presented at IAS Conference.

Human Genome Sciences and GlaxoSmithKline announce positive Phase 3 study results for Benlysta™ in systemic lupus erythematosus

Mon, 20 Jul 2009 00:00:00 GMT

GSK & HGS announced that Benlysta met the primary endpoint in BLISS-52, Phase 3 trials in patients with serologically active SLE.

GSK announces new commitments to fight HIV/AIDS in Sub-Saharan Africa - special focus on care and treatment of children

Tue, 14 Jul 2009 00:00:00 GMT

Positive Action for Children Fund created with $80 million available over 10 years to help prevent mother-to-child transmission of HIV.

WHO grants prequalification to Cervarix®: GSK’s vaccine to help combat cervical cancer in developing nations

Wed, 08 Jul 2009 00:00:00 GMT

WHO awarded prequalification to Cervarix, cervical cancer vaccine, decision is for agencies to purchase the vaccine in developing countries

Alnylam joins GSK in donating intellectual property to patent pool for neglected tropical diseases

Tue, 07 Jul 2009 00:00:00 GMT

First company to join the pool since creation in March 2009

Landmark study for GSK’s cervical cancer vaccine published in The Lancet

Mon, 06 Jul 2009 00:00:00 GMT

Largest efficacy trial of a cervical cancer vaccine showed Cervarix® protects against the five most common cancer-causing virus types

GSK further extends its product portfolio in the Middle East and North Africa

Wed, 01 Jul 2009 00:00:00 GMT

GSK announced it's acquired the generics business of BMS in Lebanon, Jordan, Syria, Libya and Yemen for a cash consideration of $23.2m.

Seretide: Irish patent litigation update

Thu, 25 Jun 2009 00:00:00 GMT

GSK announced, Commercial Court in Dublin, Ireland, ruled in patent litigation regarding GSK8217, Seretide, treatment for asthma and COPD.

Regulatory update for REZONIC™ (casopitant mesylate)

Mon, 22 Jun 2009 00:00:00 GMT

GSK confirmed today that it has received a complete response letterfrom the FDA related to the application for casopitant

GSK and Chroma Therapeutics form alliance to develop novel macrophage-targeted drugs

Mon, 22 Jun 2009 00:00:00 GMT

GlaxoSmithKline (LSE: GSK) and Chroma Therapeutics Limited announced today a collaboration to develop macrophage-targeted compounds.

FDA extends review of Arzerra™ (ofatumumab)

Tue, 16 Jun 2009 00:00:00 GMT

GSK & Genmab announced, FDA informed the companies they have extended the action date for the ofatumumab BLA application by three months.

GSK announces a strategic alliance with Dr. Reddy’s to further accelerate sales growth in emerging markets

Sun, 14 Jun 2009 00:00:00 GMT

GSK announced an agreement with Dr. Reddy's to develop and market selected products across a number of emerging markets, excluding India.

GlaxoSmithKline update: A (H1N1) influenza

Thu, 11 Jun 2009 00:00:00 GMT

WHO raises influenza pandemic alert to phase 6

GSK and Shenzhen Neptunus create new alliance to develop and manufacture influenza vaccines in China

Mon, 08 Jun 2009 00:00:00 GMT

GSK announced it's entered into JV with Neptunus focused on developing and manufacturing influenza vaccines for the Chinese market.

Large, long-term study shows Avandia has no increased overall cardiovascular risk compared to other commonly used diabetes medicines

Thu, 04 Jun 2009 00:00:00 GMT

RECORD trial also demonstrates durable blood sugar control over time with Avandia

World Health Organization grants Global Prequalification to GSK’s Rotarix™ vaccine

Thu, 04 Jun 2009 00:00:00 GMT

Opens access to Asia and Africa – potential to save hundreds of thousands of lives

Positive results with Revolade™ and Arzerra™ for difficult-to-treat blood disorders

Thu, 04 Jun 2009 00:00:00 GMT

GSK announced data for Revolade & Arzerra at EHA meeting, results show potential of improvement in QoL in two haematological conditions.

GSK and Concert Pharmaceuticals form alliance to develop novel deuterium-modified drugs

Mon, 01 Jun 2009 00:00:00 GMT

GSK & Concert Pharmaceuticals to collaborate on deuterium-containing medicines, incl. CTP-518, a protease inhibitor for the treatment of HIV

GSK’s Pazopanib significantly delayed tumor progression in patients with advanced kidney cancer

Sun, 31 May 2009 00:00:00 GMT

GSK announced results of a Phase III study - pazopanib reduced the risk of tumor progression or death by 54 percent compared to placebo.1

FDA advisory panel makes favorable recommendation for ARZERRA (ofatumumab)

Thu, 28 May 2009 00:00:00 GMT

GSK & GEN announced that FDA voted 10:3 that ofatumumab, reasonably likely to predict clinical benefit for patients with chronic CLL.

US Department of Health and Human Services (HHS) purchases GSK’s A (H1N1) influenza antigen and proprietary adjuvant system

Thu, 21 May 2009 00:00:00 GMT

GSK announced HHS has placed initial orders for H1N1 vaccine antigen and proprietary adjuvant system, AS03.

GlaxoSmithKline update: A (H1N1) influenza vaccine development

Thu, 14 May 2009 00:00:00 GMT

GSK has received orders from several governments aiming to stockpile a H1N1 adjuvanted influenza vaccine as a precautionary measure.

GSK extends strategic collaboration with Aspen

Mon, 11 May 2009 00:00:00 GMT

GSK to acquire 16% shareholding in Aspen in exchange for transfer of specialist products and manufacturing facility in Bad Oldesloe, DE.

Community healthcare charities receive £300,000 from GlaxoSmithKline in recognition of their work

Thu, 07 May 2009 00:00:00 GMT

20 charities were formally acknowledged last night for their community-based work, as GSK awards, run in partnership with The King's Fund.

GlaxoSmithKline to divest US rights for Wellbutrin XL® to Biovail for $510 million

Tue, 05 May 2009 00:00:00 GMT

GSK in agreement to divest full commercial rights for Wellbutrin to BVF for $510 million, subject to Hart-Scott-Rodino clearance in US.

GlaxoSmithKline update: influenza A (H1N1)

Thu, 30 Apr 2009 00:00:00 GMT

GSK committed to supporting governments and health authorities around the world to respond to the emergence of the new H1N1 strain.

Large, long-term study shows dutasteride reduced prostate cancer risk in men at increased risk of the disease

Sun, 26 Apr 2009 00:00:00 GMT

Primary endpoint achieved in REDUCE study as presented at American Urological Association

Emergence of a new H1N1 influenza A strain (swine influenza)

Sun, 26 Apr 2009 00:00:00 GMT

GSK is closely monitoring H1N1 strain in Mexico, US, Canada, France, Spain & New Zealand. WHO stated, situation a cause for concern.

GlaxoSmithKline launches alli® (orlistat 60 mg)

Sun, 19 Apr 2009 00:00:00 GMT

GSK announced, first clinically proven over the counter weight loss aid is available in pharmacies across Europe.

GlaxoSmithKline and Stiefel to create new world-leading specialist dermatology business

Sun, 19 Apr 2009 00:00:00 GMT

Stiefel, the world's largest independent dermatology company, acquired by GSK in deal valued at up to $3.6 billion.

GlaxoSmithKline and Pfizer announce innovative agreement to create a new world-leading, specialist HIV company

Thu, 16 Apr 2009 00:00:00 GMT

Creates a new focused HIV business with the sustainability to deliver significant improvements in treatment, access and shareholder value.

GSK submits Tyverb®/Tykerb® (lapatinib) for first-line treatment of metastatic breast cancer in Europe, US

Tue, 31 Mar 2009 00:00:00 GMT

GSK announced, submission of 2 applications to expand the use of lapatinib, therapy regimen for metastatic breast cancer.

Synflorix™, GlaxoSmithKline’s pneumococcal vaccine, receives European authorisation

Tue, 31 Mar 2009 00:00:00 GMT

Protection now possible against three pneumococcal strains not covered by currently available vaccine.

Cervarix® U.S. regulatory update

Sun, 29 Mar 2009 00:00:00 GMT

GlaxoSmithKline submits final study data to FDA for cervical cancer vaccine

GSK publishes 2008 Corporate Responsibility Report

Mon, 23 Mar 2009 00:00:00 GMT

Details on new proposals to tackle diseases of the developing world.

GlaxoSmithKline announces sale of shares in Quest Diagnostics Inc.

Thu, 19 Mar 2009 00:00:00 GMT

GSK announces it's sold 5,749,157 shares of common stock, par value of $0.01 per share of Quest Diagnostics Inc.

GlaxoSmithKline submits European marketing authorisation application for Pazopanib in advanced kidney cancer

Wed, 04 Mar 2009 00:00:00 GMT

GSK announced submission of MAA to EMEA for pazopanib, oral therapy for metastatic renal cell carcinoma (RCC).

NICE refuses funding for advanced breast cancer treatment, Tyverb® (lapatinib)

Wed, 04 Mar 2009 00:00:00 GMT

NICE issued appraisal against NHS funding for Tyverb, treatment for breast cancer (ErbB2-positive).1.

GSK initiates phase III programme for novel type 2 diabetes medication, Syncria® (albiglutide)

Tue, 17 Feb 2009 00:00:00 GMT

GSK announced start of the Phase III clinical trial programme of GLP-1 agonist Syncria in men and women with type 2 diabetes.

GlaxoSmithKline and Idenix Pharmaceuticals sign worldwide license agreement for IDX899, a novel NNRTI for the treatment of HIV

Thu, 05 Feb 2009 00:00:00 GMT

GSK & Idenix announced agreement granting GSK exclusive worldwide rights to IDX899, a NNRTI in Phase II, treatment of HIV/AIDS.

GlaxoSmithKline and Genmab seek European marketing authorisation of Arzerra™ (ofatumumab) in advanced stage blood cancer

Thu, 05 Feb 2009 00:00:00 GMT

GSK & Genmab announced submission of MAA to EMEA for Arzerra, treatment of CLL, it targets a binding site on the CD20 molecule of B-cells.

Results announcement for the fourth quarter 2008

Wed, 04 Feb 2009 00:00:00 GMT

See the quarterly results page for more information.

GSK and Theravance announce positive phase 2b results for once-daily fluticasone furoate in the treatment of asthma

Tue, 03 Feb 2009 00:00:00 GMT

Data increase confidence in the Horizon development programme

GlaxoSmithKline plc, announces board changes

Mon, 02 Feb 2009 00:00:00 GMT

GSK announces, Mr. James Murdoch has been appointed as a Non-Executive Director and will join the Board of the Company from 20/05/09.

GlaxoSmithKline and Genmab submit Arzerra (Ofatumumab) application to FDA for the treatment of advanced stage blood cancer

Thu, 29 Jan 2009 00:00:00 GMT

GSK & GEN announced submission of BLA to the FD) for Arzerra to treat patients whose CLL is resistant (refractory) to previous therapies.

Deirdre Connelly to join GSK as President, North American Pharmaceuticals

Thu, 29 Jan 2009 00:00:00 GMT

GSK announced, Deirdre Connelly will join the company as President, North American Pharmaceuticals, effective Monday 9 February 2009.

GSK announces charges for legal matters

Wed, 28 Jan 2009 00:00:00 GMT

GSK today announced that it will record a legal charge in the fourth quarter of 2008 of $400 million elating to an ongoing investigation.

The UK Government signs influenza pandemic contract with GlaxoSmithKline for Relenza®

Wed, 28 Jan 2009 00:00:00 GMT

The UK is now one of the leading countries in stockpiling antivirals for treating infected individuals in event of an influenza pandemic

GSK to drive growth in emerging markets with acquisition of UCB products

Thu, 22 Jan 2009 00:00:00 GMT

GSK signed an agreement with UCB S.A to acquire its portfolio across Africa, the Middle East, Asia Pacific and Latin America, for €515 m.

GSK’s paediatric pneumococcal candidate vaccine Synflorix™ receives positive opinion in Europe

Wed, 21 Jan 2009 00:00:00 GMT

Serotypes included in the vaccine are responsible for up to 90% of invasive pneumoccal disease in young children in Europe. 1,2,3

GlaxoSmithKline receives European Commission approval to market alli® (orlistat 60mg)

Tue, 20 Jan 2009 00:00:00 GMT

EC opens access to a treatment for people who are overweight and obese. GSK has received a non-prescription licence for alli (orlistat 60mg

GSK and Xenoport resubmit new drug application for Solzira™ in restless legs syndrome

Thu, 08 Jan 2009 00:00:00 GMT

GSK & XenoPort have resubmitted NDA to the FDA for approval of Solzira Extended Release Tablets, treatment of moderate-to-severe primary RLS