Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Can Approve Cheaper Copycat Of Heart-Failure Drug Entresto, Judge Says
Novartis has lost a bid to keep a generic version of its top-selling heart failure drug Entresto off the U.S. market by blocking regulators from approving it, though the generic's launch faces other legal roadblocks. U.S. District Judge Dabney Friedrich in Washington, D.C., in an order made public on Tuesday, said the U.S. Food and Drug Administration did not overstep its authority in approving MSN Pharmaceutical's generic of Entresto, despite a slightly different label and alleged differences between the drugs. (Pierson, 10/16)
Johnson & Johnson is cutting several programs鈥攎ost of which are in neurology and psychiatry鈥攁s the company also pulls back from the infectious diseases market. (Manalac, 10/16)
Since its inception in 1992, the FDA鈥檚 accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials. (McKenzie, 10/14)
On organ transplants and biotech breakthroughs 鈥
People with HIV can safely receive donated kidneys from deceased donors with the virus, according to a large study that comes as the U.S. government moves to expand the practice. That could shorten the wait for organs for all, regardless of HIV status. The new study, published Wednesday in the New England Journal of Medicine, looked at 198 kidney transplants performed across the U.S. Researchers found similar results whether the donated organ came from a person with or without the AIDS virus. (Johnson, 10/16)
Natasha Miller says she was getting ready to do her job preserving donated organs for transplantation when the nurses wheeled the donor into the operating room. She quickly realized something wasn鈥檛 right. Though the donor had been declared dead, he seemed to her very much alive.鈥淗e was moving around 鈥 kind of thrashing. Like, moving, thrashing around on the bed,鈥 Miller told NPR in an interview. 鈥淎nd then when we went over there, you could see he had tears coming down. He was crying visibly.鈥 (Stein, 10/17)
Scientists are gaining ground in tissue engineering that could help a host of people who deal with circulatory-system problems. One of the companies furthest along is Humacyte, a Durham, N.C.-based biotech that makes lab-grown blood vessels, which could help patients with traumatic injuries along with those who use catheters for dialysis or suffer pain from narrowed circulation to the limbs. (Whyte, 10/16)
