Young Patient In Duchenne Gene Therapy Study Died, Says Pfizer
Read recent pharmaceutical developments in KFF Health News' Prescription Drug Watch roundup.
Reuters:
Pfizer Reports Patient Death In Duchenne Gene Therapy Study
A young patient died due to cardiac arrest after receiving Pfizer's experimental gene therapy being tested in a mid-stage trial for a muscle-wasting disorder called Duchenne muscular dystrophy (DMD), the drugmaker told Reuters on Tuesday. "A fatal serious adverse event was reported as cardiac arrest for a participant in the Phase 2 DAYLIGHT study," a company spokesperson told Reuters in an emailed response. (Jain, 5/7)
Reuters:
US FDA Panel To Discuss Eli Lilly Alzheimer's Drug On June 10
Eli Lilly said on Tuesday a panel of independent U.S. FDA advisers will discuss its experimental Alzheimer's disease drug, donanemab, on June 10. Donanemab has faced two separate regulatory delays in the United States, while a similar therapy by Eisai and partner Biogen, called Leqembi, received the U.S. Food and Drug Administration's approval last year. (5/7)
CIDRAP:
Xofluza May Lower Secondary Flu Attack Rate Better Than Tamiflu
Xofluza (baloxavir marboxil, BMX) appears to be more effective than oseltamivir (OTV, Tamiflu) in lowering the secondary attack rate (SAR) of flu, according to a new study based on transmission dynamics in Japanese households. The study was published yesterday in Influenza and Other Respiratory Viruses. (Soucheray, 5/7)
Bloomberg:
Novo Asks For More Time To Answer Sanders On Ozempic’s Price
Novo Nordisk A/S is asking for more time to answer questions from US Senator Bernie Sanders on the prices of Ozempic and Wegovy, the company’s blockbuster drugs for diabetes and weight loss. “We plan to respond to the latest inquiry in a timely manner; however given the tight turnaround requested, we will need additional time to develop our response,” a spokesperson for the Danish drugmaker said Tuesday in an emailed response to questions. (Kresge and Muller, 5/7)
Stat:
Life Science Leaders Imagine How To Accelerate Drug Development
Drug development is essentially a long, expensive bet: 90% of drugs fail during clinical trials, goes one of the life science industry’s most oft-quoted statistics. But new ways of identifying and testing therapies, a more precise understanding of disease, and a renewed sense of urgency to address longstanding public health issues could change that dynamic, life science leaders argued this week. (Wosen, 5/7)
