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Posts tagged with "Regulatory Affairs"

  • Regulatory Affairs

    Liable For Generics? You Are Now!

    There was a legal ruling last week in California that we’re going to hear a lot more of in this business. Conte v. Wyeth. This case involved metaclopramide, which was sold by Wyeth as Reglan before going off-patent in 1982. The plaintiff had been prescribed the generic version of the drug, was affected by a… Read More
  • Cardiovascular Disease

    Prasugrel Today?

    I wrote back in the summer about the FDA’s delayed decision on Lilly’s potential anticoagulant blockbuster Effient (prasugrel). Well, those three months have zipped right by, and the agency is supposed to rule today. Prediction, for what it’s worth: I think the drug will be approved, but with label restrictions for the group(s) th… Read More
  • Alzheimer's Disease

    Rember for Alzheimer’s: Methylene Blue’s Comeback

    Today we take up the extremely interesting story of Rember, hailed in this week’s press as a potential wonder drug for Alzheimer’s. There are a lot of unusual features to this one. To take the most obvious first, the Phase II data seem to have been impressive. It’s hard to show decent efficacy in an… Read More
  • Clinical Trials

    Glaxo Asks the Eurocrats

    There was a story yesterday about GlaxoSmithKline taking what’s being called an unusual step to prioritize their clinical candidates. According to the Wall Street Journal, they invited officials from the national health care plans of several European countries to a presentation on the company’s pipeline and asked them which ones they’d be mor… Read More