May 19, 2025

The need-to-know this morning

Regeneron Pharma is buying 23andMe, the bankrupt genetic testing and database company, for $256 million.

nih

Some NIH grants are reinstated as researchers fight back

After an alarming wave of NIH grant terminations citing vague "agency priorities" — often targeting diversity-related studies — some scientists are mounting successful campaigns to get their research dollars back. Neurologist Charles DeCarli had his $53 million Alzheimer's study cut in March, only to see it restored a month later after rallying lawmakers, media, and advocacy groups.

Others are turning to lawsuits, congressional allies, and professional societies to contest defunding decisions, STAT's Elizabeth Cooney writes. A grassroots playbook seems to be emerging — with off-the-record webinars, political pressure, and litigation — as researchers scramble to preserve scientific integrity in an increasingly politicized funding landscape.

"We're reinstated and everything's back in order," DeCarli, who works at University of California, Davis, told STAT. "Some of the smaller universities may not want to fight this and they may just want to roll over."

fda

Covid contrarian Høeg joins FDA leadership

Tracy Beth Høeg, once a sports medicine physician and now a prominent skeptic of Covid-19 policies, has quietly assumed influential roles at the FDA under Commissioner Marty Makary and CBER chief Vinay Prasad. As a political appointee advising on vaccines, she's already participated in high-level decisions — including the delay in Novavax's Covid shot approval — raising alarms among public health experts wary of political interference.

Though Høeg is not explicitly anti-vaccine, she has publicly questioned mandates, vaccine schedules, and the regulatory rigor of U.S. health agencies. Her ascent may be the latest sign of a more skeptical approach to vaccines from U.S. regulators, STAT's Lizzy Lawrence writes.

"Americans (from the US) compared with Danes are to a much greater extent under the perception that health is something you get in a bottle, an injection, a pill, through a surgery or at the hospital," Høeg wrote in a 2023 Substack post titled "FDA's shortcomings: A list."

alzheimer's

FDA green lights first Alzheimer's blood test

The FDA on Friday cleared the first blood test to diagnose Alzheimer's disease by detecting amyloid plaques in the brain. Developed by Fujirebio Diagnostics, the test offers a faster, less invasive alternative to PET scans or spinal taps and could help catch cases earlier, potentially boosting access to next-gen drugs like Biogen and Eisai's Leqembi and Eli Lilly's Kisunla.

The test measures the proteins pTau217 and beta-amyloid 1-42, STAT's Elaine Chen and Adam Feuerstein write. This approval marks a long-awaited milestone, but experts caution that the test's ease of use might lead to overprescribing in primary care.

"The notion 10 years ago that there'd be a blood test that detects the pathologies of Alzheimer's was a bit of a science fiction fantasy kind of story, and now here it is FDA-approved and ready for clinical practice," University of Pennsylvania Alzheimer's researcher Jason Karlawish told STAT.

covid-19

Novavax's Covid-19 vaccine finally cleared by FDA

From STAT's Helen Branswell: Novavax has finally received a full license for its Covid-19 vaccine, though the FDA put restrictions on its use that its competitors do not face. Where Moderna and Pfizer have licenses that allow use of their Covid vaccines in anyone 12 years of age and older, the FDA has limited use of the Novavax vaccine to people 65 and older, and to people aged 12 to 64 who have a medical condition that puts them at high risk of severe illness if they contract Covid. The agency did not indicate why it was applying a different criterion to the Novavax vaccine.

Multiple signals have emerged suggesting that leadership at HHS and FDA envisage more restricted access to Covid vaccines going forward. Health Secretary Robert F. Kennedy Jr. has reportedly told supporters he plans to drop recommendations for children, teens, and pregnant people to get the vaccines.

In other vaccine news, it emerged late last week that Kennedy has signed off on three vaccine recommendations passed last month by the CDC's vaccines advisory panel relating to use of chikungunya vaccines. Three other recommendations passed by the ACIP in April appear to remain in limbo. They relate to use of a new meningococcal vaccine and lowering the age for who is recommended to get adult RSV vaccines.

animal testing

Diverging perspectives on animal models in medical research

The FDA last month announced it would phase out animal testing, replacing it with more "human-relevant" methods — including organoids and AI-based computational models. Opining for STAT are experts with opposing viewpoints:

"Animal models are't just helpful; they're irreplaceable," writes Carole LaBonne, president of the Society for Developmental Biology. "They remain central to understanding the complexities of biology and disease, paving the way for discoveries that continually improve — and save — human lives."

On the other end of the spectrum are veterinarian Ellen P. Carlin, a vice president at Pathway Policy Group, and virologist Jason Paragas, who is CEO of DVLP Medicines. They assert that testing on in vivo models "was never based on a scientific rationale that animals would provide predictive models for drug interactions with human physiology." In addition to being ethically complex, "the process has eliminated candidates that could have been game-changers for patients. The screening mechanism is faulty."

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