November 3, 2025

The need-to-know this morning

In a major setback, Uniqure said Monday that the timing of when it can file its experimental and promising Huntington's disease treatment for approval with the Food and Drug Administration "is now unclear," raising the prospect that the biotech may need more data.
Pfizer filed federal antitrust claims in a second lawsuit against Metsera, its controlling stockholders and Novo Nordisk.

WASHINGTON

Tidmarsh resigns from FDA amid explosive allegations

George Tidmarsh, the FDA's top drug regulator, resigned yesterday after being accused of weaponizing his authority to damage a former associate's business, STAT's Lizzy Lawrence and Adam Feuerstein report. The accusations were made by San Diego investor Kevin Tang, who alleges Tidmarsh defamed one of his companies, Aurinia Pharmaceuticals, and sought financial leverage after the agency pulled a product tied to their joint venture.

Tidmarsh, who had earlier been abruptly placed on leave by Commissioner Marty Makary, denied wrongdoing and accused senior FDA officials — including CBER chief Vinay Prasad — of wrongdoing. Tidmarsh expressed deep fear about the future of the FDA and the uncertainty of the U.S. regulatory environment.

"This is an existential threat to the FDA," Tidmarsh said. "Something's got to be done."

M&A

Pfizer sues Novo as Metsera bidding war escalates

Pfizer filed suit against Novo Nordisk and obesity biotech Metsera on Friday, seeking to block Metsera from abandoning its $4.9 billion merger agreement with Pfizer after Novo launched a rival $6 billion bid. In a Delaware complaint, Pfizer called Novo's offer "illegal," arguing its dividend-based structure skirts antitrust review and unfairly locks out competitors.

Novo dismissed the claims as "meritless."

Pfizer, which just received early FTC clearance for the deal, accuses Metsera's board of breaching fiduciary duties amid self-interested indemnification terms. The showdown underscores the fierce race for next-generation obesity drugs as Pfizer scrambles to catch up to GLP-1 leaders Novo and Eli Lilly.

CANCER

Caribou's off-the-shelf CAR-T therapy shows promise

Caribou Biosciences said this morning that its off-the-shelf CAR-T therapy induced complete and durable remissions in patients with advanced B-cell lymphoma.

The study results, while preliminary, are comparable to benchmarks set by currently approved, patient-specific CAR-T therapies for lymphoma — an achievement that could push the off-the-shelf CAR-T field forward after years of setbacks and broaden access to cell therapy for blood cancers, STAT's Adam Feuerstein reports.

"We have long believed that an allogeneic [off-the-shelf] CAR-T could drive outcomes like an autologous [patient specific] CAR-T," Caribou CEO Rachel Haurwitz said. "Whether you look at overall response rate, complete response rate or progression-free survival, vispa-cel looks exactly like Yescarta or Breyanzi."

opinion

Pharma's patient advocacy problem runs deep

Much of Big Pharma's "patient advocacy" spending serves optics more than outcomes, opines rare disease researcher and advocate Will Greene. While industry leaders tout patient-centric values, Greene says companies often underpay advocates, fund misguided charity projects, and reduce advocacy to branding.

He recounts executives calling patient stories "misery porn" and cites tone-deaf gestures — like donating wheelchairs to children with Prader-Willi syndrome — as proof of a system driven by complacency, not compassion. True advocacy, he writes, means paying patients fairly, acting on their input, and prioritizing real-world impact over photo ops.

opinion

FDA's Q-Collar authorization exposes transparency gaps

The FDA's authorization of the Q-Collar — a neck device marketed to "protect the brain" — reveals troubling gaps in regulatory transparency, opines Tufts professor James Smoliga. He argues that FOIAed internal memos show FDA reviewers doubted the device's evidence base, yet authorization through the de novo pathway allowed it to be marketed as safe despite inconclusive data.

Smoliga warns that the "FDA authorized" label misleads consumers into assuming proof of effectiveness, fueling a $200 false sense of security for athletes and parents alike. He says that genuine transparency in the de novo process would involve publication of reviewer memos, plain-language labeling that distinguishes "authorized" from "proven," and clearly stating how confident regulators are in the evidence.

"This is not just about one device," he writes. "It's about what happens when institutions grow comfortable living in their own ambiguity and hiding behind opacity."

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