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Morning. The Trump administration is already making itself felt in the world of health and medicine. Have you been personally affected by the administration’s pause at the FDA or other federal health and science agencies? If so, let us know how here.
Veru says drug preserved lean mass in patients on Wegovy
Veru said this morning that its investigational drug enobosarm helped preserve lean mass in patients taking Wegovy, though some experts were skeptical that the topline results were adequate to prove the benefits of the drug.
In a Phase 2b trial, older patients taking Wegovy and enobosarm lost on average 1.2% of lean mass after 16 weeks, compared with a 4.1% loss in patients taking Wegovy and placebo. Veru said this difference was statistically significant.
The trial, which enrolled 168 patients, tested a 3-mg and 6-mg dose of enobosarm, but the company grouped all patients who took enobosarm together in the topline readout.
Read more from STAT’s Elaine Chen.
Akero drug reverses liver scarring in study of severe MASH patients
Akero Therapeutics this morning reported strong results from a nearly two-year, placebo-controlled study showing its drug efruxifermin reversed liver scarring in patients with cirrhosis caused by the liver disease known as MASH.
After 96 weeks, 39% of patients offered a 50-mg dose of efruxifermin showed a clinically meaningful reduction in liver fibrosis, or scarring, without other symptoms of MASH getting worse, compared to 15% of participants randomized to a placebo.
Read more from STAT’s Adam Feuerstein.
Trump restrictions are rattling health agencies
Less than a week after it was announced, the Trump administration’s freeze on communications, travel, and scientific reviews across the Department of Health and Human Services and its sub-agencies is breeding chaos. Staff at the agencies and outside research scientists say the interruptions threaten to derail experiments, wither funding pipelines, and slow scientific progress.
One small example: During an online workshop about gene and cell therapies last week, FDA staff members who had been fielding niche queries went silent so suddenly that participants assumed they were having technical difficulties.
“I don’t know what to say,” said Holly Fernandez Lynch, a University of Pennsylvania medical ethicist and researcher focused on the FDA. “There is no legitimate political rationale or defense for throwing the scientific community into such intense disarray.
Read more from STAT’s Lev Facher, Jason Mast, and Angus Chen here.
Pfizer to pay $60 million for Biohaven kickbacks
Pfizer will pay nearly $60 million to resolve allegations that its Biohaven Pharmaceuticals unit paid kickbacks to doctors to boost prescriptions for Nurtec ODT, a migraine treatment.
The payments, made from March 2020 to September 2022, included speaking fees and expensive meals at upscale restaurants, with some doctors allegedly attending programs that offered no educational value, STAT’s Ed Silverman reports.
The claims were initially brought by a whistleblower, a former sales rep who claimed the company violated federal kickback laws. Nurtec ODT was the centerpiece of Pfizer’s $11.6 billion acquisition of Biohaven in 2022.
FDA approves monthly maintenance dosing for Leqembi
The FDA has approved monthly maintenance dosing of Leqembi in patients with early Alzheimer’s disease. After using the drug, made by Eisai and Biogen, every two weeks for 18 months, patients can transition to half the dose every month. The idea is that the disease can still progress even after the plaques are cleared from the brain; Leqembi is thought to keep any re-accumulation at bay.
This new approval is based on a Phase 2 study as well as modeling simulations that predicted maintenance dosing would maintain benefits of the therapy.
There had been concern that FDA approvals could be halted by the Trump administration’s pause on certain activities across the federal government’s health and science agencies. Such fears appear not to have been borne out.
More reads
- CIA now says COVID-19 ‘more likely’ to have come from lab, Reuters
- U.K. biotech launches with T cell therapy technology to treat solid tumors, Endpoints
- Takeda bids adieu to Uloric after gout med’s gradual fade from glory, FiercePharma