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  • The Keytruda Story

    This is a good history of Keytruda, the Merck immuno-oncology blockbuster, from David Shaywitz. Most big drugs have a tangled history, and this one is certainly… Read More
  • Fixing the Generic Drug Process

    It’s very early in Scott Gottlieb’s tenure at the FDA, but I like what he has to say about generic drug approvals. Several times here, I’ve go… Read More
  • 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. Reme… Read More
  • 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 Duchen… Read More
  • 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… Read More
  • 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… Read More
  • 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… Read More
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