GSK news
GSK and Nabi announce agreement for NicVAX®, a vaccine for nicotine addiction
- Upfront and potential consideration of over $500 million
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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.
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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.
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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.
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Pandemic 2009 Influenza Update: Pandemrix™ data on co-administration with annual seasonal influenza vaccine (Fluarix®)s
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 ®.
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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 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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