August 1, 2025

The need-to-know this morning

Regeneron Pharmaceuticals said the FDA rejected odronextamab, a treatment for follicular lymphoma. The agency will also delay decisions on two applications seeking expanded use of its eye drug Elyea. All three applications were negatively impacted by issues found by FDA inspectors at a Catalent contract manufacturing facility, Regeneron said. The Catalent facility was recently acquired by Novo Nordisk.
Moderna and Regeneron reported second-quarter earnings.

drug pricing

Trump demands drugmakers slash U.S. price now

President Trump yesterday intensified his push to force pharmaceutical companies to align U.S. drug prices with those in other wealthy nations, sending letters to 17 major companies and demanding compliance by Sept. 29. The letters call for sweeping changes, STAT's Elaine Chen writes, including offering Medicaid and Medicare drugs at prices comparable to the lowest levels in countries part of the Organization for Economic Co-operation and Development that have at least 60% of the U.S. GDP. The letter also called to expand direct-to-consumer sales of high-rebate drugs, and repatriating foreign profits.

While companies like Pfizer called talks "productive," industry group PhRMA warned the plan would harm innovation and U.S. competitiveness. Trump offered no clear method to enforce such a plan — only a threat to "deploy every tool" if companies refuse to act.

Congress

Senate rebukes Trump on plan to slash NIH

In a striking bipartisan move, the Senate Appropriations Committee voted 26-3 to boost the NIH's budget by $400 million — rejecting the Trump administration's proposed $17 billion cut and sweeping consolidation of its 27 institutes.

Senators also blocked efforts by the White House budget office to cap research overhead and overhaul NIH's grant structure — changes scientists warn would hobble research, STAT's Jonathan Wosen writes. Instead, the bill preserves existing funding mechanisms and directs the agency to justify its controversial "forward funding" model, which has already halved new grant approvals at the National Cancer Institute.

"This committee has had multiple hearings over the last several months and heard from patients, families and researchers about the importance of NIH funding," said Sen. Tammy Baldwin (D-Wisc.). "This committee has, in a bipartisan manner, prioritized NIH and the research it supports to develop life-saving treatments and cures for devastating diseases."

drug pricing

Trump floats 340B rebate pilot, sparks backlash

The Trump administration is proposing a voluntary rebate-based pilot program to resolve mounting tensions over the 340B drug discount program, targeting 10 high-cost therapies selected for Medicare negotiations in 2026. Drugmakers would offer post-sale rebates instead of upfront discounts, STAT's Ed Silverman writes — a shift hospitals warn might jeopardize care by forcing them to front millions in costs.

While the move was broadly welcomed by biopharma, it has upset hospital groups, which say it would increase financial pressures on care providers.

"We are concerned that this guidance authorizes a significant departure from how the 340B program has successfully operated for decades and sets a dangerous precedent for possible harmful expansions in the future," Aimee Kuhlman, advocacy and grassroots vice president at the American Hospital Association, said in a statement.

podcast

What Vinay Prasad's ouster means for biotech and FDA

This week's episode of "The Readout Loud" is focused on a single topic — the ouster of Food and Drug Administration official Vinay Prasad from his job running the agency's biologics division. This surprising development came after a series of controversial decisions he made on Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy and a barrage of political attacks from conservative voices.

We bring on Brian Skorney, senior research analyst at Baird, to talk about the implications for the biotech industry. We then have on Robert Califf, former FDA commissioner, and Ned Sharpless, a former acting FDA commissioner, to discuss the implications for the agency.

Listen here.

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