Trump administration puts focus on march-in rights

The Trump administration recently threatened to invoke a controversial provision of the Bayh-Dole Act to potentially seize and relicense Harvard University patents stemming from federally funded research, accusing the school of breaching disclosure and licensing rules. A letter from Commerce Secretary Howard Lutnick signaled a "march-in" review — a power never used before — which is being viewed by some as political retribution.

While march-in rights have long been debated as a tool to lower drug prices, the administration has largely rejected that approach as it's generally considered slow, contentious, and not terribly efficient at lowering drug prices, STAT's Ed Silverman writes.

"There's a broader issue of the National Institutes of Health not ensuring its grantees are disclosing government rights on inventions fully and completely," said Steve Knievel, an advocate for access to medicines at Public Citizen. "This is a serious issue. It would be good for the Commerce Department to look at this, but for the right reasons and not to bully a university as part of shakedown campaign."

drug pricing

Lilly says it will hike list prices for drugs abroad

Eli Lilly said yesterday that it would raise list prices for some medicines in Europe and other wealthy nations — including its blockbuster weight loss drug Mounjaro in the U.K. — as part of a strategy it says will allow U.S. prices to fall in line with the Trump administration's demands.

The move, among the first from a major drugmaker to embrace the White House's call for "rebalancing," may be more about optics than actual change in pricing, STAT's Elaine Chen and Daniel Payne write. Even though the list prices may increase, the company will offer more discounts so European governments may ultimately end up paying the same price for drugs.

"This is a way to basically symbolically suggest you're doing something about prices, but it's doing absolutely nothing to increase how much money they get from overseas or definitely not lowering prices in the U.S.," one health policy expert told STAT.

podcast

Vinay Prasad's return and mRNA upended

Have investors soured on mRNA biotechs? How will Vinay Prasad approach his role at the Food and Drug Administration the second time around? And how do you pronounce "bronchiectasis"?

We address all that and more on this week's episode of "The Readout LOUD." We also invite STAT fellow Marissa Russo on to discuss the alternatives to animal testing, and why they're the subject of hot debate among scientists.

Listen here.

cancer

Engineered antibody shows striking results in small cancer study

A modified CD40 agonist antibody, injected directly into tumors, triggered dramatic systemic immune responses in patients with different forms of metastatic cancers — shrinking tumors in half of the 12 participants and inducing complete remission in two. The engineered drug, designed to boost T-cell recruitment while avoiding severe toxicities, not only reduced injected tumors but also attacked cancer at distant sites, STAT's Veronica Paulus and Marissa Russo write.

"Injecting one discrete tumor leads to this systemic response with no evidence of systemic toxicity. That's extraordinary," the study's lead author told STAT.

That said, the approach is limited to patients with accessible lesions and hinges on the assumption that the cancer is biologically the same across the body. But that's not necessarily the case for all patients with all types of cancer.