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.
Reuters:
FDA Staff Flag 'Serious' Safety Risks For Intercept's Fatty-Liver Disease Treatment
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)
The Hill:
Apple To Release More Accessible Features For Users With Visual, Speech Impairments
Apple Inc. unveiled an array of new features to make its products more accessible to users who suffer from cognitive, visual and speech impairments. In a news release Wednesday, Apple said its new features which include Assistive Access, Live Speech, Personal Voice and Point and Speak, will “draw on advances in hardware and software,” including ensuring user privacy and expanding on the company’s “long-standing commitment to making products for everyone.” (Oshin, 5/17)
Philadelphia Inquirer:
Temple University Doctor's Blood Clot Treatment Device Approved By FDA
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’s 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’t reach the oxygen it needs to carry to the heart, brain and the rest of the body. (Gutman, 5/17)
The Washington Post:
Theranos Founder Elizabeth Holmes Must Report To Prison By May 30
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’s request to remain out of prison as she appeals her conviction. (Lerman and Mark, 5/17)
