GSK news

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
- Primary efficacy endpoint met in two pivotal Phase 3 trials, as specified by Special Protocol Assessment agreement with FDA

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

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™

GSK and Genmab announced the accelerated approval of ArzerraTM (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.

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 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.

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.

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.

GlaxoSmithKline and Prosensa form alliance to fight Duchenne Muscular Dystrophy

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)

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