Trump's priority review vouchers and a GLP-1 deal

The Food and Drug Administration issued a second round of “Commissioner’s National Priority Vouchers,” giving companies speedier reviews for drugs deemed aligned with U.S. priorities. This time, they’re tied to the Trump administration deals with Eli Lilly and Novo Nordisk to cut prices on blockbuster weight loss drugs.

A different version of Novo’s Wegovy, and Lilly’s orforglipron will both get accelerated decisions, alongside vouchers for Boehringer Ingelheim’s lung cancer therapy, J&J’s TB antibiotic, and other therapies. The program, meant to spur affordability and access, is also drawing scrutiny for its broad criteria and political overtones.

And could the White House GLP-1 deal reshape U.S. health policy, despite a lack of details about certain legal authorities and policy pathways? STAT’s Daniel Payne and colleagues address the seven biggest questions around the confidential agreements.

Analysts say the move could massively expand access — and profits — for Lilly and Novo if Medicare adoption is broad, despite concerns over long-term safety, adherence, and the economic impact of GLP-1 use. Telehealth companies that thrived on compounded GLP-1s may now face new competition as branded drugs get cheaper and easier to prescribe.

gene editing

Patient with liver damage in Intellia trial dies

The patient whose hospitalization with liver damage late last month led to the pause of two late-stage CRISPR gene-editing trials sponsored by Intellia Therapeutics has died, the company said yesterday.

The company — already reeling from a 43% stock plunge and criticism that its programs target diseases with well-served markets — is now scrambling to assess the risk while reaffirming belief in its pipeline.

Intellia still plans to present new data at AHA and ACAAI this month, touting progress in its hereditary angioedema program, and ended the third quarter with $670 million in cash, enough to operate into mid-2027.

drug pricing

Mark Cuban shakes up J&J Stelara pricing with biosimilar deal

Mark Cuban’s Cost Plus Drug Company is taking on the biopharmaceutical industry again, unveiling plans to sell a low-cost biosimilar of Johnson & Johnson’s blockbuster autoimmune drug Stelara for just $1,380 a year for a 90-milligram dose — a fraction of the Stelara list price, before any rebates or discounts, of about $29,100.

The biosimilar, Starjemza, made by Bio-Thera Solutions and marketed by Hikma, will test whether Cuban’s more transparent, rebate-free model can crack a system dominated by pharmacy benefit managers that profit from opaque discounts.

Analysts say the move could pressure insurers and employers to rethink rebate-driven formularies, much as biosimilars to Humira disrupted that market. But private-label biosimilars from giants like CVS and Cigna may still hold the upper hand, making Cuban’s low-cost revolution an uphill fight.

Read more from STAT's Ed Silverman and Elaine Chen.

hiv/aids

Can Gilead produce a $25 HIV prevention shot?

CVS Caremark has declined to cover Gilead Sciences’ new twice-yearly HIV prevention shot, Yeztugo, arguing its $28,000 price tag is excessive despite near-perfect efficacy in trials. Other major insurers are moving to include the injectable, but critics warn its cost could stall U.S. efforts to curb HIV infections.

In an interview with STAT’s Ed Silverman, University of Liverpool pharmacology professor Andrew Hill argued the drug could still be profitable at $2,000 per year — or even manufactured for as little as $25 at scale — allowing broad access that could meaningfully drive down infection rates.

podcast

Melodrama at the FDA and the Pfizer-Novo bidding war

On a jam-packed show, your co-hosts, minus the vacationing Allison DeAngelis, chat with STAT’s D.C. correspondent Lizzy Lawrence about a slow-boiling feud between Vinay Prasad, the head of the FDA’s biologics and vaccine branch, and his staff that has triggered even more exits and plunging morale.

On the drug side of the agency, we dish on the shocking exit of director George Tidmarsh after he was accused of using his regulatory position to exact personal revenge against a former business partner. Bonus: Prasad and Tidmarsh hate each other.

We should all be loved as much as Metsera is loved … by Pfizer and Novo Nordisk. Everyone’s favorite obesity drug bidding war escalated this week. Bids are rising. Tempers are flaring, and the lawyers are winning. We break it all down.

Listen here.

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