PharmExec Blog
Follow Us
RSS
Bookstore
Tag Archives: GSK
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
FDA and GSK on the Hunt for Stolen Drugs
Image by Johnny Grim via Flickr
We typically don’t get emails from FDA asking for information about stolen goods with massive bold letters, but that’s what just came into our inbox. Looks like a transport truck containing a mix of GlaxoSmithKline’s pharmaceutical and over-the-counter medications was jacked in Puerto Rico on January 29, and the feds [...]
Posted in FDA, News Also tagged Food and Drug Administration, Medicine, Pharmaceutical drug, Puerto Rico, Security, Theft 1 Comment
Justice to Pharma: "Do the Perp Walk!"