FDA Can Approve Cheaper Copycat Of Heart-Failure Drug Entresto, Judge Says
Novartis, which made more than $6 billion in revenue from the drug last year, says it will appeal the ruling. In other news: A study shows that people with HIV can safely receive donated kidneys from deceased donors who also had HIV.
Reuters:
Novartis Loses Latest Bid To Block Generic Version Of Blockbuster Heart Drug
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)
BioSpace:
J&J Scraps Pipeline Assets Including Alzheimer’s And Parkinson’s Candidates
Johnson & Johnson is cutting several programs—most of which are in neurology and psychiatry—as the company also pulls back from the infectious diseases market. (Manalac, 10/16)
BioSpace:
5 Accelerated Approvals Gone Wrong
Since its inception in 1992, the FDA’s 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 —
AP:
Kidney Transplants Are Safe Between People With HIV, New US Study Shows
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)
NPR:
A Man Declared Dead Almost Had Surgery To Donate His Organs, But He Was Still Alive
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’t right. Though the donor had been declared dead, he seemed to her very much alive.“He was moving around — kind of thrashing. Like, moving, thrashing around on the bed,” Miller told NPR in an interview. “And then when we went over there, you could see he had tears coming down. He was crying visibly.” (Stein, 10/17)
The Wall Street Journal:
Lab-Grown Blood Vessels By Biotech Humacyte Could Change Trauma Treatment
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)
