FDA cites Dr. Reddy’s for quality control problems at a biologics plant; What antidepressants are saying 30 years after the publication of ‘Listening to Prozac’

Taking stock of the drug industry, from the lab to the medicine chest

November 16, 2023 Check out STAT+

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By Ed Silverman Pharmalot Columnist, Senior Writer

Adobe STAT+ | FDA cites Dr. Reddy's for quality control problems at a biologics plant This is the latest in a growing list of quality-control issues the FDA found at various Dr. Reddy's plants in India over the last six years. By Ed Silverman Opinion: What antidepressants are saying 30 years after the publication of 'Listening to Prozac' Author Peter D. Kramer writes that the questions at the heart of "Listening to Prozac" about meds and the nature of the self remain relevant. By Peter D. Kramer STAT+ | House panel passes PBM reforms, ratcheting up chance for passage Panels in both the House and Senate have now passed restrictions to drug middlemen business practices like spread pricing. By John Wilkerson Bill Sikes/AP STAT+ | U.K. approves world's first CRISPR-based medicine, giving green light to therapy for sickle cell, thalassemia The approval of the therapy, from Vertex Pharmaceuticals and CRISPR Therapeutics, ushers in a new era of genetic medicine.  By Andrew Joseph and Adam Feuerstein STAT+ | Bristol wins U.S. approval for lung cancer drug targeting rare genetic mutation The drug was developed by a small biotech company, Turning Point Therapeutics, that was acquired by Bristol in June 2022. By Adam Feuerstein

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