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Monthly Archives: July 2010
Judgment Day for Avandia
Judgment Day has finally arrived for GSK’s Avandia. FDA’s Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees met July 13 and 14 to finally recommend, after months of deck-stacking against GSK, that the drug be severely restricted, if not outright pulled from the market. In the vote, 12 of 33 panelists [...]
Avandia on Trial
The mid-July FDA advisory committee meeting to decide the fate of GlaxoSmithKline’s Avandia (rosiglitazone) is widely viewed as a test case of how the agency’s new leadership will address controversial drugs with serious risks but confusing data. A request that GSK yank its diabetes blockbuster—three years after first being associated with an increased risk of [...]
The Bizarre European Political Bazaar
Pharm Exec Europe’s Brussels correspondent Reflector is exasperated by some of the European Union’s more unusual institutional arrangements.
A senior Spanish diplomat told Reflector recently that, on the face of it, the European Union is a crazy set-up. He was talking about some of its bizarre institutional arrangements — such as a Commission composed of 27 [...]
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Merck to Close Eight Plants
Image by Getty Images via @daylife
Over the next two years, Merck will shut down eight manufacturing plants, as well as eight research sites, as part of the ongoing Schering-Plough merger process. The company said in a statement that the various site exits will help “create a flexible R&D organization.”
Taking a page out of Pfizer’s book [...]
Posted in Strategy Tagged business, Canada, Factory, Infectious disease, Merck, Research and development, Schering Plough, South America 3 Comments
Weight-Loss Drug Qnexa Loses in FDA Committee Ruling