GSK news
World Health Organization Grants Prequalification for Global Use to GSK’s 10-Valent Synflorix™ Vaccine
Endorsement is first for vaccine for pneumococcal disease - a life-threatening disease affecting many children; follows first-ever World Pneumonia Day
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World Health Organization Grants Prequalification for Global Use to GSK’s 10-Valent Synflorix™ Vaccine
Endorsement is first for vaccine for pneumococcal disease - a life-threatening disease affecting many children; follows first-ever World Pneumonia Day
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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
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ViiV Healthcare launches: A new specialist HIV company dedicated to delivering advances in HIV treatment and care
Dr Dominique Limet, CEO of ViiV Healthcare, promises 'relentless pursuit' of new treatments
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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
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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
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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
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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.
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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.
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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.
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