Endpoints changed in some late-stage trials of cancer drugs; FDA advisers vote against approving Intercept’s NASH drug

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

May 19, 2023 Check out STAT+

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By Ed Silverman Pharmalot Columnist, Senior Writer

STAT+ | Study: 1 in 5 primary endpoints changed in late-stage trials of cancer drugs already underway A new study found that one in five primary endpoints were changed after a late-stage study began, and 70% of trials did not report revisions. By Ed Silverman STAT+ | FDA advisers vote against approving Intercept's NASH drug The group voted 12-2, with two abstentions, that the benefits of Intercept's medicine did not outweigh its risks. By Damian Garde STAT+ | Novo Nordisk pauses ads for weight loss drug Wegovy as it struggles to meet demand "To avoid stimulating further demand for this medicine, we're pausing some key Wegovy promotional efforts," Novo Nordisk said. By Elaine Chen Constanza Hevia for STAT STAT+ | FDA approves first treatment for skin condition that causes persistent wounds, a redosable gene therapy The gene therapy, known as Vyjuvek and made by Krystal Biotech, will soon be available for patients with dystrophic epidermolysis bullosa. By Andrew Joseph Opinion: How I helped Pfizer think through the ethics of Viagra 25 years ago Pfizer executives were terrified that marketing Viagra might lead to all manner of sex-related controversy. So they called me for a consult. By Arthur L. Caplan STAT+ | FDA official offers insights into whether gene therapy makers could use common manufacturing process FDA provides insights into its thinking about a groundbreaking approach to making gene therapies that could help commercialize the products. By John Wilkerson Alex Hogan/STAT STAT+ | Up and down the ladder: The latest comings and goings From new hires to departures, transfers and promotions, here are the latest comings and goings in the pharmaceutical industry. By Ed Silverman

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