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Tag Archives: GSK
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 Avandia, FDA, GlaxoSmithKline, Regulatory, REMS 2 Comments
Europe’s Fiscal Crisis: Can Big Pharma Emerge Unscathed?
Europe’s current fiscal crisis, symbolized by the meltdown in Greece, is seen by big pharma as a temporary situation to be taken in stride—after all, the EU southern and eastern tier, with its chronically shaky finances and per capita incomes as low as a third of the EU norm, has historically been a marginal player [...]
Posted in Europe Also tagged Andrew Witty, Drug Prices, Europe, Financial Crisis, Greece, Spain 2 Comments
Avandia Trial in Trouble
GSK’s Avandia just won’t stay out of the news. Now comes a report from The Wall Street Journal that the FDA is considering dealing the beleaguered diabetes drug another blow by stopping one of its safety trials.
The TIDE trial, which received approval in 2007, pits Avandia (rosiglitazone) against Takeda’s Actos (pioglitazone), a drug that [...]
Posted in Strategy Also tagged Actos, Avandia, FDA, Geodon, Pfizer, Takeda, US Senate Finance Committee Leave a comment
Lives of Patients Keep Sales Reps off Life Support