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Posts tagged with "Regulatory Affairs"

  • Current Events

    Health Care Reform and the Drug Industry: How Goes It?

    We haven’t had enough controversy and arguing around here this week, have we? Let’s talk politics for the morning, then. Here’s a piece from a former VP for public affairs at Pfizer, arguing that PhRMA got thoroughly snookered during the health care reform bill. He’s looking over the current budget proposal: For biotech and… Read More
  • Cancer

    Not Enough Progress Against Cancer?

    Here’s a topic that’s come up here before: for a new cancer drug, how much benefit is worthwhile? As it stands, we approve things when they show a statistically meaningful difference versus standard of care (with consideration of toxicology and side effects). But should our standards be higher? That’s what this paper in the Journa… Read More
  • Animal Testing

    Reboxetine Doesn’t Work. But That’s Not the Real Problem.

    Some time ago, I took nominations for Least Useful Animal Models. There were a number of good candidates, many of them from the CNS field. A recent report makes me think that these are even stronger contenders than I thought. The antidepressant reboxetine (not approved in the US, but sold in a number of other… Read More
  • Business and Markets

    Ahem: “Sell Gobs of Dope”?

    Thanks to Jim Edwards at Bnet, we have an example of some of the worst pharma sales techniques imaginable. A lawsuit alleging that Gilead Pharmaceuticals had been illegally pushing off-label indications for their angina medication Ranexa (ranolizine) was dropped recently, which brought a lot of court papers into view. According to the whistle-blowe… Read More
  • Regulatory Affairs

    Drug Approvals 2010

    2010 wasn’t, though, a particularly good year for getting new drugs on the market. But it wasn’t an outstandingly bad one, either. The 21 approvals last year are lower than the previous two years (25 and 24), but still better than 2007’s 18. It’s actually right in the recent range, with the weirdo exception of… Read More
  • Cancer

    The Avastin Decision: A Reality Check

    So the FDA did indeed rescind their conditional approval for Avastin in metastatic breast cancer. I think that this was the right thing to do, given that the weight of the evidence now says that it doesn’t do any good in that situation. Problem is, there are a lot of people trying to make political… Read More
  • Regulatory Affairs

    A Whistleblowing Record

    The former GSK employee who went to the FDA about quality control problems in their manufacturing has been awarded $96 million dollars for her work (it’s calculated as a share of the fine against the company). This breaks all previous records – and you know, I think that’s a good thing. I’ve written about this… Read More
  • Diabetes and Obesity

    Lorcaserin’s Complete Response

    Arena released their complete response from the FDA over the weekend, regarding the non-approval of their weight loss drug Lorcaserin. And the arguing has already started about just how bad the news is. There are several levels that this process could be tracking on, and we just don’t know which one it’s on yet. And… Read More
  • Diabetes and Obesity

    Avandia Goes Down: A Research Rant

    So now Avandia (rosiglitazone) looks to be withdrawn from the market in Europe, and heavily restricted here in the US. This isn’t much of a surprise, given all the cardiovascular worries about it in recent years, but hindsight. Oh, hindsight: all that time and effort put into PPAR ligands, back when rosi- and pioglitazone were… Read More
  • Diabetes and Obesity

    Live-Blogging Arena’s FDA Committee Hearing

    San Diego newspaper blogger Keith Darce is doing it here. The meeting should start up again about 1 PM Eastern. So far, the company and the FDA staff have been presenting reviews of the Lorcaserin data. The committee member questions don’t look particularly encouraging. . . Update: the committee votes “No”, 9-5. We’ll see wh… Read More