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Posts tagged with "Regulatory Affairs"

  • Cardiovascular Disease

    Statin Safety?

    Senator Charles Grassley of Iowa has sent the FDA a letter asking if the agency has sufficiently considered adverse events from statin drugs. I’ve been unable to find the text of the letter, but here’s a summary at Business Week. (Grassley’s own list of press releases, like most other senators and representatives, is a long… Read More
  • Business and Markets

    The Drug Business: A Turbulent Future?

    One of this blog’s regular correspondents has just been attending a chemistry outsourcing conference (program here), and heard a very interesting talk from Stefan Loren of a Baltimore investment advisory firm, Westwicke Partners. Loren’s a product of the Sharpless lab, who went on to Abbott, then Wall Street (Legg Mason and into the hed… Read More
  • Business and Markets

    A 2.3 Billion Dollar Attention-Getter

    No sooner do I write another post about pharma marketing than Pfizer finds itself paying 3.2 2.3 billion dollars in fines for doing it improperly. 1.2 billion of that is a criminal penalty, and needless to say, they’ve set the current record. The issues were off-label promotion of Bexxtra, Geodon, Zyvox, and Lyrica, with the… Read More
  • Regulatory Affairs

    REACH for the Sky!

    I wrote years ago on this blog about REACH, the European program to (as the acronym has it) Register, Evaluate, Authorize and Restrict Chemical substances. (I’m not sure where that second R got off to in there). This is a massive effort to do a sort of catch-up for chemicals that were introduced before modern… Read More
  • Diabetes and Obesity

    Obesity Shows Up in the Death Rate? Right?

    Here’s an interesting post at Chemiotics (a new addition to the blogroll): Something is Wrong With the Model . . . The Center for Disease Control released new data for 2007 (based on 90% of all USA death certificiates) showing that mortality rates dropped again (by over 2%) to 760/100,000 population. It’s been dropping for… Read More
  • Current Events

    The PhRMA Deal

    I’m not always a fan of John Boehner, but I think he’s on the right track with his letter to Billy Tauzin (PDF here from NPR’s health care site). I understand that line about how in Washington, if you’re not at the table you’re on the menu. And I understand how the industry wants to… Read More
  • Current Events

    PhRMA’s Negotiating Game

    Now for a bit on the pharma industry and the current fight over health care legislation. Does the industry want a new system to come into force, or not? Depends on what that new system is, of course. But the industry is naturally trying to make sure that it has a hand in whatever passes. Read More
  • Business and Markets

    Savient Feels The Pains of Gout

    Well, here’s a nasty surprise for you: your new drug gets a 14 to 1 “Yes” vote from an FDA advisory committee, but the agency turns you down, anyway. That’s what’s just happened to Savient and their new biologic product for gout, Krystexxa (pegloticase). The FDA isn’t required to say why they do such things… Read More
  • Current Events

    Health Care Reform – Really?

    I haven’t written about the various health care reform packages that are being hammered out and hammered through the various parts of Congress. That’s partly because I began to think fairly early on in the process that we weren’t actually going to see something happen as quickly as the administration wanted, which meant that there… Read More
  • Business and Markets

    Vanda Comes Back From the Dead

    I wrote last summer about Vanda Pharmaceuticals and their difficulty getting a new antipsychotic Fanapt (iloperidone) through the FDA. At the time, they’d received one of those wonderful requests for more information from the agency, of the kind that spread cheer whenever they appear. I couldn’t see how the company could clear this up w… Read More
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