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Posts tagged with "Regulatory Affairs"

  • Regulatory Affairs

    A New FDA Commissioner, Suddenly

    The big news late yesterday afternoon was the resignation of Scott Gottlieb as FDA commissioner. I have no idea why he’s leaving, naturally. He’s spoken about wanting to spend more time with his family and being dissatisfied with going back and forth between Connecticut and DC, and I have no doubt that both of those… Read More
  • Business and Markets

    Breakthroughs, Sort of

    We’re all familiar with the FDA’s “breakthrough” designation for drugs (and drug indications) in the clinical trial/approval process. Opinions vary on the whole idea – useful way to prioritize regulatory attention, PR device for all involved because they’re handing ’em out like Halloween candy these days, o… Read More
  • Regulatory Affairs

    The FDA and the Dietary Supplements

    I’ve been complaining for years on this blog about the “dietary supplement” industry, which exists in its present form thanks to Sen. Orrin Hatch. That’s the 1994 “Dietary Supplement Health and Education Act”, which like many a federal bill has a name that is somewhat detached from reality. I would suggest the &# Read More
  • Business and Markets

    The Clinic Giveth And Most Definitely Taketh Away

    There have been some pretty dramatic clinical trial results coming out recently, and unfortunately drama is a variable that can take either a positive or a negative sign in front of it. On the plus side, MacroGenix, a company that not many people had been paying attention to, announced results of a head-to-head trial of… Read More
  • Drug Development

    2018 Drug Approvals: A Closer Look

    Let’s have a look at the recent new drug approvals. 2018 was quite a year, by the numbers. C&E News has a comprehensive roundup: 59 approvals (versus 46 in 2017, which was already a record by itself), and about two-thirds of those small molecules. There are some very interesting molecules in the list, and I… Read More
  • Analytical Chemistry

    The Sartan Contamination Story

    There’s a chemical contamination story in the generic drug industry that just isn’t going away. Late last summer, some lots of valsartan were recalled due to detection of N-nitrosodimethylamine (NDMA), and the problem has just continued since then. We’ll get into the chemistry of this problem in a minute, but first off, looking at… Read More
  • Current Events

    Sen. Warren’s Generic Drug Idea

    Here’s a proposal from Sen. Elizabeth Warren to have the government manufacture generic drugs directly. (I was traveling yesterday and wasn’t able to blog this then). It’s clear that there are some problems with parts of the generic drug system that we have, so my first thoughts were (1) whether Warren saw the same problems… Read More
  • Drug Prices

    Blame the FDA for This Fiasco

    Back in 2013 and again in 2016, I wrote about Catalyst Pharmaceuticals, a South Florida company whose business plan I found repellant. That’s because said plan involved running an old generic compound (3,4-diaminopyridine) through the FDA modern approval process, which under the agency’s rules would grant them market exclusivity. I have… Read More
  • Business and Markets

    Worse Than Useless

    Time for another look at AbbVie’s work on Rova-T (an antibody-drug conjugate targeting the tumor antigen DLL3), and for some hard thoughts about what drug development is really like. The last time I wrote about this program, things didn’t look good. Now they look even worse. A Phase III trial of the drug has been… Read More
  • Alzheimer's Disease

    Failure Shouldn’t Be Such an Orphan

    The drug industry has  a huge stockpile of results on projects that have not worked. That much is clear – clinical success rates continue at about 10%, on average, so we have a steady stream failures of all kinds, for all reasons. It would be foolish not to learn as much as we could from… Read More
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