Trump may not be done with import tariffs on drugs

The Trump administration has prepared an order that would impose a 100% tariff on some imports of patented medications and their active ingredients, according to a draft obtained by STAT reporter Daniel Payne. The tariffs could be announced as soon as today, according to a person familiar with the matter, although it's also possible timelines and plans could shift.

The order offers several options for drugmakers to avoid the tariffs. They won't apply to companies that have struck "most-favored nation" deals to sell drugs in the U.S. at similar prices to other wealthy countries, or to companies negotiating such deals, until the end of Trump's term in office.

The administration previously threatened the tariffs in a bid to convince pharmaceutical companies to make deals to lower their drug costs in line with what other countries pay.

pharma

Lilly's new obesity pill enters the oral GLP-1 game

The FDA just approved orforglipron, or Foundayo, Eli Lilly's oral obesity drug. The decision launches a showdown with Novo Nordisk's oral Wegovy, STAT's Elaine Chen writes. Foundayo's convenience is central to its marketability — no injections, easier distribution, and fewer dosing restrictions than oral Wegovy.

But Novo may still have certain advantages. The company has argued its pill boasts slightly stronger weight loss data, and that there's more safety data attached to its injectables.

Foundayo was also approved via FDA's new priority voucher program, which has both expedited reviews and come with some controversy.

Pharma

Novo: Our oral GLP-1 is still better

From my colleague Andrew Joseph: Fresh off the Eli Lilly approval, Novo Nordisk this morning released an analysis arguing its own oral obesity medication was more powerful than its chief rival's new drug.

The comparison is based on existing trial data, not a new head-to-head study. The findings are also not really a surprise. In their individual Phase 3 trials, Novo's oral version of Wegovy led to 13.6% weight loss over 64 weeks, while Lilly's Foundayo helped patients lose 11.2% of their weight over 72 weeks.

But the Novo study highlights the fierce competition between the two companies over the obesity medicine market, where a new front has opened with the arrival of the weight loss pills. The companies have been jockeying over factors such as efficacy, safety, ease of use, and price.

In a press release, Novo said its analysis showed that oral Wegovy demonstrated greater average weight loss than Foundayo, and that Lilly's drug had a higher discontinuation rate among participants for GI-related adverse events. (Novo added, however, that "while a significant difference was observed for tolerability, the magnitude of these differences should be interpreted with caution due to low adverse event counts.")

"These studies add to the growing body of evidence supporting the clinical strength of semaglutide and highlight attributes that patients value when choosing an obesity medicine that fits their lifestyle," Jamey Millar, Novo's executive vice president of U.S. operations, said in a statement, referencing the key ingredient in Wegovy.

Novo said it will present the full data from its analysis later this month at the Obesity Medicine Association's conference in San Diego.

WASHINGTON

FDA 'breakthrough' device label drifts toward ambitious AI projects

The FDA's "breakthrough" designation for medical devices is subtly shifting. The AI tools receiving this status are moving beyond narrow image-reading aids toward broader systems that can detect multiple conditions, predict outcomes, or surface signals clinicians can't see, STAT's Katie Palmer writes.

A new analysis of STAT's Breakthrough Device Tracker suggests the agency is prioritizing more ambitious tools — especially in cancer and cardiovascular disease — while also laying the early groundwork for generative AI. But the label itself still does more to speed review than validate performance.

"People like to use breakthrough as a sort of marketing thing," said Josh Makower, co-founder of the Stanford Mussallem Center for Biodesign. But when a newly approved technology reaches hospitals and health systems, the label alone doesn't mean much, he said: "Okay, it's a breakthrough. Let's see what the evidence is."

artificial intelligence

Insilico CEO discusses AI for high throughput drugmaking

Insilico Medicine says it's pitching a stripped-down view of AI drug discovery: speed and output over hype. In an interview with STAT's Brittany Trang after its new deal with Eli Lilly, CEO Alex Zhavoronkov said the company's real advantage isn't any single model or platform, but its ability to repeatedly generate preclinical candidates and license them before the slow, regulated clinical phase.

Instead of marking Insilico's success by a drug's approval, Insilico's approach is more about consistently producing assets someone else will pay for.

"Everything that we do is modeled after SpaceX," Zhavoronkov said. "We think that that's the only company that you should replicate."

WASHINGTON

GAO finds FDA transparency gaps on ad comm conflicts of interest

The FDA has spent more than a decade failing to finalize and publicly share guidance on how it evaluates financial conflicts of interest among advisory committee members and guest speakers, according to a new review from the Government Accountability Office. The review recommends that the FDA should establish a timeframe for issuing conflict of interest guidances.

The report also highlights the broader pullback in advisory meetings, especially for drugs, and ongoing concern about industry influence.

"If the agency does not believe that disclosure of appearance conflicts is within its authority, then I would urge members of Congress to include such a provision in future law," Genevieve Kanter, an associate professor of public policy at the University of Southern California, told STAT's Ed Silverman.

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