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Posts tagged with "Regulatory Affairs"

  • 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
  • Academia (vs. Industry)

    Reporting Clinical Trials

    In 2015, a study looked at drug-industry sponsored clinical trials versus those funded by the NIH, and concluded that about 20% of industry trials did not report results when required to do so, while the figure for NIH-sponsored research was about 50% (and even more for trials funded by other institutions). At the time, I… Read More
  • Drug Prices

    A “Moral Imperative”

    Unfortunately, we have another example of “price of ancient generic drug shoots through roof”. Whenever this happens, the first thing to look at is the regulatory environment. After that you can go on about the greed of the company and its executives, the stupidity of the insurance companies, all the usual stuff, and you won’t… Read More
  • Clinical Trials

    Sangamo’s Gene Therapy Results

    Let the arguing commence! That’s my response to the announcement this morning by Sangamo, a company that’s been trying to do gene therapy in the clinic. They’re not a CRISPR outfit, though – they’re using an alternate technique for gene silencing, using zinc finger regions instead. Even at that level, there’s mor… Read More
  • Cancer

    Real-Time Approval

    Here’s an example of the current regulatory framework – you may like it, you may not, but if you’re doing drug research you should know that it’s going on. The way it’s traditionally worked – for decades – has been that a company develops a drug, runs clinical trials, etc., puts together a (huge) data… Read More
  • Business and Markets

    Anarchist Drugs For All. Yeahboy.

    I’ve had numerous requests for my opinion about this article, so here it comes: it’s largely bullshit. It’s about “a volunteer network of anarchists and hackers developing DIY medical technologies”, and I can see why Vice.com is running the article, because that drugs/anarchists/hackers combo is absolute catnip to thei… Read More
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