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Posts tagged with "Regulatory Affairs"

  • Cardiovascular Disease

    Takeda Gets A Surprise

    DPP-IV is short for “dipeptidylpeptidase IV”, understandably, and we need a good abbreviation for it. It’s an important enzyme target for diabetes therapy, since under normal conditions it breaks down glucagon-like-peptide 1. Longer-circulating GLP-1 would actually do a lot of diabetics good, and people have actually made such proteins as sep… Read More
  • Regulatory Affairs

    More on Wyeth v. Levine and Preemption

    For those who want it, I have more thoughts on the Wyeth v. Levine pre-emption decision over at The Atlantic’s business site. Reading the decision, it looks less like a loss for the drug companies than a loss for the FDA, but see what you think. Read More
  • Current Events

    Wyeth v. Levine: Pre-emption Goes Away

    The idea of preemption in drug liability cases has been coming up a lot in recent years. If the FDA approves a drug, does that Federal-level approval stop liability suits at the state level, or not? The Supreme Court has ruled today in the Wyeth v. Levine case, which directly addresses this issue. And pre-emption… Read More
  • Regulatory Affairs

    We Won’t Stay Off The Radar Screen For Long, Y’Know

    And here’s an even more Macro topic: when do you think the new administration is going to turn its attention to the drug industry? That’ll be after this stimulus-bill business is settled, one way or another – and the only thing I’ll say about that, this not being the soapbox for my political opinions, is… Read More
  • Business and Markets

    Lilly Pays the Price

    Eli Lilly has been in trouble for some time now regarding off-label promotion of their antipsychotic Zyprexa – specifically, their sales reps seem to have gone around saying that it was useful in treating the dementia of Alzheimer’s patients, although there was no FDA approval for that indication. (Whether it actually is any good for… Read More
  • 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
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