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Posts tagged with "Regulatory Affairs"

  • Alzheimer's Disease

    There Are Failures, You Know

    This exact point came up around here when we last discussed FDA reform, so it’s good to see it made at length in the New England Journal of Medicine. Remember solanezumab? That was the amyloid-targeting antibody that Eli Lilly kept on investigating in trial after trial, looking for some effect on Alzheimer’s. Last November, the final… Read More
  • Business and Markets

    Marathon Pharmaceuticals Cashes Out

    You may recall Marathon Pharmaceuticals, the small company that announced plans to sell a long-used steroid treatment (Emflaza, deflazacort) in the US to Duchenne muscular dystrophy patients. The price was set to go up steeply, since the company was awarded years of market exclusivity by the FDA (under their program to reward orphan-drug indication… Read More
  • Regulatory Affairs

    Gottlieb At the FDA

    So today is when FDA Commissioner nominee Scott Gottlieb goes before the Senate committee, and it’s time for some thoughts on him, and some more thoughts on the FDA under the new administration. I purposely did not write about all the names that were mentioned for the post, because I just didn’t feel like spending… Read More
  • Pharmacokinetics

    The First Deuterated Drug Arrives

    The first deuterated drug has finally been approved by the FDA. It’s Austedo (deutetrabenazine), from Teva, and it targets Huntington’s chorea. This is an interesting development on several levels. The idea of adding deuteriums (instead of plain hydrogens) to drug structures had been kicking around for many years, but only in the last 8… Read More
  • Clinical Trials

    The Coming Landscape?

    Adam Feuerstein has an important list of companies (the “Gnarly Nine”) that will be going to the FDA soon. That process is always important for the companies involved, but these will serve as indicators of how the agency is dealing with the pressures for lowering the standards for drug approval. We don’t have a new FDA… Read More
  • Drug Prices

    The Case of Marathon Pharmaceuticals

    So since drug pricing and FDA regulations are so much in the news, it would seem like the perfect time for a small company to game the system for big profits, right? That’s apparently what Marathon Pharmaceuticals believes. They just got approval for deflazacort, a steroid, as a treatment for Duchenne Muscular Dystrophy. Duchenne is… Read More
  • Business and Markets

    Thoughts on Corruption

    I’ve had many questions about what I think of the PhARMA meeting with the new administration, but I haven’t written about it yet. That’s largely because it’s been difficult to figure out what it actually accomplished – statements about it have been all over the place, and I get the impression that different people took… Read More
  • Clinical Trials

    I Do Hate To Tell You This, But. . .

    The timing of this report from the FDA is surely no accident, but it’s always a good time to think about this: the great majority of all drugs that enter clinical trials fail. They fail because they don’t do anyone any good, or because what good they might do is outweighed by some serious and… Read More
  • Regulatory Affairs

    You Wouldn’t Be Lying About That, Would You?

    Biocentury has a really good interview with John Jenkins, who’s departing the FDA this week after 15 years as director of the Office of New Drugs at the agency’s CDER (Center for Drug Evaluation and Research). Any drug that’s been through the regulatory process during that time has gone across his desk, so he’s seen… Read More
  • Regulatory Affairs

    The Politics of the 21st Century Cures Act

    The “21st Century Cures Act” has now been signed into law. I only wish it promised the cure for some of what the 21st century has had to offer so far, but we’ll take what we can get. So what are we getting? Steve Usdin of Biocentury put it well when he said “Start with… Read More
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