December 1, 2025

The need-to-know this morning

Regeneron Pharmaceuticals and Tessera Therapeutics have signed a partnership agreement to co-develop Tessera's experimental gene-editing treatment for alpha-1 antitrypsin deficiency (AATD), an inherited disease that affects the lungs and liver.
Novocure CEO Ashley Cordovo resigned and is being replaced by current president Frank Leonard.
Belite Bio said its oral treatment called tinlarebant achieved the primary goal of a Phase 3 clinical trial by slowing the growth of retinal lesions compared to a placebo in patients with Stargardt disease, an eye disease that leads to progressive vision loss.

vaccines

Unpacking Prasad's CBER email on vaccine policy

In an unusually blunt internal memo obtained by STAT, CBER chief Vinay Prasad shared his rationale for the agency's sweeping overhaul of U.S. vaccine regulation — one that questions pandemic-era choices and demands randomized clinical trial evidence for nearly every future product.

"I have no doubt that many vaccines have saved millions of lives globally, and many have benefits that far exceed risks, but vaccines are like any other medical product," Prasad writes.

Prasad's CBER-wide email was prompted by a finding that 10 children died as a result of Covid-19 vaccines. But as STAT's Matthew Herper and Helen Branswell point out, experts are skeptical of the memo's "extraordinary" claim, which was not accompanied by any detailed data.

"Jumping from these case reports to their preexisting vaccine policy preferences is awfully convenient," one employee told STAT on condition of anonymity. Several told STAT that the email was "misleading" and "politically charged." Former CBER leader Jesse Goodman said the memo was "destined to go externally," given that it was emailed to the entire department.

In the note, Prasad told staff the agency will no longer rely on antibody titers or observational data to justify approvals or population expansions, will require clinical-endpoint trials even in pregnant women, and intends to rebuild the annual flu-vaccine framework, which he calls an "evidence-based catastrophe."

obesity

GLP-1 access alone won't fix the obesity epidemic

Wider access to GLP-1 drugs could meaningfully impact U.S. mortality rates, but a Boston University global health and sociology expert, Andrew C. Stokes, argues that policymakers shouldn't treat these medications as a substitute for preventing obesity and other metabolic diseases.

In a new First Opinion essay, Stokes says that even if Wegovy and Zepbound become broadly affordable, the upstream drivers of obesity — low wages, segregation, food insecurity, chronic stress, and an under-regulated food industry — will continue to shape health outcomes.

Preventive policies like limits on ultra-processed foods, stronger nutrition standards, expanded SNAP and school-meal programs, and protections against weight discrimination remain essential.

"Ultimately, public health efforts to address the social, policy, and structural drivers fo obesity are necessary actions to confront stagnating life expectancy trends that gripped the U.S. since 2010," he writes.

drug pricing

Pharmacies could face fallout from new Medicare negotiations

As CMS prepares to launch the first wave of Medicare-negotiated drug prices in 2026, pharmacy groups, patient advocates, and even bipartisan lawmakers are sounding alarms, writes Sujith Ramachandran, an associate professor of pharmacy administration at the University of Missisippi. They're concerned that the program's intricate new refund-based payment model could leave pharmacies underpaid, understocked, or unable to dispense key medicines, he writes in a First Opinion piece for STAT.

Without aggressive, real-time monitoring of dispensing data, reimbursement timelines, and pharmacy closures, patients could lose access to lifesaving drugs and the projected Medicare savings could evaporate.

"Pharmacies are afraid that this new manufacturer-issued refund will either be inadequate or late, and patient advocates are concerned that these fears will lead pharmacies to refuse to stock or dispense the drugs," he writes.