Tag Archives: GSK

GSK Submits Malaria Vaccine Candidate for EMA Approval

GSK announced that it has submitted a regulatory filing to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S. RTS,S is intended for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa (SSA). It is estimated that malaria accounts for approximately 90% of deaths in SSA, of which 77% occur […]
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FDA Warning to GSK Biologicals

FDA issued a warning letter to GlaxoSmithKline Biologicals (GSK), North America on June 12, 2014 for deviations from cCGMP requirements found during an inspection from Mar. 31 to Apr. 9, 2014 of its influenza vaccine manufacturing facility in Quebec. GSK is making progress in addressing FDA’s concerns and is working to meet supply commitments, the […]
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GSK's Tykerb "Little More" to Offer

The future of GSK’s Tykerb (lapatinib) in the breast cancer market is unclear, after the combination of Tykerb and Herceptin in the large Phase III trial, ALTTO, showed no statistical superiority over Herceptin alone for improving disease-free survival, says research and consulting firm GlobalData.
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Big Pharma’s Big Tuesday: A New Age of Megamerger?

What’s the opposite of Black Tuesday? White Tuesday? Bright Tuesday? Because Tuesday the stock market was buzzing following the news that Novartis is to acquire GSK’s cancer drugs business, while selling its vaccines division to GSK. With the speculation of a $100bn Pfizer bid for AstraZeneca and Valeant Pharmaceuticals added in, prices went soaring. As of […]
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Frontrunners in Innovation: New Drug Approvals 2013

Frontrunners in Innovation: New Drug Approvals 2013 Trying to nail down the actual number of new drugs approvals in 2013 is like trying to swat a fly—it can be highly illusive.  Safe to say, however, as 2013 drew to a close,  the total number of new did not match 2012’s  high of 39. And yet, […]
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