FDA Panel Votes In Favor Of Expanding CAR-T Therapy For Blood Cancer
The vote in favor happened Friday, despite what Stat notes are concerns about the treatment's side effects. Separately, the failure of ALS drug Relyvrio highlights controversial FDA drug approvals.
Stat:
FDA Advisers Back CAR-T Cell Therapies In Blood Cancer, Despite Concerns
A panel of expert advisers to the Food and Drug Administration on Friday voted in favor of expanding the use of CAR-T therapy in blood cancer, despite concerns about the powerful treatment’s side effects. (Garde, 3/15)
The Washington Post:
Failure Of ALS Drug Puts A Spotlight On Controversial FDA Approvals
Justin Klee and Josh Cohen had pulled off an improbable success, turning an idea they hashed out as undergraduates into a drug that aimed to slow one of the world’s most implacable and deadly neurological diseases. On the strength of a single clinical trial, they’d won U.S. regulatory approval for their drug to treat amyotrophic lateral sclerosis, or ALS. They expected that a larger trial would cement the effectiveness of their treatment. Instead, the trial showed that their drug, Relyvrio, doesn’t work. (Gilbert, 3/16)
Reuters:
Reckitt Unit Hit With $60 Million Verdict In Enfamil Baby Formula Case In Illinois
An Illinois jury has ordered Reckitt Benckiser unit Mead Johnson to pay $60 million to the mother of a premature baby who died of an intestinal disease after being fed the company's Enfamil baby formula. The jury in an Illinois state court in St. Clair County on Wednesday found that Mead Johnson was negligent and that it failed to warn of the risk of necrotizing enterocolitis (NEC). The disease, which causes the death of bowel tissue, mostly affects premature newborns and has a fatality rate of about 15% to 40%. (Pierson, 3/15)
Stat:
CVS Caremark Has Created A New Ploy: The Drug ‘Rebate Credit’
The biggest enticement that large pharmacy benefit managers offer to the employers that hire them is drug rebates — a steady stream of money sent back to their clients, a tangible symbol of the discounts that PBMs are able to wrangle out of pharmaceutical companies. (Herman, 3/18)
Reuters:
Lilly Weight-Loss Drug Zepbound New US Prescriptions Surpass Wegovy For First Time
Eli Lilly’s powerful weight-loss drug Zepbound hit 77,590 new prescriptions in the U.S. for the week ending March 8, surpassing Novo Nordisk’s rival obesity medicine Wegovy for the first time since it was launched, according to data from IQVIA. Some 6,000 fewer Wegovy prescriptions were filled in the United States that week, but Novo maintained its lead for total weekly prescriptions over Zepbound by 25,307, according to the data published by JPMorgan in a weekly note.
Los Angeles Times:
Oprah Left WeightWatchers To Make Weight-Loss Drug TV Special
Oprah Winfrey has revealed why she left her nearly 10-year post as a WeightWatchers board member last month. Her resignation was motivated by her work on an upcoming TV special on the rise of prescription weight-loss drugs, she said during a Thursday appearance on “Jimmy Kimmel Live!” (Mendez, 3/15)