September 15, 2025

The need-to-know this morning

Monte Rosa Therapeutics signed a research collaboration agreement with Novartis to develop new treatments for autoimmune diseases based on Monte Rosa's protein degrader technology.
ATyr Pharma said its experimental drug efzofitimod failed to reduce the use of oral steroids compared to placebo in a Phase 3 study of pulmonary sarcoidosis, a type of inflammatory lung disease.

regulation

FDA retreats from expert drug panels

FDA leaders under President Trump are moving to curtail the agency’s decades-old practice of convening public advisory committees to review drug applications. This is sparking worry that drug approval decisions could be shielded from outside scrutiny.

George Tidmarsh, head of the FDA’s drug review center, said the panels are “redundant” and too resource-intensive, pointing instead to newly public complete response letters as a transparency substitute. But former FDA chiefs, academics, and watchdogs warn that abandoning drug-specific advisory panel meetings and votes strips away one of the few opportunities for independent experts and the public to question regulators and industry.

“Another theory is that this decision is strategic,” said Genevieve Kanter, an associate professor of public policy at the University of Southern California, “in terms of consolidating power in the agencies so that you are no longer accountable to outside experts or the public.”

united kingdom

U.S. pressures U.K. as pharma pauses investments there

The U.S. ambassador to the U.K. has pressed Chancellor of the Exchequer Rachel Reeves to sweeten Britain’s drug-pricing framework, warning that the U.K.’s “value for money” system risks driving away global pharma. This comes on the heels of Merck axing a £1 billion London R&D hub and AstraZeneca freezing a £200 million Cambridge expansion, the Financial Times writes.

The intervention, described as “frosty,” underscores transatlantic tensions as companies rail against soaring clawback taxes and warn the U.K. is falling behind in competitiveness. With Eli Lilly also pausing plans and AstraZeneca shelving a vaccine site, industry pushback is colliding with President Trump’s demands that Europe stop “piggybacking” on U.S. pharma ahead of his state visit and looming trade negotiations.

Vaccines

CDC funds autism-vaccine study critics call misguided

The CDC plans to fund new research probing a discredited link between vaccines and autism, and aims to award a sole-source contract to Rensselaer Polytechnic Institute at the urging of health secretary Robert F. Kennedy Jr.

The move has alarmed scientists, who note that dozens of large studies have already debunked any causal connection and warn that Kennedy is reshaping the agency around his personal anti-vaccine views. RPI’s Juergen Hahn, a biomedical engineer who has done past work on autism risk factors and toxic metals, would lead the project.

FDA targets pharma ads, but the impact is limited

The Trump administration, led by Kennedy, is pushing to clamp down on direct-to-consumer pharmaceutical ads — an American practice shared only by New Zealand. A new FDA directive promises stricter enforcement of regulations, fuller disclosure of risks, and expanded oversight of social media promotions.

But Harvard’s Aaron S. Kesselheim and epidemiologist Katelyn K. Jetelina opine the plan has little bite: While Kennedy has made eliminating drug ads a signature goal, pharma’s lobbying muscle is formidable. Warning letters rarely result in penalties, and constitutional protections for commercial speech make an outright ban unlikely. The two answer nine burning questions about pharmaceutical ads.