Pharma and BioTech Daily

Pharma and Biotech Daily: FDA Updates, Industry Involvement, and New Approvals


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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. In a recent interview with former Fox News journalist Megyn Kelly, FDA Commissioner Marty Makary discussed a potential new mechanism-driven pathway for expedited rare disease approvals, as well as the possibility of certain environmental factors contributing to autism. Despite Makary's announcement of a directive to limit industry participation in the FDA's advisory committees, industry involvement is actually required by a 1997 law, and banning industry representatives would not have a significant impact. Additionally, the FDA recently approved Sanofi/Regeneron's Dupixent for chronic hives after initially rejecting it, and Lilly has promised to manufacture a weight-loss pill in the US following a Phase III win. The newsletter also includes other news stories, opinions, and upcoming events in the biopharmaceutical industry.
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