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Tag Archives: Avandia
Justice to Pharma: "Do the Perp Walk!"
Former GSK counsel is the first target in government’s executive-liability crackdown. Could J&J be next?
The US Department of Justice filed criminal charges last week against Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. Going after pharma execs marks a seismic shift in the government’s efforts to stem the tide of fraud and [...]
Avandia, Pharma, and the New FDA
The Harvard prof who wrote the book on FDA (literally) deconstructs the decision on Avandia—and its future implications.
GlaxoSmithKline’s diabetes drug Avandia became mired in such controversy regarding its safety in recent years that it was dubbed “another Vioxx”—exactly what the pharmaceutical industry had vowed never to produce. Two weeks ago, FDA’s decided to restrict access [...]
Posted in FDA, Regulatory, Safety Also tagged FDA, GlaxoSmithKline, GSK, Regulatory, REMS 2 Comments
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 [...]
Accelerated Approvals Could Raise Risks for Patients