November 10, 2025

The need-to-know this morning

Cogent Biosciences said its experimental drug, called bezuclastinib, lowered the risk of tumor progression or death by 50% compared to a standard treatment for advanced gastrointestinal stromal tumors — meeting the primary goal of a Phase 3 study.

glp-1 drugs

How impactful could Trump's GLP-1 deal be?

President Trump's GLP-1 deal with Novo Nordisk and Eli Lilly last week marked a major policy shift that will finally allow Medicare to cover obesity treatments for high-risk patients.

"It's fantastic for access. It's fantastic for patients. These are really important drugs," said Sean Sullivan, a professor at the University of Washington who researches health economics.

Although the agreement could significantly expand access within Medicare, what's less certain is whether people with private insurance or Medicaid will also benefit from the price reductions. On the other hand, drugmakers have been under pressure to lower prices due to a variety of factors, including negotiations tied to the Inflation Reduction Act as well as growing competition.

heart disease

Three new cholesterol studies from AHA

At the American Heart Association meeting in New Orleans, three major advances in cholesterol treatment showed how fast the field is evolving — from gene editing to next-generation biologics and pills. CRISPR Therapeutics unveiled early human data showing its one-time gene-editing therapy could slash LDL and triglycerides by roughly half, hinting at a future in which DNA tweaks might help prevent heart attacks — though safety remains uncertain.

Amgen's injectable PCSK9 inhibitor Repatha proved it can cut first heart attacks by 36% in high-risk patients, cementing its role alongside statins. And Merck's new oral PCSK9 inhibitor, enlicitide, matched injectable drugs' potency with up to 60% LDL reductions, offering a scalable, pill-based alternative for everyday use.

Together, the findings suggest cholesterol control is entering a new, more potent phase — with patients soon choosing between shots, pills, or permanent genetic fixes.

WASHINGTON

FDA scrambles to fill CDER chief void

The FDA is scrambling to find a new head for its drug division after George Tidmarsh's abrupt ouster amid allegations of personal vendettas and clashes with vaccine chief Vinay Prasad. Top internal candidates — oncology chief Richard Pazdur and Office of New Drugs Director Mary Thanh Hai — have declined to pursue the role, STAT's Lizzy Lawrence reports.

The upheaval has rattled an agency already strained by staff departures and infighting between its drug and biologics centers.

"This just reeks of desperation, and it's a desperation entirely of their own doing," said Peter Lurie, a former associate commissioner at FDA during the Obama administration. "I mean, why willingly expose yourself to this hornet's nest?"

obesity

Pfizer clinches $10 billion deal for Metsera

In case you missed it, Pfizer very late Friday prevailed in a fierce bidding war with Novo Nordisk to acquire obesity-drug developer Metsera in a deal worth up to $10 billion, paying $65.60 per share in cash plus a potential $20.65 contingent payment.

The decision, STAT's Elaine Chen writes, followed a warning from the Federal Trade Commission that Novo's rival bid posed "unacceptably high" antitrust risks due to its complex structure, which would have paid shareholders a large dividend before regulatory approval.

Pfizer, which lacks an approved obesity therapy, will gain access to Metsera's promising monthly GLP-1 and amylin candidates — potential game-changers in a market dominated by Novo's Wegovy and Eli Lilly's Zepbound.

drug pricing

Medicaid's 'GENEROUS' pricing may not save states money

Despite President Trump's claim that his new Medicaid drug deals would secure "the lowest price anywhere in the world," analysts say state programs might already be paying less.

The administration's new pilot, Generating Cost Reductions for U.S. Medicaid (nicknamed "GENEROUS"), pegs "most-favored nation" prices to the average net cost across eight wealthy nations — not the lowest price, STAT's John Wilkerson writes.

Research firm Capstone found traditional Medicaid programs already pay about 72% below list price, roughly 7% lower than what GENEROUS would yield.