FDA is criticized for taking a ‘ministerial’ role in sorting out some pharma patents; Late-stage results set up Cytokinetics heart drug to compete with Bristol

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

May 13, 2024 Check out STAT+

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By Ed Silverman Pharmalot Columnist, Senior Writer

I'm wishing a hearty congratulations to my colleagues Casey Ross and Bob Herman this afternoon for being named Pulitzer Prize finalists in investigative reporting. Revisit their "Denied by AI" series: How Medicare Advantage plans use algorithms to cut off care for seniors in need How UnitedHealth's acquisition of a popular Medicare Advantage algorithm sparked internal dissent over denied care UnitedHealth pushed employees to follow an algorithm to cut off Medicare patients' rehab care UnitedHealth used secret rules to restrict rehab care for seriously ill Medicare Advantage patients

Molly Ferguson for STAT STAT+ | FDA is criticized for taking a 'ministerial' role in sorting out some pharma patents The agency "needs to show some leadership ... but instead, they have been flip-flopping for years," said Tahir Amin of the nonprofit I-MAK. By Ed Silverman STAT+ | Late-stage results set up Cytokinetics heart drug to compete with Bristol Overall, the results suggest aficamten could be used more flexibly than Camzyos while delivering similar levels of efficacy and safety. By Elaine Chen STAT+ | Sandoz disavows U.K. trade group over dispute about promoting a biosimilar for multiple sclerosis At issue was an anonymous complaint filed in May 2023 by a physician who contended that Sandoz unfairly attempted to promote its medicine. By Ed Silverman Courtesy Yiwei Shi STAT+ | Can AI build custom 'n-of-1' drugs faster? Maybe not yet, new case study suggests Advocates and biotech executives hope that AI can help speed a wave of custom medicines. A new study suggests that outcome may still be years away. By Jason Mast

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