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Posts tagged with "Regulatory Affairs"

  • 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
  • Cancer

    Mylotarg and the FDA

    Someone completely outside the industry asked me the other day what I thought about the FDA. I replied that I had a lot of sympathy for them, actually. There’s almost no way that they can avoid being yelled at by one group or another. You know – they’re a bunch of foot-dragging nitpickers who are… Read More
  • Drug Development

    Flibanserin: Not a “Female Viagra” At All

    I haven’t commented on the controversy over Boehringer Ingleheim’s drug for female libido, flibanserin. An FDA advisory panel voted it down on Friday, and it wasn’t close: 10-1 against whether the drug showed efficacy, and unanimously against its side effect profile. I really don’t see how the drug is going to make it back f… Read More
  • Blog Housekeeping

    Nativis: In Which the Distant Footfalls of Lawyers Can Be Heard

    I’ve received a letter from John Kingma, the Chief Financial Officer of Nativis. I reproduce it below word-for-word (Here’s the PDF of the original, in case anyone would like to check): Dear Dr. Lowe, The scientific nature of your blog seems to have taken a turn for the worse with the negative personal attacks on… Read More
  • Cancer

    Eribulin Gets Reviewed, Finally

    So it looks like the FDA is giving reviewing Eisai’s oncology drug Eribulin (E7389) a priority review. The company had hoped to get it reviewed three years ago, but the FDA told them to get back into the clinic and collect more data. The compound is being reviewed for advanced breast cancer, and the earlier… Read More
  • Regulatory Affairs

    Regulatory Approvals in the US versus Europe

    I was looking at the list the other day of the 2009 drug approvals from the FDA. Here’s a breakdown from Nature Reviews Drug Discovery – 25 total, 16 small molecules and 9 biologics. And here, from the same journal, is a look at approvals in Europe. There were 29 – but the weird thing… Read More