Skip to Content

Posts tagged with "Regulatory Affairs"

  • 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
  • Regulatory Affairs

    Snort Yourself Some Zinc. Or Maybe Not.

    I missed commenting on this earlier, but many readers may have noticed the recent scandal caused by Zicam. This is a cold remedy which was sold as a homeopathic medicine, but its makers committed the unforgivable sin of actually having something in its formula besides well-shaken distilled water. A lot of people are convinced that… Read More
  • Regulatory Affairs

    Selling Zyprexa

    Well, this doesn’t look good for Lilly. A huge pile of court documents has been unsealed in the ongoing lawsuits about Zyprexa’s off-label promotion. The company has already paid some serious fines, and is now fighting it out with insurance companies and other plaintiffs who are seeking to recover their costs. Several states are suing… Read More
  • Business and Markets

    Arena, Lorcaserin, and the FDA

    I’ve been getting a lot of objections to my opinion on Arena’s obesity candidate lorcaserin. Specifically, the first level of the dispute seems to be whether or not the recent clinical trial results met the FDA’s criteria for efficacy or not. So, let’s look at the details. Here’s how Arena press-released the results of the… Read More
  • Drug Industry History

    Book Review Department

    For those who are interested, I have a review up at Nature Biotechnology of Reasonable Rx: Solving the Drug Price Crisis, a book that proposes an. . .interesting solution for reworking the drug industry. And as Fate would have it, I also have a review in the latest issue of Nature Chemistry of Drug Truths: Read More
  • Business and Markets

    Dendreon’s Revenge?

    Post updated below – DBL Dendreon is a company that’s really been through it, as have their investors. Many will remember the upheaval back in 2007, when the company showed what they felt were impressive results for their autologous prostate cancer immunotherapy Provenge, got a favorable reception from the FDA’s advisory panel, bu… Read More
...222324...