Data: Cassava Sciences Alzheimer’s Drug Only As Effective As Placebo
Stat says the experimental drug, called simufilam, has long been claimed to be capable of improving patients' cognition. But a mid-stage study shows its results only compare with a placebo. Separately, the FDA denied marketing orders for two menthol vape products.
Stat:
New Data Show Cassava Alzheimer's Drug Has Placebo-Like Efficacy
Cassava Sciences had long claimed that its experimental treatment for Alzheimer’s disease was capable of improving the cognition of patients — a benefit no other Alzheimer’s drug has ever shown. But mid-stage study results updated on Tuesday now show the cognitive status of patients worsening to the point where Cassava’s drug, called simufilam, doesn’t look any more effective than a placebo. (Feuerstein, 1/24)
In news about the FDA —
CNN:
FDA Rejects Two Menthol Vuse E-Cigarette Products
The US Food and Drug Administration issued marketing denial orders for two menthol e-cigarette products marketed by R.J. Reynolds Vapor Company. The agency said Tuesday that Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5% should not be marketed or distributed. (Christensen, 1/24)
Stat:
Doctors' Group Files FDA Complaint Over Wegovy TV Segment
A physicians’ group has filed a complaint with the Food and Drug Administration alleging that a recent 60 Minutes segment about the Wegovy weight-loss drug was actually an advertisement and demanded the agency withdraw the report from circulation. (Silverman, 1/24)
Stat:
The 4 Big Questions About FDA’s Coming Changes To Accelerated Approvals
Congress just boosted the FDA’s authority over the post-market clinical trials that are a condition of speedy drug approvals, and industry lobbyists are anxious to know how the agency plans to wield that new power, which includes criminal prosecution. (Wilkerson, 1/25)
Stat:
Many Pediatric Drug Study Results Were Never Posted To A U.S. Government Database
Amid ongoing controversy over clinical trial transparency, a new analysis found that results of 43 studies involving thousands of children were never reported to a U.S. government database or published in the scientific literature. In some cases, medicines being studied were for such life-threatening conditions as congenital heart disease and Duchenne muscular dystrophy. (Silverman, 1/24)
In other pharmaceutical news —
The Boston Globe:
Microbiome Firm Finch Therapeutics Cuts 95 Percent Of Its Workforce
A Somerville startup that hoped to harness the healing power of poop is flushing away its dreams. Finch Therapeutics announced Tuesday that it would cut 77 jobs, about 95 percent of the company’s workforce, and give up on developing its pill made using human feces as a treatment for people struggling to clear recurrent infections of a dangerous bacterium. (Cross, 1/24)
Axios:
Venture Capital Money Flows Into Fertility Tech
Fertility technology startups are in the midst of a funding frenzy, reaching more than $800 million in 2022 as demand for fertility services continues to climb. Increasing demand is not being met with increasing access, and so tech-forward companies strive to fill the gap. (Brodwin, 1/25)
TBIJ:
The Drug Was Meant To Save Children’s Lives. Instead, They’re Dying
Emily was combing her baby daughter’s hair when she first felt the lumps. It was a week before Christmas, and her youngest daughter, Isadora, had been feverish and listless, unwilling to play or take a bottle. The lumps were clustered on the back of Isadora’s neck, the size of small beans. Something was very wrong. (Furneaux and Margottini, 1/25)
