FDA withdraws approval of preterm birth drug; the latest pushback on Vertex's drug pricing

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

April 6, 2023 Check out STAT+

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By Ed Silverman Pharmalot Columnist, Senior Writer

FDA STAT+ | FDA withdraws approval of controversial drug to prevent preterm births "The touchstone of FDA drug approval is a favorable benefit-risk assessment," said FDA Commissioner Robert Califf in explaining the decision. By Ed Silverman STAT+ | Brazilian government advisory committee says a Vertex cystic fibrosis drug is not cost-effective and should not be reimbursed "It is our goal to provide our medicines to as many cystic fibrosis patients around the world as possible, including Brazil," Vertex said. By Ed Silverman Genentech review of Tessier-Lavigne paper finds no evidence of fraud — but hints at a different misconduct case The review points to another previously undisclosed case of scientific misconduct by a post-doctoral researcher in Tessier-Lavigne's lab. By Jonathan Wosen Abbott Laboratories via AP Abbott recalls 4 million glucose monitor readers over risk they can catch fire Abbott has recalled millions of readers for its FreeStyle Libre glucose monitors over concerns they can overheat or catch fire, the FDA said. By Lizzy Lawrence STAT+ | With weight loss drug ads, telehealth companies wade into a regulatory gray area Telehealth companies like Ro are advertising in subway stations for weight loss drugs such as Wegovy. That raises regulatory questions. By Mohana Ravindranath Listen: Illumina's boardroom intrigue, the next big Alzheimer's readout, & J&J's creative lawyers This week, we explain how Illumina lost the faith of shareholders, why J&J investors are happy about a $9 billion payout, and look ahead to biotech's Q2. By Damian Garde and Meg Tirrell and Adam Feuerstein

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