Skip to Content

Posts tagged with "Regulatory Affairs"

  • 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    So now Avandia (rosiglitazone) looks to be withdrawn from the market in Europe, and heavily restricted here in the US.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
  • Diabetes and Obesity

    Lorcaserin in Trouble

    The FDA committee that will be looking over Arena’s lorcaserin for weight loss has released its briefing information, and there were some nasty surprises therein. A memo states that the drug did not satisfy the mean efficacy requirements that the FDA has laid down for obesity therapies, and satisfied the categorical efficacy one “by a… Read More
  • Regulatory Affairs

    A New Way to Approve Drugs

    Who are our customers in this drug business? Well, sick patients, naturally. But their physicians, too, since they’re the ones who will be writing the prescriptions. And the insurance companies, of course, since in most cases they’re the ones who will be paying at least some of the bill. But the customer before we get… Read More
  • Cancer

    Avastin For Metastatic Breast Cancer: The Whole Story

    Here’s an excellent roundup of the Avastin story, referenced in an earlier post here. I have to say, I’ve been disappointed in some of the commentary on this issue (which that article goes into as well). Too many people have jumped right to the conclusion that yep, here’s what the new health care plan is… Read More
  • Regulatory Affairs

    Not Your Usual FDA Hearing

    You always had to wonder how the move of appointing Sidney Wolfe to the Drugs Safety and Risks Management Committee at the FDA was going to work out. The signs of friction are appearing. I’m with the InVivo Blog: this is the first time I’ve heard of an FDA committee cutting off the microphone on… Read More
  • Business and Markets

    Going Hollywood

    A reader at one of the big pharma companies sends along this note: . . .Over my 10 years or so of experience, I have seen a severe decline in risk tolerance at my company, and other large companies as well. When we put a project forward, we are told that either: (a) There are… Read More
  • Business and Markets

    Biosimilars: Not Easy, But Not Impossible, Either

    So we actually had two converging stories on Friday afternoon – the news that Sanofi-Aventis is going after Genzyme, and the news that tiny Momenta Pharmaceuticals finally got FDA approval for a biogeneric of Lovenox (enoxaparin). . .a big seller for Sanofi-Aventis. I knew something was going on with those folks – I’m close enough… Read More
  • Clinical Trials

    Vivus, Qnexa, Arena, Lorcaserin and the FDA

    One big story from the last week was the FDA advisory panel’s “No” decision on Qnexa, the drug-combo obesity therapy developed by Vivus. This is the one that’s a combination of phentermine and topiramate, both of which have been around for a long time. And clinical trials showed that patients could indeed lose weight on… Read More