Press releases
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.
