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Posts tagged with "Regulatory Affairs"

  • 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
  • Drug Prices

    The Latest Drug Reimportation Idea

    It’s been a while since we talked about drug reimportation here, but it’s been back in the news recently. Drug prices are, naturally, of economic, medical, and political importance, and the administration has been making a great deal of noise about lowering them. To that end, HHS Secretary Alex Azar has announced the formation of a… Read More
  • Business and Markets

    Welcome to Right to Try

    Update: Brainstorm has now abandoned their Right-to-Try approach. Who’s next? That didn’t take long. That didn’t take long at all. The federal “Right to Try” bill was just signed the other week, and we already have a company that’s willing – no, eager – to try it out. I will now cruelly caricature som… Read More
  • Clinical Trials

    Finger-Pointing at Celgene

    Just what is going on at Celgene? They’ve had some odd recent setbacks (such as as the failure of Mongersen), and another such acquisition, Ozanimod, had its filing recently rejected by the FDA. Several things about that incident were eyebrow-raisers – for one, it’s rare for a large, established company to get an outright refusal- Read More
  • Cancer

    More Thoughts on AbbVie’s Rova-T Implosion

    I wrote a couple of months ago about the disappointing results that AbbVie had obtained with their cancer stem cell therapy “Rova-T” (rovalpituzumab tesirine) in small-cell lung cancer. This was the antibody-drug conjugate that they’d purchased from Stemcentryx – OK, let’s clarify that, they bought Stemcentryx out comp… Read More
  • Clinical Trials

    The FDA’s Latest Actions and Problems

    It’s been clear for many years now that some drug companies are abusing the “restricted distribution” idea to keep generic competitors from being able to enter their markets. That, in fact, was a basic part of Martin Shkreli’s entire business plan, but guess what? He was not the first person to think of doing that… Read More
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