Press releases
GlaxoSmithKline announces start of phase III study of Benlysta® (belimumab ) in patients with vasculitis
GlaxoSmithKline plc (GSK) today announced the start of a Phase III study to evaluate Benlysta® (belimumab) in patients with ANCA (Anti-neutrophil Cytoplasmic Antibodies) positive vasculitis – a condition that involves inflammation of the blood vessels.
GSK announces first four-strain seasonal influenza vaccine granted marketing authorisation in Germany and the UK
GlaxoSmithKline plc has announced the marketing authorisation of its quadrivalent (four-strain) influenza vaccine in Germany and the UK.
Regulatory update: GlaxoSmithKline receives complete response from FDA for candidate pandemic H5N1 adjuvanted influenza vaccine
GlaxoSmithKline [NYSE:GSK] announced today that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) in response to the Biologics License Application (BLA) for its Pandemic Influenza A Virus Monovalent Adjuvanted candidate vaccine, referred to as Q-Pan H5N1.
GSK publishes 2012 Corporate Responsibility report
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
Donation Will Enable Patients and Families with Limited Financial Means to Benefit from Cutting-Edge Cancer Research and Treatments at Children’s Hospital
Young scientists challenged by GSK and McLaren to help drive science behind Formula 1™
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
GlaxoSmithKline plc (GSK) today announced the submission of a Marketing Authorisation Application (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
ViiV Healthcare presents 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
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
GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the New Drug Application (NDA) for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the U.S. Food and Drug Administration (FDA) indicating that the application is sufficiently complete to permit a substantive review
ViiV Healthcare announces FDA priority review designation for dolutegravir as a potential treatment for HIV infection
ViiV Healthcare today announced that the U.S. Food and Drug Administration (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
GlaxoSmithKline (GSK) plc today announced submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) for trametinib (MEK) as monotherapy and in combination with dabrafenib (BRAF) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation
Results announcement for the fourth quarter 2012
GSK delivers 2012 core EPS of 112.7p and returns £6.3bn to shareholders
GSK announces support for AllTrials campaign for clinical data transparency
Campaign calls for full disclosure of clinical trial results and clinical study reports to help drive scientific understanding.
GSK increases stake in its publicly-listed Consumer Healthcare subsidiary in India to 72.5 per cent
GlaxoSmithKline plc (LSE: GSK) announced today that, pursuant to the voluntary open offer undertaken by its subsidiary, GlaxoSmithKline Pte. Ltd, GSK has successfully increased its stake in GlaxoSmithKline Consumer Healthcare Ltd, its publicly-listed Consumer Healthcare subsidiary in India, from 43.2% to 72.5%
GlaxoSmithKline starts Phase III study to test combined BRAF/MEK inhibition in patients with BRAF positive melanoma following surgery
GlaxoSmithKline plc. today announced the start of COMBI-AD, a Phase III study evaluating the combination of dabrafenib, its BRAF inhibitor and trametinib, its MEK inhibitor as adjuvant therapy for melanoma.
GSK and Biological E. announce joint venture to develop combination vaccine for India and other developing countries
GlaxoSmithKline (GSK) and Biological E Limited (Biological E.), a leading Indian vaccines company, today announced an agreement to form a 50/50 joint venture (JV) for the early stage research and development of a six-in-one combination paediatric vaccine to help protect children in India and other developing countries from polio and other infectious diseases.
GSK appoints Hans Wijers to its Board as a Non-Executive Director
GlaxoSmithKline plc (LSE: GSK) today 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
Pledge to reduce the sugar and calorie content of Lucozade Energy and Ribena products.
GSK and Theravance announce regulatory submission for ANORO™ (UMEC/VI) in Europe
GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the submission of a regulatory application in the European Union for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD).
GlaxoSmithKline and Amicus Therapeutics announce top-line six-month primary treatment period results from first Phase III Fabry monotherapy study
GlaxoSmithKline plc (GSK) and Amicus Therapeutics (Nasdaq: FOLD) today announced the six-month primary treatment period results from the first Phase III global registration study (Study 011) of investigational oral migalastat HCl monotherapy in males and females with Fabry disease who had genetic mutations identified as amenable to migalastat HCl in a cell-based assay.
GSK and Theravance announce regulatory submission for UMEC/VI (LAMA/LABA) in the US
GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the submission of a regulatory application in the US for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD).
ViiV Healthcare announces regulatory submissions for dolutegravir in the EU, US and Canada
London, UK - 17 December, 2012 – ViiV Healthcare today announced the submission of regulatory applications in the European Union (EU), United States (US) and Canada for the investigational integrase inhibitor dolutegravir (S/GSK1349572) for the treatment of HIV infection in adults and adolescents
FDA Approves GlaxoSmithKline’s four-strain seasonal influenza vaccine for use in the US
GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved FLUARIX® QUADRIVALENT (Influenza Virus Vaccine) for the immunisation of children (three years and older) and adults to help prevent disease caused by seasonal influenza (flu) virus subtypes A and type B contained in the vaccine.
GSK receives FDA approval for raxibacumab anti-toxin for the treatment of inhalational anthrax
GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved raxibacumab for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.
GSK forms partnership with Vodafone to help increase childhood vaccination in Mozambique
GSK today announced it has formed a partnership with Vodafone to harness innovative mobile technology to help vaccinate more children against common infectious diseases in Africa.
GSK welcomes the publication of the 2012 Access to Medicines Index
GSK welcomes the publication of the third Access to Medicines (ATM) Index, which measures the performance of the top 20 pharmaceutical companies on their efforts to improve access to medicines and healthcare in developing countries.
GSK announces agreement in principle to increase its stake in GlaxoSmithKline Consumer Nigeria PLC
GlaxoSmithKline plc (“GSK”) (LSE: GSK) and GlaxoSmithKline Consumer Nigeria PLC (“GSK Nigeria” or the “Company”) today announced that they have reached agreement in principle on the terms of a proposal whereby GSK would increase its ownership in the Company from 46.4% to 80% (the “Proposal”).
GSK initiates voluntary open offer to increase stake in its publically-listed Consumer Healthcare subsidiary in India
GlaxoSmithKline (“GSK”) (LSE: GSK) today announced a Voluntary Open Offer (the “Offer”) to increase its stake in its publicly-listed Consumer Healthcare subsidiary in India (GlaxoSmithKline Consumer Healthcare Ltd, the “Company”) from 43.2% to up to 75% at a price of INR 3,900 per share.
GSK supports Coronation Festival event at Buckingham Palace Gardens marking 60 years of innovation and excellence
GlaxoSmithKline (GSK) today announced it will be a headline partner at the Coronation Festival, which will take place from the 11th-14th July 2013 to celebrate 60 years of British industry, innovation and excellence and commemorate the 60th anniversary of Her Majesty The Queen’s Coronation.
FDA approves new indication for PROMACTA® (eltrombopag)
GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved PROMACTA for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.
Data published in The Lancet show GlaxoSmithKline’s Synflorix is highly effective at preventing invasive pneumococcal disease
Results from the first randomised controlled European clinical trial of a pneumococcal conjugate vaccine (PCV) to examine impact on invasive pneumococcal disease (IPD) were published today in The Lancet.
GlaxoSmithKline announces vote from FDA advisory committee to recommend approval of H5N1 influenza vaccine candidate.
GlaxoSmithKline plc (GSK) announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously 14-0 that the safety and immunogenicity data of the H5N1 adjuvanted influenza vaccine candidate supports its licensure for the active immunisation for the prevention of disease in persons 18 years of age and older who are at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine.
ViiV Healthcare presents phase III data from VIKING-3 study of dolutegravir in HIV-1 infected integrase inhibitor-resistant adults
ViiV Healthcare today announced 24-week data from the VIKING-3 Phase III study evaluating the investigational integrase inhibitor (INI) dolutegravir in HIV-1 infected adults with multiple class antiretroviral (ARV) resistance including resistance to integrase inhibitors (raltegravir and/or elvitegravir).
GSK Responds to Hurricane Sandy Relief Needs
- $330,000 Donated for Community Relief
RTS,S malaria candidate vaccine reduces malaria by approximately one-third in African infants
Results of ongoing Phase III clinical trial announced.
GlaxoSmithKline and XenoPort mutually agree to terminate their collaboration on Horizant
GlaxoSmithKline (GSK) plc announced today that it has reached an agreement with XenoPort, Inc., to terminate their collaboration concerning Horizant® (gabapentin enacarbil) Extended-Release Tablets, for which GSK had commercialisation rights and certain development rights in the United States.
GSK announces FDA Advisory Committee vote in favour of raxibacumab for the treatment of inhalational anthrax infection
GlaxoSmithKline announced today that the Anti-Infective Drugs Advisory Committee to the US Food and Drug Administration (FDA) voted 16 to 1 in support of the clinical benefit of raxibacumab for the treatment of inhalational anthrax, with one abstention.
GSK supports BMJ commitment on clinical trial data transparency
GlaxoSmithKline today responded to the news that the BMJ will only publish scientific papers where there is a commitment to make the relevant anonymised patient level data available on reasonable request.
Results announcement for the third quarter 2012
GSK delivers Q3 core EPS of 26.5p and dividend of 18p.
GSK announces start of Phase lll programme for mepolizumab in severe refractory asthma
GlaxoSmithKline plc (GSK) today announced the start of a Phase III programme to evaluate the efficacy and safety of mepolizumab, an investigational IL-5 antagonist, as adjunctive therapy in severe uncontrolled refractory asthma.
Shionogi and ViiV Healthcare announce new agreement to commercialise and develop integrase inhibitor portfolio
ViiV Healthcare Ltd and Shionogi & Co., Ltd. today announced that they have entered into an agreement substantially revising their integrase inhibitor relationship.
Results from five phase III studies presented for GSK’s two candidate quadrivalent influenza vaccines
GSK today announced that results from five Phase III studies investigating its two candidate quadrivalent influenza vaccines were presented at the Influenza Vaccines for the World congress in Valencia, Spain and the Infectious Diseases week congress in San Diego, USA in October.
GSK announces further initiatives to advance openness and collaboration to help tackle global health challenges
Speaking at a meeting hosted by the Wellcome Trust in London today, GSK CEO Sir Andrew Witty will outline new steps to build on the encouraging signs of progress resulting from GSK’s ‘open innovation’ approach to R&D, designed to help develop new solutions for the world’s most serious health challenges.
Millions of children in Pakistan to be protected against pneumococcal disease with GSK’s Synflorix
GlaxoSmithKline (GSK) welcomes today’s announcement from the GAVI Alliance that its 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
Shionogi-ViiV Healthcare LLC today announced that the phase III data required for initial regulatory filings of the investigational integrase inhibitor dolutegravir in adults infected with HIV are in house.
Head-to-head study of GSK’s Votrient® (pazopanib) vs sunitinib in advanced renal cell carcinoma meets primary endpoint; findings presented at ESMO 2012 Congress
GlaxoSmithKline (GSK) plc announced today that the pivotal Phase III study COMPARZ (COMParing the efficacy, sAfety and toleRability of paZopanib vs. sunitinib) has met its primary endpoint.
GlaxoSmithKline plc announces changes to its Board and Committees
GlaxoSmithKline plc today announces the following changes to its Board and Committee structure.
GSK and Theravance announce FDA acceptance of FF/VI New Drug Application (NDA) submission in the US for COPD
GSK and Theravance, Inc. today announced that the New Drug Application for the once-daily investigational medicine fluticasone furoate “FF”/vilanterol “VI” for patients with chronic obstructive pulmonary disease, has been accepted by the US Food and Drug Administration indicating that the application is sufficiently complete to permit a substantive review.
Regulatory Update: GSK announces submission for a new indication for Synflorix™ in Europe
GlaxoSmithKline plc (GSK) announced today that it has submitted a regulatory application in the European Union (EU) seeking approval of an additional indication for Synflorix™, a paediatric pneumococcal vaccine, for the active immunisation against pneumonia caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age.
GSK to acquire five million shares in Response Genetics for US$1.10 per share in cash
GlaxoSmithKline plc (LSE: GSK) today announces that it has acquired five million newly issued shares of Response Genetics Inc. (RGI) (NASDAQ: RGDX) common stock at a purchase 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
GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the completion of the phase III programme of an investigational LAMA/LABA involving approximately 6,000 patients with chronic obstructive pulmonary disease (COPD).
GSK announces start of Phase III programme of sirukumab in rheumatoid arthritis
GlaxoSmithKline plc (GSK) today announced that - as part of their collaboration with Janssen Biologics (Ireland) - the Phase III programme evaluating sirukumab (CNTO 136), a human anti-interleukin (IL)-6 monoclonal antibody in the treatment of patients with moderately to severely active rheumatoid arthritis (RA), has commenced dosing.
GlaxoSmithKline reaches agreement to divest majority of Classic Brands in Australia for £172m
GlaxoSmithKline plc (GSK) today announced that it has reached agreement to divest the majority of its “Classic Brands” (25 non-promoted and genericised products) in Australia to Aspen Global Incorporated (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
GlaxoSmithKline plc announced today that the European Commission has granted pazopanib marketing authorisation for the treatment of patients with advanced soft tissue sarcoma (aSTS) who have received prior chemotherapy or have progressed within 12 months after (neo) adjuvant therapy.
Regulatory update – GSK announces submissions in the EU and US for dabrafenib and trametinib
GlaxoSmithKline (GSK) plc today announced regulatory submissions in the European Union and United States (US) related to single-agent use of its BRAF inhibitor dabrafenib and MEK inhibitor trametinib to treat patients with BRAF V600 mutation positive metastatic melanoma.
GSK completes acquisition of Human Genome Sciences
GlaxoSmithKline plc (LSE: GSK) today announced that it has completed its acquisition of Human Genome Sciences (NASDAQ: HGSI) for US$3.6 billion on an equity basis, or approximately US$3 billion net of cash and debt. All outstanding shares of HGS were acquired for US$14.25 per share in cash.
GSK announces acquisition of 79% of Human Genome Sciences shares; commences subsequent offering period
GlaxoSmithKline plc (LSE: GSK) today announced the results of its initial tender offer for all outstanding shares of Human Genome Sciences (NASDAQ: HGSI) for US$14.25 per share in cash, valuing HGS at approximately US$3.6 billion on an equity basis, or approximately US$3 billion net of cash and debt.
Maximuscle powers Vodafone McLaren Mercedes drivers through the 2012 Formula 1™ season
Leading sports nutrition brand continues its presence with on-car logos in Hungary
Once-daily dolutegravir is non-inferior to twice-daily raltegravir in treatment-naïve adults with HIV-1
Shionogi-ViiV Healthcare LLC present full 48-week data results from SPRING-2 Phase III study at International AIDS Conference
Results announcement for the second quarter 2012
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
GlaxoSmithKline today issued the following statement in anticipation of the BBC Panorama programme, “The truth about sports products”, which is scheduled to be aired this evening.
GlaxoSmithKline and Amicus Therapeutics expand Fabry disease collaboration
Glaxo Group Limited (GSK) and Amicus Therapeutics (Nasdaq: FOLD) today announced an expansion of their collaboration to develop and commercialise the investigational pharmacological chaperone migalastat HCl for Fabry disease.
GlaxoSmithKline celebrates its role in supporting the biggest anti-doping operation in the history of the Olympic Games
GSK today marks its role as Official Laboratory Services Provider for the London 2012 Olympic and Paralympic Games by launching its first UK advertising campaign to celebrate the role that anti-doping science will play in helping ensure this summer’s Games are the cleanest possible.
GSK to acquire Human Genome Sciences for US$14.25 per share in cash
GlaxoSmithKline plc (LSE: GSK) and Human Genome Sciences (NASDAQ: HGSI) today announced that the companies have entered into a definitive agreement under which GSK will acquire HGS for US$14.25 per share in cash.
GSK and Theravance announce regulatory submissions for FF/VI in the US and Europe
GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the submission of regulatory applications in the US and European Union for the once-daily investigational medicine fluticasone furoate “FF”/vilanterol “VI” (FF/VI) for patients with chronic obstructive pulmonary disease (COPD) and a regulatory application for asthma in the European Union.
US Regulatory Update – Tykerb® (lapatinib)
GSK plc announced today that it has withdrawn a supplemental NDA to the US FDA for Tykerb (lapatinib) in combination with trastuzumab for the treatment of patients with HER2 (ErbB2)-positive metastatic breast cancer who have received prior trastuzumab therapy.
GSK announces positive data from Harmony 8 and completion of clinical registration package for albiglutide in type 2 diabetes
GSK today announced that data have been received from the Phase III Harmony 8 study and from the event driven meta-analysis for assessment of cardiovascular safety conducted across the albiglutide clinical programme.
Shionogi-ViiV Healthcare announces positive initial data from phase III study of dolutegravir-based regimen vs Atripla in HIV
Shionogi-ViiV Healthcare LLC today announced that initial results have been received from the Phase III SINGLE (ING114467) study of the investigational integrase inhibitor dolutegravir in treatment-naïve adults with HIV-1.
GSK and Theravance announce positive results from four pivotal phase III studies for once-daily LAMA/LABA (UMEC/VI) in COPD
GSK plc and Theravance, Inc. today announced the results of four pivotal phase III studies of investigational LAMA/LABA involving over 4,000 patients with chronic obstructive pulmonary disease (COPD).
GlaxoSmithKline concludes previously announced agreement in principle to resolve multiple investigations with US Government and numerous states
GSK today announced that it has reached an agreement with the US Government, multiple states and the District of Columbia to conclude the Company’s most significant ongoing Federal government investigations.
GSK sets 20 July for expiration of tender offer to acquire Human Genome Sciences
GlaxoSmithKline plc (LSE: GSK) today announced it has extended its tender offer to acquire all of the outstanding shares of Human Genome Sciences (NASDAQ: HGSI) for US$13.00 per share in cash to 5:00 p.m. New York City time on 20 July 2012.
GSK continues with tender offer to acquire all outstanding shares of Human Genome Sciences
GSK today confirmed that it has received a renewed invitation from Human Genome Sciences to participate in its strategic alternatives review process which started in April.
GSK receives FDA approval for MenHibrix
GSK plc announced today that the US FDA has approved the vaccine MenHibrix® [Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine].
Stiefel signs worldwide acquisition and license agreement for Toctino®
Stiefel, a GSK company, today announced that 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
Detailed findings from a Phase III study comparing the investigational GLP-1 receptor agonist 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
GSK today announced it has extended its tender offer to acquire all of the outstanding shares of Human Genome Sciences for US$13.00 per share in cash to 5:00 pm New York City time on Friday 29 June 2012.
GSK and XenoPort receive FDA approval for Horizant® for postherpetic neuralgia
GlaxoSmithKline plc (GSK) and XenoPort, Inc. (Nasdaq: XNPT) announced today that the United States (US) Food and Drug Administration (FDA) has approvedHorizant® (gabapentin enacarbil) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults.
GSK presents positive results for investigational BRAF and MEK inhibitors dabrafenib and trametinib at ASCO
Findings from GSK’s Phase III clinical study programme evaluating single agent therapy with the targeted anti cancer agents, dabrafenib and trametinib, in patients with BRAF V600 mutation positive metastatic melanoma were presented at the Annual Meeting of the American Society of Clinical Oncology in Chicago.
GSK announces expiration of Hart-Scott-Rodino waiting period for tender offer for HGS
GSK today announced that the waiting period under the HSR Act, as amended, has expired with respect to GSK’s tender offer for all the outstanding shares of Human Genome Sciences.
GSK and EPSRC announce creation of new Chair in Sustainable Chemistry at the University of Nottingham
GSK and The Engineering and Physical Sciences Research Council today announced that they will jointly contribute to the funding for a Chair in Sustainable Chemistry to be based at the planned GSK Carbon Neutral Laboratory for Sustainable Chemistry at the University of Nottingham.
Regulatory Update – GSK announces submissions in the EU & US for new indications for Promacta®/Revolade®
GSK announced today that it has submitted regulatory applications in the EU and US related to eltrombopag (Promacta®/Revolade® ) and its use to increase platelet counts in patients with chronic hepatitis C virus infection and low platelets.
GSK secures future of local playing fields with Fields in Trust as part of London 2012 legacy
GSK has today entered a partnership with Fields in Trust (FIT) to secure the future of its Swyncombe Avenue Playing Fields, where hundreds of local people already enjoy sport, by placing them into trust in perpetuity.
GSK announces start of Phase III programme for combination of dabrafenib (GSK2118436) and trametinib (GSK1120212) in BRAF V600 mutation-positive metastatic cutaneous melanoma
GlaxoSmithKline plc. today announced the start of a Phase III programme evaluating the combination of dabrafenib, its BRAF inhibitor, and trametinib, its MEK inhibitor, in patients with BRAF mutation-positive metastatic cutaneous melanoma.
GlaxoSmithKline confirms US District Court ruling in Pronova BioPharma’s favour on Lovaza™ patents
GlaxoSmithKline plc (GSK) which has the marketing rights for Lovaza (omega-3-acid ethyl esters) in the US and Puerto Rico, confirmed that U.S. District Judge Sue Lewis Robinson, the presiding judge in the U.S. District Court for the District of Delaware, ruled in Pronova’s favour in Pronova’s patent litigation involving U.S. Patent Nos. 5,656,667 (“’667 patent”) and 5,502,077 (“’077” patent) covering Lovaza.
GSK receives positive opinion from European CHMP for pazopanib in the treatment of patients with certain advanced soft tissue sarcomas
GSK announced that the EMA's CHMP has issued a positive opinion recommending marketing authorisation for Votrient for the treatment of adult patients with selective subtypes of advanced STS.
Innovative public-private collaboration launches to tackle antibiotic research
GlaxoSmithKline and AstraZeneca today welcomed the launch of a pioneering approach to antibiotic research in Europe that will see pharmaceutical and biotechnology companies working alongside public partners to tackle the rising threat from antibiotic resistance and address some of the key barriers to the development of effective antibiotics.
Two overall winners announced at prestigious national award ceremony in London’s Science Museum
For the first time in its 15 year history the judges of the GlaxoSmithKline (GSK) IMPACT Awards could not choose one overall winner for the awards so instead awarded two prizes. The accolade was received by both the Cornish Women’s Rape and Sexual Abuse Centre (WRSAC) and Target Ovarian Cancer.
GSK statement on tender offer to acquire Human Genome Sciences
GSK today commented on Human Genome Sciences Board of Directors' decision to recommend against GSK’s tender offer to acquire all of the outstanding shares of HGS for US$13.00 per share in cash.
GlaxoSmithKline completes transaction to increase its ownership in Theravance
Following approval by Theravance, Inc.'s stockholders at their Annual Meeting held on 15 May 2012, GSKs acquisition of 10,000,000 shares of Theravance common stock has now completed.
GlaxoSmithKline to fully acquire Cellzome for £61 million
GSK today announced that it has entered into an agreement to acquire those shares it does not currently own in Cellzome, a leader in the development and advancement of proteomics technologies, for £61 million (US$99 million) in cash.
GSK statement on BBC Panorama broadcast: ‘the truth about tax’
GSK issued the following statement in response to the BBC Panorama programme related to Corporation Tax payments in the UK and Luxembourg broadcast tonight, Monday 14 May 2012.
Stiefel receives US FDA approval of Fabior™ Foam, 0.1%
Stiefel, a GSK company, today announced that the US Food and Drug Administration 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
GSK today announced that it has commenced its previously announced tender offer to acquire all of the outstanding shares of Human Genome Sciences for US$13.00 per share in cash.
GSK to commence tender offer to acquire Human Genome Sciences for US $13.00 per share in cash
GSK today announced that it will not participate in Human Genome Sciences strategic alternatives review process and will instead commence a tender offer this week to acquire all of the outstanding shares of HGS for US$13.00 per share in cash.
James Shannon named GlaxoSmithKline Chief Medical Officer
James Shannon has been named GSK’s Chief Medical Officer (CMO), effective 1 May. James will report to R&D Chairman Moncef Slaoui and be based in London. He will be accountable for medical governance and patient safety for all of GSK: Pharmaceuticals, Consumer Healthcare, Vaccines and the global businesses.
GlaxoSmithKline plc appoints two Non-Executive Directors to its Board
GSK announces that Ms. Lynn Elsenhans and Ms. Jing Ulrich will join the Board of the Company 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
GlaxoSmithKline plc (GSK) and Yale University have established a drug discovery research collaboration to design a potential new class of medicines that degrade disease-causing proteins.
GlaxoSmithKline receives European authorisation for Nimenrix™ (Meningococcal group A, C, W-135 and Y conjugate vaccine)
GlaxoSmithKline plc (GSK) announced today that the European Commission has granted marketing authorisation for Nimenrix (Meningococcal group A, C, W-135 and Y conjugate vaccine) for active immunisation against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y.
FDA approves Votrient® for treatment of patients with certain types of advanced soft tissue sarcoma
GSK announced today that the U.S. FDA has approved Votrient® (pazopanib) for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy.
Children in Ghana to be vaccinated against diarrhoeal disease with the introduction of GSK’s Rotarix™ vaccine
GSK welcomes today’s GAVI announcement that GSK’s rotavirus vaccine, Rotarix™, will be introduced into the newly started national vaccination programme in Ghana.
GSK and University of Nottingham collaborate to create Centre of Excellence for sustainable chemistry
GSK and the University of Nottingham today formalised a collaboration to establish a new laboratory to accommodate the Centre of Excellence for sustainable chemistry and to construct an innovative carbon neutral sustainable chemistry laboratory.
Results announcement for the first quarter 2012
- Sales growth of +2% CER - Further R&D delivery, operational leverage and continued 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
GlaxoSmithKline Plc (GSK) today announced that it has reached agreement to divest the previously identified non-core OTC brands in its international markets to Aspen Pharmacare Holdings Limited (Aspen) for £164 million in cash.
GSK confirms offer to acquire Human Genome Sciences for US$13.00 per share in cash
GlaxoSmithKline plc today confirms that it made an offer to the Board of Directors of Human Genome Sciences on 11th April proposing to acquire all of the outstanding shares of HGS for US$13.00 per share in cash, representing a 81 percent premium to yesterday’s closing share price.
GSK provides update on corporate responsibility commitments in 2011 report
GSK has today published its Corporate Responsibility Report, in which the company reiterates its commitment to operate responsibly, openly and transparently and sets out advances made on this agenda during 2011.
GSK receives further data from phase lll studies of albiglutide in type 2 diabetes
GSK today announced that topline results have been received from seven of the eight ‘Harmony’ Phase III studies investigating the use of albiglutide in type 2 diabetes. Albiglutide is an investigational once weekly glucagon-like peptide-1 (GLP-1) agonist.
GlaxoSmithKline to increase its ownership in Theravance
GSK and Theravance, Inc. announced they have entered into a stock purchase agreement, under which Theravance will issue, and 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.
Shionogi-ViiV Healthcare announces initial data from pivotal phase III study of dolutegravir in HIV
SPRING-2 study meets primary endpoint of non-inferiority of dolutegravir compared to raltegravir over 48 weeks in treatment-naïve HIV patients.
GSK and Theravance announce completion of the Relovair™* registrational programme and topline results from Relovair™ vs. Advair® phase III studies in COPD
GSK and Theravance, Inc. today announced the registrational programme for Relovair™ is now complete. In addition, results from two studies for the once-daily investigational medicine Relovair™ in patients with COPD and results from a study to evaluate the efficacy and safety of FF and FP compared to placebo in the treatment of persistent asthma in adults and adolescents were announced.
GSK confirms significant investments in UK manufacturing: Ulverston in Cumbria selected as site of new biopharmaceutical factory
GSK today confirmed that it will invest more than £500m in the UK across its manufacturing sites to increase production of key active ingredients for its pharmaceutical products and vaccines.
GSK announces positive vote from FDA panel for pazopanib in certain advanced soft tissue sarcomas
GSK announced today that the Oncologic Drugs Advisory Committee (ODAC) to the US FDA voted 11 to 2 that evidence from clinical studies support a favourable benefit – risk assessment for use of Votrient in treating patients with advanced soft tissue sarcoma.
GlaxoSmithKline provides further update on divestment of non-core over-the-counter (OTC) brands
In February 2011, GSK announced its intention to divest non-core Consumer Healthcare OTC products predominantly in the United States and Europe with aggregate sales of approximately £500 million.
GSK reinforces commitment to youth training with launch of new UK apprenticeship programme
GSK today announced the launch of a new multi-disciplinary apprenticeship scheme. The programme, which will sit alongside GSK’s established graduate and undergraduate recruitment schemes, is aimed at 16-24 year olds.
Regulatory Update: GSK announces submissions for two influenza vaccines
GlaxoSmithKline [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
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
GlaxoSmithKline (GSK) today announced that it has signed an agreement with Daiichi Sankyo Co., Ltd. to form a Joint Venture (JV) which is expected to create the number one vaccines company in Japan.
GlaxoSmithKline receives positive opinion in Europe from the CHMP for Nimenrix®
GSK announced that the EMA's Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorisation for Nimenrix® for active immunisation against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y.
EU and US Regulatory Update – Tykerb/Tyverb® (lapatinib)
GlaxoSmithKline announced today that it has submitted regulatory applications in Europe and the US related to Tykerb/ Tyverb (lapatinib) and its use in combination with trastuzumab to treat patients with HER2 (ErbB2)-positive metastatic breast cancer.
GSK results announcement for Q4 and full year 2011
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
GSK today announced it has joined other global pharmaceutical companies and leading organisations including the WHO, the Bill & Melinda Gates Foundation, the UK Department for International Development and the USAID in a new united effort to support developing countries to defeat neglected tropical diseases.
GSK announces changes to the Board
GlaxoSmithKline plc today announced that at the company’s Annual General Meeting (AGM) in 2013, following nine years of respective service to the GSK Board, 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
GlaxoSmithKline respectfully disagrees with the recent court ruling in favour of the ANMAT on the fine issued to GSK regarding the administrative 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
GSK and Theravance, Inc. today announced the completion of the phase III registration programme for the once-daily investigational medicine Relovair™* in patients with COPD and of all but one of the pivotal studies in patients with asthma.
GlaxoSmithKline provides update on divestment of non-core over-the-counter (OTC) brands
Agreement reached to divest brands in USA and Canada to Prestige Brands Holdings, Inc. for £426m ($660m). Process continues for divesting brands outside these markets and global rights for alli.
GSK extends pneumococcal vaccine agreement with GAVI Alliance
GSK today announced it has expanded its agreement with the GAVI Alliance in a move to help protect millions more children in the world's poorest countries from pneumococcal disease. Pneumococcal disease can lead to pneumonia, meningitis and sepsis and is a leading cause of death in children under the age of five in developing countries.
GlaxoSmithKline and Human Genome Sciences initiate phase III trial of belimumab (Benlysta®) administered subcutaneously in subjects with systemic lupus erythematosus
GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that dosing has been initiated in BLISS-SC, a new Phase III trialto evaluate the efficacy, safety and tolerability of BENLYSTA® (belimumab) administered subcutaneously (SC) once-weekly to autoantibody-positive adults with active systemic lupus erythematosus (SLE).
GSK presents phase lll data for lapatinib at San Antonio breast cancer symposium
Improvement in disease-free survival does not reach statistical significance in study of delayed adjuvant therapy with lapatinib (Tykerb or Tyverb) monotherapy in HER2 positive breast cancer.
GSK and Help for Heroes partner to support the rehabilitation of wounded servicemen and women in the UK
GSK and Help for Heroes today announced a new partnership to help support injured British armed forces personnel successfully transition back into civilian life. The partnership will focus on the creation of a specialist 'Wellness Centre' at Tedworth House, a Personnel Recovery and Assessment Centre located in Wiltshire.
GSK statement in response to the Prime Minister’s speech on life sciences
"The Government’s strategy for Life Sciences is a very important next step on the journey to make the UK the best place in the world to locate pharmaceutical investment. The actions on research and manufacturing will further strengthen the attractiveness of the UK and most importantly the results of the Innovation Review should ensure that the NHS is a stronger adopter of innovative medicines and technology, ensuring that all patients can benefit from cost-effective treatments and interventions approved by NICE.
Regulatory Update: GlaxoSmithKline submits additional information for candidate meningococcal and Hib combination vaccine
GlaxoSmithKline [NYSE:GSK] today submitted additional information to the U.S. Food and Drug Administration (FDA) in support of the Biologics License Application (BLA) for the candidate meningococcal and Hib combination vaccine MenHibrix® (Hib-MenCY-TT). This information was submitted in response to the September 2011 Complete Response letter received from the FDA.
Reporting on a core earnings basis will begin with effect from Q1 2012
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
GlaxoSmithKline today welcomed the decision of the GAVI Board to provide funding to facilitate the provision of cervical cancer immunisation programmes and rubella vaccination, across the world’s poorest countries.
GlaxoSmithKline welcomes innovative knowledge-sharing collaboration to break deadlock in antibiotic discovery and development
GlaxoSmithKline (GSK) today welcomes the European Commission’s commitment to promote collaborative research efforts to develop new antibiotics against the growing threat from resistant bacteria.
GSK receives initial data from the first completed phase lll study of albiglutide in type 2 diabetes
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 caused by HPV 16 and 18 and also efficacy against certain other cancer-causing HPV types
An analysis published today in TheLancet Oncology reinforces previous findings showing that GlaxoSmithKline’s Cervarix®, provided protection against advanced precancerous lesions (CIN3+), above that expected from a vaccine that protects against human papillomavirus (HPV) types 16 and 18. CIN3+ is the immediate step before invasive cervical cancer and data showing protection against this type of lesion are considered the most stringent evidence of potential cervical cancer prevention.1
GSK presents phase III results for eltrombopag in hepatitis C virus related thrombocytopenia
Full results from ENABLE 1 and initial data from ENABLE 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
- $3 billion settlement covered by existing legal provisions - Fundamental changes to US compliance, marketing and selling procedures implemented in recent years
GSK joins WIPO Re:Search open innovation platform as part of its commitment to tackling diseases of the developing world
GlaxoSmithKline (GSK) today announced it has joined WIPO Re:Search as part of its open innovation strategy to help accelerate the development of new and better treatments against neglected tropical diseases (NTDs) which affect more than a billion people in the world’s poorest countries each year.
GSK delivers strong Q3 performance with underlying sales growth of 6% and reported sales growth of 3%
- EPS 28.5p +1% before major restructuring* - Dividend +6% to 17p - 2011 share buyback expectations increased to up to £2.3 billion Full details of GSK's results for the third quarter of 2011 can be found in the Investors section of GSK.com.
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
Half the world’s population is at risk of malaria which is responsible for close to 800,000 deaths each year, most of whom are children under five in sub-Saharan Africa
Regulatory Update: GlaxoSmithKline receives Complete Response letter from FDA for candidate meningococcal and Hib combination vaccine
GlaxoSmithKline [NYSE:GSK] announced today that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for the candidate meningococcal and Hib combination vaccine, MenHibrix® (Hib-MenCY-TT). The proposed indication for this combination vaccine is active immunization of infants and toddlers 6 weeks through 15 months of age for the prevention of invasive diseases caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (Hib).
Lucozade to help drive Vodafone McLaren Mercedes performance
Ahead of this weekend’s Singapore Grand Prix, Lucozade – the UK’s leading sports and energy drink – today announces an innovative performance partnership with the Vodafone McLaren Mercedes Formula 1 team.
GlaxoSmithKline (GSK) and McLaren Group announce innovative strategic partnership
GlaxoSmithKline (GSK) today announced that it has formed a long term strategic partnership with McLaren Group. The partnership, which will run initially until 2016, brings together two UK companies focused 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
GlaxoSmithKline (GSK) today announced that it has committed $1 million in Cervarix® cervical cancer vaccine to the Pink Ribbon Red Ribbon partnership over the next five years. GSK has also pledged $50,000 to support the program operations. As a result of this donation, more than 10,000 girls and women will have access to vaccination
GlaxoSmithKline and Amicus Therapeutics commence second phase III study of Amigal™ for Fabry disease
GlaxoSmithKline (GSK) and Amicus Therapeutics today announced the first patient has commenced dosing in a Phase III global registration study (Study 012) to compare the safety and efficacy of Amigal™ (migalastat HCl) and enzyme replacement therapy (ERT) for the treatment of Fabry disease. The randomised, open-label, 18-month study will provide longer-term clinical data comparing migalastat HCl to ERT in patients with Fabry disease, a rare inherited lysosomal storage disorder.
GSK gives update on agreement with World Health Organization to support de-worming of school age children in endemic countries
First African countries, Togo and Rwanda, receive albendazole donations to scale-up school based de-worming programmes for children at risk of intestinal worms. Donations to go beyond Africa to include endemic countries in Asia Pacific and Latin America.
Lapatinib clinical trial update
A planned interim review of early data from ALTTO a Phase III, four arm study of adjuvant lapatinib (Tykerb/Tyverb®), trastuzumab, their sequence and their combination in patients with HER2 positive early stage breast cancer, has resulted in a change to the ongoing study. The independent data monitoring committee that carried out the review has recommended that three of the trial arms continue without modification. However, the committee has indicated that the lapatinib alone arm is unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival. Consequent to this finding, patients assigned to the lapatinib alone arm of the trial will discontinue lapatinib and discuss treatment options with their study physician. This study is fully recruited and the remaining three arms of the trial will continue as planned. Use of lapatinib in an adjuvant setting is not approved anywhere in the world.
Jens Eckstein named President of SR One, GSK’s venture healthcare group
Jens Eckstein has been named President of SR One, GSK’s independent healthcare venture organisation, effective 1 October. Jens will report to R&D Chairman Moncef Slaoui and be based in Boston. He replaces Christoph Westphal, who will be leaving GSK at the end of the year to focus on external business interests, including the Longwood Founder’s Fund, in which GSK is an investor.
GlaxoSmithKline (GSK) shows sign of things to come at London 2012 Olympic and Paralympic Games
2012 provider, GSK, unveils sign celebrating its scientific contribution to the Games
GSK awarded contract by BARDA to support research on potential novel antibiotic
GSK and the Biomedical Advanced Research and Development Authority (BARDA) have agreed to a contract that will support the development by GSK of a potentially new antibiotic against both hospital Gram negative and biothreat pathogens.
GSK takes minority stake in new spin out Autifony Therapeutics
GlaxoSmithKline plc today announced that its wholly-owned subsidiary Glaxo Group Limited (GSK) will receive a 25.4% minority equity stake, representing a £1,250,000 investment, in Autifony Therapeutics Limited, a UK-based biotechnology start up created through a funding round of up to £10 million alongside investors Imperial Innovations and SV Life Sciences.
GSK and Impax announce positive topline results of ASCEND-PD Phase III study of IPX066 in Advanced Parkinson’s disease
- IPX066 demonstrated statistically significant improvement over carbidopa-levodopa plus entacapone in reducing the percentage of “off time” during waking hours
GSK and Enigma Diagnostics announce collaboration on assay development and commercialisation of Enigma’s ML platform
GlaxoSmithKline (GSK) and Enigma Diagnostics Limited today announced that they have signed agreements for the supply and commercialisation on an exclusive basis of the Enigma® ML system in Europe and other designated key countries, including India, Brazil and Russia. The agreements include development by Enigma of an initial range of respiratory tests for use on its real-time Polymerase Chain Reaction (PCR) technology platform, and provide GSK the opportunity to generate revenues from further test developments in infectious diseases and in other therapeutic areas relevant to its healthcare business.
Regulatory Update: GSK and XenoPort submit supplemental New Drug Application to FDA for Horizant™ in postherpetic neuralgia
GlaxoSmithKline (NYSE and LSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) announced today that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting approval of Horizant™ (gabapentin enacarbil) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults. The sNDA has been submitted to the FDA by GSK.
Regulatory update – Stiefel, a GSK company, files NDA for tazarotene foam
Stiefel, a GSK company, announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for tazarotene foam for the topical treatment of facial acne vulgaris in patients 12 years of age or older.
GSK delivers strong Q2 performance with underlying sales growth* of 5%, increased pipeline visibility and dividend of 16p, up 7%
Full details of GSK's results for the second quarter of 2011 can be found in the
GlaxoSmithKline European regulatory update on Pandemrix™
GlaxoSmithKline (GSK) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (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)
GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that the European Commission (EC) has granted marketing authorisation for Benlysta®(belimumab) 10mg/kg as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus (SLE), with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy1.
EU and US Regulatory Update - Votrient® (pazopanib)
GlaxoSmithKline (GSK) announced today that it has submitted a variation to the Marketing Authorisation Application to the European Medicines Agency for Votrient (pazopanib) for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy, or for patients who are unsuited for such therapy.
London 2012 partner, GlaxoSmithKline, shares scientific expertise with World Anti-Doping Agency to help fight against abuse of drugs in sport
London 2012 partner GlaxoSmithKline (GSK) today signed a long-term agreement with the World Anti-Doping Agency (WADA) that will help the agency create early detection methods for medicines that have performance-enhancing potential in sport.
GlaxoSmithKline receives new approval for Rotarix and significant new indication for Lamictal® (lamotrigine) in Japan
– GSK’s rotavirus vaccine approved for use in babies for the prevention of rotavirus gastroenteritis – 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
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
Research led by the University of East Anglia has been published in the Journal of the American Geriatrics Society i examining the long term health impacts of anticholinergic medicines, a wide-ranging group of drugs frequently taken by older people.
GSK statement on agreements with State Attorneys General on former Cidra manufacturing facility
GlaxoSmithKline (GSK) has agreed to pay $40.75 million, which will be divided among 37 states and the District of Columbia, as part of an agreement reached related to events during the early 2000s at its former manufacturing facility in Cidra, Puerto Rico.
GSK to purchase Shenzhen Neptunus stake in previously formed joint venture for influenza vaccines in China
GlaxoSmithKline (GSK) announced today that it has entered into an agreement to acquire the remaining 51% equity interest of Shenzhen Neptunus Interlong Bio-Technique Co. Ltd (Neptunus) in the joint venture (JV) company, Shenzhen GSK-Neptunus Biologicals Co. Ltd. (GSKNB), for a total cash consideration of£24 million (US$39 million). After approval of this agreement by the Peoples Republic of China’s authorities, GSK will become the sole owner of GSKNB.
GlaxoSmithKline and Valeant announce US FDA approval of Potiga™ (ezogabine)
GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) announced today that the U.S. Food and Drug Administration (FDA) has approved Potiga™ (ezogabine) Tablets, a potassium channel opener, as adjunctive treatment of partial-onset seizures in patients aged 18 years and older.
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
GSK today announced that it has made a new offer to supply its rotavirus vaccine, 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
Results of the PALETTE (PAzopanib ExpLorEd in SofT-Tissue Sarcoma) study presented at the 2011 Annual Meeting of the American Society for Clinical Oncology demonstrated a statistically significant improvement in the time to first occurrence of tumour progression or death (progression free survival or PFS) for study patients treated with the multi-tyrosine kinase inhibitor pazopanib, compared to placebo. PALETTE is a randomised, double-blind, placebo controlled Phase III trial in patients with metastatic soft tissue sarcomas (excluding gastrointestinal stromal tumours and adipocytic sarcomas) and was jointly conducted by GlaxoSmithKline and the European Organisation for Research and Treatment of Cancer (EORTC) in collaboration with cancer centres across the world. Use of pazopanib to treat soft tissue sarcomas is investigational and subject to evaluation of benefits and risks by regulatory authorities before being made available for that use.
GSK and Theravance announce results of two pivotal Phase III studies for Relovair in COPD
GSK and Theravance, Inc. today 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
- 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
GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending marketing authorisation for Benlysta® (belimumab) as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus, with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy.
Young people’s health charity steps forward to claim top accolade and £35,000
Tower Hamlets-based charity, Step Forward, has beaten more than 400 organisations from around the UK to be crowned the overall winner of this year’s GlaxoSmithKline (GSK) IMPACT Awards, run in partnership with health think-tank The King’s Fund. The charity picked up their award and £35,000 prize at a ceremony last night, held at London’s Science Museum.
pharmaceutical industry and university create manchester collaborative centre for inflammation research
GlaxoSmithKline (GSK), The University of Manchester, and AstraZeneca announce today the creation of the Manchester Collaborative Centre for Inflammation Research (MCCIR), a unique collaboration to establish a world-leading translational centre for inflammatory diseases. The project starts out w ith an initial investment of £5M from each partner over a three year period.
GSK Q1 performance demonstrates continued progress with delivery of underlying sales growth, cash generation and pipeline visibility
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
GSK and Valeant Pharmaceuticals International, Inc. submitted on 15 April 2011 the response to the U.S. 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
GlaxoSmithKline (GSK) welcomes the agreement reached at the Open Ended Working Group (OEWG) coordinated by the World Health Organisation (WHO) on a Framework to support global preparedness for a future influenza pandemic. The agreement establishes the principles of an improved process for influenza virus and benefit-sharing between the WHO GISN (Global Influenza Surveillance Network) and industry.
Regulatory Update - Tyverb® lapatinib
GlaxoSmithKline plc (GSK) announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Tyverb (lapatinib) in combination with paclitaxel for the treatment of patients with metastatic breast cancer whose tumours over-express HER2 (ErbB2).
GSK European regulatory update on Pandemrix™
GlaxoSmithKline (GSK) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended changes to the product label for Pandemrix. The amendment includes prescribing advice based on information on a potential increased risk of narcolepsy in children or adolescents. This is based onpreliminary results from epidemiological studies on the risk of narcolepsy from Finland, Sweden and France. This does not apply to adults where to date no data support such a change. The EMA state that this is an interim measure pending the outcome of the European review expected to conclude in July 2011.
GlaxoSmithKline announces non-core OTC products to be divested
GSK today identified the non-core OTC brands that it intends to divest as the company focuses its Consumer Healthcare business around a portfolio of fast-growing priority brands and the emerging markets. GSK’s intention to divest its non-core Consumer assets was announced at the company’s fourth quarter 2010 results on 3rd February 2011.
Unique research alliance expands collaboration opportunities at state-of-the-art medical imaging centre
The UK research community will soon have access to world-class medical imaging facilities in London with the signing of an agreement today between an alliance of leading London-based universities, the Medical Research Council (MRC) and the pharmaceutical company GlaxoSmithKline (GSK).
GlaxoSmithKline and XenoPort receive FDA approval for Horizant™
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved Horizant™ (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome in adults. Horizant is not recommended for patients who are required to sleep during the daytime and remain awake at night. The efficacy of Horizant in the treatment of patients with moderate-to-severe primary Restless Legs Syndrome was demonstrated in two 12-week clinical trials in adults. It is the first medication in its class to be approved for the treatment of moderate-to-severe primary Restless Legs Syndrome.
GSK publishes payments for research consulting and advising by US healthcare professionals
GlaxoSmithKline (NYSE:GSK) today published a list of payments made during 2010 for clinical research studies led by U.S. healthcare professionals. Clinical trials are an important step in the lengthy process of discovering and developing new medicines. GSK works with these independent institutions and healthcare professionals because they have considerable expertise in conducting research that contributes to the body of knowledge about diseases and potential new treatments.
GlaxoSmithKline confirms Pronova BioPharma reaches agreement with Apotex regarding Lovaza™ US patent litigation
GlaxoSmithKline (GSK), which has the marketing rights for Lovaza (omega-3-acid ethyl esters) in the US and Puerto Rico, confirmed today that Pronova BioPharma Norge AS, which owns the patents for Lovaza, has entered into an agreement with Apotex Corp. and Apotex Inc. (collectively “Apotex”), to settle their patent litigation in the United States related to Lovaza.
GSK and Valeant receive European authorisation for Trobalt (retigabine)
GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International, Inc. (NYSE & TSX: VRX) announced today that the European Commission has granted marketing authorisation for Trobalt™(retigabine) as an adjunctive (add-on) treatment of partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalisation in adults aged 18 years and above with epilepsy.1
GSK publishes 2010 Corporate Responsibility Report
In its Corporate Responsibility Report published today, GlaxoSmithKline (GSK) reiterated its commitment to building its business on strong values and ethical standards. The Report covers key responsibility issues including access to medicines, research and business ethics, environmental sustainability, employment practices, stakeholder engagement and investment in communities. In particular, new measures were outlined to strengthen the company’s commitment to the environment and increase access to medicines for people living in the world’s poorest countries. GSK also reported a substantive increase in its level of charitable support.
GSK statement on Avodart™ (dutasteride) for prostate cancer risk reduction
GlaxoSmithKline (GSK) announced today that it will no longer pursue global approval (marketing authorisation) for the use of Avodart™ (dutasteride) to reduce the risk of prostate cancer. The Company will withdraw applications from regulatory review where procedures are ongoing and, in the limited number of countries where dutasteride is already indicated for use in prostate cancer risk reduction, GSK will work with regulatory agencies to remove this indication from the product’s licence and support physicians to communicate appropriately to patients.
GSK launches London 2012 initiative with King’s College London to inspire young people into science careers
At the launch of the new ‘Scientists in Sport’ education programme designed to inspire young people into a range of scientific careers, a study has found that eight out of 10 secondary school pupils are now worried about getting a job in the future.
GSK supports recovery efforts to help those affected by the Japan earthquake
In response to events in Japan as a result of the Tohoku Kanto Earthquake and tsunami that devastated Japan’s north east coastline region, GlaxoSmithKline (GSK) is supporting the ongoing relief efforts by working with the Japanese authorities, the Japan Pharmaceutical Manufacturers Association and local NGOs to assist medical support and pharmaceutical donation needs.
GSK announces positive topline results of Phase lll study of IPX066 in advanced Parkinson’s disease
GlaxoSmithKline (GSK) today announced positive, top-line results of the ADVANCE-Parkinson’s Disease (PD) Phase III clinical study, conducted by Impax Pharmaceuticals, of IPX066 versus immediate-release (IR) carbidopa-levodopa (CD-LD) in advanced PD patients experiencing motor fluctuations. IPX066 is an investigational extended release (ER) CD-LD product which is being developed by Impax in collaboration with GSK. Under the terms of a development and commercialisation agreement, Impax will develop and commercialise IPX066 in the United States and Taiwan, and GSK will develop and commercialise IPX066 in all other markets throughout the world.
GlaxoSmithKline and Tolerx announce phase III DEFEND-1 study of otelixizumab in type 1 diabetes did not meet its primary endpoint
GlaxoSmithKline (GSK) and Tolerx, Inc. today announced that the Phase III DEFEND-1 study of otelixizumab, an investigational humanised anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide at month 12 in patients with new-onset autoimmune type 1 diabetes.
GlaxoSmithKline and Human Genome Sciences announce FDA approval of Benlysta® (belimumab) for the treatment of systemic lupus erythematosus
GlaxoSmithKline plc (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that the U.S. Food and Drug Administration (FDA) has approved Benlysta® (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.
GlaxoSmithKline plc appoints two Non-Executive Directors to its Board
GlaxoSmithKline plc (GSK) announces that Ms. Judy Lewent and Ms. Stacey Cartwright have been appointed as Non-Executive Directors and will join the Board of the Company with effect from 1st April 2011.
Regulatory update: Nimenrix® (MenACWY vaccine)
GlaxoSmithKline (GSK) announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for its candidate conjugate meningitis vaccine, Nimenrix®, for active immunisation against invasive meningococcal diseases caused by Neisseria meningitidis serogroups A, C, W-135 and Y.
GSK outlines new plan to drive recruitment and attract graduate talent in the UK
GlaxoSmithKline (GSK) today outlined new plans to encourage talented students graduating from UK universities to consider pursuing a career within the company. These measures are part of the company’s ongoing efforts, as one of the leading FTSE companies and employers in the UK, to ensure the ongoing success of the business.
Reward for charities bridging gaps in health care provision
Ten UK charities have each won £25,000 in recognition of their outstanding contribution to improving health care. The charities beat more than 400 entrants to become winners of this year’s GlaxoSmithKline (GSK) IMPACT Awards, run in partnership with The King’s Fund.
World’s first everyday fluoride toothpaste with NovaMin® technology that can repair sensitive teeth
GlaxoSmithKline Consumer Healthcare, the maker of leading sensitive toothpaste brand Sensodyne®, today announced a breakthrough in dental care with the launch of new Sensodyne Repair & Protect. The breakthrough formulation, which the company will launch in over 50 European and International markets during 2011, is the first everyday fluoride toothpaste to contain patented NovaMin® technology, which is scientifically proven to repair* sensitive teeth by forming a tooth-like layer over exposed dentine to help continually repair and protect sensitive areas.
David Redfern appointed as new Chairman of ViiV Healthcare
GlaxoSmithKline (GSK), ViiV Healthcare, and Pfizer today announced the appointment of David Redfern as the new Chairman of the Board for ViiV Healthcare with effect from 1st April 2011, following the retirement of Julian Heslop. David will continue to serve as Chief Strategy Officer at GSK, which owns a majority share in ViiV Healthcare.
GSK European regulatory update on Pandemrix™
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
GlaxoSmithKline (GSK) announced the incorporation of its pneumococcal vaccine into the Kenyan national immunisation programme. Kenya is the first African country to receive pneumococcal vaccines through the innovative financing mechanism known as the Advance Market Commitment (AMC), which is designed to bring heavily discounted vaccines to children living in the world’s poorest countries.
GlaxoSmithKline moving to new building at Philadelphia Navy Yard
GlaxoSmithKline (NYSE:GSK), a leading worldwide research-based pharmaceutical company, and Liberty Property Trust (NYSE:LRY) today announced that GSK has signed a 15.5-year lease for a new building to be developed by Liberty Property Trust and Synterra Partners. Located at Five Crescent Drive in the Navy Yard Corporate Center, the 205,000 square-foot, four-story facility will be designed to achieve LEED® Platinum certification, the highest possible designation in the internationally-recognized sustainable building rating system. The project represents an $81 million investment by Liberty.
GSK revises US Avandia label to include new restrictions on use
GlaxoSmithKline (GSK) today announced revised US prescribing information and medication guides for all rosiglitazone-containing medicines (Avandia®, Avandamet® and Avandaryl®) to include additional safety information and restrictions on the use of these medicines. The new label content reflects the US Food and Drug Administration’s review of cardiovascular event data in type 2 diabetes patients treated with Avandia, and follows a meeting of the joint Advisory Committees in July 2010 and a decision in September 2010 by the FDA to restrict access to these medicines.
GlaxoSmithKline and Human Genome Sciences announce publication of BLISS-52 phase lll study results for Benlysta® in The Lancet
GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced publication of the BLISS-52 study of Benlysta® (belimumab) in autoantibody-positive patients with active systemic lupus erythematosus (SLE) in The Lancet .
GSK results announcement for the fourth quarter
Strategic progress drives positive underlying sales growth*,increasing pipeline potential and improved cash generation. Increased dividend and new long-term share buy-back programme enhance returns to shareholders.
GSK and Theravance announce progression of LAMA/LABA combination treatment into Phase III development for COPD
GSK and Theravance, Inc. today announced major milestones in two clinical development programmes focused on new treatments for patients with COPD, a leading cause of chronic illness and death worldwide.
GSK announces the sale of its entire shareholding in Quest Diagnostics
GlaxoSmithKline plc (“GSK”) announces that it has sold its entire holding of 30,755,151 shares of common stock in Quest Diagnostics Inc. (“Quest”). The sale comprised a secondary public offering by GSK (the “Offering”) and an accompanying repurchase of shares by Quest (the “Repurchase”). GSK originally acquired the shareholding as partial consideration for the sale of its clinical laboratories business in 1999 and has since gradually reduced its stake in stages.
Update on Pandemrix™ and interim Finnish report on narcolepsy
GSK is aware of today’s interim report by the Finnish National narcolepsy committee [1] on their investigation into reported cases of narcolepsy in Finland. This investigation is independent of a broader ongoing European Medicines Agency (EMA) investigation initiated in 2010. GSK is reviewing the report and believes it would be premature to draw any conclusions on a potential association between Pandemrix and narcolepsy until this European investigation has been completed.
GSK and Actelion discontinue clinical development of almorexant
GlaxoSmithKline (GSK) and Actelion Ltd (SIX: ATLN) today announced that clinical development of the Phase III investigational dual orexin receptor antagonist, almorexant, has been discontinued. This decision follows a review of data from additional clinical studies, which were conducted to further establish the clinical profile of almorexant, including the tolerability profile.
GSK receives FDA Complete Response letter for Avodart for prostate cancer risk reduction supplemental indication
GlaxoSmithKline (GSK) today announced that the Company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for reducing the risk of prostate cancer in men at increased risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA).
GlaxoSmithKline announces start of two phase III studies in advanced/metastatic melanoma
GlaxoSmithKline (GSK) announced today the start of two global Phase III studies in advanced or metastatic melanoma patients with a BRAF V600 mutation. The studies will separately assess the efficacy and safety of two investigational agents, GSK2118436 and GSK1120212, to determine their individual ability to stop or slow the progression of skin cancer in patients whose tumours contain a BRAF V600 mutation, which occurs in 50 to 60 percent of melanoma patients.Commencement of these studies confirms previously announced plans to progress these assets into Phase III.
Regulatory update - GSK and Valeant receive positive opinion in Europe from the CHMP for Trobalt (retigabine)
GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International, Inc. (NYSE & TSX: VRX) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending marketing authorisation for Trobalt™(retigabine) as an adjunctive (add-on) treatment of partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalisation in adults aged 18 years and above with epilepsy.
GSK and Prosensa announce start of Phase III study of investigational Duchenne Muscular Dystrophy medication
GlaxoSmithKline (GSK) and Prosensa today announced that the first patient has commenced treatment in the Phase III clinical study investigating GSK2402968 (`968), in ambulant boys with Duchenne Muscular Dystrophy (DMD), who have a dystrophin gene mutation amenable to an exon 51 skip (up to 13% of boys with DMD). Commencement of this study confirms previously announced plans to progress this asset into Phase III.
GlaxoSmithKline commences Phase III study of intravenous zanamivir for hospitalised patients with influenza
GlaxoSmithKline (GSK) announced today that the first patient has received treatment in a pivotal Phase III study of hospitalised patients with influenza which compares intravenous (IV) zanamivir to oral oseltamivir. The primary endpoint of this study is time to clinical response in patients with confirmed influenza.
GlaxoSmithKline announces Q4 2010 legal charge
GlaxoSmithKline (GSK) today announces that it expects to record a legal charge for the fourth quarter of 2010 of £2.2 billion ($3.4 billion) (equating to an after tax cost of £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
GlaxoSmithKline (GSK) and ChemoCentryx, Inc. announced today that the first patient with Crohn’s disease has initiated treatment in the initial pivotal induction study comparing Traficet-EN, now designated GSK1605786 (‘786), to placebo. This marks the start of the Phase III clinical development programme for ‘786 for the treatment of this serious and chronic disease.
GlaxoSmithKline and DENTSPLY International sign global agreement to create a portfolio of co-branded professional oral care products
GlaxoSmithKline (GSK) and DENTSPLY International, a global leader in professional dental products, today announced that they have entered into an agreement to create a portfolio of co-branded oral care products to be used in the dental office by patients suffering from tooth sensitivity, a problem which is estimated to affect 1 in 3 people.
GSK responds to 60 Minutes
GlaxoSmithKline [GSK] issued the following response regarding a 60 Minutes program on January 2 that focused on a manufacturing facility in Puerto Rico which was formerly owned by the company
Press release for testing purposes
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Sed lobortis interdum mattis. Cras cursus tincidunt imperdiet. Fusce sed neque mauris.
GlaxoSmithKline and Theravance commence MABA Phase IIb COPD study
GlaxoSmithKline (GSK) and Theravance (NASDAQ: THRX) announced today that the first patient has started treatment with an investigational inhaled bifunctional compound GSK961081 (‘081) in a Phase IIb study to evaluate efficacy and safety in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Andrew Witty appointed Lead Non-Executive Board Member for the Department for Business, Innovation and Skills (BIS)
The UK Government today announced that Andrew Witty has been appointed as the Lead Non-Executive Board Member for the Department for Business, Innovation and Skills. This appointment forms part of a wider announcement by the Government to create Boards for each Department, including representation from the commercial private sector.
GlaxoSmithKline and Impax Pharmaceuticals enter global agreement to develop and commercialise a late stage compound for Parkinson’s Disease
GlaxoSmithKline (GSK) and Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (Impax), today announced an agreement for the development and commercialisation of IPX066, Impax’s novel extended release carbidopa-levodopa product, outside the United States and Taiwan. IPX066, an investigational product under development for the treatment of Parkinson’s Disease (PD), is currently in Phase III clinical trials.
GSK to strengthen Nutritional Healthcare business with acquisition of Maxinutrition
GlaxoSmithKline (‘GSK’) and Maxinutrition Group Holdings Limited (‘Maxinutrition’) today announced they have entered into an agreement for GSK to acquire Maxinutrition, a UK company that manufactures protein-enhanced functional nutrition products, from Darwin Private Equity. Subject to approval from the Office of Fair Trading, GSK will acquire 100 per cent of the shares of Maxinutrition for a cash consideration of approximately £162 million including the repayment of outstanding debt.
Phase III study in HER2-positive advanced breast cancer shows overall survival benefit when Tykerb is combined with paclitaxel
In a blinded, randomised, Phase III study, women with previously untreated HER2-positive metastatic breast cancer achieved a statistically-significant improvement in overall survival when treated with an investigational combination of Tykerb® (lapatinib) plus paclitaxel, a widely used chemotherapy agent.[i] The results of the Phase III study in HER2-positve metastatic breast cancer were presented during the 33rd annual meeting of the CTRC-AACR San Antonio Breast Cancer Symposium, held in San Antonio, Texas (8-12 December 2010).
Data from Tykerb investigational phase III studies in neo-adjuvant HER2-positive breast cancer presented at breast cancer symposium
Topline results were presented today from two Phase III studies examining the effect of Tykerb (lapatinib) in the neo-adjuvant setting of HER2-positive breast cancer.i, ii The combination of lapatinib and trastuzumab, with standard chemotherapy, was compared to standard chemotherapy plus either lapatinib or trastuzumab in a trial called NeoALTTO. In another trial, known as GeparQuinto, lapatinib plus standard chemotherapy was compared to trastuzumab plus standard chemotherapy. The studies were conducted and presented by international cooperative groups, with research being funded in part by GlaxoSmithKline. Data findings from both trials were presented at the 33rd annual meeting of the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), held in San Antonio, Texas (8-12 December 2010).
GSK signs agreement to acquire Nanjing MeiRui Pharmaceuticals in China
GlaxoSmithKline plc (GSK) today announced that it has entered into an agreement to acquire Nanjing MeiRui Pharma Co., Ltd (MeiRui) for a cash consideration of approximately $70 million. Ninety per cent of the share capital of MeiRui is to be acquired from Pagoda Pharmaceuticals Limited and the remaining ten per cent from Allergon AB in a move to further expand GSK’s presence in China, one of the fastest-growing and most significant of the emerging markets.
GlaxoSmithKline and Human Genome Sciences announce FDA extension of Benlysta® PDUFA target date to 10th March 2011
GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target date for its priority review of the Biologics License Application (BLA) for Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus (SLE) from 9th December 2010 to 10th March 2011.
Avodart reviewed by FDA advisory committee for prostate cancer risk reduction
GlaxoSmithKline (NYSE: GSK) today announced the results of a U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for reducing the risk of prostate cancer in men at risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA). When asked if the dutasteride risk/benefit profile is favorable for reduction in the risk of prostate cancer in this target population, the ODAC voted 14 against, 2 in favor, and 2 abstentions.
GSK and Valeant announce receipt of U.S. FDA Complete Response letter for ezogabine
GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) announced receipt of a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ezogabine*, an investigational anti-epileptic drug being studied for the adjunctive treatment of adults with partial-onset seizures.
Government patent box proposals ‘transform’ UK attractiveness for investment
GSK welcomes the publication today of the Government’s proposals to establish a ‘patent box’. The measure is designed to encourage investment in R&D and related manufacturing in the UK by introducing a lower rate of corporation tax on profits generated from UK-owned intellectual property. Specific details of how the mechanism will work are now the subject of consultation
GlaxoSmithKline to increase its shareholding in Theravance
GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) (the “Company”) announced today that GSK will increase its shareholding in Theravance through the purchase of Theravance common stock in a private placement. GSK and Theravance have entered into a stock purchase agreement for GSK to purchase 5,750,000 shares of Theravance common stock at a price of $22.50 per share, for a total investment of $129,375,000. The transaction is scheduled to close later today. Following this purchase, GSK will own 15,151,499 shares of Theravance common stock and Class A common stock, which represent approximately 19% of the total outstanding capital stock of Theravance. The most recent five-day volume-weighted average price per share of Theravance common stock was $22.35.
GlaxoSmithKline and JSC Binnopharm enter vaccine production alliance in Russia
GlaxoSmithKline (GSK) and JSC Binnopharm (Binnopharm) today announced an alliance to enable the local secondary manufacture of a number of GSK vaccines in Russia. The agreement was signed in Moscow during the session of the Russian-British Intergovernmental Steering Committee (ISC) for Trade and Investment.
Human Genome Sciences and GlaxoSmithKline announce vote of FDA advisory committee to recommend approval of Benlysta® for systemic lupus erythematosus
Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 2 to recommend that the FDA approve BENLYSTA® (belimumab) for the treatment of autoantibody-positive patients with active systemic lupus erythematosus (SLE).
New study findings show no benefit of prescription omega-3 fatty acids in prevention of recurrent symptomatic atrial fibrillation in affected patients
Findings from a new study show, compared to placebo, treatment with high-dose prescription omega-3 fatty acids did not reduce the recurrence of symptomatic atrial fibrillation (AF) among patients with symptomatic paroxysmal AF or persistent AF who have no evidence of substantial structural heart disease. The study was presented today at the American Heart Association’s Scientific Sessions and also published online in The Journal of the American Medical Association.
GlaxoSmithKline and Fiocruz extend innovative collaboration to research and develop new medicines for neglected tropical diseases
GlaxoSmithKline and the Oswald Cruz Foundation (Fiocruz) have today announced a unique collaboration to research and develop new and innovative medicines to treat diseases which disproportionately affect people living in the world’s poorest countries.
GlaxoSmithKline receives approval in Japan for two medicines: Revolade and Xyzal
GlaxoSmithKline (GSK) announced that it has received approval in Japan from the Ministry of Health, Labour and Welfare for Revolade (eltrombopag) for the treatment of the blood disorder, chronic idiopathic thrombocytopenic purpura (ITP), and for Xyzal (levocetirizine dihydrochloride), the first new anti-histamine to be made available in Japan for eight years
GSK and Amicus Therapeutics enter exclusive worldwide agreement to develop and commercialise Amigal™ for Fabry disease
GlaxoSmithKline (GSK) and Amicus Therapeutics (Amicus) today announced a definitive agreement to develop and commercialise AmigalTM (migalastat HCl), currently in Phase 3 for the treatment of Fabry disease, a rare inherited disorder. Under the terms of the agreement, GSK will receive an exclusive worldwide license to develop, manufacture and commercialise migalastat HCl. Additionally, as part of the agreement, GSK and Amicus also intend to advance clinical studies exploring the co-administration of migalastat HCl with enzyme replacement therapy (ERT) for the treatment of Fabry disease.
GSK completes previously reported settlement with U.S. Department of Justice regarding former manufacturing plant
GlaxoSmithKline today announced that it has finalized a previously reported agreement in principle with the U.S. Attorney’s Office for the District of Massachusetts and the U.S. Department of Justice (DOJ) with respect to the investigation of the company’s former manufacturing facility in Cidra, Puerto Rico.
GSK outlines approach to delivering advances in the treatment of rare diseases
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
GlaxoSmithKline PLC (GSK), Fondazione Telethon and Fondazione San Raffaele today announced a new strategic alliance to research and develop novel treatments to address rare genetic disorders, using gene therapy carried out on stem cells taken from the patient’s bone marrow (ex vivo). The alliance capitalises on research performed at the San Raffaele Telethon Institute for Gene Therapy (HSR-TIGET), a joint venture between Fondazione Telethon and Fondazione San Raffaele established since 1995
GSK increases support for WHO strategy to improve children’s health with new 5-year commitment to expand donations of albendazole medicine
At the launch of the World Health Organization’s (WHO) first report on Neglected Tropical Diseases today, GSK announced a new five year commitment to expand the donation of its medicine albendazole to treat children at risk of intestinal worms, known as soil-transmitted helminths (STH).
GSK takes minority stake in newly formed Convergence Pharmaceuticals
GlaxoSmithKline plc (GSK) today announced that it has taken an 18% minority equity stake in Convergence Pharmaceuticals Limited, a new biotechnology company that will focus on the development of new analgesic compounds. Convergence Pharmaceuticals, which was officially launched today, recently raised around $35.4 million in Series A financing from a syndicate of leading European and US life science investors.
GSK provides update on Herpevac trial for women evaluating Simplirix™ (Herpes Simplex Vaccine)
GlaxoSmithKline (GSK) has made the decision not to pursue further worldwide development of Simplirix™ (Herpes Simplex Vaccine), an experimental vaccine intended to prevent genital herpes disease in women
GlaxoSmithKline receives EU approval for a new therapeutic indication for Arixtra® (fondaparinux)
GlaxoSmithKline (GSK) confirmed today that the European Commission (EC) has granted an amendment of their marketing authorisation for their anti-clotting agent (antithrombotic) Arixtra® (fondaparinux) in the European Union for a new therapeutic indication. Fondaparinux 1.5 and 2.5 mg is now indicated for thetreatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis. It is the only anti-clotting agent to have this indication.
GSK regulatory update on Avandia following EMA and FDA reviews
GlaxoSmithKline (GSK) confirms that following a review of Avandia® (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), each agency has today announced their individual regulatory decisions and the resulting actions.
GSK EU regulatory update on Pandemrix™
GlaxoSmithKline (GSK) today confirmed that on behalf of the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) has concluded that the available data are insufficient to demonstrate a causal relationship between Pandemrix and the observed cases of narcolepsy. The CHMP has further concluded that any temporary restriction on the use of Pandemrix is not considered warranted
GSK and Theravance announce combination ICS/LABA Phase II results in the Relovair™ development programme
Additional data presentations for fluticasone furoate and vilanterol trifenatate support the potential of developmental combination treatment, Relovair, in COPD and asthma
GlaxoSmithKline and Genmab refocus development programme for ofatumumab in autoimmune indications
Following the 1st July announcement by GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) of an amendment to the collaborative agreement for ofatumumab in which GSK assumed development responsibility for autoimmune indications, GSK and Genmab announced today plans to refocus the development programme of ofatumumab in autoimmune indications. After review of the programme’s full development strategy, GSK will focus development efforts on the subcutaneous delivery of ofatumumab in autoimmune indications and will stop further development work on the intravenous route of administration in autoimmune disease.
Three-year results from ECLIPSE study indicate that COPD patients may require prevention strategies to manage exacerbations, regardless of disease severity
Today the New England Journal of Medicine published results from ECLIPSE (Evaluation of COPD* Longitudinally to Identify Predictive Surrogate End-points), an extensive research programme sponsored by GlaxoSmithKline (GSK) designed to advance understanding of the underlying mechanisms of Chronic Obstructive Pulmonary Disease (COPD), a disease which accounts for 2.75 million deaths worldwide each year1, as well as define markers of disease progression
GSK and BJD collaborate on a new educational programme to reduce global burden of joint pain
The Bone and Joint Decade (BJD) international initiative and GlaxoSmithKline (GSK) today announced the launch of the LIBERATE™ joint pain management programme during the BJD’s World Conference in Lund, Sweden. The BJD, which is endorsed by the United Nation’s World Health Organisation, and GSK have partnered to develop the global programme that provides information on practical and clinically proven techniques that people can use to self-manage their joint pain.
Audio recording of meeting between GSK and Dr Nissen to discuss Avandia
Audio recording of meeting between GSK and Dr Nissen to discuss Avandia
GSK announces succession plan for Chief Financial Officer
GlaxoSmithKline plc (GSK) today announces that Julian Heslop is to retire as Chief Financial Officer and Executive Director of the company at the end of March 2011. He will be succeeded by Simon Dingemans who is appointed Chief Financial Officer designate and Executive Director effective 4 January 2011.
Galapagos reaches agreement to acquire GlaxoSmithKline research centre in Zagreb, Croatia
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
GlaxoSmithKline (GSK) and Lonza today announced that they have entered into a new agreement under which Lonza will support the ongoing development of GSK’s biopharmaceutical pipeline by supplying manufacturing capacity for five early stage monoclonal antibodies.
GlaxoSmithKline and Genmab announce start of ofatumumab Phase III combination study in non-Hodgkin’s lymphoma
GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today the start of a Phase III study in patients with indolent B-cell non-Hodgkin’s lymphoma (B-NHL) who did not respond to or progressed during, or within 6 months of a rituximab containing regimen. Under the terms of Genmab’s collaboration with GlaxoSmithKline (GSK), Genmab will receive a milestone payment of approximately DKK 116 million (approximately USD 20 million), triggered by the treatment of the first patient in the study
BBC Panorama – 6 September 2010: “A Risk Worth Taking?” Programme. GlaxoSmithKline Right of Reply Statement
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
GlaxoSmithKline today issued the following statement in anticipation of the BBC Panorama programme, 'A risk worth taking?' which is scheduled to be aired this evening.
GlaxoSmithKline responds to British Medical Journal article regarding Avandia® (rosiglitazone)
GlaxoSmithKline (GSK) continues to work in the best interest of diabetes patients who face this chronic and serious disease. Patients taking Avandia should speak with their doctor about their treatment and any questions they may have regarding their medicine.
Reports of narcolepsy in Europe following vaccination with Pandemrix™
GSK initially became aware of possible cases of narcolepsy following vaccination with the adjuvanted H1N1 pandemic vaccine Pandemrix through adverse event reports received by the Swedish Medical Products Agency, and subsequently via media reports in Finland.
GSK and Valeant announce new U.S. FDA PDUFA goal date for ezogabine
GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International (NYSE: VRX) announced today the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for ezogabine* to 30 November 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
GlaxoSmithKline confirmed today that the company has commenced the Phase III clinical trials programme of its candidate herpes zoster vaccine currently being developed for the prevention of shingles. The phase III clinical trials will study more than 30,000 patients globally and will evaluate the efficacy, safety and immunogenicity of the candidate vaccine.
GlaxoSmithKline and Human Genome Sciences announce FDA priority review designation for Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus
GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted a priority review designation to Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus (SLE). A priority review designation is granted to drugs that, if approved, offer major advances in treatment or provide a treatment where no adequate therapy exists. The FDA has assigned belimumab a Prescription Drug User Fee Act (PDUFA) target date of 9 December 2010.
GSK and Genmab announce topline results from the concluded pivotal trial of Arzerra (ofatumumab) in fludarabine and alemtuzumab refractory chronic lymphocytic leukemia
GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today top line results from the concluded pivotal trial of ofatumumab in patients with fludarabine and alemtuzumab refractory chronic lymphocytic leukemia (CLL).
Image of new antibiotic in action opens up new opportunities to combat antibacterial resistance
Detailed pictures have been published today showing how a new type of experimental antibiotic can kill bacteria already resistant to existing treatments.1 The findings could ultimately help scientists to develop new antibiotics to tackle the bacteria responsible for many hospital and community-acquired infections.
GSK exercises option on Anacor’s novel antibiotic for the treatment of gram-negative infections
GlaxoSmithKline PLC (GSK) and Anacor Pharmaceuticals today announced that GSK has exercised its option to obtain an exclusive licence to develop and commercialise GSK2251052 (GSK ‘052), formerly known as AN3365. GSK ‘052 is a novel, systemic antibiotic derived from Anacor’s boron chemistry platform.
GSK receives CHMP positive opinion for a new indication for Arixtra
GlaxoSmithKline (GSK) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Arixtra (fondaparinux),an anti-clotting drug (antithrombotic) for the treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis (SVT) of the lower limbs without concomitant deep-vein thrombosis.
GlaxoSmithKline statement in response to FDA announcement on TIDE trial
GlaxoSmithKline [NYSE: GSK] confirmed today that it will suspend enrollment of new patients in the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) clinical trial at the request of the U.S. Food and Drug Administration (FDA) pending FDA review of recommendations from its Advisory Committee meeting July 13-14. Patients already enrolled may continue in the trial.
GSK announces Q2 results for 2010
Q2 EPS before major restructuring* 2.6p (29.3p excluding pre-announced legal charge)
GlaxoSmithKline legal update
GlaxoSmithKline (GSK) today announces that it expects to record a legal charge for the second quarter of 2010 of £1.57billion ($2.36 billion) (equating to an after tax cost of £1.35 billion). The charge includes settlements, agreements in principle to settle, and other provisioning for long-standing legal cases.
GlaxoSmithKline statement in response to FDA Advisory Committees’ vote on safety of Avandia® (rosiglitazone)
GlaxoSmithKline [NYSE: GSK] confirmed today that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow Avandia to remain on the market. Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions (20) to withdrawal from the U.S. market (12).
GlaxoSmithKline (GSK) responds to Senate Finance Committee letter of 12 July to FDA
The Senate Finance Committee (SFC) has released a small subset of the 14 million pages of documents provided to plaintiffs' counsel in the product liability litigation. They include drafts and other documents taken out of context, which therefore are incomplete and misleading. The documents do not offer new clinically relevant scientific information, and do not provide the full extent of GSK’s studies and evaluation of Avandia. GSK has been diligent in providing its safety data on Avandia to the FDA and in publishing its clinical trial data in peer-reviewed journals or on its clinical trial website.
Data support Avandia (rosiglitazone maleate) cardiovascular safety profile
The U.S. Food and Drug Administration (FDA) today posted a comprehensive review conducted by GlaxoSmithKline (GSK) of the cardiovascular safety data on Avandia® (rosiglitazone maleate). GSK’s review supports the overall positive benefit-risk profile of rosiglitazone as an important medicine for patients with type 2 diabetes.
GSK EU regulatory update on Avandia (rosiglitazone)
GlaxoSmithKline (GSK) today confirmed that on behalf of the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (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
GlaxoSmithKline (GSK) and the Singapore Economic Development Board (EDB), the government agency responsible for economic growth and development, today jointly awarded funding for eight research projects based in Singapore aimed at growing local capabilities and talent in green and sustainable manufacturing.
GlaxoSmithKline creates a new operating unit dedicated to expanding access to medicines for people living in the world’s poorest countries
As part of its commitment to further transform the company’s approach to diseases that disproportionately affect the world’s poorest people, GlaxoSmithKline (GSK) today announced that it is creating a new operating unit dedicated to the Least Developed Countries (LDCs*).
GSK and Aptuit finalise agreement for Aptuit to acquire GSK’s research operations in Italy
Augments Aptuit’s global, integrated scientific and operational capabilities and preserves scientific expertise at the centre
GlaxoSmithKline and Genmab announce amendment to Ofatumumab agreement
GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today an amendment to the ofatumumab co-development and commercialisation agreement. Under the terms of the amendment, GSK will take responsibility for developing ofatumumab in autoimmune indications whilst continuing to jointly develop ofatumumab with Genmab in oncology indications
GlaxoSmithKline receives EU authorisation for a new therapeutic indication for Tyverb® (lapatinib)
GlaxoSmithKline (GSK) confirmed today that the European Commission (EC) has granted a variation to the conditional marketing authorisation for Tyverb® (lapatinib) in the European Union for a new therapeutic indication. Tyverb, in combination with an aromatase inhibitor, is indicated for the treatment of post-menopausal women with hormone receptor-positive, HER2 (ErbB2) over-expressing metastatic breast cancer and for whom chemotherapy is currently not intended. The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor.
GlaxoSmithKline enters agreement with Medivir for exclusive rights to cold sore treatment Xerclear™
GlaxoSmithKline (GSK) and Medivir (STO: MVIR-B) today announced an exclusive agreement for the commercialisation of cold sore treatment, Xerclear™ (acyclovir and hydrocortisone) for non-prescription use (OTC) in key global markets. Xerclear is the first and only topical herpes labialis (cold sores) treatment clinically proven to help prevent cold sore lesions appearing.[i]
GlaxoSmithKline receives conditional marketing authorisation in the EU for Votrient® (pazopanib)
GlaxoSmithKline (GSK) confirmed today that the European Commission (EC) has granted a conditional marketing authorisation for Votrient® (pazopanib) for the first-line treatment of advanced Renal Cell Carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. 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
Administration (FDA) has approved Jalyn, a single-capsule combination of dutasteride (0.5 mg) and tamsulosin (0.4 mg) to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. 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. In a clinical study of nearly 5,000 men, co-administration of these two medicines significantly improved symptoms of BPH compared to either medicine taken alone. GSK expects to make the product available during the second half of 2010.
GlaxoSmithKline Receives Complete Response from FDA for Candidate Meningococcal and Hib Combination Vaccine
GlaxoSmithKline [NYSE:GSK] announced today that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for the candidate meningococcal and Hib combination vaccine, MenHibrix® (Hib-MenCY). The proposed indication for this combination vaccine is immunization of infants and toddlers against meningococcal serogroups C & Y, and Haemophilus influenzae type b (Hib) diseases at two, four, six and 12-15 months of age. 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
GlaxoSmithKline plc (GSK) today announced that it has acquired Laboratorios Phoenix S.A.C.yF (‘Phoenix’), a leading Argentine pharmaceutical business, for a cash consideration of approximately $253 million. Under the terms of the transaction, GSK will gain full ownership of Phoenix in a move to accelerate sales growth and further extend its pharmaceutical portfolio in Argentina and the Latin America region.
Regulatory update – BLA filed for Benlysta® (belimumab)
GlaxoSmithKline PLC (GSK) announced today that Human Genome Sciences, Inc. (HGS) has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), for Benlysta (belimumab) for reducing disease activity in adult patients with autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standardtherapy. Benlysta is being developed by GSK and HGS under a co-development and commercialisation agreement entered into in 2006.
Regulatory update - Benlysta® (belimumab)
GlaxoSmithKline PLC (GSK) announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), for Benlysta (belimumab) for reducing disease activity in adult patients with autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standardtherapy. The submission was made in collaboration with Human Genome Sciences, Inc (HGS). Benlysta is being developed by GSK and HGS under a co-development and commercialisation agreement entered into in 2006.
GSK announces revised product labels for Serevent and Advair
GlaxoSmithKline [NYSE:GSK] today announced that it has received a letter from the U.S. Food and Drug Administration directing revisions to product labeling for its respiratory products Serevent® and Advair®. The letter concludes discussions between GSK and the agency following FDA advisory committee meetings regarding the safety profile of long-acting beta2-agonists in the treatment of asthma, including salmeterol, the active ingredient in Serevent and one of the active ingredients in Advair. 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)
GlaxoSmithKline (GSK) today confirmed that following a meeting of the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency (EMA) has maintained its position that there is no evidence that the presence of porcine circovirus (PCV) in Rotarix™ presents a risk to public health and that there is no need to restrict its use in the European Union. This announcement is in line with the assessment of the US Food and Drug Administration earlier this month which stated that the benefits of the rotavirus vaccines are substantial, and include prevention of death in some parts of the world and hospitalisation for severe rotavirus disease in the United States.
Viani (Seretide): German patent litigation update
GlaxoSmithKline (GSK) today confirmed that the Federal Patents Court in Munich, Germany, has ruled in patent litigation regarding GSK’s product Viani, an inhaled respiratory treatment for asthma and COPD. The Court ruled in favour of the claimants Mylan dura GmbH, Hexal AG, Neolab Ltd., and IVAX International B.V. in deciding that under German law GSK’s German combination patent for Viani (relating to the combination of the active ingredients salmeterol and fluticasone propionate) was not valid
New research identifies promising leads to follow in search for medicines to fight malaria
New research conducted by GlaxoSmithKline (GSK) was today published in Nature1 identifying promising potential leads to develop new medicines to treat malaria. The research comes from a year-long screening of more than 2 million compounds in GSK’s chemical library to seek out those that could inhibit the malaria parasite, P. falciparum, and reports on an analysis of the more than 13,500 compounds, or hits, that showed greatest activity
FDA says Healthcare Providers can resume use of Rotarix (Rotavirus Vaccine, Live, Oral)
GlaxoSmithKline (NYSE: GSK) announced that the Food and Drug Administration (FDA) has determined that U.S. healthcare practitioners can resume the use of Rotarix® (Rotavirus Vaccine, Live, Oral), effective immediately. This action supersedes theFDA’s recommendation from March 22, 2010 and reflects the agency’s assessment that the presence of porcine circovirus type 1 (PCV-1) in the vaccine poses no safety risk.
Patrick Vallance appointed to GSK executive leadership team
GlaxoSmithKline (GSK) today announced the appointment of Patrick Vallance, as Senior Vice President, Medicines Discovery and Development and as a member of the company’s Corporate Executive Team both with effect from 1st July 2010.
GSK extends presence in Asia with new strategic alliance in South Korea
GlaxoSmithKline (GSK) today entered into a strategic alliance with Dong-A Pharmaceuticals Co., Ltd. (Dong-A), the number one pharmaceutical and OTC Company in South Korea. As part of the transaction, GSK will acquire a 9.9 percent minority equity shareholding in Dong-A for £73.9m (KRW 142.9bn).
GSK Statement on FDA Advisory Committee meeting on Rotavirus vaccines
GlaxoSmithKline (NYSE: GSK) today participated in a U.S. Food and Drug Administration (FDA) advisory committee meeting convened to discuss recent findings of porcine circovirus (PCV) in rotavirus vaccines. Although the committee did not issue any formal recommendations, members widely acknowledged that the benefits of vaccinating infants worldwide against rotavirus disease clearly outweigh the theoretical risks associated with the presence of porcine circovirus type 1 (PCV-1) in the vaccines.
GSK announces Q1 results for 2010
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
GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) and today announced topline secondary endpoints from BLISS-76, the second of two pivotal Phase 3 trials of Benlysta™ (belimumab) in seropositive patients with systemic lupus erythematosus (SLE). Benlysta 10 mg/kg already met its primary efficacy endpoint at Week 52 in both BLISS-52 and BLISS-76, as announced in July and November 2009.
GlaxoSmithKline receives conditional marketing authorisation in the EU for Arzerra® (ofatumumab)
GlaxoSmithKline (GSK) and Genmab AS confirmed today that the European Commission (EC) has granted a conditional marketing authorisation for Arzerra® (ofatumumab) for the treatment of refractory chronic lymphocytic leukaemia (CLL). Ofatumumab is indicated for the treatment of CLL in patients who are refractory (have not responded) to fludarabine and alemtuzumab. Fludarabine and alemtuzumab are standard therapies currently used to treat CLL.
GSK and Isis Pharmaceuticals collaborate on RNA therapeutics for rare and infectious diseases
GSK has right to license and commercialise compounds at clinical proof-of-concept
GSK receives European approval for Duodart®
The first fixed dose combination medicine for benign prostatic hyperplasia
GSK regulatory update – Avodart (dutasteride)
GlaxoSmithKline (GSK) announced today that it has re-submitted the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease to the US Food and Drug Administration (FDA).
Updated GlaxoSmithKline statement on European regulatory guidance relating to manufacture of Rotarix (rotavirus vaccine)
GlaxoSmithKline (GSK) today confirmed that the European Medicines Agency (EMA) has maintained its position that it “sees no safety concerns with the Rotarix oral vaccine” and healthcare practitioners in the European Union should continue to use Rotarix™ as indicated. This follows a meeting of the Committee for Medicinal Products for Human Use (CHMP) held on 25th March 2010 to further review all available data relating to the presence of material from PCV-1 in the vaccine. Having done so, the CHMP has reconfirmed its position which is in line with previous communications by WHO, FDA, other national regulatory agencies as well as GSK that the presence of the material does not present a safety risk.
GlaxoSmithKline update: Government orders for pandemic H1N1 vaccine
GlaxoSmithKline has been working closely with governments around the world to respond to their pandemic needs since the start of the H1N1 pandemic. We recognise that pandemics are unpredictable and that government needs and plans have evolved as understanding of the H1N1 pandemic has increased. We are committed to working with them to respond their needs as the pandemic evolves and find appropriate and fair solutions.
GSK joins global vaccine alliance to help prevent millions of children from contracting pneumococcal disease in the world’s poorest countries
Unique finance mechanism ensures vaccinations will begin in 2010 - Up to 300 million doses to be supplied over ten years - Synflorix™ supplied at around 90% reduction of cost in developed markets
GSK announces succession plan for leadership of Consumer Healthcare business
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)
GlaxoSmithKline (GSK) today confirmed that it has notified regulatory authorities of the presence of material from a virus called PCV-1 in its oral rotavirus vaccine, Rotarix™. PCV-1 does not multiply in humans and is not known to cause illness in humans.1, 2. It is found in everyday meat products and is frequently eaten with no resulting disease or illness.
GlaxoSmithKline announces Swiss approval of Duodart®
The first fixed dose combination medicine for benign prostatic hyperplasia
GlaxoSmithKline commences Relovair Phase III asthma programme
GlaxoSmithKline (GSK) announced today that the first asthma patient has commenced treatment with Relovair™ (fluticasone furoate/vilanterol trifenatate) in an asthma exacerbation study, marking the start of the Phase III clinical development programme with this once daily therapy, for this serious and chronic disease.
GSK publishes 2009 Corporate Responsibility Report
In its 2009 Corporate Responsibility Report published online today, GSK reiterated its commitment to running its business responsibly and to making the company more responsive, more flexible and more open to the expectations of society
GlaxoSmithKline receives marketing authorisation in the EU for Revolade® (eltrombopag)
GlaxoSmithKline (GSK) confirmed today that the European Commission (EC) has granted marketing authorisation for Revolade ® (eltrombopag) for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP). Eltrombopag is indicated for adult chronic ITP splenectomised patients who are refractory (have not responded) to other treatments, such as corticosteroids and immunoglobulins. Eltrombopag may also be considered as second-line treatment for adult non‑splenectomised patients where surgery is contraindicated.
GSK commences succession plan for management of vaccines business
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
GlaxoSmithKline (GSK) CEO Andrew Witty today dedicated a new production facility at its Nashik site in India to the manufacture of albendazole, part of a combination treatment used within the World Health Organization’s (WHO) Global Programme to Eliminate Lymphatic Filariasis (LF).
GlaxoSmithKline responds to US Senate Committee on Finance report on Avandia
Today, GlaxoSmithKline (GSK) responded to the recently released Senate Committee on Finance’s January 2010 “Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia” (the “Staff Report”) by releasing a White Paper. To view GSK’s response, visit http://www.gsk.com/media/downloads/GSK-White-Paper-Avandia-23-Feb-2010.pdf
GSK rejects conclusions of Senate Committee on Finance Staff Report on Avandia
The Staff Report of the Senate Committee on Finance draws conclusions on the safety of Avandia (rosiglitazone) that are based on analyses that are not consistent with the rigorous scientific evidence supporting the safety of the drug. In addition, the report cherry-picks information from documents, which mischaracterizes GlaxoSmithKline’s comprehensive efforts to research Avandia and communicate those findings to regulators, physicians and patients. In fact, the safety and effectiveness of Avandia is well characterized in the label approved by the FDA.
GSK rejects conclusions reported in The New York Times story on Avandia
GlaxoSmithKline (GSK) rejects the conclusions about the safety of Avandia (rosiglitazone) reported in the February 20, 2010, New York Times story.
GSK receives positive opinions in Europe for Tyverb® (lapatinib) and Votrient™ (pazopanib)
GlaxoSmithKline (GSK) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (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
GlaxoSmithKline is reviewing label changes proposed today by the US Food and Drug Administration (FDA) for asthma medications containing long-acting beta-agonists (LABAs), such as GSK’s Advair (salmeterol / fluticasone propionate). GSK and makers of the other affected medicines containing LABAs have 30 days to agree with the proposed changes or state why they are not warranted.
GSK Consumer Healthcare warns consumers of potential health risks associated with long-term excessive use of zinc-containing denture adhesives
Because the safety and health of our consumers is our primary concern, GlaxoSmithKline (GSK) Consumer Healthcare is issuing a Consumer Advisory warning consumers about the potential health risks associated with long-term excessive use of zinc-containing denture adhesives.
GlaxoSmithKline and XenoPort receive FDA Complete Response letter for Horizant™ (GSK1838262/XP13512) for RLS
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) Wednesday received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Horizant™(gabapentin enacarbil) Extended-Release Tablets, an investigational non-dopaminergic treatment for moderate-to-severe primary Restless Legs Syndrome (RLS).
GSK launches new specialist unit to research and develop medicines for rare diseases
GSK today announces the formation of a new standalone unit specialising in the development and commercialisation of medicines for rare diseases.
GSK announces appointment of Philippe Fauchet as President of GSK Japan
GSK today announces the appointment of Philippe Fauchet as President of GSK Japan. Philippe will report to Marc Dunoyer, who takes the new role as Chairman of GSK Japan. Marc will continue to take overall leadership responsibility for GSK’s Pharmaceuticals business across the Asia Pacific/ Japan Region.
Results announcement for the fourth quarter 2009
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
GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using Tykerb® (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer.
Rotarix™ significantly reduced severe rotavirus gastroenteritis in African babies during their first year of life
The New England Journal of Medicine (NEJM) today published the first study demonstrating that Rotarix™, GlaxoSmithKline’s rotavirus vaccine, significantly prevented severe rotavirus gastroenteritis during the first year of life in African babies. In the study Rotarix prevented the disease in 61.2% of these infants. The study also showed that Rotarix. provided broad protection against diverse circulating rotavirus strains.
GSK announces ‘open innovation’ strategy to help deliver new and better medicines for people living in the world’s poorest countries
'Open Lab' established with $8m seed funding for new research
GSK contributes to Haiti relief efforts
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
GlaxoSmithKline(GSK) andChemoCentryx Inc. today announced that GSK has exercised its option to obtain an exclusive license for further development and worldwide commercialisation of Traficet-EN™ (CCX282-B), a specific CCR9 antagonist with the potential to offer a new approach for the treatment of inflammatory bowel diseases, including Crohn’s disease. The option also encompasses two further identified backup compounds and represents the first product licensing opportunity resulting from the original collaboration with ChemoCentryx through GSK’s Centre of Excellence for External Drug Discovery (CEEDD).
Revolade (eltrombopag) receives positive opinion in Europe for chronic immune thrombocytopenic purpura
GlaxoSmithKline (GSK) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Revolade (eltrombopag), for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP).
GlaxoSmithKline and NanoBio announce OTC licensing agreement for cold sore treatment
Next advance in the treatment of cold sores - Strengthens a key OTC franchise
GSK publishes speaking, consulting fees paid to US healthcare professionals
Company progresses commitments to increase transparency
GSK and Intercell form strategic alliance to develop and commercialise innovative needle-free patch-based vaccines
GlaxoSmithKline Biologicals SA (GSK) and Intercell today announced an agreement to form a strategic alliance to accelerate the development and commercialisation of needle-free, patch-based vaccines. The agreement will include Intercell’s candidate vaccine for travellers’ diarrhoea (TD) and an investigational single application pandemic influenza vaccine, as well as the use of the patch technology for other vaccines in GSK’s portfolio.
GSK study showed targeted therapy combination achieved 14 month overall survival in patients with advanced breast cancer
London UK, Philadelphia, PA – In a clinical study, women with an aggressive form of breast cancer experienced a median survival of 14 months when treated with an investigational combination of TYKERB® (lapatinib) plus HERCEPTIN® (trastuzumab). The results of the Phase III study in ErbB2-positive metastatic breast cancer were presented during the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium, held in San Antonio, Texas (Dec. 9 – 13).
Pre-Budget Report response - GSK comments on patent box
GlaxoSmithKline (GSK) welcomes the introduction of a new measure – the ‘patent box’ – 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
GlaxoSmithKline today announced initiation of the second large-scale Phase III clinical trial to evaluate long-term treatment with the investigational Lp-PLA2 inhibitor
GSK completes extension of strategic collaboration with Aspen
GSK announced that yesterday it completed the extension of its strategic relationship with Aspen Pharmacare Holdings Limited (Aspen) and the acquisition of a minority shareholding in the South African based pharmaceuticals company. This is part of a wide ranging agreement which includes combining commercial activities in Sub-Saharan Africa and the divestment of several assets to Aspen
GSK Update: GSK’s Arepanrix™ H1N1 pandemic vaccine prequalified by the World Health Organization
First prequalification for an H1N1 pandemic vaccine
GlaxoSmithKline announced as Tier 3 Sponsor as London 2012 anti-doping plans confirmed
GSK becomes Laboratory Services Provider
Regulatory Update: GSK files Rotarix for prevention of rotavirus in Japan
GlaxoSmithKline (GSK) announced today that it has filed its vaccine for the prevention of rotavirus gastroenteritis (approved as Rotarix ® in a number of countries outside of Japan). The candidate vaccine, which is given orally, is the first to be filed for approval for the prevention of rotavirus gastroenteritis in infants in Japan. Rotavirus infection is the leading cause of severe acute gastroenteritis in infants.
GlaxoSmithKline and Gilead announce agreement to commercialise Viread® for chronic hepatitis B in key Asian countries
GlaxoSmithKline (GSK) and Gilead Sciences, Inc. (Nasdaq: GILD) today announced a licensing agreement to commercialise Viread® (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B (HBV) infection in adults in five countries in Asia. The companies’ combined commercialisation activities will expand access to tenofovir for the treatment of HBV, once approved, to patients
Pandemic 2009 Influenza Update: Pandemrix™ data in children and adolescents from 3 to 17 years of age
GlaxoSmithKline (GSK) today announced that over 40 million doses of its adjuvanted pandemic H1N1 vaccine have been distributed to countries globally for use in government-initiated vaccination programmes. GSK also announced new results from the clinical trial assessing the use of Pandemrix™ in children and adolescents aged 3 to 17 years of age. The trial, which is ongoing, shows that after the first dose of adjuvanted vaccine, a strong immune response was demonstrated in all age groups. The immune response elicited by Pandemrix exceeded the immunogenicity criteria, as defined by international licensing authorities for a pandemic influenza vaccine. All study participants in this trial received 3.75 micrograms of GSK’s adjuvanted H1N1 vaccine which is equivalent to the full adult dose.
GSK Regulatory Update: Avodart
GlaxoSmithKline (GSK) announced today that in order to provide an update to the application, the company is withdrawing its US Supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease. GSK expects to resubmit the file shortly. This action is not the result of new findings related to safety or efficacy
GSK and Nabi announce agreement for NicVAX®, a vaccine for nicotine addiction
GlaxoSmithKline Biologicals SA (GSK) and Nabi Biopharmaceuticals (Nabi) today announcedan exclusive worldwide option and licensing agreement for a nicotine conjugate candidate vaccine (NicVAX®), an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse, as well as for the development of a second generation nicotine vaccine
GSK signs agreement with the WHO to donate 50 million doses of pandemic H1N1 vaccine for distribution to developing countries
GlaxoSmithKline (GSK) today announced that it has signed an agreement with the World Health Organization (WHO) to donate 50 million doses of its adjuvanted pandemic H1N1 influenza vaccine to WHO for distribution to developing countries most in need. GSK is working with WHO and health authorities to prepare for initial shipments of the vaccine to developing countries by the end of November.
Pandemic 2009 Influenza Update: US FDA approves GSK’s pandemic H1N1 vaccine
GlaxoSmithKline (GSK) today announced that the US Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for its unadjuvanted influenza A (H1N1) pandemic vaccine. The approval of the sBLA, which was filed as a strain change supplement to GSK’s FluLaval seasonal flu vaccine, allows the company to manufacture a flu vaccine for use in adults to prevent influenza caused by the 2009 pandemic H1N1 influenza A strain.
Pandemic 2009 Influenza Update: Pandemrix™ data on co-administration with annual seasonal influenza vaccine (Fluarix®)
GlaxoSmithKline (GSK) today announced the results from the clinical trial assessing Pandemrix™, GSK’s adjuvanted H1N1 pandemic influenza vaccine, administered at the same time as the annual seasonal influenza vaccine, Fluarix ® . The trial showed that co-administration of one dose of both vaccines in separate arms, induced a strong response in adults for both the H1N1 pandemic vaccine as well as the seasonal vaccine. The trial involves 168 adults aged over 60 years of age, and was designed to evaluate the tolerability and immunogenicity of the co-administration of Pandemrix and Fluarix.
GlaxoSmithKline and XenoPort announce extension of GSK1838262 (XP13512) FDA review date to 9 February 2010
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) today announced that the U.S. Food and Drug Administration (FDA) has extended the original Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for GSK1838262/XP13512 (gabapentin enacarbil) to February 9, 2010. The NDA currently under review by FDA is for the treatment for moderate-to-severe primary Restless Legs Syndrome (RLS). The original PDUFA date for this NDA review was November 9, 2009.
World Health Organization Grants Prequalification for Global Use to GSK’s 10-Valent Synflorix™ Vaccine
First prequalification for pneumococcal disease vaccine - a life-threatening disease affecting many children; follows first-ever World Pneumonia Day
World’s largest malaria vaccine trial now underway in seven African countries
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
CEO promises ‘relentless pursuit’ of new treatments
Retigabine Regulatory Update
GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International (VRX) announced today that, on 30 October, they filed a New Drug Application with the US Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMEA), for retigabine, used as adjunctive therapy to treat adult epilepsy patients with partial-onset seizures
GlaxoSmithKline and Human Genome Sciences announce positive results in second of two phase 3 trials of Benlysta in systemic lupus erythematosus
Benlysta (belimumab) 10 mg/kg plus standard of care met its primary efficacy endpoint by achieving a statistically significant improvement in patient response rate versus placebo plus standard of care at Week 52 in BLISS-76
Results announcement for the third quarter 2009
See the quarterly results page for more information.
Pandemic 2009 Influenza Update: Pandemrix™ data in an elderly population
GlaxoSmithKline (GSK) today announced that this week, approximately half a million people will have received its pandemic H1N1 vaccine, Pandemrix™, as part of Government initiated vaccination programmes across Europe, which commenced earlier this month. GSK also announced new results from a clinical trial assessing the use of Pandemrix in adults aged 18 to 85 years of age. The trial, which is ongoing, shows that after the first dose of adjuvanted vaccine, a strong immune response was demonstrated, inclusive of the over 60 age group. The immune response elicited by Pandemrix in all age groups exceeded the immunogenicity criteria as defined by international licensing authorities for a pandemic influenza vaccine. The adjuvanted vaccine in this trial contains the dose of H1N1 antigen (3.75 µg) which is the EMEA approved final formulation
GlaxoSmithKline and Theravance commence Phase III Horizon programme to develop a next-generation treatment for COPD
GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the first patient has commenced treatment as part of the Phase III programme being undertaken to develop a next-generation combination treatment for patients with chronic obstructive pulmonary disorder (COPD), a leading cause of chronic illness and death.
GSK and Genmab receive accelerated approval for Arzerra™
Today, GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced the accelerated approval of Arzerra TM (ofatumumab) from the US Food and Drug Administration for use in patients with chronic lymphocytic leukemia (CLL) that is refractory to fludarabine and alemtuzumab.
Pandemic (H1N1) 2009 Influenza Update: Experience of GSK’s H1N1 adjuvanted vaccine, Pandemrix™, and preliminary paediatric results
GlaxoSmithKline (GSK) today announced that, to date, more than 150,000 people have received GSK's pandemic H1N1 vaccine, Pandemrix™, as part of Government initiated vaccination programmes across Europe which commenced last week. Additionally, over 2,000 people have received Pandemrix in clinical trials which are ongoing.
GlaxoSmithKline and Human Genome Sciences announce full presentation at ACR of positive phase 3 study results for Benlysta in systemic lupus erythematosus
Benlysta (belimumab) significantly reduced SLE disease activity, disease flare rates and fatigue; significantly delayed time-to-first SLE disease flare; reduced prednisone use and improved health-related patient quality of life in the BLISS-52 study
FDA approves GlaxoSmithKline’s Votrient™ for advanced renal cell cancer
GlaxoSmithKline [NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved Votrient™ (pazopanib) to treat patients with advanced renal cell carcinoma (RCC), a form of kidney cancer. Approximately 57,700 people in the U.S. will be diagnosed with kidney cancer this year, and 13,000 people will die from this disease.
FDA approves Cervarix, GlaxoSmithKline’s cervical cancer vaccine
GlaxoSmithKline (GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved Cervarix® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).
Pandemic (H1N1) 2009 Influenza Update: Results from second clinical trial of GSK’s H1N1 adjuvanted vaccine confirm immune response and tolerability
GlaxoSmithKline (GSK) today announced results from a second clinical trial of its pandemic (H1N1) adjuvanted vaccine, which demonstrate that one dose of the vaccine can provide a strong immune response which exceeds criteria as defined by international licensing authorities using the lowest dose of antigen available in pandemic vaccines. The data from GSK’s H1N1 trials announced to date demonstrate the vaccine is generally well tolerated. The vaccine in this trial contains 3.75 µg of H1N1 antigen, which is the EMEA approved final formulation
GSK’s Cervarix® becomes the first cervical cancer vaccine to gain approval in Japan
Landmark approval paves the way for access to the vaccine for women in Japan
GSK partners with UK Government and Wellcome Trust to stimulate innovation through the creation of a world-class science park
GlaxoSmithKline (NYSE: GSK) announced today the U.S. Food and Drug Administration (FDA) has not yet completed the review of the Biologics License Application (BLA) for CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant], the Company’s candidate cervical cancer vaccine. As a result of this, the review will continue beyond the September 29, 2009, action date
GlaxoSmithKline and Prosensa form alliance to fight Duchenne Muscular Dystrophy
GlaxoSmithKline plc (GSK) announced today that it has entered into a unique partnership with the UK Government, The Wellcome Trust and the East of England Development Agency (EEDA) to develop an innovative new biotechnology science park located at GSK’s site at Stevenage.
GSK’s Avodart® / tamsulosin combination showed benefits for men with prostate enlargement
GlaxoSmithKline (GSK) announced today that it has filed a supplemental New Drug Application (sNDA) for Avodart® (dutasteride) with the US Food and Drug Administration (FDA) for prostate cancer risk reduction among men at increased risk of developing the disease. EU filings also are underway via the European Mutual Recognition Variation Procedure, with Sweden acting as the Reference Member State.
GlaxoSmithKline and U.S. Patent and Trademark Office file a motion to dismiss litigation over Final Regulations
GlaxoSmithKline (GSK) and Prosensa, the Dutch based biopharmaceutical company focusing on RNA modulating therapeutics, today announced that they have entered into an exclusive worldwide collaboration for the development and commercialisation of RNA based therapeutics for Duchenne Muscular Dystrophy (DMD). DMD is a severely debilitating childhood neuromuscular disease that affects one in 3,500 newborn boys.
GlaxoSmithKline update: Government orders for pandemic (H1N1) 2009 vaccine
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
GlaxoSmithKline (GSK) and Jiangsu Walvax Biotech Company (Walvax) today announced a cooperation agreement to form a long-term Joint Venture (JV) to develop and manufacture paediatric vaccines for use in China. The JV will produce vaccines for measles, mumps, and rubella (MMR) (Priorix™) and potentially other paediatric vaccines. GSK will also transfer the technology to enable the JV to manufacture the vaccines locally over time.
Positive phase II results for GSK1838262 (XP13512) reported for subjects with post-herpetic neuralgia and a history of inadequate response to gabapentin
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) today announced top-line results from a Phase II clinical trial evaluating GSK1838262/XP13512 (gabapentin enacarbil) in adult patients with neuropathic pain associated with post-herpetic neuralgia (PHN) who have had a history of inadequate response to gabapentin doses of 1800 mg/day or higher. In this double-blind, two-period cross-over study, 3600 mg/day of GSK 1838262 demonstrated a statistically significant improvement over 1200 mg/day of GSK1838262 on the primary endpoint, which was the change from baseline to the end of the treatment period in the 24-hour average pain intensity score. A greater reduction in the 24-hour average pain score was observed for the 3600
GlaxoSmithKline receives unanimous FDA Panel approval recommendation for Votrient™
GlaxoSmithKline [NYSE: GSK] today announced that the United States Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously in support of the approval of Votrient™ (pazopanib). Specifically, the panel voted that the benefit-to-risk profile is acceptable for patients with advanced renal cell carcinoma (RCC). Pazopanib is an investigational, oral treatment for patients with advanced RCC.
Avodart (dutasteride) regulatory update
GlaxoSmithKline (GSK) announced today that it has filed a supplemental New Drug Application (sNDA) for Avodart® (dutasteride) with the US Food and Drug Administration (FDA) for prostate cancer risk reduction among men at increased risk of developing the disease. EU filings also are underway via the European Mutual Recognition Variation Procedure, with Sweden acting as the Reference Member State.
Pandemic (H1N1) 2009 Influenza Update: GSK’s H1N1 ‘Pandemrix’ vaccine receives European Commission Approval
GlaxoSmithKline (GSK) confirmed today that the European Commission has granted marketing authorisation of GSK’s pandemic (H1N1) adjuvanted vaccine Pandemrix™ for protection against pandemic H1N1 2009 influenza.
GlaxoSmithKline update on FDA review of Cervarix
GlaxoSmithKline (NYSE: GSK) announced today the U.S. Food and Drug Administration (FDA) has not yet completed the review of the Biologics License Application (BLA) for CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant], the Company’s candidate cervical cancer vaccine. As a result of this, the review will continue beyond the September 29, 2009, action date
Fatality reported in UK HPV vaccine immunisation programme
GSK was notified by the UK’s Department of Health on Monday 28 September of the death of a 14 year old girl, Natalie Morton, who was vaccinated at a school in Coventry with GSK’s cervical cancer vaccine, Cervarix, as part of the national HPV immunisation programme.
GSK provides update on regulatory filings for Zunrisa/Rezonic
GlaxoSmithKline (GSK) has made the difficult decision to discontinue the regulatory filings for Zunrisa/Rezonic (casopitant), which was being developed for chemotherapy-induced and post-operative nausea and vomiting. Regulatory applications were filed in a number of countries worldwide and GSK is currently communicating with those authorities and all study investigators.
GSK and UPCH to launch Lucozade across China
GlaxoSmithKline (GSK) today announced an exclusive agreement with President (Shanghai) Trading Co. Ltd, a wholly-owned trading arm of Uni-President China Holdings Ltd (UPCH), one of the leading food and beverage companies in China, to launch GSK's highly successful Lucozade drinks franchise across China. GSK and UPCH are also in the early stages of discussions on a range of additional opportunities.
Pandemic (H1N1) 2009 Influenza Update: GSK’s H1N1 ‘Pandemrix’ vaccine receives positive opinion from European Regulators
GlaxoSmithKline (GSK) announced today that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion and recommends approval of GSK’s candidate pandemic (H1N1) adjuvanted vaccine Pandemrix™.
Pandemic (H1N1) 2009 Influenza Update: Initial results from first clinical trial of GSK’s H1N1 adjuvanted vaccine
GlaxoSmithKline (GSK) today announced results from its first clinical trial assessing use of its pandemic (H1N1) adjuvanted vaccine. The results demonstrate that after one dose the candidate vaccine can provide a strong immune response which exceeds the immunogenicity criteria as defined by international licensing authorities for a pandemic influenza 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
Shionogi-GlaxoSmithKline Pharmaceuticals, LLC announced today results from a Phase 1-2a study evaluating the pharmacokinetics (PK), safety and antiviral activity of its investigational integrase inhibitor (INI) S/GSK1265744 in healthy subjects and HIV-infected patients. The data showed a significant decline in viral load in HIV-infected patients, as well as favorable pharmacokinetic and short-term safety profiles in healthy subjects and HIV-infected patients. The results of this study were presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)held this week in San Francisco, California.
FDA Advisory Committee makes favorable recommendation for Cervarix, GlaxoSmithKline’s candidate cervical cancer vaccine
GSK announced today that the US FDA's Vaccines and Related Biological Products Advisory Committee voted that clinical data support both the efficacy and safety of Cervarix®, the company’s candidate cervical cancer vaccine (12-1 and 11-1, respectively).
GSK and Brazil’s Fiocruz form partnership for new R&D effort and increased vaccine access
GlaxoSmithKline plc (GSK) announced today that it has launched a unique partnership with Brazil’s Oswaldo Cruz Foundation (Fiocruz) to develop and manufacture vaccines for pressing public health priorities in Brazil. The agreement will establish a new research and development collaboration programme at Fiocruz to develop a vaccine for dengue fever, a mosquito-borne disease that globally places 2.5 billion people at risk of infection[i].
GlaxoSmithKline and Genmab announce results from a study of Arzerra in rituximab refractory follicular NHL
GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today top-line results from an international multi-center study of Arzerra™ (ofatumumab) in rituximab refractory follicular non-Hodgkin’s lymphoma (NHL).
Pandemic (H1N1) 2009 influenza update
GSK today issued an update on its progress to develop a vaccine against the Pandemic (H1N1) 2009 influenza virus, and announced that it has commenced the clinical development programme for its adjuvanted pandemic vaccine. Enrolment into this first study has been completed.
Shionogi-GlaxoSmithKline Pharmaceuticals acknowledges position of the European AIDS Treatment Group and the AIDS Treatment Activists Coalition to revise protocol for ING112276, a clinical study for S/GSK1349572
Shionogi-GlaxoSmithKline Pharmaceuticals, LLC, in collaboration with the European AIDS Treatment Group (EATG) and the Drug Development Committee (DDC) of the AIDS Treatment Activists Coalition (ATAC), today announces plans to revise inclusion criteria for Study ING112276. The ING112276 study is a dose-ranging study of the investigational integrase inhibitor S/GSK1349572 in antiretroviral therapy-naïve patients.
GlaxoSmithKline and Genmab announce top-line results for ofatumumab in rheumatoid arthritis
GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today preliminary top-line results from a Phase III study of ofatumumab administered intravenously for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to methotrexate. The study met the primary endpoint, ACR20 at 24 weeks, which indicates a 20 percent or greater improvement in the number of swollen and tender joints, as well as improvements in other disease-activity measures.
Regulatory update: mepolizumab for the treatment of hypereosinophilic syndrome (HES)
GSK today announced that it has notified the European Medicines Agency of its decision to withdraw the Marketing Authorisation Application (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)
Amgen to retain full rights for denosumab in the United States and Canada and for oncology indications in Europe.
GlaxoSmithKline completes acquisition of Stiefel
GSK creates new world-leading specialist dermatology business with revenues of approximately $1.5 billion
Results announcement for the second quarter 2009
See the quarterly results page for more information
GSK and Enigma Diagnostics announce commercial partnership to develop point-of-care influenza diagnostics
GlaxoSmithKline (GSK) and Enigma Diagnostics Limited today announced that they have signed worldwide agreements to develop and supply the first point-of-care diagnostic influenza tests to identify specific influenza virus strains using its real-time Polymerase Chain Reaction (PCR) technology platform, the Enigma ML (Mini Laboratory).
Antiviral activity of S/GSK1349572, the only once-daily, unboosted integrase inhibitor in clinical development, evaluated in phase 2 study
Shionogi-GlaxoSmithKline Pharmaceuticals, LLC announced today results from a Phase 2a study evaluating antiviral activity of its investigational integrase inhibitor (INI), S/GSK1349572. The results of this study were presented at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention held this week in Cape Town, South Africa.
Human Genome Sciences and GlaxoSmithKline announce positive Phase 3 study results for Benlysta™ in systemic lupus erythematosus
Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced that Benlysta™ (belimumab, formerly LymphoStat-B®) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone. Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups.
GSK announces new commitments to fight HIV/AIDS in Sub-Saharan Africa - special focus on care and treatment of children
New 'Positive Action for Children’ Fund created with £50 million ($80 million) available over 10 years to help prevent mother-to-child transmission of HIV and to support orphans and vulnerable children
WHO grants prequalification to Cervarix®: GSK’s vaccine to help combat cervical cancer in developing nations
The World Health Organization (WHO) has awarded prequalification to Cervarix®, GlaxoSmithKline’s cervical cancer vaccine. The WHO decision is necessary for UN agencies and the GAVI Alliance to purchase the vaccine in partnership with developing countries and will help speed access to Cervarix globally.
Alnylam joins GSK in donating intellectual property to patent pool for neglected tropical diseases
First company to join the pool since creation in March 2009
Landmark study for GSK’s cervical cancer vaccine published in The Lancet
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
GlaxoSmithKline plc (GSK) today announced that it has acquired the branded generics business of Bristol Myers Squibb (BMS) in Lebanon, Jordan, Syria, Libya and Yemen for a cash consideration of $23.2m (£14.2m). The business comprises a portfolio of 13 branded pharmaceuticals with annual sales in 2008 of $11.8m. This purchase is another step forward in GSK’s strategy to accelerate growth in emerging markets and signals a strong commitment to provide quality medicines to patients in the Middle East and North Africa.
Seretide: Irish patent litigation update
GlaxoSmithKline (GSK) today announced that the Commercial Court in Dublin, Ireland, ruled in patent litigation regarding GSK’s product Seretide, an inhaled respiratory treatment for asthma and COPD.
GSK and Chroma Therapeutics form alliance to develop novel macrophage-targeted drugs
GlaxoSmithKline (LSE: GSK) and Chroma Therapeutics Limited announced today a collaboration to develop macrophage-targeted compounds using Chroma’s proprietary esterase-sensitive motif (ESM) technology, which adds amino acid esters to compounds with the aim of targeting the compounds to specific cells in the inflammatory disease process
Regulatory update for REZONIC™ (casopitant mesylate)
GlaxoSmithKline (NYSE: GSK) confirmed today that it has received a complete response letterfrom the FDA related to the application for casopitant
FDA extends review of Arzerra™ (ofatumumab)
GlaxoSmithKline and Genmab A/S today announced that the United States Food and Drug Administration (FDA) informed the companies that the agency has 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
GlaxoSmithKline plc (GSK) today announced an agreement with Dr. Reddy’s Laboratories Ltd (Dr. Reddy’s) to develop and market selected products across an extensive number of emerging markets, excluding India.
GlaxoSmithKline update: A (H1N1) influenza
WHO raises influenza pandemic alert to phase 6
GSK and Shenzhen Neptunus create new alliance to develop and manufacture influenza vaccines in China
GlaxoSmithKline plc (GSK) today announced it has entered into a definitive agreement to form a new Joint Venture with Shenzhen Neptunus Interlong Bio-Technique Co. Ltd (Shenzhen Neptunus) focused on developing and manufacturing influenza vaccines for the Chinese market.
Positive results with Revolade™ and Arzerra™ for difficult-to-treat blood disorders
GlaxoSmithKline (GSK) Oncology today announced further encouraging data for their investigational products Revolade™ (eltrombopag) and Arzerra™ (ofatumumab) at the 14th Congress of European Hematology meeting, organised by The European Hematology Association (EHA). The results demonstrate the potential of these drugs to improve patient outcomes and quality of life (QoL) in two haematological conditions.
Large, long-term study shows Avandia has no increased overall cardiovascular risk compared to other commonly used diabetes medicines
RECORD trial also demonstrates durable blood sugar control over time with Avandia
World Health Organization grants Global Prequalification to GSK’s Rotarix™ vaccine
Opens access to Asia and Africa – potential to save hundreds of thousands of lives
GSK and Concert Pharmaceuticals form alliance to develop novel deuterium-modified drugs
GlaxoSmithKline (NYSE: GSK) and Concert Pharmaceuticals announced today that they will collaborate to develop and commercialise deuterium-containing medicines. The deal includes three of Concert’s research and development programs; namely, CTP-518, a protease inhibitor for the treatment of HIV expected to enter Phase I clinical trials in the second half of 2009, a preclinical compound for chronic renal disease, and a third research product in Concert’s pipeline. Concert will also provide GSK with deuterium-modified versions of three GSK pipeline compounds for GSK to develop.
GSK’s Pazopanib significantly delayed tumor progression in patients with advanced kidney cancer
Today, GlaxoSmithKline announced the results of a Phase III study demonstrating that 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)
GlaxoSmithKline [NYSE: GSK] and Genmab A/S [OMX: GEN] today announced that the United States Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to three that the ARZERRA™ (ofatumumab) data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab. Ofatumumab is an investigational treatment.
US Department of Health and Human Services (HHS) purchases GSK’s A (H1N1) influenza antigen and proprietary adjuvant system
GSK announced today that the US Department of Health and Human Services (HHS) has placed initial orders for A (H1N1) influenza vaccine antigen and the company’s proprietary adjuvant system, AS03, to support its pandemic influenza preparation efforts.
GlaxoSmithKline update: A (H1N1) influenza vaccine development
GSK has received orders from several governments aiming to stockpile a new candidate A (H1N1) adjuvanted influenza vaccine as a precautionary measure
GSK extends strategic collaboration with Aspen
GSK to acquire 16% shareholding in Aspen in exchange for transfer of specialist products and manufacturing facility in Bad Oldesloe, Germany
Community healthcare charities receive £300,000 from GlaxoSmithKline in recognition of their work
Twenty local healthcare charities were formally acknowledged last night for their community-based work, as GlaxoSmithKline awards a total of £300,000 at the annual GlaxoSmithKline IMPACT Awards, run in partnership with the independent health charity, The King’s Fund.
GlaxoSmithKline to divest US rights for Wellbutrin XL® to Biovail for $510 million
GlaxoSmithKline plc (GSK) today announced that it has entered into an agreement to divest full commercial rights to Wellbutrin XL® in the United States to Biovail International Laboratories SRL, a subsidiary of Biovail Corporation (NYSE, TSX: BVF), for $510 million (£340 million). The agreement is subject to Hart-Scott-Rodino regulatory clearance in the United States.
GlaxoSmithKline update: influenza A (H1N1)
GlaxoSmithKline (GSK) is committed to supporting governments and health authorities around the world to respond to the emergence of the new influenza A (H1N1) strain.
Large, long-term study shows dutasteride reduced prostate cancer risk in men at increased risk of the disease
Primary endpoint achieved in REDUCE study as presented at American Urological Association
Emergence of a new H1N1 influenza A strain (swine influenza)
GlaxoSmithKline (GSK) is closely monitoring the situation regarding the emergence of a new influenza A (H1N1) strain in Mexico, the United States of America, Canada, France, Spain and New Zealand. The World Health Organization (WHO) has stated that the current situation constitutes a public health emergency of international concern and they have raised their level of influenza surveillance globally.
GlaxoSmithKline launches alli® (orlistat 60 mg)
GSK has today announced that alli – the 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
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
Creates a new focused HIV business with the independence and 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
GlaxoSmithKline (GSK) today announced the submission of two simultaneous regulatory applications to expand the use of Tyverb®/Tykerb® (lapatinib). If authorised, lapatinib could be used as a first-line therapy regimen combined with anti-hormonal therapy for patients with hormone-sensitive, metastatic (or advanced) breast cancer in Europe and the United States.
Synflorix™, GlaxoSmithKline’s pneumococcal vaccine, receives European authorisation
Protection now possible against three pneumococcal strains not covered by currently available vaccine
Cervarix® U.S. regulatory update
GlaxoSmithKline submits final study data to FDA for cervical cancer vaccine
GSK publishes 2008 Corporate Responsibility Report
Details on new proposals to tackle diseases of the developing world
GlaxoSmithKline announces sale of shares in Quest Diagnostics Inc.
GlaxoSmithKline plc (the “Group”) announces today that it has sold 5,749,157 shares of common stock, par value of $0.01 per share (the “Shares”), of Quest Diagnostics Inc. (“Quest”).
NICE refuses funding for advanced breast cancer treatment, Tyverb® (lapatinib)
NICE today issued its final appraisal determinationadvising against NHS funding for Tyverb® (lapatinib), a treatment for an aggressive form of advanced breast cancer (ErbB2-positive).1 Lapatinib (in combination with Xeloda® [capecitebine]) offers a new treatment option for women whose disease has returned despite treatment with standard chemotherapies and Herceptin® (trastuzumab).2 There are very few treatment options available for these women and lapatinib offers a chance of additional time without their disease progressing.3 Lapatinib is the only licensed ErbB2 targeted treatment* for these patients
GlaxoSmithKline submits European marketing authorisation application for Pazopanib in advanced kidney cancer
GlaxoSmithKline (GSK) today announced the submission of a Marketing Authorisation Application (MAA) tothe European Medicines Agency (EMEA) for pazopanib as an oral therapy for patients with advanced and/or metastatic renal cell carcinoma (RCC).
GSK initiates phase III programme for novel type 2 diabetes medication, Syncria® (albiglutide)
GlaxoSmithKline today announced initiation and dosing of the first patient of the Phase III clinical trial programme to evaluate the efficacy, safety and tolerability of the investigational GLP-1 (Glucagon-like peptide 1) agonist Syncria® (albiglutide) in men and women with type 2 diabetes. The Phase III programme will include more than 4,000 patients.
GlaxoSmithKline and Idenix Pharmaceuticals sign worldwide license agreement for IDX899, a novel NNRTI for the treatment of HIV
GlaxoSmithKline and Idenix Pharmaceuticals, Inc.today announced the execution of a license agreement granting GSK exclusive worldwide rights to IDX899. IDX899 is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI) in Phase II clinical development being developed by Idenix for the treatment of HIV/AIDS. New NNRTIs are needed to address the increasing prevalence of viral resistance and side effects associated with this drug class. To date, IDX899 has demonstrated high potency with low milligram doses, a high barrier to drug resistance, favourable risk/benefit profile, and the convenience of once-a-day administration.
GlaxoSmithKline and Genmab seek European marketing authorisation of Arzerra™ (ofatumumab) in advanced stage blood cancer
GlaxoSmithKline and Genmab A/S announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for Arzerra™ (ofatumumab) for the treatment of chronic lymphocytic leukaemia (CLL). If approved, ofatumumab would be indicated for the treatment of patients with CLL who have previously failed, or are inappropriate for, standard therapies. Ofatumumab targets a distinct binding site on the CD20 molecule of B-cells and it could become the first monoclonal antibody targeted to CD20 available for these patients. GSK and Genmab announced the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) on Friday 30 January 2009.
Results announcement for the fourth quarter 2008
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
Data increase confidence in the Horizon development programme
GlaxoSmithKline plc, announces board changes
GlaxoSmithKline plc (GSK) announces that Mr. James Murdoch has been appointed as a Non-Executive Director and will join the Board of the Company with effect from 20th May 2009. On appointment, James will also become a member of GSK’s Corporate Responsibility Committee. James is Chairman and Chief Executive of News Corporation Europe and Asia.
GlaxoSmithKline and Genmab submit Arzerra (Ofatumumab) application to FDA for the treatment of advanced stage blood cancer
GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Arzerra™(ofatumumab) to treat patients whose chronic lymphocytic leukaemia (CLL) is resistant (refractory) to previous therapies. If approved, ofatumumab would be the first anti-CD20 monoclonal antibody available for this patient population.
Deirdre Connelly to join GSK as President, North American Pharmaceuticals
GlaxoSmithKline (GSK) today announced that Deirdre Connelly will join the company as President, North American Pharmaceuticals, effective Monday 9 February 2009. She will report to Andrew Witty, Chief Executive Officer and become a member of GSK’s Corporate Executive Team
GSK announces charges for legal matters
GlaxoSmithKline plc (GSK) today announced that it will record a legal charge in the fourth quarter of 2008 of $400 million (£278 million) relating to an ongoing investigation initiated by the US Attorney’s Office in Colorado into the Group’s US marketing and promotional practices for several products for the period 1997 to 2004. This charge is in addition to legal charges for other matters to be taken in the fourth quarter.
The UK Government signs influenza pandemic contract with GlaxoSmithKline for Relenza®
The UK is now one of the world’s leading countries in stockpiling antivirals for treating infected individuals in the event of an influenza pandemic
GSK to drive growth in emerging markets with acquisition of UCB products
GlaxoSmithKline plc (GSK) today announced that it has signed an agreement with UCB S.A to acquire its current marketed product portfolio across certain territories in Africa, the Middle East, Asia Pacific and Latin America, for a cash consideration of €515 million (£483 million.)
GSK’s paediatric pneumococcal candidate vaccine Synflorix™ receives positive opinion in Europe
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)
A decision made by the European Commission today opens access to a treatment that could help people who are overweight and obese. GlaxoSmithKline (GSK) has received a non-prescription licence for alli (orlistat 60mg); the first time the European Commission has approved a non-prescription product for weight loss. The centrally approved marketing authorisation means GSK can now introduce alli for adults with a BMI of 28 kg/m2 or more, in all 27 EU member countries. Plans are underway to launch alli in the coming months.
GSK and Xenoport resubmit new drug application for Solzira™ in restless legs syndrome
GlaxoSmithKline and XenoPort, Inc. announced today that GSK has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira™ (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
GlaxoSmithKline and Archemix form strategic alliance to develop aptamers to treat inflammatory diseases
GlaxoSmithKline and Archemix Corp. today announced a worldwide strategic alliance to discover, develop and commercialise aptamer therapeutics to treat inflammatory diseases, such as rheumatoid arthritis and inflammatory bowel disease. Aptamers are synthetised oligonucleotides, or short nucleic acid sequences, that bind to proteins with high affinity and specificity.
GlaxoSmithKline to cease providing corporate political contributions
GlaxoSmithKline today announced a new global policy to voluntarily stop all corporate political contributions. In the past, GSK – in common with many companies and in full compliance with local laws – has made a number of corporate contributions in countries such as the US and Canada. GSK's new policy will ensure that no such contributions will be made in the future.
Two new studies in the New England Journal of Medicine show malaria vaccine candidate advancing in Africa
Results published online today in the New England Journal of Medicine revealed that the world’s most clinically advanced malaria vaccine candidate provides both infants and young children with significant protection against malaria. Two separate phase II trials reaffirmed earlier study results and support the ongoing efforts, pending regulatory approvals, to launch the phase III study of GlaxoSmithKline (GSK) Biologicals’ RTS,S/AS vaccine candidate across Africa.[1],[2]
GlaxoSmithKline extends tender offer for Genelabs Technologies, Inc.
GlaxoSmithKline [LSE/NYSE: GSK] announced today that it has extended its previously announced tender offer to purchase all of the outstanding shares of common stock of Genelabs Technologies, Inc. [Nasdaq: GNLB], for $1.30 in cash per share without interest and less any required withholding taxes, until 12:00 midnight EST on Friday, December 12, 2008, unless the tender offer is further extended. The tender offer was originally scheduled to expire at 12:00 midnight EST on Wednesday, December 10, 2008.
GSK and Neptunus sign cooperation agreement to form joint venture for the co-development of flu vaccines in China, Hong Kong and Macau
GlaxoSmithKline (GSK) today announced that it has signed an exclusive Cooperation Agreement with Shenzhen Neptunus Interlong Bio-Technique Co. Ltd. (NIBT) as a preliminary step in forming a Joint Venture (JV) between the two companies. The agreement outlines the proposed terms for establishing a JV company, which will seek to co-develop seasonal influenza vaccines and pre-pandemic/pandemic influenza vaccines, firstly targeting against strains of the virus specific to China, Hong Kong and Macau.
Cervarix, GSK’s cervical cancer vaccine, wins tender for Dutch national immunisation programme
GlaxoSmithKline’s (GSK) cervical cancer vaccine, Cervarix TM, was today confirmed by the Netherlands Vaccine Institute (NVI) as the cervical cancer vaccine for the Dutch National Immunisation Programme (NIP). GSK will supply Cervarixfor the programme, which aims to vaccinate all 12 year old girls. A catch-up programme for all girls aged 13 to 16 will also start within the first half of 2009, with the aim of reducing the risk of HPV infection and cervical cancer for a broader group of Dutch girls. The National programme for girls aged between 12 and 13 will commence in September 2009. It is estimated that more than 350,000 girls in total will be vaccinated with Cervarix in the first year.
GlaxoSmithKline and AFFiRiS sign an exclusive licence and option agreement for therapeutic Alzheimer’s disease candidate vaccines
GlaxoSmithKline Biologicals S.A. (GSK) and AFFiRiS GmbH announced today the execution of a collaboration agreement granting GSK exclusive rights to AFFiRiS’s Alzheimer’s disease vaccine programmes, aimed at treating Alzheimer’s by targeting beta-amyloid.
GlaxoSmithKline to acquire the leading dry mouth brand, Biotene
GlaxoSmithKline Consumer Healthcare announced today that it has reached an agreement with Laclede, a privately held company, to purchase the leading Dry Mouth brand Biotene® for $170 million. The transaction is subject to regulatory review by competition authorities in the United States and Europe, and is expected to complete by early 2009.
GSK’s Emerging Markets strategy advances with acquisition in Egypt
GlaxoSmithKline plc (GSK) today announced that it will acquire the Egyptian mature products business of Bristol Myers Squibb (BMS), for $210 (£125) million, in a move to accelerate sales growth and further extend its pharmaceutical portfolio in emerging markets.
GSK responds to NICE’s second technology appraisal consultation document on the use of Tyverb, in combination with capecitabine, for women with previously treated advanced or metastatic breast cancer
The draft recommendations announced today by NICE in the second technology appraisal consultation document (ACD) suggest that Tyverb (lapatinib) should not be used in the NHS, except in clinical trials.
LF Elimination programme treats over half billion people and protects millions more from debilitating disease
A study published today confirms that in the ten years since its initiation, the international effort to eliminate lymphatic filariasis (LF) has made unprecedented strides towards ridding the world of one of its most debilitating diseases. The study found that the LF elimination programme has prevented 6.6 million children from acquiring LF and stopped another 9.5 million people already infected with the disease from progressing to more debilitating stages. All of this is the result of the most rapid scale-up of a drug administration programme in public health history, delivering what the study calls the “best buy in public health”.
GSK update on FDA review of Promacta® (eltrombopag)
GlaxoSmithKline today announced that the United States Food and Drug Administration (FDA)continues to review the new drug application for Promacta® (eltrombopag) beyond the September 19, 2008 action date. GSK continues to work closely with the FDA towards the approval of Promacta in order to provide physicians and chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients with a novel, once-daily oral option.
GSK and Xenoport announce submission of new drug application requesting FDA approval of Solzira™ for Restless Legs Syndrome
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira™ (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS affects an estimated 12 million people in the United States and can result in distressing symptoms that disrupt sleep and significantly impact daily activities.
New data for GlaxoSmithKline’s pre-pandemic H5N1 influenza vaccine, Prepandrix™, show administration flexibility for pandemic planning
Results from two new clinical studies announced at the Third European Influenza Conference (ESWI) demonstrate that Prepandrix™, GlaxoSmithKline’s (GSK) H5N1 adjuvanted pre-pandemic influenza vaccine, confers broad cross-clade immunity that is maintained when the second dose is given many months after the first dose, and even if the second dose is formulated from a different H5N1 strain. Greater administration flexibility, adaptable to local pre-pandemic vaccination policies, could potentially reduce the impact on vital healthcare resources during the first intensive months of a pandemic.
Tyverb® demonstrates encouraging results in Phase II study in advanced head and neck cancer
Data on ESMO abstract #688O. Del Campo, et al. Effect of lapatinib monotherapy on apoptosis and proliferation: Results of a Phase II randomised study in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
ESMO 2008 - GlaxoSmithKline to present encouraging new data supporting late stage development programme
At the 33rd meeting of the European Society of Medical Oncology (ESMO) Stockholm, Sweden, GlaxoSmithKline (GSK) Oncology will present exciting new data for Tyverb® (lapatinib) and pazopanib. These new data form the foundation of Phase III development plans for these molecules across a variety of tumours including Head and Neck, Ovarian, Lung, and Soft Tissue Sarcoma.
GlaxoSmithKline and Cellzome announce major strategic alliance
GlaxoSmithKline and Cellzome Inc. announce the signing of a worldwide strategic alliance to discover, develop and market novel kinase-targeted therapeutics to treat inflammatory diseases.
GlaxoSmithKline and Valeant Pharmaceuticals announce worldwide collaboration agreement for retigabine
GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International (NYSE: VRX) today announced that they have entered into an exclusive worldwide collaboration agreement for the investigational drug retigabine, a first in class neuronal potassium channel opener for treatment of adult epilepsy patients with refractory partial onset seizures. Retigabine has shown robust efficacy and safety as demonstrated in two large, completed Phase III trials conducted in patients with refractory epilepsy receiving treatment with up to three antiepileptic drugs (AEDs). Valeant and GSK plan to file a New Drug Application in the US and a Marketing Authorisation Application in Europe by early 2009. The retigabine programme also includes an ongoing study in patients with post-herpetic neuralgia (PHN), a painful and common complication of shingles.
GlaxoSmithKline and the Harvard Stem Cell Institute announce a unique collaboration to enable the discovery of new medicines
GlaxoSmithKline (GSK) and the Harvard Stem Cell Institute (HSCI) today announced that they have entered into a five-year, $25 million-plus collaborative agreement to build a unique alliance in stem cell science, leading to the development of new medicines.
GSK enters transformational agreement with Aspen to drive growth in emerging markets
GlaxoSmithKline (GSK) today announced a transformational agreement to significantly extend its pharmaceutical portfolio in emerging markets. The licensing collaboration between GSK and South African based pharmaceuticals company, Aspen, and its joint venture partner, Strides Arcolab Ltd (Strides), signals a significant new strategy from GSK to accelerate sales growth in emerging markets
Results announcement for the second quarter 2008
GlaxoSmithKline (GSK) today announced a transformational agreement to significantly extend its pharmaceutical portfolio in emerging markets. The licensing collaboration between GSK and South African based pharmaceuticals company, Aspen, and its joint venture partner, Strides Arcolab Ltd (Strides), signals a significant new strategy from GSK to accelerate sales growth in emerging markets
GSK receives BITC CommunityMark for global community programmes
GlaxoSmithKline (GSK) today became one of the first companies to be awarded the new CommunityMark by the UK organisation Business in the Community (BITC)*. GSK was assessed alongside some the UK’s largest retailers, banks, and professional services firms and following a rigorous selection and review process becomes the only manufacturing company to receive the award.
GlaxoSmithKline responds to FDA on Cervarix® and plans to submit final study data for approval
GlaxoSmithKline today provided the following update regarding its application to the U.S. Food and Drug Administration (FDA) for approval of Cervarix®, its vaccine to prevent cervical cancer.
GlaxoSmithKline responds to Government announcement on the PPRS
GlaxoSmithKline (GSK) has been actively involved in discussions with the Department of Health and the pharmaceutical industry since the review of the PPRS was announced in July 2007.
Cervarix™, GSK’s cervical cancer vaccine, wins tender for UK national immunisation programme
GlaxoSmithKline’s (GSK) cervical cancer vaccine, Cervarix TM, was today confirmed as the UK Department of Health’s vaccine of choice for its national human papillomavirus (HPV) immunisation programme. The programme, which aims to protect against the two types of HPV that are responsible for approximately 70% of cervical cancers1, will start in September 2008 and will vaccinate girls aged 12 to 13 each year. There will also be a catch up programme for girls aged 14 up to 18 years, which will be implemented over the next 2-3 years.
Revolade® (eltrombopag) data presented at EHA: updated data for EXTEND plus new data for REPEAT and DELPHI studies
GlaxoSmithKline today announced data on the long-term safety and efficacy of its investigational drug Revolade® (eltrombopag) for the treatment of chronic idiopathic thrombocytopenic purpura (ITP). [1] Results from the ongoing, open label EXTEND (Eltrombopag eXTENded Dosing) (Abstract 0949) study showed that 80% of patients achieved a platelet count of >50,000/µL at least once and 78% of these patients maintained platelets >50,000/µL for over 50% of their time in the study. These results suggest that eltrombopag sustains increased platelet counts during long-term treatment.1 Chronic ITP is a disorder characterised by low platelet levels which can result in excessive bruising and bleeding. [2] This research was presented at the 13th congress of the European Hematology Association, 12-15 June 2008, Copenhagen, Denmark.
GlaxoSmithKline receives marketing authorisation in the EU for Tyverb® (lapatinib), the first oral targeted therapy for ErbB2-positive breast cancer
GlaxoSmithKline (GSK) announced today that the European Commission has granted a conditional marketing authorisation for Tyverb® (lapatinib), the firstoral, small molecule dual targeted therapy, for all 27 European Union (EU) member states. Lapatinib, in combination with capecitabine, is indicated for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2). Patients should have progressive disease following prior therapy, which must include anthracyclines and taxanes, and therapy with trastuzumab in the metastatic setting
GlaxoSmithKline acquires Sirtris Pharmaceuticals, Inc., a world leader in sirtuin research and development
GlaxoSmithKline (GSK) announced today that it has completed its acquisition of Sirtris Pharmaceuticals, Inc. (Sirtris) for approximately USD720 million (or approx. GBP362 million) through a cash tender offer of USD22.50 (or approx. GBP11.33) per share.
GlaxoSmithKline and Boston’s Immune Disease Institute put scientists head-to-head in race for new discoveries
GlaxoSmithKline (GSK) and the Immune Disease Institute, Boston (IDI) today announced a five year collaboration worth $25 million to build a unique partnership in immunoinflammation research.
GlaxoSmithKline successfully completes tender offer for shares of Sirtris Pharmaceuticals
GlaxoSmithKline plc (GSK) announced today the successful completion of the tender offer by its wholly-owned subsidiary Fountain Acquisition Corporation (FAC) for shares of common stock of Sirtris Pharmaceuticals, Inc. (Nasdaq: SIRT).
New data offer insights into the potential role for Tykerb® / Tyverb® (lapatinib) in non-cytotoxic chemotherapy-based treatment regimens
GlaxoSmithKline today announced the results of three studies evaluating lapatinib - an oral, small molecule inhibitor of HER2 - in various breast cancer settings, either in combination with other targeted therapies or as a monotherapy. Use of lapatinib in these settings is investigational. Results from these studies are being presented during the annual American Society of Clinical Oncology (ASCO) meeting in Chicago, May 30 – June 3, 2008.
New data on MAGE-A3 cancer immuno therapy support novel options of treating non-small cell lung cancer and melanoma
New data presented by GlaxoSmithKline (GSK) today highlighted the potential of its investigational MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) through results of three studies evaluating highly targeted immunotherapy as a treatment for metastatic melanoma and non-small cell lung cancer (NSCLC). These data were presented at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago[Abstract Nos: 9065 [i] , 9045 [ii] and 7501 [iii] .
GlaxoSmithKline announces new drug application and Phase III results for Rezonic™ / Zunrisa™ (casopitant)
GlaxoSmithKline (GSK) today announced the submission of a new drug application to the US Food and Drug Administration and new data from two Phase III trials for Rezonic™/Zunrisa™ (casopitant), a novel, investigational NK-1 receptor antagonist. The data demonstrated a significant and clinically meaningful reduction in the number of patients experiencing chemotherapy-induced nausea and vomiting (CINV). Adding a single oral dose regimen of casopitant to the standard dual therapy of Zofran® (ondansetron HCI), and dexamethasone, achieved this effect in patients taking highly emetogenic chemotherapy (HEC) and those on moderately emetogenic chemotherapy (MEC) treatment regimens.1,2 CINV can be a serious, feared and distressing side effect of chemotherapy for patients and their families.3 CINV can last for about five days and the risk of nausea and vomiting without prophylaxis is greater than 90 percent for patients receiving HEC and 30-90 percent for patients receiving MEC.4,5
GlaxoSmithKline announces $500,000 in fellowships at Stanford Graduate School of Business
GlaxoSmithKline (NYSE: GSK) today announced the establishment of two fellowships totaling $500,000 in honor of former Chief Executive Officer Jean-Pierre Garnier, to support students enrolled at Stanford Graduate School of Business. Dr. Garnier, who received his Masters of Business Administration from the school in 1974, retired from GSK on May 21, 2008.
Elesclomol study shows significant improvement in progression-free survival for chemotherapy-naïve patients with metastatic melanoma
GlaxoSmithKline and Synta Pharmaceuticals Corp. today announced positive Phase II clinical data for elesclomol (formerly STA-4783), an investigational agent currently in development for metastatic melanoma. A retrospective analysis showed that stage IV metastatic melanoma patients treated with elesclomol and paclitaxel who had not previously received chemotherapy had a statistically significant improvement in progression-free survival (PFS) compared to patients who received paclitaxel alone.1 These data will be presented at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Elesclomol is not yet approved for any indication in any market.
First pre-pandemic vaccine approved to help protect against pandemic influenza
GlaxoSmithKline (GSK plc) announced today that the European Commission has granted a marketing authorisation for its H5N1 adjuvanted pre-pandemic vaccine, Prepandrix™, in all 27 EU member states. GSK is the first company to obtain a European licence for a pre-pandemic vaccine, thereby offering European governments the potential for protecting their population in advance or at the onset of an officially declared influenza pandemic.
GSK announces results of first Phase III trial evaluating Tykerb®/Tyverb® (lapatinib) plus Herceptin® (trastuzumab)
GlaxoSmithKline today announced positive data from the first-ever randomised, multi-centre, open label Phase III trial of the combination of two targeted agents, lapatinib and trastuzumab, in women with HER2-positive metastatic breast cancer.1 HER2-positive breast cancer is a particularly aggressive form of cancer that affects approximately 25 to 30 percent of breast cancer patients.2 The study results demonstrated a benefit from the combination. Both treatments target the HER2 protein but work in different ways.1 Trastuzumab attaches to the outside of the HER2 protein, while lapatinib goes inside the cell to block signals from the HER2 protein for the cancer to grow.3 GlaxoSmithKline Oncology will present these and other new data in breast cancer at the annual American Society of Clinical Oncology (ASCO) meeting in Chicago beginning Friday 30th May.
The battle against obesity: European experts and pharmacists call for an increased role for pharmacy
Dr Terry Maguire, a community pharmacist in Belfast, UK, past-president of the Pharmaceutical Society of Northern Ireland and a Fellow of both the Pharmaceutical Society of Ireland and the Royal Pharmaceutical Society of Great Britain says: “As possibly the biggest public and personal health threat to Europe today, pharmacy is an under-utilised resource that could be tackling obesity, providing ongoing advice and valuable behavioural change support direct to the general public. The obesity ‘epidemic’ is, as yet, unabated and we urgently need to look at broadening our options to help people lose weight. What we are currently doing is not enough.”
Scientists publishing in Nature call for the diversification of antiviral stockpiles in preparation for an influenza pandemic
GlaxoSmithKline welcomes the online publication in Nature of the article 'The mechanism of H5N1 Influenza resistance to Tamiflu and implications for drug stockpiles' in which the authors state ''our results indicate that it would be prudent for pandemic stockpiles of oseltamivir to be augmented by additional antiviral drugs, including zanamivir.”
Cervarix™ provides longest duration of sustained neutralising antibodies reported for any vaccine against HPV 16 and 18 to date
New data from an extended follow-up study show that Cervarix generates sustained high levels of neutralising antibodies against the two most common cervical cancer-causing virus types for up to 6.4 years.4 This is the longest duration of sustained neutralising antibody levels reported against both virus types HPV 16 and 18 with a cervical cancer vaccine to date.
GlaxoSmithKline commences tender offer to acquire Sirtris Pharmaceuticals
GlaxoSmithKline plc (GSK) announced today that Fountain Acquisition Corporation, a wholly-owned subsidiary of GSK, is commencing a cash tender offer to purchase all outstanding shares of common stock of Sirtris Pharmaceuticals, Inc. (Nasdaq: SIRT) (Sirtris), for $22.50 in cash without interest and less any required withholding taxes. The tender offer is being made pursuant to a previously announced definitive agreement dated April 22, 2008 among Sirtris, Fountain Acquisition Corporation and SmithKline Beecham Corporation, a wholly-owned subsidiary of GSK.
FDA approves Advair 250/50 for reduction of exacerbations in patients with COPD
The U.S. Food and Drug Administration today approved Advair Diskus 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder) for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) who have a history of exacerbations. With this approval, Advair becomes the only treatment FDA has approved to reduce COPD exacerbations. Treatment guidelines for COPD state that the reduction of exacerbations is a key goal in managing the disease.
GSK announces changes to Corporate Executive Team
GlaxoSmithKline (GSK) today announced a number of changes to its Corporate Executive management team. In a message to employees, Andrew Witty, CEO designate, detailed new appointments and his new management team which will take effect on 22nd May when he assumes the role of Chief Executive Officer.
GlaxoSmithKline awards £300,000 to community health charities in recognition of their work
Twenty charities were last night rewarded for their community-based work, with awards totaling £300,000 at the annual GlaxoSmithKline IMPACT Awards, run in conjunction with the independent health charity, the King’s Fund.
GSK receives positive opinion for conditional approval of new oral breast cancer treatment, Tyverb (lapatinib)
GlaxoSmithKline (GSK) announced today that the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a revised positive opinion confirming the positive benefit-risk profile for Tyverb® (lapatinib), GSK’s new oral treatment for breast cancer. The positive opinion recommends grant of a conditional marketing authorisation.
Results announcement for the first quarter 2008
Results announcement for the first quarter 2008
GlaxoSmithKline gains approval for co-administration of Avodart® (dutasteride) with tamsulosin for the treatment of benign prostatic hyperplasia under the European Mutual Recognition Procedure
GlaxoSmithKline (GSK) announced today that regulatory approval has been granted in Sweden for its 5α-reductase inhibitor (5ARI) Avodart®, the only dual acting 5ARI, in combination with tamsulosin, a widely prescribed a-blocker, for the treatment of patients with moderate-to-severe benign prostatic hyperplasia (BPH) symptoms. Approval was granted through the European Mutual Recognition Variation Procedure, with Sweden acting as the Reference Member State. Further approvals are anticipated in the coming months across a further 26 European countries.
GlaxoSmithKline reports further progress of oncology portfolio
GlaxoSmithKline Oncology will present a wide range of new data at the annual American Society of Clinical Oncology (ASCO) meeting in Chicago starting Friday, May 30th. The data cover a variety of therapies, experimental medicines and immunotherapeutics for the treatment and supportive care of cancer patients. At this year’s ASCO meeting, GSK Oncology will present data that demonstrate trends in cancer research, including the combination of targeted therapies and a focus on oral treatment options.
GlaxoSmithKline to acquire Sirtris Pharmaceuticals, a world leader in 'Sirtuin' research and development
GlaxoSmithKline (NYSE: GSK) and Sirtris Pharmaceuticals Incorporated (Nasdaq: SIRT) announced today that they have entered into a definitive agreement pursuant to which GlaxoSmithKline will acquire Sirtris Pharmaceuticals for approximately USD720 million (or approx. GBP362 million) through a cash tender offer of USD22.50 (or approx. GBP11.33) per share.
GlaxoSmithKline and Regulus Therapeutics form strategic alliance to develop microRNA targeted therapeutics to treat inflammatory diseases
GlaxoSmithKline (GSK) and Regulus Therapeutics LLC (Regulus) today announced a worldwide strategic alliance to discover, develop and market novel microRNA-targeted therapeutics to treat inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease. Regulus is a joint venture between Alnylam Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc.
Treximet (sumatriptan and naproxen sodium) tablets approved by FDA for acute treatment of migraine
GlaxoSmithKline (LSE & NYSE: GSK) and POZEN Inc. (NASDAQ: POZN) announced today that the FDA has approved Treximet for the acute treatment of migraine attacks with or without aura in adults. Treximet is the first and only migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of migraine-specific medicines pioneered by GSK, and an anti-inflammatory pain reliever in a single tablet.
GlaxoSmithKline confirms receipt of FDA letter on regulatory reporting
GlaxoSmithKline today confirmed it has received a warning letter from the US Food and Drug Administration (FDA) related to reporting requirements for approved medicines. The letter follows a routine FDA inspection of GSK’s reporting processes conducted last year.
FDA approves Rotarix [Rotavirus Vaccine, live, oral], the first vaccine licensed to complete the rotavirus immunisation series by four months of age
GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved Rotarix® [Rotavirus Vaccine, live, oral] for the prevention of rotavirus gastroenteritis in infants. Rotarix will offer protection against the most commonly circulating rotavirus types in the U.S. and allow infants to complete the vaccination series by four months of age. The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that children complete the rotavirus immunization series by six months of age. Since rotavirus disproportionately affects young children -- severe rotavirus diarrhea and dehydration can occur as young as three months of age -- Rotarix could help prevent many of the 55,000-70,000 hospitalizations of young children that result from rotavirus in the U.S. each year.
Tyverb (lapatinib) European regulatory update
GlaxoSmithKline confirms that the EU Commission has referred Tyverb (lapatinib), GSK’s new oral treatment for breast cancer, back to the Committee for Medicinal Products for Human Use (CHMP) for further discussion, after receiving new data from GSK observed during a standard pharmacovigilance review of clinical trial and post-marketing data.[1] The CHMP is requested to discuss these new data prior to the Commission issuing its adoption of the CHMP’s opinion and releasing the marketing authorisation.
Phase III study of Bosatria (mepolizumab) showed disease control with reduced corticosteroid use in hypereosinophilic syndrome
Results from a Phase III study demonstrate that significantly more patients who received GlaxoSmithKline’s investigational monoclonal antibody, Bosatria® (mepolizumab), for the treatment of hypereosinophilic syndrome (HES), were able to maintain control of their disease with a reduced dose of a corticosteroid, compared to those who received placebo (84% vs. 43%, p<0.001)
FDA grants Priority Review For Promacta / Revolade (Eltrombopag)
GlaxoSmithKline today announced that the United States Food and Drug Administration (FDA) has granted Priority Review for Promacta® / Revolade® (eltrombopag) for the short-term treatment of patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag is an investigational, once-daily oral treatment that induces the production of cells in the bone marrow to generate platelets, which are critical in minimising the incidence of bleeding in chronic ITP.
Update on GSK's malaria treatments: Dacart and Lapdap
Malaria is a devastating disease killing over one million people, mostly young children and pregnant women every year. There is an urgent need for new medicines to treat the disease as resistance builds to older treatments. GSK and Medicines for Malaria Venture (MMV) are working in partnerships on a number of projects dedicated to finding new malaria treatments.
XenoPort and GlaxoSmithKline report positive top-line results of final pivotal trial of XP13512/GSK1838262 for restless legs syndrome
XenoPort, Inc. (Nasdaq: XNPT) and GlaxoSmithKline (NYSE: GSK) today announced positive top-line results from the final pivotal Phase 3 clinical trial of XP13512 (GSK1838262) for the treatment of moderate-to-severe symptoms of primary restless legs syndrome, or RLS. XP13512 demonstrated statistically significant improvements compared to placebo on both of the co-primary endpoints of the trial and was generally well-tolerated.
GlaxoSmithKline statement: Public Library of Science Medicine article on antidepressant medicines
Untreated, major depressive disorder can have serious consequences, with devastating impact, for patients and their families. The lack of effective care and the continued social stigma associated with mental disorders remain fundamental barriers to diagnosis and treatment of depression.
GlaxoSmithKline and Theravance announce expansion of the Horizon programme with start of large Phase 2B study of LABA in COPD patients
GlaxoSmithKline Plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the expansion of the Horizon programme into development of a next-generation combination treatment for patients with chronic obstructive pulmonary disorder (COPD). A large Phase 2b COPD dose-optimisation study with the lead long-acting beta agonist (LABA) GW642444 (‘444) has commenced, with screening of the first patient undertaken.
GSK's Volibris (ambrisentan) receives EMEA positive opinion for approval to treat class II and II pulmonary arterial hypertension (PAH)
GlaxoSmithKline (GSK) announced today that Volibris® (ambrisentan) has received a positive opinion from the European Committee for Human Medicinal Products (CHMP) for the treatment of Pulmonary Arterial Hypertension (PAH) in patients classified as World Health Organisation (WHO) Functional Class II and III, to improve exercise capacity1. Approval by the European Commission and Marketing Authorisation is expected to be granted by the end of April 2008.
New price reductions for GSK antiretrovirals in the world's poorest countries
GSK today announced significant new price reductions for its HIV medicines offered on a not-for-profit basis to the world’s poorest countries. This reduction is the fifth time the company has made a price reduction as part of its pioneering preferential pricing policy originally introduced in 1997.
FDA extends review of NDA for Entereg® (alvimopan)
Adolor Corporation (Nasdaq: ADLR) and GlaxoSmithKline (NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has informed Adolor that the Prescription Drug User Fee Act action date for the New Drug Application (NDA) for Entereg® (alvimopan) has been extended to May 10, 2008. Adolor also today announced the submission to the FDA of a revised Risk Management Program for Entereg.
Novel anti-CD20 monoclonal antibody ofatumumab demonstrates anti-tumour responses in patients with relapsed/refractory B-cell chronic lymphocytic leukaemia
Data from a Phase I/II study of the novel antiCD20 monoclonal antibody, ofatumumab (formerly HuMax-CD20) in patients with relapsed or refractory B-cell chronic lymphocytic leukaemia (CLL) demonstrate anti-tumour responses in half of the patients treated in one of the three cohorts.1 The study is published in the February issue of the journal Blood. Ofatumumab is being co-developed by GlaxoSmithKline (GSK) and Genmab A/S and has not received regulatory approval in any market for any indication at this time.
GlaxoSmithKline responds to findings in ACCORD study
These could be important findings if they can shed more light on how we improve the management of patients with diabetes. We certainly need to know a lot more about these data and what they mean, given the complexity of the disease and its management. Importantly for patients currently on treatment, The National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has said that none of the medicines in the study appear to be the cause of the increased risk. The study is continuing, and patients will continue to receive Avandia (rosiglitazone maleate) and all other diabetes medicines; however, the goal for glucose control will be adjusted. Patients will be moved from intensive management to standard glucose control.
GlaxoSmithKline and Amira Pharmaceuticals enter global agreement for FLAP inhibitor programme
GlaxoSmithKline and Amira Pharmaceuticals today announced they have entered into a worldwide exclusive agreement to develop, manufacture and commercialise FLAP (5-Lipoxygenase Activating Protein) inhibitors for the treatment of respiratory and cardiovascular disease.
GlaxoSmithKline receives EMEA positive opinion for the approval of Hycamtin® (topotecan) hard capsules for the treatment of relapsed small cell lung cancer
GlaxoSmithKline (GSK) announced that oral Hycamtin™ (topotecan hard capsules) has received a positive opinion from the European Medicines Agency (EMEA) recommending marketing authorisation. GSK expects final approval by the European Commission and Marketing Authorisation for this indication in approximately two months. Topotecan capsules will be indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. [1]
GlaxoSmithKline files pneumococcal paediatric vaccine in the EU
SynflorixTM (Pneumococcal Haemophilus influenzae Protein D conjugate vaccine) has been accepted for review by the European Medicines Agency (EMEA), GlaxoSmithKline (GSK) announced today. The 10-valent vaccine is designed to protect children against both invasive pneumococcal disease (IPD) and bacterial respiratory infections such as acute middle ear infections (otitis media). GSK utilizes a breakthrough approach in pneumococcal vaccine technology with this candidate vaccine. It has been designed with an active carrier protein to induce protection against non-typeable Haemophilus influenzae (NTHi) in addition to Streptococcus pneumoniae.
GlaxoSmithKline welcomes European guidance that stockpiling more than one antiviral would be useful in preparing for a flu pandemic
GlaxoSmithKline (GSK) welcomes the new guidance from the European Medicines Agency (EMEA) on the use of antivirals during a flu pandemic and the recommendation that the availability of more than one antiviral would be useful in preparing for a flu pandemic.1 The guidance has been revised in light of new evidence including emerging viral resistance.
GlaxoSmithKline and Synta announce elesclomol granted US orphan drug designation by the FDA
SynflorixTM (Pneumococcal Haemophilus influenzae Protein D conjugate vaccine) has been accepted for review by the European Medicines Agency (EMEA), GlaxoSmithKline (GSK) announced today. The 10-valent vaccine is designed to protect children against both invasive pneumococcal disease (IPD) and bacterial respiratory infections such as acute middle ear infections (otitis media). GSK utilizes a breakthrough approach in pneumococcal vaccine technology with this candidate vaccine. It has been designed with an active carrier protein to induce protection against non-typeable Haemophilus influenzae (NTHi) in addition to Streptococcus pneumoniae.
GlaxoSmithKline to revise Avandia® (rosiglitazone maleate) label in Europe following assessment by CHMP
GlaxoSmithKline (GSK) announced today that it will revise its European label for Avandia® (rosiglitazone maleate). The EMEA’s Committee for Medicinal Products for Human Use (CHMP) completed a positive benefit risk review of the thiazolidinediones (TZDs) including rosiglitazone in October 2007 and these label amendments are the result of this process
GlaxoSmithKline and Medicines For Malaria Venture announce new collaboration to investigate novel antimalarial compounds
GlaxoSmithKline (GSK) and the not-for-profit group, Medicines for Malaria Venture (MMV), today announced a new collaboration to identify novel drugs for the treatment of malaria. Research will focus on macrolide antibiotics, based on azithromycin, which may have promise as an antimalarial treatment. Under the new agreement, MMV will provide funding for research to be performed at GSK.
GlaxoSmithKline and TB Alliance renew tuberculosis drug discovery programme
GlaxoSmithKline (GSK) and the Global Alliance for TB Drug Development (TB Alliance) have renewed their joint research programme with the goal to improve the treatment of tuberculosis (TB), which is caused by the bacillus Mycobacterium tuberculosis (M.tb). The research collaboration, initiated in 2004, currently includes a portfolio of early projects which may ultimately yield new medicines that attack M.tb, including drug-resistance strains.
GSK and MRC to identify new therapeutic targets and biomarkers from genetic association studies
GlaxoSmithKline (GSK) and The Medical Research Council (MRC) have today announced the creation of a jointly funded programme seeking to identify and validate genes associated with common human diseases. A key aim of the programme will be to translate these observations into identifying new targets and biomarkers of disease.
GSK appoints Lon Cardon to focus genetics on new disease targets
GlaxoSmithKline has appointed Lon Cardon to head its Genetics organisation. Lon will combine Pharmacogenetics and Medical Genetics as a single, integrated function. The primary focus of the new organisation will be to focus on the prediction of individual variations in drug response as well as to support new disease target identification and validation.
GlaxoSmithKline and Adolor report favourable FDA Advisory Committee meeting for Entereg® (alvimopan) for the management of postoperative ileus in bowel resection
GlaxoSmithKline and Adolor Corporation (Nasdaq: ADLR) today announced that a majority (9-6) of the Gastrointestinal Drugs Advisory Committee (GIDAC) of the U.S. Food and Drug Administration (FDA) voted that the overall benefits of treatment with Entereg® (alvimopan), an investigational mu-opioid receptor antagonist, outweighed potential risks for short-term, in-hospital use in patients following partial large or small bowel resection surgery with primary anastomosis. The FDA is reviewing Adolor’s New Drug Application (NDA) for Entereg for the proposed indication of acceleration of upper and lower gastrointestinal (GI) recovery following partial large or small bowel resection surgery with primary anastomosis. There are no drugs approved for this indication.
GlaxoSmithKline and XenoPort report positive top-line results of second phase 3 restless legs syndrome trial for XP13512/GSK1838262
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) today announced positive top-line results from a placebo-controlled Phase 3 clinical trial designed to evaluate the potential of XP13512(GSK1838262) to maintain efficacy over the course of nine months in patients with moderate-to-severe primary Restless Legs Syndrome, or RLS. Data from this randomised withdrawal trial showed that XP13512 was generally well-tolerated and that there was a statistically significant difference between the percentage of patients treated with XP13512 and placebo who met a pre-specified relapse criteria during the randomised phase of the study.
New allergic rhinitis treatment Avamys™ approved in Europe
GlaxoSmithKline plc today announced that once-daily Avamys ™ (fluticasone furoate) nasal spray has been granted marketing authorisation by the European Commission for all 27 European member states, for the treatment of the symptoms of allergic rhinitis in adults, adolescents (12 years and older) and children (6 – 11 years).
GlaxoSmithKline and Theravance announce start of large Phase 2B ICS and LABA studies for asthma in the Horizon programme
GlaxoSmithKline Plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the start of large Phase 2b asthma dose-optimisation studies with both the lead inhaled corticosteroid (ICS) GW685698 (‘698) and the lead long-acting beta agonist (LABA) GW642444 (‘444) assets in the ‘Horizon’ programme to develop a next-generation combination product.
First head-to-head study comparing common treatments for patients with COPD shows quality of life and survival benefits for patients treated with Seretide
The INSPIRE (Investigating New Standards for Prophylaxis In Reduction of Exacerbations) study, published today in The American Journal of Respiratory and Critical Care Medicine showed that while the two study medications; Seretide™ 50/500µg Diskus™ (salmeterol/fluticasone propionate) and tiotropium bromide 18µg Handihaler® had a similar impact on rate of exacerbations, patients treated with Seretide gained a significant improvement in health status and greater survival benefit than patients treated with tiotropium. INSPIRE is the first prospective study to report a statistically significant difference in the relative risk of all-cause mortality between two established treatments for COPD.1
GlaxoSmithKline files for FDA approval of Promacta/Revolade (eltrombopag) to be the first oral platelet growth factor for rare blood disorder
Application data show Promacta/Revolade significantly raised platelet counts and lowered bleeding risk in clinical trials for the short-term treatment of patients with chronic idiopathic thrombocytopenic purpura (ITP)
GlaxoSmithKline and Santaris Pharma enter global R&D alliance to discover, develop and commercialise RNA antagonists as novel antivirals
GlaxoSmithKline (GSK) and Santaris Pharma today announced that they have entered into a worldwide strategic alliance for the discovery, development and commercialisation of novel medicines against viral diseases. The collaboration provides GSK access to patented RNA antagonist compounds, based on Santaris Pharma's unique Locked Nucleic Acid technology, for development as potential new therapies for selected viral diseases.
GlaxoSmithKline completes acquisition of Reliant Pharmaceuticals
GlaxoSmithKline (LSE & NYSE: GSK) announced today that it had completed the acquisition of Reliant Pharmaceuticals. This follows the US Federal Trade Commission’s early termination of the waiting period required by US antitrust law.
GlaxoSmithKline receives FDA ‘complete response’ letter for cervical cancer vaccine
GlaxoSmithKline (NYSE: GSK) announced today that it has received a complete response letter from the U.S. Food and Drug Administration related to its application for the cervical cancer vaccine, Cervarix®. A complete response letter is issued by FDA’s Center for Biologics Evaluation and Research (CBER) when the review of a file is completed and questions remain to be answered prior to approval. GSK will work closely with the FDA to prepare its response, which it intends to submit to the agency as soon as possible.
GlaxoSmithKline announces data on Tykerb® (lapatinib) plus capecitabine for the treatment of HER2-positive breast cancer brain metastases
Study shows Tykerb combination reduced the size of brain tumours associated with HER2-positive breast cancer
GlaxoSmithKline, via its Centre Of Excellence for External Drug Discovery, exercises its options to further develop and commercialise Exelixis’ anti-cancer C-Met inhibitior XL880
Exelixis, Inc. (Nasdaq: EXEL) today announced that GlaxoSmithKline (GSK) has exercised its option to exclusively license XL880 for further development and commercialisation. XL880 is a small molecule compound currently being evaluated in phase 2 trials in patients with papillary renal cell carcinoma (PRC), gastric cancer and head and neck cancer. Under the terms of the collaboration between Exelixis and GSK initiated in October 2002 and amended in January 2005, GSK’s selection of XL880 entitles Exelixis to a selection milestone of $35 million and additional payments upon the attainment of specific development and commercialisation milestones. The $35 million selection milestone will be applied to repayment of an advance that GSK paid to Exelixis in 2005. Exelixis is also entitled to receive double-digit royalties on product sales if the compound is approved for marketing and commercialised. Exelixis will have certain co-promotion rights to XL880 in North America.
GlaxoSmithKline presents innovative neuroscience pipeline
GlaxoSmithKline (GSK) plc today presented an overview of its neuroscience portfolio and the company’s disease area strategy to investors and analysts at a meeting in New York.
GlaxoSmithKline responds to JAMA article on the ICES thiazolidinediones and cardiovascular outcomes in older patients with diabetes
The following is GlaxoSmithKline’s [NYSE: GSK] response to the retrospective analysis by the Institute for Clinical Evaluative Sciences (ICES) titled “Thiazolidinediones and Cardiovascular Outcomes in Older Patients with Diabetes”.
GlaxoSmithKline receives decision from US FDA on Requip® XL™
GlaxoSmithKline (NYSE:GSK) today announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for the New Drug Application for Requip® (ropinirole) XL™ Extended-Release Tablets for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S. marketing approval.
Long-term safety and efficacy data on Promacta™ (eltrombopag) presented at American Society of Hematology Annual Meeting
Preliminary results demonstrate patients with chronic idiopathic thrombocytopenic purpura increased and maintained platelet counts at ≥50,000/µL with extended treatment
GlaxoSmithKline and OncoMed Pharmaceuticals form strategic alliance to develop cancer stem cell antibody therapeutics
GlaxoSmithKline (GSK) and OncoMed Pharmaceuticals (OncoMed) today announced a worldwide strategic alliance to discover, develop and market novel antibody therapeutics to target cancer stem cells which are believed to play a key role in the establishment, metastasis and recurrence of cancer. The alliance with GSK will be conducted through its Center of Excellence for External Drug Discovery (CEEDD).
GlaxoSmithKline and Galapagos enter strategic alliance to develop novel antibacterials and antivirals
Discovery and development of novel anti-infective medicines based on Galapagos’ natural product drug discovery platform
GlaxoSmithKline announces appointments to the Board of Directors
GlaxoSmithKline plc (GSK) today announced the following executive appointments and changes:
GSK’s continued commitment to fighting HIV/AIDS results in approval of new formulations of three medicines for the treatment of children
GlaxoSmithKline (GSK) today announced that it had gained approval from the European Commission for a new indication for use in children and infants of its HIV fixed-dose combination medicine, Combivir (lamivudine/3TC and Zidovudine/AZT). Previously, Combivir has only been prescribed for use in adults and children over 12 years of age, the shift to new weight based prescribing will allow Combivir to be used in much younger children. Approvals have also been granted to new scored-tablet formulations of Combivir , Epivir (lamivudine/3TC) and Ziagen (abacavir) for use in children weighing more than 14kg, part of GSK’s ongoing efforts to fight HIV/AIDS in children.
Statement from GlaxoSmithKline: publication of update regarding thiazolidinediones to treatment guidelines for the management of type 2 diabetes mellitus by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA)
The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) recently convened a panel of physicians to recommend updates to diabetes treatment guidelines with new information on the thiazolidinediones (TZDs). The panel developed a consensus statement published in the online edition of EASD’s Diabetologia and ADA’s Diabetes Care the week of 27 November. It is important to note that, according to the ADA, a consensus statement does not reflect the official association position, but rather the consensus opinion of the panel members.
GSK response to Nature Medicine article on rosiglitazone and bone in mice
The Nature Medicine study adds further context on the possible involvement of thiazolidinediones (TZDs) in osteoclast activity. However, the TZD class of medicines (both rosiglitazone and pioglitazone) has already been widely studied in relation to bone fracture, and fractures have been previously reported in female patients taking this class of drugs. There is a precaution for fracture on the labels of both rosiglitazone and pioglitazone and this information has been widely communicated for both products through dear healthcare professional letters in Europe and the U.S
GSK statement on US Food and Drug Administration Pediatric Advisory Committee recommendations regarding salmeterol
Untreated and uncontrolled asthma is an urgent public health issue and Serevent® (salmeterol xinafoate) and Advair® (fluticasone propionate and salmeterol) when taken as indicated help children and adults with asthma control their symptoms. As discussed at today’s meeting, Serevent should only be used as additional therapy for patients who continue to have symptoms on another controller as outlined in the product label.
GlaxoSmithKline obtains exclusive US OTC marketing rights to Mevacor® (lovastatin) from Merck & Co., Inc.
GlaxoSmithKline plc (GSK) and Merck & Co., Inc., Whitehouse Station, NJ, USA (Merck), announced today that they have entered into an agreement for over-the-counter (OTC) marketing rights for Mevacor® (lovastatin). Under the agreement, GSK will have exclusive rights to market non-prescription Mevacor in the United States. Terms of the agreement are confidential but include milestone and royalty payments from GSK to Merck.
New data published in The Lancet show GSK's rotavirus vaccine Rotarix offers sustained and broad protection against all common circulating rotavirus types
New data from a large European clinical vaccine trial, published today in The Lancet, shows Rotarix™, GSK’s rotavirus vaccine, to be effective against the five most commonly circulating rotavirus types (G1, G2, G3, G4 and G9).These virus types are responsible for more than 98% of rotavirus gastroenteritis (RVGE) disease in Europe during the first two years of life2. In the European Region alone, rotavirus may cause annually up to 87,000 hospitalizations and close to 700,000 outpatient visits every year in children under the age of five3. Importantly, the protection afforded by the vaccine’s two-dose schedule in infants occurs before six months of age.
GlaxoSmithKline to acquire Reliant Pharmaceuticals
GlaxoSmithKline and Reliant Pharmaceuticals Inc. announced today that they had reached an agreement under which Reliant will be acquired by GSK for $1.65 billion (£800 million) in cash.
GlaxoSmithKline and Genmab initiate ofatumumab rheumatoid arthritis Phase III programme
GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today the initiation of the Phase III programme with ofatumumab to treat rheumatoid arthritis (RA). The programme will commence with two studies (OFA110635/GEN410 and OFA110634/GEN411), which will be conducted outside the US, in two distinct patient populations. One study will be in patients who have had an inadequate response to methotrexate therapy; and the other in patients who have had an inadequate response to TNF-alpha antagonist therapy. Further studies to support the programme are planned for 2008.
GSK and the European Foundation for the Study of Diabetes (EFSD) commit €1 million to diabetes research in Europe
The first group of European researchers to benefit from a significant new scientific research programme in diabetes, funded by GlaxoSmithKline in partnership with the European Foundation for the Study of Diabetes (EFSD) have been announced. Each winner will receive a grant toward their research of €100,000 with a total contribution in 2007 of €500,000. The collaboration will also award up to an additional €500,000 toward this programme in 2008.
GlaxoSmithKline revises US labeling for Avandia
GlaxoSmithKline announced today that it is implementing changes to the US product label for Avandia® (rosiglitazone maleate),based on an extensive and thorough review by the FDA of myocardial ischemia data on Avandia, the most widely studied oral anti-diabetic medicine available.
Prometheus to acquire Lotronex® from GlaxoSmithKline
Prometheus Laboratories Inc., a speciality pharmaceutical company has signed an agreement with GlaxoSmithKline to acquire exclusive rights to Lotronex® (alosetron hydrochloride) Tablets in the United States. Lotronex is the only prescription drug approved by the FDA for use in adult female patients with severe diarrhea-predominant irritable bowel syndrome who meet the conditions stated in the label. Prometheus will market and sell Lotronex under an exclusive distribution agreement until the acquisition is completed, which is expected in January 2008. Prometheus will continue to offer Lotronex exclusively through the currently established Prescribing Program for Lotronex (PPL). Lotronex may be prescribed only by physicians who have enrolled in the PPL.
New innovation grants boost malaria advocacy efforts in Africa
Malaria Consortium announced today three grants for malaria advocacy to civil society organisations covering twelve African countries.
GlaxoSmithKline initiates trials of Promacta®/Revolade™ (eltrombopag) to investigate the potential to aid hepatitis C patients in achieving sustained virological response
GlaxoSmithKline (GSK) today announced the commencement of two parallel Phase III studies to assess the clinical benefits of its investigational compound Promacta®/Revolade™ (eltrombopag) in hepatitis C-associated thrombocytopenia, a condition characterised by decreased platelet counts. The studies, ENABLE 1 and ENABLE 2 (Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C related Liver DiseasE), will measure the ability of eltrombopag to raise platelet counts sufficiently enough to enable the initiation of antiviral therapy and to allow sustained antiviral therapy in thrombocytopenic hepatitis C patients. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve sustained virological response (SVR).
Fabre Kramer Pharmaceuticals receives decision from FDA on gepirone ER for major depressive disorder
Fabre-Kramer Pharmaceuticals Inc. (FKP) and GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the new drug application for gepirone extended-release (ER) tablets, submitted for the treatment of adults with major depressive disorder.
GlaxoSmithKline and Tolerx form worldwide collaboration for development and commercialisation of novel medication
GlaxoSmithKline and Tolerx, Inc. today announced the execution of a worldwide alliance to develop and commercialise otelixizumab (TRX4), a novel humanised anti-CD3 monoclonal antibody that has potential across a broad range of autoimmune and immune-mediated inflammatory diseases, including type 1 diabetes. Otelixizumab has been evaluated in type 1 diabetes in two Phase II studies and in psoriasis in two Phase I studies. In clinical trials, otelixizumab has been shown to preserve the function of insulin-producing beta cells in the pancreas in patients with type 1 diabetes, reducing the amount of administered insulin needed to control blood glucose levels.
New allergic rhinitis treatment Avamys™ receives positive opinion in Europe
GlaxoSmithKline plc today announced that once-daily Avamys ™ (fluticasone furoate) nasal spray has received a positive opinion from the European Medicines Agency (EMEA) for the treatment of the symptoms of allergic rhinitis in adults, adolescents (12 years and over) and children (6-11 years).
European Medicine Agency (EMEA) confirms positive Avandia benefit risk assessment
GlaxoSmithKline confirms that the EMEA’s Committee for Medicinal Products for Human Use(CHMP) has completed its benefit risk review of the Thiazolidinediones (TZD) class and have concluded that the benefits of rosiglitazone continue to outweigh the risks.
New Lancet study: Malaria vaccine candidate has promising safety, tolerability profile in infants
The first study to test GlaxoSmithKline’s (GSK) investigational RTS,S/AS02 malaria vaccine in African infants serves as the first proof of concept in this population that the vaccine has a promising safety and tolerability profile and reduces malaria parasite infection and clinical illness due to malaria, according to a paper published today online in The Lancet.
GSK receives approval for Hycamtin® (topotecan) capsules for the treatment of relapsed small cell lung cancer
GlaxoSmithKline [NYSE: GSK] announced today approval by the U.S. Food and Drug Administration (FDA) for oral Hycamtin® (topotecan) capsules for the treatment of relapsed small cell lung cancer (SCLC).
GlaxoSmithKline and Synta Pharmaceuticals announce development and commercialisation collaboration for STA-4783 in oncology
GlaxoSmithKline (GSK) and Synta Pharmaceuticals Corp. today announced the execution of a global collaboration agreement for the joint development and commercialisation of STA-4783, a first-in-class, small-molecule, oxidative stress inducer that is entering Phase 3 clinical development for the treatment of metastatic melanoma.
GlaxoSmithKline appoints Andrew Witty CEO designate
The Board of GlaxoSmithKline plc (“GSK”) (LSE & NYSE: GSK) today announced the appointment of Andrew Witty as CEO Designate, GlaxoSmithKline.
GSK seeks prequalification for Cervarix™ from the World Health Organization after obtaining marketing approval in Europe
GlaxoSmithKline (GSK) announced today that it has submitted a file on its cervical cancer vaccine, Cervarix™, to the World Health Organization (WHO) for pre-qualification, following the granting of a marketing authorisation approval by regulatory authorities in Europe on 20 September.
GSK applies for licence to market OTC weight loss product In Europe
GlaxoSmithKline (GSK) today announced its marketing application for non-prescription orlistat 60mg for weight loss has been accepted for review by the European Agency for the Evaluation of Medicinal Products (EMEA).
GSK submits Cervarix licence application to Japan's health authorities
GlaxoSmithKline (GSK) today announced that it has submitted a licence application for its cervical cancer candidate vaccine Cervarix ™ to the Japanese Ministry of Health, Labor and Welfare (MHLW). This is the first vaccine for the prevention of cervical cancer to be filed for approval in Japan.
GlaxoSmithKline helps form the Serious Adverse Events Consortium
GlaxoSmithKline (NYSE: GSK) announced today that it will join with other pharmaceutical companies, academic institutions and the U.S. Food and Drug Administration to research genetic markers that may help predict who is at risk for serious drug-related adverse events.
GlaxoSmithKline named to Working Mother "100 Best Companies" list
For the sixteenth consecutive year, GlaxoSmithKline (NYSE: GSK) has been named one of the “100 Best Companies” by Working Mother magazine, the company announced today. In 2006, GSK was inducted into the Working Mother Hall of Fame in recognition of its fifteenth consecutive year on the list.
Cervarix, GSK's cervical cancer vaccine, approved In Europe
GlaxoSmithKline (GSK) today announced that the European Commission has granted a marketing authorisation for its cervical cancer vaccine, Cervarix TM for all 27 European member states*. Cervarix, with its innovative AS04 adjuvant system, is indicated for the prevention of precancerous cervical lesions (high-grade cervical intraepithelial neoplasia [CIN] grades 2 and 3) and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18. The indication is based on data generated in girls and women aged between 10 and 25.1,2
GSK receives decision from FDA on Lamictal®XR™ Extended-Release Tablets
GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for the new drug application (NDA) for Lamictal®XR™ (lamotrigine) Extended-Release Tablets.
GlaxoSmithKline and Sepracor Inc. announce international alliance for commercialisation of Lunivia
GlaxoSmithKline (GSK) and Sepracor Inc. (Nasdaq: SEPR) today announced an agreement for the commercialisation of Sepracor’s eszopiclone product for all markets worldwide (excluding the U.S., Canada, Mexico and Japan). Sepracor’s eszopiclone product will be marketed by GSK in these areas as Lunivia for the treatment of insomnia. Under the agreement, Sepracor is entitled to receive an initial payment of $20 million plus subsequent payments upon accomplishment of various milestones. If all milestones are met, GSK will be obligated to pay Sepracor $155 million in aggregate license and milestone payments. In addition, Sepracor will receive double-digit royalties that escalate upon increased product sales and compensation for supplying the product to GSK.
GlaxoSmithKline responds to JAMA articles
GlaxoSmithKline (NYSE: GSK) believes that conclusions drawn from the most recent meta-analyses published by Drs. Nissen et. al. and Furberg et. al. in the Journal of the American Medical Association (JAMA) do not confirm a difference in the safety profile of Avandia (rosiglitazone) and Actos (pioglitazone).1, 2 These analyses reflect limitations that are common to all meta-analyses, by the authors’ own admission. These analyses do not yield data robust enough to guide doctors in selecting appropriate diabetes treatments for their patients. Comparisons between different meta-analyses with different endpoints and patient populations are even more unreliable.
Study shows combination therapy incorporating Avodart® and tamsulosin provides continuous symptom improvement over two years
GlaxoSmithKline today announced new results from a large study that demonstrate combination treatment with Avodart ® (dutasteride) and the alpha blocker, tamsulosin, provides significantly greater urinary symptom improvement for men with enlarged prostate than either Avodart or tamsulosin monotherapy over 24 months. Three analyses from the study — Combination therapy with A vodart and tamsulosin (CombAT) — were presented today at the 29th annual meeting of the Société Internationale d'Urologie in Paris.
GlaxoSmithKline's Arixtra® receives European authorisation for the treatment of acute coronary syndromes
GlaxoSmithKline announced today that the European Medicines Agency (EMEA) has authorised a new indication for its once-daily anticoagulant ARIXTRA® 2.5 mg (fondaparinux sodium) for the treatment of specific acute coronary syndromes (ACS). ACS conditions affect approximately 3 million people worldwide1,2 and include chest pain (unstable angina [UA]) and two specific types of heart attacks (NSTEMI* and STEMI**).
GlaxoSmithKline receives approval for Atriance® (nelarabine) in Europe for the treatment of difficult-to-treat leukaemias and lymphomas
GlaxoSmithKline announced today that Atriance® (nelarabine solution for infusion) has received approval from the European Commission for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to, or has relapsed following, treatment with at least two chemotherapy regimens.1
FDA accepts for review complete response to approvable letter for Entereg® (alvimopan) for POI
GlaxoSmithKline and Adolor Corporation announced today that the US Food and Drug Administration (FDA) has accepted as complete, Adolor’s response to the November 2006 New Drug Application (NDA) approvable letter for Entereg® (alvimopan) for the management of postoperative ileus (POI). The FDA informed Adolor that the response is considered a complete class 2 response with a Prescription Drug User Fee Act (PDUFA) goal date of February 10, 2008.
GlaxoSmithKline signs contract for its pandemic flu vaccine with UK Government
GlaxoSmithKline (GSK) today announced that it has entered into an agreement with the UK Government to provide its pandemic influenza vaccine in the event of a flu pandemic. It is one of the largest contracts signed by GSK to date for its proprietary adjuvanted pandemic flu vaccine.
GlaxoSmithKline's application for Rotarix® is accepted for review by the FDA
GlaxoSmithKline (NYSE:GSK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for Rotarix®, an oral candidate vaccine for infants to prevent rotavirus gastroenteritis. Severe, dehydrating gastroenteritis occurs primarily among children aged three to 35 months. Of children hospitalized with rotavirus, approximately 17 percent are younger than six months old. If approved, the GSK candidate vaccine could offer completion of the rotavirus vaccination series by four months of age. The rotavirus candidate vaccine is a live-attenuated vaccine derived from the most common human rotavirus strain. Published data show that immunity resulting from natural human rotavirus infection provides significant protection against moderate to severe disease, regardless of rotavirus strain.
GlaxoSmithKline updates prescribing information for Avandia in the US
GlaxoSmithKline [NYSE:GSK] today announced that the US Food and Drug Administration (FDA) has approved updated US prescribing information for the thiazolidinediones (TZD) class of medicines used in the treatment of Type 2 diabetes. This approval allows GSK to implement changes in the label for Avandia® (rosiglitazone maleate) as previously committed.
GSK gives consent under Canada's Access to Medicines Regime for generic version of HIV/AIDS medicine for use in Rwanda
As part of its broad commitment to improving access to medicines, GlaxoSmithKline today announced it has given consent through Canada's Access to Medicines Regime to enable a Canadian company (Apotex) to manufacture a generic fixed dose combination (FDC) antiretroviral (ARV), containing two molecules over which GSK has patent rights (zidovudine and lamivudine) for the treatment of HIV/AIDS in Rwanda.
GSK receives decision from FDA on Advair 500/50 for COPD
GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the supplemental drug application for the 500/50 strength of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in the treatment of patients with chronic obstructive pulmonary disease (COPD).
GlaxoSmithKline receives new HHS order for H5N1 bulk antigen
GlaxoSmithKline (NYSE:GSK), one of the world’s largest vaccine manufacturers, today announced that HHS has placed another order to purchase bulk H5N1 antigen for the US national stockpile of pre-pandemic vaccines. The company also announced the start of the first North American pre-pandemic vaccine trials in the company’s global pre-pandemic influenza program.
FDA issues second approvable letter for Trexima™
GlaxoSmithKline (LSE & NYSE: GSK) and POZEN Inc. (NASDAQ: POZN) today announced that the U.S. Food and Drug Administration (FDA) has issued a second approvable letter for Trexima™ (sumatriptan/naproxen sodium). An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S. marketing approval.
GSK comments on UK Government announcement to renegotiate current Pharmaceutical Pricing and Regulation Scheme agreement
GlaxoSmithKline (GSK) today made the following comment regarding the UK Government's announcement that it intends to re-negotiate the Pharmaceutical Pricing and Regulation Scheme (PPRS) agreement, which was concluded in 2005
GlaxoSmithKline presents Avandia data to FDA
The following summarizes GlaxoSmithKline’s [NYSE: GSK] presentation of data on Avandia® (rosiglitazone maleate) to an Advisory Committee of the Food and Drug Administration (FDA) on July 30, 2007.
Pharmetrics epidemiology study
A study analyzing data on more than 400,000 type 2 diabetes patients in a real-world setting provides strong evidence that Avandia is not associated with the increased risk of heart attack suggested as part of a previously published meta-analysis.
FDA Advisory Panel votes 22 to 1 for Avandia® to remain available to patients in the US
GlaxoSmithKline [NYSE: GSK] today welcomed the nearly unanimous recommendation of a US Food and Drug Administration’s (FDA) advisory committee to support Avandia’s (rosiglitazone maleate) continued availability to patients in the US. The company said it will continue to provide information to the FDA to assist in the Agency’s final decision-making.
GlaxoSmithKline statement in diabetes care study thiazolidinediones and heart failure: a teleo-analysis [1]
This is an analysis of existing data that has been previously published (online in Diabetes Care, 29 May 2007) and provides no new information on the risk of heart failure associated with the thiazolinediones (TZD) class.
GlaxoSmithKline and Targacept form alliance in therapeutics for CNS-related disorders
GlaxoSmithKline (GSK) and Targacept, Inc. (NASDAQ: TRGT) today announced a strategic alliance to discover, develop and market novel therapeutics that selectively target specified neuronal nicotinic receptors (NNRs).
New head-to-head study comparing Lexiva® and atazanavir show similar efficacy and lipid changes
A new study comparing two protease inhibitors used in the treatment of HIV patients showed similar efficacy and lipid effects between the two drugs. The head to head study, evaluated the use of GSK’s LEXIVA® (fosamprenavir calcium) given on an open label, randomized basis to 106 antiretroviral naïve patients versus the protease inhibitor atazanavir* (Reyataz®). These data, from a study known as ALERT, were presented today at the 4th International AIDS Society Conference (IAS) in Sydney, Australia.
GSK's cervical cancer candidate vaccine Cervarix™ receives positive opinion in Europe for prevention of cervical cancer
GSK today announced that its cervical cancer candidate vaccine received a positive opinion from the CHMP for the prevention of precancerous lesions and cervical cancer causally related to human papillomavirus types 16 and 18.
GSK responds to online review of rosiglitazone by The Cochrane Collaboration
The following is GlaxoSmithKline’s [NYSE: GSK] response to an online review published by The Cochrane Collaboration titled “Rosiglitazone for type 2 diabetes mellitus.
Largest cervical cancer vaccine efficacy trial shows Cervarix™ provides excellent protection against lesions caused by most common cancer-causing virus types
Results also show significant additional protection against infection with virus types beyond 16 and 18 with the GSK cervical cancer candidate vaccine.
GlaxoSmithKline's Arixtra® (fondaparinux sodium) receives positive opinion in Europe for the treatment of acute coronary syndromes
GlaxoSmithKline announced today that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the once-daily anticoagulant Arixtra® 2.5mg (fondaparinux sodium) for the treatment of patients with acute coronary syndromes (ACS) 1. ACS conditions include chest pain (unstable angina) and two specific types of heart attacks (NSTEMI* and STEMI**).
New data show patients treated with Avandia® (rosiglitazone maleate) incurred lower medical costs and used fewer healthcare resources when compared to patients treated with sulphonylureas
New findings from a retrospective cohort study using real-world claims data of more than 15,000 drug naive patients with type 2 diabetes showed that initial therapy with Avandia® (rosiglitazone maleate) was associated with significantly fewer healthcare visits and lower total medical costs when compared to patients initiating therapy with a sulfonylurea. These data will be presented Sunday, June 24, 2007 at the American Diabetes Association 67th Scientific Sessions [poster # 1191].
GlaxoSmithKline's Atriance (nelarabine) receives positive opinion in Europe for the treatment of rare, difficult to treat leukaemias and lymphomas
GlaxoSmithKline announced today that Atriance® (nelarabine solution for infusion) has received a positive opinion from the European Medicines Agency (EMEA) for the treatment of T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) patients whose disease has not responded to, or has relapsed following, treatment with at least two chemotherapy regimens.[1] Nelarabine will now be considered for final marketing approval by the European Commission.
GlaxoSmithKline expects to launch up to five major new medicines for oncology in next three years
GlaxoSmithKline plc (GSK) today presented an overview on its expanding and innovative oncology portfolio, with clinical updates on several important new medicines, to investors and analysts at a meeting in London.
GlaxoSmithKlline and Genmab present positive Phase II results with ofatumumab in patients with rheumatoid arthritis (RA)
GlaxoSmithKline (GSK) and Genmab A/S (CSE: GEN) announced today positive primary efficacy data (evaluated at 24 Weeks) to be presented at EULAR 2007, the Annual European Congress of Rheumatology (abstract number: OPO232) from a Phase II study of ofatumumab (HuMax-CD20®) in patients with rheumatoid arthritis (RA). Ofatumumab is being co-developed under a worldwide agreement between GlaxoSmithKline and Genmab.
GlaxoSmithKline, Imperial College London, and The Medical Research Council officially open the UK's world-leading Clinical Imaging Centre
GlaxoSmithKline’s (GSK) new Clinical Imaging Centre (CIC) was officially opened today by the Right Honourable Alistair Darling MP, Secretary of State for Trade and Industry. The new centre represents an investment of over £50 million and is a pioneering collaboration between industry, academia and the public sector. Commenting on the collaboration and state-of-the-art facility, Mr Darling said, "This new centre is right at the forefront of the fight against some of the major diseases in the world. It means a world leading facility based here in the UK bringing the best of industry and academia together backed by the Government. It will give researchers what they need to enhance our reputation as a world leader in science, research and putting great ideas into practice, speeding up the process to deliver the new medicines that patients need.
GlaxoSmithKline to make unprecedented vaccine donation to WHO pandemic flu stockpile
GlaxoSmithKline (GSK) today announced its intention to donate 50 million doses of H5N1 adjuvanted pre-pandemic influenza vaccine to the World Health Organization (WHO) in support of its stockpile initiative. The donation will help establish a much needed stockpile of pre-pandemic vaccines that can be distributed to the world’s poorest countries at short notice by the WHO. Delivered over a three-year period, it will provide enough doses of vaccine for 25 million people at 2 injections per person.
GlaxoSmithKline's application for DTaP-IPV vaccine is accepted for review by the FDA
GlaxoSmithKline (NYSE:GSK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for a DTaP-IPV combination vaccine (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine combined). GlaxoSmithKline is seeking U.S. approval for the new DTaP-IPV pediatric booster vaccine for immunization against diphtheria, tetanus, whooping cough (pertussis), and polio diseases in children 4 through 6 years of age.
alli™ - the OTC weight loss product - on shelves nationwide in the US later this week
GlaxoSmithKline Consumer Healthcare [NYSE: GSK] announces that alli™, the only FDA-approved over-the-counter weight loss product will be on shelves of pharmacies, grocery stores and mass merchandisers nationwide later this week. alli is designed to be a partner for overweight adults willing to change how they eat and lose weight gradually. Adding alli to diet and exercise can help people lose 50 per cent more weight than with dieting alone. alli is being supported by an unprecedented multicultural and bilingual educational effort, making it more than just a pill but a comprehensive weight loss program. With alli, people will have access to an individualized online action plan with a year’s worth of lessons included in each alli purchase, at www.myalli.com.
FDA grants priority review for oral formulation of HYCAMTIN (topotecan) to treat relapsed small cell lung cancer
GlaxoSmithKline (GSK) announced today that its new drug application (NDA) for ORAL HYCAMTIN® (topotecan) capsules, a treatment for relapsed small cell lung cancer (SCLC), has been granted Priority Review by the United States Food and Drug Administration (FDA).
GlaxoSmithKline and Adolor update alvimopan (Entereg/Entrareg) development programme
GlaxoSmithKline and Adolor Corporation today provided an update on the alvimopan (Entereg/Entrareg®) development programme.
Pivotal phase III trial showed RevoladeTM (eltrombopag) raised platelet counts and reduced bleeding in patients with chronic ITP
GlaxoSmithKline plc today announced results from an international, pivotal Phase III study of its investigational non-peptide oral platelet growth factor, Revolade® (eltrombopag). Data from this study showed that eltrombopag at 50-75mg once daily resulted in a statistically significant increase in platelet counts and also reduced bleeding in adult patients with chronic idiopathic thrombocytopenia purpura (ITP). These patients had previously received and failed current standard ITP treatments. These data, which are part of a six-week study of eltrombopag in patients with chronic ITP, were presented today at the 12th congress of the European Hematology Association (EHA) in Vienna, Austria.[1]
Newly published data from large study support cardiovascular safety of Avandia (rosiglitazone maleate)
A study of more than 33,000 type 2 diabetes patients in a real-world setting was published today. This study shows that the incidence of hospitaliations for heart attack, and/or for a surgery known as coronary revascularization for patients on Avandia is the same as for other diabetes treatments. The study results were released in a paper titled “Coronary Heart Disease Outcomes in Patients Receiving Antidiabetic Agents” in Pharmacoepidemiology and Drug Safety.
Statement of Moncef Slaoui, PhD, Chairman Research & Development, GlaxoSmithKline
Mr. Chairman, Ranking Member and Members of the Committee: Good morning, my name is Dr. Moncef Slaoui, and I am the Chairman of Research & Development for GlaxoSmithKline, or GSK. GSK is one of the world’s leading research-based pharmaceutical and healthcare companies. I’m here to share with you GSK’s extensive and ongoing efforts to research both the safety and the benefits of Avandia®, an important medicine that has been proven to help patients fight the devastating effects of type 2 diabetes
Encouraging clinical activity of GSK's novel cancer immunotherapeutic confirmed in phase II study in patients with most common form of lung cancer
GlaxoSmithKline (GSK) today announced final results of a Phase II proof-of-concept clinical trial of its investigational MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) in MAGE-A3 positive patients with stage IB or II Non-Small Cell Lung Cancer (NSCLC). These data were presented at the 2007 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois, [Abstract No: 7554]. Final trial analysis showed a 27% reduction in the relative risk of cancer recurrence following surgery in patients treated with the MAGE-A3 ASCI, compared to placebo.
Cervarix, the GSK cervical cancer candidate vaccine, provides sustained immune response in 100 per cent of women up to 55 years of age
GlaxoSmithKline today announced new Phase III data show that at 18 months after the first of a three-dose regimen, 100 per cent of women up to age 55 vaccinated with the GlaxoSmithKline (GSK) cervical cancer candidate vaccine had antibodies present against the two most common cancer-causing human papillomavirus types, 16 and 18. These data indicate that the vaccine, formulated with a proprietary adjuvant system called AS04, is highly immunogenic and generally well-tolerated, with antibody levels at least 10 times greater than those produced by natural infection. These new extended follow-up data were presented at the American Society of Clinical Oncology (ASCO) annual meeting (abstract #3007).
Interim data from RECORD study show no significant difference between Avandia and standard therapy in risk of cardiovascular hospitalization or death
GlaxoSmithKline [NYSE:GSK] said today that findings from an interim analysis of RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycemia in Diabetes), a prospective clinical trial designed specifically to determine cardiovascular outcomes in more than 4,400 patients with type 2 diabetes, adds further evidence to the overall cardiovascular safety profile of Avandia® (rosiglitazone maleate). The study results, authored by Philip D. Home and colleagues on the RECORD Steering Committee, were published Tuesday in the online edition of The New England Journal of Medicine.
GlaxoSmithKline response to New England Journal of Medicine editorials
The following is GlaxoSmithKline’s [NYSE:GSK] response to editorials written in the New England Journal of Medicine (NEJM) regarding Avandia ® for the treatment of type 2 diabetes.
GSK's pazopanib shows positive results in patients with advanced renal cell carcinoma, ovarian cancer and soft tissue sarcoma
GlaxoSmithKline (GSK) today announced results from ongoing Phase II studies of pazopanib in advanced or metastatic renal cell carcinoma (RCC), ovarian cancer and soft tissue sarcoma (STS). These trials were presented at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago . The results observed in these trials with pazopanib support further investigations.
Eight-year long-term data demonstrate prolonged overall survival and length of disease remission with BEXXAR
GlaxoSmithKline plc [LSE and NYSE: GSK] announced today long-term efficacy data from a Phase II trial of a single one-week course of frontline treatment with the BEXXAR ® Therapeutic Regimen (Tositumomab and Iodine I-131 Tositumomab) in 76 patients with newly diagnosed advanced follicular non-Hodgkin’s lymphoma (NHL). This regimen was found to induce durable clinical and molecular remissions in patients with this disease. Specifically, researchers reported that patients who received a single one-week treatment of BEXXAR as monotherapy achieved estimated 8-year and 10-year overall survival (OS) rates of 86%. Additionally, 50% of patients survived without progression of disease at 8 years following therapy. For patients who achieved complete remission, the median time before their disease progressed was 9.2 years. An overall response rate and complete remission rate of 95% and 75%, respectively, were observed. These data were presented today at the 2007 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois(Abstract #8033).1
GlaxoSmithKline reports positive new data on Tykerb (lapatinib) at the 2007 American Society of Clinical Oncology (ASCO) annual meeting
Activity demonstrated for the first time in the treatment of first-line metastatic HER2-(ErbB2) positive breast cancer in combination with paclitaxel (Taxol®), one of the most commonly used chemotherapies1.
GlaxoSmithKline announces Altargo approved in Europe for treatment of Impetigo and other skin infections
GlaxoSmithKline (GSK) today announced that the European Commission approved its novel topical antibacterial ALTARGO ® (retapamulin ointment,1%) for the treatment of impetigo and infected small lacerations, abrasions or sutured wounds. ALTARGO is first in a class of antibacterials called pleuromutilins to be approved for treatment of skin infections in humans, and is indicated for use twice daily for a five-day period (10 doses) in patients nine months of age and older. Other prescription topical antibacterials are used as often as three times daily for at least seven days, involving more than 21 doses.
GlaxoSmithKline honours cancer research pioneer Gianni Bonadonna with new ASCO award and fellowship
GlaxoSmithKline Oncology (GSK), in support of The American Society of Clinical Oncology (ASCO) and The ASCO Foundation, proudly announce today the creation of the Gianni Bonadonna Breast Cancer Award and Fellowship as a tribute to Dr. Bonadonna’s outstanding contributions in the field of cancer research.
Data affirms Avandia (rosiglitazone maleate) cardiovascular safety profile
GlaxoSmithKline (NYSE: GSK) today confirms that a letter to the editor summarizing additional Avandia cardiovascular safety data from several large-scale clinical trials was published online today in The Lancet . This letter, written by Ronald L. Krall, MD, Chief Medical Officer of GlaxoSmithKline, provides the necessary context and clarifies the safety record of Avandia, which is based on sound science and backed by one of the largest research programs ever in diabetes.
Retrospective observational study shows combination vaccines may improve vaccination coverage rates in infants
A new analysis from a retrospective observational study of administrative claims data from the Georgia State Medicaid program showed that infants who received at least one shot of PEDIARIX ® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined] or Comvax® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine] had higher immunization coverage rates for most of the vaccines or vaccine series studied in the first two years of life compared to infants given no doses of either of these combination vaccines. Results from the study were published in the June 2007 issue of the Pediatric Infectious Disease Journal.
GlaxoSmithKline launches Chinese R&D centre with appointment of head in Shanghai
GlaxoSmithKline (GSK) today announces the appointment of Jingwu Zang to head a new GSK research and development centre in Shanghai, China. His appointment, as Senior Vice President, will be effective in June.
GlaxoSmithKline announces Swiss approval of Tyverb®, a new oral treatment for advanced breast cancer
GlaxoSmithKline announced today an important milestone for advanced breast cancer patients across Europe with approval of the first oral ErbB1 and ErbB2 dual inhibitor, Tyverb ® (lapatinib). Lapatinib, in combination with capecitabine, received approval from Switzerland’s regulatory authority,Swissmedic, for the treatment of patients with advanced ormetastatic breast cancer whose tumours over-express ErbB2 (HER-2) and who have relapsed after, or not responded to, trastuzumab therapy.
alli™ debuts through the alli Experience
Today, GlaxoSmithKline Consumer Healthcare [NYSE:GSK] introduces a new approach to weight loss that will debut through a public multi-media exhibit in New York City— the alli TM Experience. The alli Experience represents part of GSK Consumer Healthcare’s comprehensive educational program to prepare adults interested in losing weight with alli — the only over-the-counter weight loss product approved by the U.S. Food and Drug Administration (FDA) — before it goes on sale in pharmacies and mass retailers beginning on or about June 15. The alli Experience will be open daily beginning Tuesday May 22 through Sunday June 10, 2007, and is open Monday through Fridays from 11 a.m. until 6 p.m., Saturdays from 10 a.m.until 6 p.m.and Sundays from 11 a.m.to 5 p.m.The exhibit is located in New York City at 20 Union Square East (located at the Southeast corner of the Square).
Cervarix™ is approved in Australia for females 10-45 years old
Cervarix TM, the cervical cancer vaccine from GSK, has been granted a licence by the Therapeutic Goods Administration (TGA) of Australia for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus types. Cervarix TM is now approved in Australia for use in females aged 10 to 45 years old. This is the first major market licence for Cervarix TM, GSK’s cervical cancer vaccine
GlaxoSmithKline responds to NEJM article on Avandia
GlaxoSmithKline [NYSE:GSK] today issued the following response to an article in the New England Journal of Medicine (NEJM) on Avandia® (rosiglitazone maleate), a widely used and highly effective treatment for type 2 diabetes:
GlaxoSmithKline strongly defends its record on Avandia
The following is GlaxoSmithKline’s (NYSE: GSK) response to a press release issued by the US Senate Committee on Finance about Avandia® (rosiglitazone maleate):
Sally Field addresses members of Congress about osteoporosis during national osteoporosis awareness month
Actress Sally Field took her campaign to raise awareness around osteoporosis and bone health to Capitol Hill today, calling on women in Congress to take steps to protect their own health and to help spread the word to their constituents.
GlaxoSmithKline's Hib-MenCY-TT combination vaccine meets phase II study endpoints of immunogenicity and safety compared to licensed vaccines
GlaxoSmithKline (GSK) announced results from a Phase II vaccine clinical study presented this week at the Pediatric Academic Societies’ (PAS) Annual Meeting in Toronto, Canada. The new data suggest that the investigational Hib-MenCY-TT vaccine holds potential to protect infants in the first year of life against invasive disease caused by three strains of bacteria: Neisseria meningitidis serogroups C (MenC) and Y (MenY) and Haemophilus influenzae type b (Hib). The pediatric combination vaccine is currently in Phase III clinical studies and an application for licensure in the United States has not been submitted.
Cervarix® data show that higher levels of antibodies in the bloodstream correlate to higher levels in cervico-vaginal secretions
New data in women 15 to 55 years of age show that the GlaxoSmithKline (GSK) cervical cancer candidate vaccine induces an immune response to cancer-causing human papillomavirus types 16 and 18 in the bloodstream which highly correlates to antibody levels in the cervico-vaginal secretions. Furthermore, these antibodies to cancer-causing virus types 16 and 18 were detected and sustained for one year following completion of the vaccination course. These data were presented Tuesday at the American College of Obstetrics and Gynecology (ACOG) annual meeting.
Fabre-Kramer refiles gepirone ER with the FDA for the treatment of major depressive disorder
Fabre-Kramer Pharmaceuticals Inc. and GlaxoSmithKline announced today the submission by Fabre-Kramer to the Food and Drug Administration of an amendment to the New Drug Application for gepirone extended release (ER). The amendment responds to the FDA’s June 2004 request for an additional positive short term efficacy trial for gepirone ER.
GlaxoSmithKline's investigational DTaP-IPV combination vaccine shown to be immunogenic and well-tolerated in Phase III clinical trial
GlaxoSmithKline (GSK) today announced results from a U.S. phase III vaccine clinical study presented this week at the Pediatric Academic Societies’ (PAS) Annual Meeting in Toronto, Canada. The study evaluated the immune response and safety profile of the investigational combination DTaP-IPV (diphtheria, tetanus, acellular pertussis - inactivated poliovirus) vaccine in children ages 4 to 6 years-old as compared to separately administered DTaP (INFANRIX®) and IPV (IPOL®) vaccines, when co-administered with measles, mumps and rubella (MMR) vaccine (M-M-RII®) at a separate site. Study results showed that children receiving the combination vaccine demonstrated overall a comparable immunogenicity and safety profile to children receiving the separately administered component vaccines.
GlaxoSmithKline supports World Health Organization efforts to strengthen global pandemic preparedness plans
GlaxoSmithKline [GSK: NYSE] today commended the commitment of the World Health Organization (WHO) to progress plans for ensuring that the world’s most vulnerable people are protected in the event of a pandemic. Key elements of that commitment include progress being made towards the development of an H5N1 vaccine global stockpile by the WHO, and efforts to establish an additional mechanism to ensure broader access to pandemic influenza vaccine for developing world countries.
Trexima™ (sumatriptan/naproxen sodium) provided relief of both traditional and non-traditional migraine symptoms
While many migraine sufferers experience traditional symptoms such as nausea or sensitivity to light and sound, migraine attacks can also involve symptoms like neck pain or sinus pain that are not traditionally associated with migraine headaches. New data show that significantly more patients using the investigational migraine treatment Trexima early in their migraine attacks were pain free at two hours and experienced relief from both traditional and non-traditional symptoms, compared to patients taking placebo. These data were presented today at the 59th Annual Meeting of the American Academy of Neurology.
Trexima™ (sumatriptan/naproxen sodium) demonstrated efficacy across multiple migraine attacks
Patients who suffer from migraines frequently cite inconsistent effectiveness as a reason for their dissatisfaction with their medicine. New data from more than 1,100 patients show that the investigational migraine therapy Trexima , when taken early, produced pain-free results at two and four hours, as well as a sustained pain-free response 2-24 hours, across individual patients’ multiple migraine attacks, demonstrating the consistency in efficacy that patients desire. Furthermore, nearly one third of all patients were pain free at two hours. These findings were presented today at the 59th Annual Meeting of the American Academy of Neurology.
FDA Advisory Committee finds substantial evidence to support Advair 500/50 in reducing COPD exacerbations
An Advisory Committee to the U.S. Food and Drug Administration (FDA) today unanimously agreed (11 to 0) that GlaxoSmithKline’s Advair Diskus® 500/50 (fluticasone propionate and salmeterol inhalation powder) demonstrated a significant reduction in the risk of exacerbations in patients with chronic obstructive pulmonary disease (COPD), the fourth leading cause of death in the U.S. Additionally, they voted unanimously (11 to 0) that Advair 500/50 provides substantial advantages over salmeterol in the treatment of patients with COPD.
New data shows once a day Lamictal® XR™ is effective in treating patients with partial seizures
Boston, MA, May 1, 2007– Data from two clinical trials presented today at the American Academy of Neurology (AAN) meeting suggest that an investigational once daily extended re-lease formulation of Lamictal® (lamotrigine) is effective as add-on treatment in patients with partial epilepsy with and without secondary generalization. Lamictal XR Extended-Release Tablets are currently in development for the treatment of epilepsy. If approved, it will be the first extended release, new generation epilepsy treatment taken once-daily.
GlaxoSmithKline and Wellcome Trust announce partnership to target drug-resistant hospital infections
GlaxoSmithKline (GSK) and The Wellcome Trust today announced a collaboration to develop a new class of antibacterial to combat the rise of certain drug-resistant hospital-acquired infections, including those that lead to pneumonia. The collaboration is part of the Wellcome Trust’s Seeding Drug Discovery initiative, aimed at tackling unmet medical needs.
FDA approves once-daily Veramyst (fluticasone furoate) Nasal Spray for treatment of seasonal and year-round allergy symptoms in adults and children as young as two years
The U.S. Food and Drug Administration today approved once-daily Veramyst™ (fluticasone furoate) Nasal Spray to treat seasonal and year-round allergy symptoms in adults and children two years of age and older. Veramyst will be available by prescription nationwide by late May 2007.
GlaxoSmithKline receives Japanese approval for two major new product opportunities: Seretide/Advair and Arixtra
GlaxoSmithKline (GSK) today announced that it has received approval for Seretide/Advair Diskus (salmeterol and fluticasone proprionate combination) and Arixtra (fondaparinux sodium) from the Ministry of Health, Labour and Welfare in Japan.
Community health charities receive £265,000 in recognition of their work from GlaxoSmithKline
Twenty-five community based charities have been rewarded for their community-based work, as GlaxoSmithKline awards a total of £265,000 at the annual GlaxoSmithKline IMPACT Awards, run in conjunction with the independent health charity, the King’s Fund.
Cervarix®, GSK cervical cancer candidate vaccine, demonstrates 100 percent protection against precancerous lesions caused by cancer-causing human papillomavirus types 16 & 18 for more than five years
The GlaxoSmithKline (NYSE: GSK) cervical cancer candidate vaccine, CERVARIX ®, demonstrated 100 per cent efficacy in preventing precancerous lesions due to cancer-causing human papillomavirus types 16 and 18 for up to 5.5 years in an extended follow-up trial, according to data presented today at the American Association for Cancer Research. The trial results demonstrate the longest duration of protection seen in any cervical cancer vaccine trial reported to date.
GSK initiates repeat dosing study of its novel oral platelet growth factor, eltrombopag, in ITP
GlaxoSmithKline plc today announced the initiation of a global, open-label, single group trial that will assess the efficacy, safety and tolerability of eltrombopag in patients previously treated for chronic idiopathic thrombocytopenic purpura (ITP). The trial, called REPEAT (Repeat ExPosure to Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura) will evaluate a repeated dosing schedule of three six week cycles of eltrombopag treatment in 50 patients with chronic ITP who will be enrolled at multiple centres.
GSK announces FDA approval of Altabax (retapamulin ointment), 1%
GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved its antibacterial Altabax for the topical treatment of impetigo due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes, the two most common types of bacteria in this kind of infection.
GSK and Adolor announce preliminary results from phase 3 Safety study of Alvimopan (Entereg/Entrareg)
GlaxoSmithKline (LSE and NYSE:GSK) and Adolor Corporation (Nasdaq:ADLR) today announced data from Study 767905/014 and provided an update on the clinical development program for alvimopan (Entereg/Entrareg®).
Trexima (sumatriptan/naproxen sodium) superior efficacy data published in JAMA
(NYSE: GSK; NNASDAQ: POZN) — Findings from two pivotal efficacy studies of more than 2,900 migraine sufferers demonstrated that Trexima™ provided superior headache relief at two hours and four hours compared to placebo, and two through 24-hour sustained pain-free results versus sumatriptan or naproxen monotherapy. The results were published today in the Journal of the American Medical Association (JAMA).
Once daily, extended-release ropinirole improves Parkinson's symptoms in patients not optimally controlled with levodopa
Adding the once daily, investigational medication Requip ® (ropinirole HCl) XL 24-Hour™ Extended-Release Tablets to Parkinson’s patients’ existing levodopa (L-dopa) therapy significantly reduced ‘off’ time, allowing patients to continue their daily activities for a longer period of time. ‘Off time’ describes the return of Parkinson’s symptoms as a patient’s medication wears off. The Ropinirole 24-Hour Prolonged Release Randomized, Controlled Study in Advanced Parkinson Disease (EASE-PD Adjunct Study) results, published in the April 3 issue of Neurology, show that adjunct treatment with Requip XL 24-Hour significantly reduced ‘off’ time by an average of more than two hours per day when compared to baseline prior to treatment.
FDA approves accelerated dosing schedule for GlaxoSmithKline's Twinrix
GlaxoSmithKline [NYSE:GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved Twinrix ® [Hepatitis A Vaccine (Inactivated) and Hepatitis B (Recombinant) Vaccine], for an accelerated dosing schedule that consists of three doses given within three weeks followed by a booster dose at 12 months. The approval means Twinrix, the only hepatitis A and hepatitis B combination vaccine available in the United States, is now available on a dosing schedule at 0, 7, 21-30 days, followed by a booster dose at 12 months. The vaccine was first approved for adults over age 18 years by the FDA in May 2001 on a 0, 1, 6-month dosing schedule.
GlaxoSmithKline KK seeks approval in Japan for lapatinib, a new treatment for breast cancer
GlaxoSmithKline KK (Head Office: Shibuya-ku, Tokyo, President: Marc Dunoyer, hereinafter referred to as GSK) announced the submission of a New Drug Application (NDA) to the Japanese authorities for approval to market lapatinib, its new cancer drug on 30 March. The indication for which the company seeks approval is for both monotherapy and for combination treatment with capecitabine* for patients with advanced or metastatic HER2 positive breast cancer in women who have received prior therapy including an anthracycline, a taxane, and trastuzumab.
GlaxoSmithKline files meningococcal conjugate vaccine
GlaxoSmithKline announced today the submission of a regulatory file to European Medicines Agency (EMEA) under Article 58 for the combination vaccine candidate Globorix™ (diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, Neisseria meningitides serogroups A and C). In clinical trials including countries in Africaand Asia, the conjugate meningococcal vaccine has demonstrated a good safety profile and immunogenicity against meningococcal meningitis caused by Neisseria meningitidis serogroups A and C in addition to five other major childhood diseases. Under Article 58, the EMEA, in cooperation with the World Health Organization (WHO), gives a scientific opinion on the efficacy, quality and safety of medicinal products intended for use exclusively outside the European Union.
GlaxoSmithKline submits biologics license application to US Food and Drug Administration for Cervarix
GlaxoSmithKline (NYSE: GSK) announced today that the company has submitted a Biologics License Application (BLA) for CERVARIX® (human papillomavirus vaccine, AS04 adjuvant-adsorbed), its cervical cancer candidate vaccine, to the U.S. Food and Drug Administration (FDA). If licensed, the vaccine will be indicated for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus types. For this candidate vaccine, GSK selected a novel proprietary adjuvant system called AS04, intended to enhance immune response and increase duration of protection.
GlaxoSmithKline appoints Zhi Hong to head infectious-diseases research centre
GlaxoSmithKline announces the appointment of Zhi Hong, Ph.D., to lead a newly organised research unit dedicated to discovering therapies for infectious diseases, effective 23 April.
New study indicates nicotine patches may be safe for helping patients with coronary artery disease to quit smoking
A new study presented today at the American College of Cardiology’s 56th Annual Scientific Session, a gathering of over 30,000 cardiovascular experts, indicates that nicotine patches may be safe to use in patients with coronary artery disease (CAD).[1] Currently, 40 percent of smokers continue to smoke after a coronary event.[2] Quitting smoking can reduce the risk of subsequent mortality and further cardiac events in smokers with coronary artery disease by as much as 50 percent in the first year.[3]
GlaxoSmithKline announces Altargo receives positive opinion in Europe for treatment of impetigo and other skin infections
GlaxoSmithKline (GSK) today announced that its new, novel topical antibiotic Altargo® (retapamulin ointment, 1%) received a positive opinion from the European Committee for Human Medicinal Products (CHMP) for the treatment of impetigo and infected small lacerations, abrasions or sutured wounds. Impetigo is a superficial skin infection most commonly seen in children. The CHMP's positive opinion will now be proposed for final marketing approval by the European Commission.
GSK giving figures exceed £300 million for fourth year running: medicines for Lymphatic Filariasis elimination valued at £16 million
GlaxoSmithKline today announced its global giving to charitable initiatives totalled £302 million, equivalent to almost 4% of pre-tax profits for the company (with the FTSE 100 average around 1%). GSK has been the largest charitable giver on the FTSE 100 since GSK was formed in 2000. Donations of albendazole for the Company’s flagship programme to eliminate Lymphatic Filariasis were valued at £16 million, with 155 million albendazole treatments delivered to 34 countries around the world. Cash grants of £1 million were also made to support this major programme
GSK announces nationwide availability of once-a-day Coreg CR for the treatment of three key cardiovascular conditions
GlaxoSmithKline (NYSE: GSK) announced today that Coreg CR ™ (carvedilol phosphate) extended-release capsules, a once-a-day beta-blocker, is now available at pharmacies nationwide.
FiberChoice plus multivitamins issues allergy alert
GlaxoSmithKline (GSK) Consumer Healthcare, marketers of FiberChoice® fiber supplement is recalling the newest variant of FiberChoice® plus Multivitamins fiber supplement. This recall affects 90 count (16oz.) plastic bottles with the UPC #5714500581, which is located on the side of the bottle in black lettering. One of the following lot numbers appears on the bottom of the bottle in black lettering:
FDA approves Tykerb (lapatinib) in combination with Xeloda (capecitabine) for the treatment of advanced or metastatic breast cancer in women who have progressed on prior therapy
GlaxoSmithKline plc [NYSE: GSK, LSE: GSK] announced today that the United States Food and Drug Administration (FDA) approved Tykerb ® (lapatinib), in combination with Xeloda® (capecitabine), for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. It is the first targeted, once-daily oral treatment option for this patient population. Tykerb was granted Priority Review by the FDA in November 2006.
New JACC analysis details cardiovascular protective benefits of carvedilol in heart failure patients
Patients with heart failure who received the heart medication carvedilol suffered fewer heart attacks and strokes and were less likely to die of these and other vascular events than patients prescribed another beta blocker, metoprolol tartrate, according to a retrospective analysis of COMET (the Carvedilol or Metoprolol European Trial) published in the March 6th issue of The Journal of the American College of Cardiology.
New studies indicate GSK's pre-pandemic influenza vaccine can protect against different strains of H5N1
GlaxoSmithKline (GSK) announces clinical trial data from two new studies, which show, for the first time, that GSK’s candidate pre-pandemic split antigen H5N1 vaccine, formulated with GSK’s proprietary adjuvant system, provides a substantial level of cross-immunity against a ‘drifted’ (diverse) strain of H5N1. It is hoped that the immune response elicited with this vaccine, could help prepare or ‘prime’ the immune system to rapidly respond against variants of the H5N1 strain and therefore protect the vaccinated population in the event of an H5N1 human pandemic.
Study published in New England Journal of Medicine: Vaccine 95.5% effective against neglected hepatitis E
A new candidate vaccine against hepatitis E, developed collaboratively by GlaxoSmithKline (GSK) and the Walter Reed Army Institute of Research (WRAIR), was found to be 95.5% effective in a Phase Two trial, according to a study to be published in the New England Journal of Medicine. Hepatitis E, a waterborne strain of hepatitis that occurs almost exclusively in the developing world, is currently without cure or medical prophylaxis.
New data show fluticasone furoate nasal spray effectively treated nasal symptoms of allergic rhinitis
GlaxoSmithKline (GSK) today announced the presentation of new data on fluticasone furoate nasal spray (FFNS), an enhanced affinity intranasal corticosteroid (INS) currently in development for use in the treatment of allergic rhinitis.
GSK initiates first global Phase III study of Tykerb (lapatinib) in head and neck cancer
GlaxoSmithKline today announced the start of an international Phase III trial of its investigational cancer treatment Tykerb® (lapatinib) in squamous cell carcinoma of the head and neck (SCCHN). This announcement follows the International Meeting on Innovative Approaches in Head & Neck Oncology, Barcelona, Spain, 22nd-24th February supported by the European Society for Therapeutic Radiology and Oncology (ESTRO), where GSK presented results from a Phase I study of lapatinib in SCCHN.
Landmark study shows important benefits of Seretide treatment for patients with fatal lung disease, COPD
Results of the TOwards a Revolution in COPD Health (TORCH)study, the largest of its kind, have been published today in the New England Journal of Medicine 1 and represent a landmark in COPD, a disease which kills more people each year than breast cancer and lung cancer combined.2,3 The results show important benefits of Seretide in the treatment of patients with COPD. The three year study was designed to investigate reductions in death from any cause as the primary endpoint and also measured improvements in exacerbations (or worsening of symptoms) and quality of life as key secondary findings. The results from TORCH have been submitted to the regulatory authorities for consideration for inclusion into Seretide prescribing information.
GlaxoSmithKline acquires exclusive rights to over-the-counter orlistat for markets outside the US from Roche Group
GlaxoSmithKline plc (GSK) announced today that it has acquired from Roche Group exclusive rights to the weight-loss medicine, orlistat, for over-the-counter (OTC) use in markets outside the US, excluding Japan. GSK anticipates filing orlistat for OTC approval in Europe and certain key international markets by the end of 2007.
OFT market study into the Pharmaceutical Price Regulation Scheme
The Office of Fair Trading (OFT) has today raised several important questions on the current approach, taken by the Pharmaceutical Price and Regulation Scheme (PPRS), and its role in the control of NHS expenditure.
GlaxoSmithKline successfully completes tender offer for shares of Praecis Pharmaceuticals
GlaxoSmithKline plc [NYSE: GSK] announced today the successful completion of the tender offer by its wholly-owned subsidiary Pilgrim Acquisition Corporation (PAC) for shares of common stock (including the associated preferred stock purchase rights) of Praecis Pharmaceuticals Incorporate (Nasdaq: PRCS).
GlaxoSmithKline Diseases of the Developing World ad campaign receives industry award
GlaxoSmithKline (GSK) today announced that its “Facing the Challenge” print advertisement campaign has received a Mobius Award certificate in the “Outstanding Creativity in Corporate Identity and Branding” category. The “Facing the Challenge” series of ads emphasizes GSK’s ongoing commitment to delivering needed treatment and resources for malaria and tuberculosis (TB) in Africa. The Mobius Awards, in its 36th year, is an international organization recognizing creativity in advertising. This year the Mobius Awards recognized creativity among television, radio and print advertising, as well as new media, package design, direct and mixed media campaigns.
WHO awards prequalification status to GSK rotavirus vaccine
GlaxoSmithKline announced today that the company’s rotavirus vaccine has been awarded prequalification status by the World Health Organization (WHO). It is the first time a vaccine against rotavirus gastroenteritis has received such clearance.
GlaxoSmithKline and Human Genome Sciences announce initiation of Phase 3 clinical trial of Lymphostat-B in systemic lupus erythematosus
GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced the initiation of dosing in BLISS-76, one of two pivotal Phase 3 clinical trials of LymphoStat-B® (belimumab) in patients with active systemic lupus erythematosus (SLE). LymphoStat-B is being developed by HGS and GSK under a definitive development and commercialisation agreement entered into in August 2006.
GlaxoSmithKline offers new tools to help patients get free medicines
GlaxoSmithKline [NYSE:GSK] has launched a new website and toll-free help line to make it easier to enroll in GSK Access, the company’s new patient assistance program for low income Medicare Part D patients. Beginning today, patients can log onto www.gsk-access.com or call 1-866-475-3678 to get information on GSK Access, which offers prescription medicines for free to eligible Part D-enrolled patients.
GlaxoSmithKline commends $1.5 billion advance market commitment for pneumococcal vaccines
Funding from Canada, Italy, Norway and the UK may save millions of poor children and pave the way for rapid introduction of future vaccines, including AIDS, malaria and TB
GlaxoSmithKline and XenoPort announce agreement on late-stage compound for RLS and neuropathic pain
GlaxoSmithKline (GSK) and XenoPort, Inc. (Nasdaq: XNPT) today announced an exclusive agreement to co-develop and commercialise XP13512, a unique prodrug of gabapentin that improves its bioavailability, in the US and other countries worldwide, excluding certain Asian countries. XP13512 is currently in Phase III development for Restless Legs Syndrome (RLS) and in Phase II development for neuropathic pain. Prior clinical trial results have been encouraging.
GlaxoSmithKline and Fabre-Kramer Pharmaceuticals enter global agreement for new treatment of major depressive disorder
GlaxoSmithKline (GSK) and Fabre-Kramer Pharmaceuticals, Inc. (FKP) today announced an exclusive worldwide agreement for gepirone ER, a 5HT1a agonist expected to be submitted in this quarter for Food and Drug Administration (FDA) review in the US for major depressive disorder (MDD). The agreement includes development and commercialisation of gepirone ER as well as development opportunities for follow-on products.
FDA approves alli (orlistat 60 mg capsules) over-the-counter
GlaxoSmithKline [NYSE:GSK] Consumer Healthcare announces today that the US Food and Drug Administration (FDA) approved the weight-loss product orlistat 60 mg capsules for over-the-counter (OTC) use in the United States. GSK Consumer Healthcare will market OTC orlistat under the brand name alli ™ (pronounced AL-eye). Approved for use by overweight adults in conjunction with a reduced-calorie, low-fat diet, alli helps people lose 50 per cent more weight than with diet alone. alli is the only FDA-approved weight-loss product available to consumers without a prescription, and it is the first clinically-proven over-the-counter product to be combined with a comprehensive support program. alli is expected to be available in stores nationwide by summer 2007. This approval marks the start of an educational program that includes a series of resources online at myalli.com.
GlaxoSmithKline accepts shares in tender offer for shares of Praecis Pharmaceuticals and commences subsequent offering period
GlaxoSmithKline plc (GSK) announced today the expiration of the initial offering period of the tender offer by its wholly-owned subsidiary Pilgrim Acquisition Corporation (PAC) for all outstanding shares of common stock (including the associated preferred stock purchase rights) of Praecis Pharmaceuticals Incorporated (Nasdaq: PRCS). The initial offering period expired, as scheduled, at 12:00 midnight, New York City time, on Tuesday, February 6, 2007.
GlaxoSmithKline receives approvable letter for new indications for Arixtra (fondaparinux sodium) injection
GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for the once-daily anticoagulant, ARIXTRA (fondaparinux sodium) Injection, for the treatment of patients with:
Valtrex (valacyclovir) - US patent litigation update
GlaxoSmithKline (GSK) today issued an update on USpatent litigation regarding Valtrex (valacyclovir), an antiviral drug used for the treatment and suppression of genital herpes, herpes zoster (shingles), and cold sores. In May 2003, GSK filed a patent infringement suit, in the US District Court of New Jersey, against Ranbaxy alleging that its generic product would infringe GSK’s basic “composition of matter” patent (4957924) for Valtrex, which expires in June 2009 (excluding paediatric exclusivity). No trial date has yet been set for this litigation.
GlaxoSmithKline files its new pre-pandemic influenza vaccine in Europe
GlaxoSmithKline (GSK plc) today announced that its new generation H5N1 split antigen pre-pandemic influenza vaccine has been accepted for review by the Committee for Medicinal Products for Human Use (CHMP) in Europe. This innovative vaccine utilises GSK’s novel proprietary adjuvant system technology which allows a very low amount of antigen (3.8µg) to be used to elicit a strong seroprotective response – the so-called ‘antigen-sparing’ effect.
GlaxoSmithKline statement - BBC Panorama - 29 January 2007
GlaxoSmithKline (GSK) strongly denies the allegations made by Panorama in their programme that it has acted in any way improperly and wishes to make the following points:
GlaxoSmithKline initiates head-to-head study of cervical cancer vaccines
GlaxoSmithKline announced today the initiation of the first study of its kind designed to compare the immunogenicity of its cervical cancer candidate vaccine, Cervarix®, versus Gardasil ®. The primary objective of the head-to-head trial is to compare the immune responses to HPV types 16 and 18 in U.S. women 18 to 26-years-old. Secondary objectives include evaluating the immune responses to HPV 16 and 18 in women 27 to 35-years-old and 36 to 45-years-old. In addition, the study will compare immune responses to other cancer-causing HPV types. Initial study results are anticipated 12 months after study enrollment is completed, and extended follow up will continue for another 17 months.
GlaxoSmithKline awarded $63 million HHS contract for pandemic vaccine research and development: Company begins government and retail shipments of its antiviral Relenza
GlaxoSmithKline [NYSE: GSK], one of the world’s largest vaccine manufacturers, has been awarded a contract from the U.S. Department of Health and Human Services (HHS) for the development of pre-pandemic and pandemic flu vaccines. With a value of at least $63.3 million, the contract supports GSK’s ongoing pandemic vaccine research in using the company’s innovative adjuvant technology in combination with antigens to induce a strong immune response.
GlaxoSmithKline receives first European approval for Wellbutrin XR
GlaxoSmithKline announced today that Wellbutrin XR®* (bupropion hydrochloride modified-release tablets), has been granted a marketing license in The Netherlands for the treatment of adult patients with major depressive episodes. The medicine is also considered approvable by the regulatory agencies of 21 other countries** under the Decentralised Procedure.
GlaxoSmithKline commences tender offer to acquire Praecis Pharmaceuticals
GlaxoSmithKline plc (GSK) announced today that Pilgrim Acquisition Corporation, a wholly-owned subsidiary of GSK, is today commencing a cash tender offer to purchase all outstanding shares of common stock of Praecis Pharmaceuticals Incorporated (Nasdaq: PRCS), including the associated preferred stock purchase rights, for $5.00 in cash without interest and less any required withholding taxes. The tender offer is being made pursuant to a previously announced merger agreement dated December 20, 2006 among Praecis, Pilgrim Acquisition Corporation, and SmithKline Beecham Corporation, a wholly-owned subsidiary of GSK.