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Morning Briefing

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Thursday, May 18 2023

Full Issue

FDA Questions Intercept's Fatty Liver Disease Treatment

The FDA staff warned of increased risk of diabetes and liver injury from using Intercept Pharmaceuticals' oral tablets, called obeticholic acid. In other news, Apple designs more accessibility features into its devices, and the Theranos founder must report to prison May 30.

The U.S. health regulator's staff reviewers on Wednesday raised a string of concerns with Intercept Pharmaceuticals' treatment for a type of fatty liver disease, sending the drugmaker's shares plunging 22%. The U.S. Food and Drug Administration's reviewers flagged increased risk of diabetes and liver injury from using the oral tablets, called obeticholic acid (OCA), for the treatment of nonalcoholic steatohepatitis (NASH). (Roy, 5/17)

Apple Inc. unveiled an array of new features to make its products more accessible to users who suffer from cognitive, visual and speech impairments.聽In a news release Wednesday, Apple said its new features which include Assistive Access, Live Speech, Personal Voice and Point and Speak, will 鈥渄raw on advances in hardware and software,鈥 including ensuring user privacy and expanding on the company鈥檚 鈥渓ong-standing commitment to making products for everyone.鈥 (Oshin, 5/17)

Riyaz Bashir was frustrated with the tools he had to treat blood clots in the lungs. So the Temple University Hospital cardiologist invented a new device to treat the nation鈥檚 third leading cardiovascular cause of death. Last month, the Food and Drug Administration approved his invention. Bashir believes the device is a significant milestone in the treatment of pulmonary embolism, which occurs when a blood clot gets stuck in one of the arteries in the lung. Blood then can鈥檛 reach the oxygen it needs to carry to the heart, brain and the rest of the body. (Gutman, 5/17)

On Wednesday, U.S. District Court Judge Edward J. Davila ordered Elizabeth Holmes to report to prison no later than 2 p.m. on May 30. The order comes a day after the U.S. Court of Appeals for the 9th Circuit denied Holmes鈥檚 request to remain out of prison as she appeals her conviction. (Lerman and Mark, 5/17)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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