Medicare advisers endorse reforms to lower drug spending; how a top FDA official intervened on a Sarepta gene therapy

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

April 13, 2023 Check out STAT+

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By Ed Silverman Pharmalot Columnist, Senior Writer

Adobe STAT+ | Medicare advisers endorse reforms to lower drug spending The most notable recommendation involves capping payments for drugs for which accelerated approval is granted by the FDA. By Ed Silverman STAT+ | FDA staff leaned toward rejecting Sarepta gene therapy before top official intervened Inside the FDA office that oversees gene therapies, some staff believed Sarepta's gene therapy for Duchenne should be rejected. By Adam Feuerstein and Jason Mast STAT+ | Sickle cell gene therapies could be cost-effective even if priced as high as $1.9 million An early analysis suggests that a pair of forthcoming treatments for sickle cell disease would be cost-effective even if priced as high as $1.9 million. By Ed Silverman David Erickson/AP Abortion drug battle will head to Supreme Court after appeals court decision The judges said it could no longer be sent to patients through the mail and that it could only be used up to seven weeks into a pregnancy. By Andrew Joseph and Sarah Owermohle Promising new malaria vaccine for kids approved in Ghana Preliminary results have suggested the vaccine is far more effective than the only malaria vaccine now authorized for use by the WHO. By Sam Mednick — Associated Press Listen: How the legal battle over abortion could thwart research, plus: the FDA 'bully pulpit' and Moderna's future Ovid Therapeutics CEO Jeremy Levin joins us to discuss a judge's decision to overturn the FDA approval of the abortion pill mifepristone. By Damian Garde and Meg Tirrell

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