Trump's pharma claims go unchecked by the industry

From my colleague Daniel Payne: President Trump made a series of remarkable claims Tuesday about the state of negotiations with pharmaceutical companies to lower drug prices — claims the companies are declining to confirm or deny.

The president said during a marathon cabinet meeting that he had talked with “an incredible” Eli Lilly executive who admitted he couldn’t defend drug companies charging more in the U.S. than other countries.

“He said, ‘it's the hardest part of my job defending that I'm not going to do it anymore,’” Trump recounted.

A Lilly spokesperson declined to comment on Trump’s recollection, referring STAT to an earlier statement in which the company said it would increase the prices of medicines in Europe and other developed markets to lower them in the U.S.

Lilly, as well as other companies, have a long history of explaining why prices are usually substantially higher in the U.S. than they are elsewhere, including research cost and investments and, more recently, other countries not paying their fair share.

Trump also said during the meeting that pharmaceutical companies and the government are “all set” for a deal.

“This thing should go fast,” he said.

Still, several companies negotiating with the administration declined to comment or did not respond to questions from STAT.

Companies have held off on making a deal, and strategists working with them have suggested in recent months that a voluntary but significant drop in drug prices in the U.S. is unlikely. Still, fears of public battles with the administration are figuring significantly into their strategies, the advisers said.

obesity

Novo wants to develop self-replicating RNA obesity drugs

From my colleague Elaine Chen: Novo Nordisk will be partnering with Replicate Bioscience to develop self-replicating (srRNA) candidates for obesity, type 2 diabetes, and other cardiometabolic conditions, according to an announcement this morning.

Under the deal, Novo will get an exclusive license to develop and commercialize the lead programs using Replicate’s srRNA platform. Meanwhile, Replicate will receive research funding and up to $550 million in an up-front payment and potential milestone payments. The biotech is also eligible to receive royalties on future drug sales.

Self-replicating RNA is a type of messenger RNA that can make copies of itself, with the hope of achieving longer therapeutic effects.

Novo has, for awhile, been researching how to develop longer-lasting obesity therapies — for example, using RNA interference (RNAi) technology.

covid-19

FDA approves Covid shots with restrictions

The FDA has approved updated Covid boosters while ending emergency authorizations — a move announced not by the agency but on the social media site X by health secretary Robert F. Kennedy Jr. He framed it as delivering on campaign promises to end mandates and the Covid “emergency,” STAT’s Lizzy Lawrence and Matthew Herper write.

Moderna’s vaccine remains available for children as young as 6 months with underlying conditions, Pfizer’s for those over 5, and Novavax’s for those over 12 — leaving healthy children under 5 with sharply reduced access.

The moves mark a broader realignment of U.S. vaccine policy under Kennedy. The changes drew alarm from the American Academy of Pediatrics, which called them “deeply troubling,” noting that infants are at higher risk of hospitalization.

cancer

Lilly's Verzenio improves overall survival in breast cancer

Eli Lilly’s blockbuster cancer drug Verzenio delivered a long-sought overall survival benefit in a Phase 3 study, showing it can extend lives for patients with high-risk HR-positive, HER2-negative early breast cancer when added to endocrine therapy after surgery.

The new data bolsters Verzenio’s gambit against fellow CDK4/6 inhibitor Kisqali, made by Novartis, which won expanded FDA approval last year to cover a similar patient population — and which has rapidly seized market share. While Kisqali currently leads the category with surging sales and broader eligibility, FiercePharma writes, Lilly can counter with survival data that could change adjuvant treatment in breast cancer, should it win further FDA approval.

rare disease

Amylyx stops testing Relyvrio in rare palsy after trial failure

Amylyx has scrapped development of its withdrawn ALS drug Relyvrio, now called AMX0035, in progressive supranuclear palsy after the oral therapy failed to move the needle on either primary or secondary endpoints in a clinical trial. With no signs of efficacy, the company terminated the next stage of the study and will discontinue further development.

AMX0035 is still being evaluated in a small study for Wolfram syndrome. Meanwhile, Amylyx is shifting its focus to another pipepline drug, called avexitide, for post-bariatric hypoglycemia.

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