April 28, 2025

The need-to-know this morning

Scholar Rock named current Chairman David Hallal as its new CEO, succeeding Jay Backstrom.
Biohaven signed a $600 million debt and and royalty agreement with Oberland Capital.
Novavax said this morning that it believes its Covid vaccine is approvable with a commitment to conduct a new study after approval. For more on the FDA's controversial handling of Novavax's case, read here.

A long-awaited biotech acquisition is finally happening

After months of discussion, Germany's Merck KGaA said this morning that it would buy SpringWorks Therapeutics for $47 a share in cash, a deal with an equity value of nearly $4 billion.

The acquisition was in many ways expected. Merck had said publicly it was negotiating with SpringWorks after media reports on the subject, including in the Wall Street Journal last week.

SpringWorks, based in Connecticut, has an approved drug in the U.S. called Ogsiveo that treats desmoid tumors, localized cancers that affect soft tissue and muscles. Another drug, called Gomekli, won U.S. approval in February and treats a genetic disorder that causes the growth of tumors. Both drugs are under review in Europe.

REGULATION

FDA's Covid booster shift sparks industry confusion

Confusion erupted over the weekend after FDA Commissioner Marty Makary defended the agency's delay in fully approving Novavax's Covid-19 vaccine — and an HHS official hinted that Pfizer and Moderna could soon face tougher standards for their boosters. At issue is what, exactly, qualifies as a new product, STAT's Helen Branswell reports.

Makary said on the social media site X on Saturday that the vaccine for which Novavax is seeking a biologics license application would require "new clinical studies," following a Wall Street Journal story that said the FDA is asking Novavax to conduct a new randomized controlled trial.

An HHS official separately suggested all manufacturers might need fresh clinical trials for boosters — a move experts warn could cripple timely rollouts.

tariffs

Medical device makers minimizing tariff impact

Medical device makers like Boston Scientific, Intuitive Surgical, and Resmed are largely shrugging off the financial hit from President Trump's tariffs. They're finding ways to offset hundreds of millions in added costs through U.S. manufacturing, tariff exemptions, and stronger pricing power.

While the broader biomedical industry braces for potential price hikes if tariffs persist, most firms are holding steady for now — a stark contrast to other sectors battered by trade policies, STAT's Bob Herman writes. Still, higher device costs could eventually trickle down to taxpayers and patients through Medicare, Medicaid, and private insurance premiums.

"Raw materials is a big question," one Baird analyst told STAT. "But when you think about some pieces of the metal, plastic tubing components that are going into catheters, and other devices — a lot of those are coming from in the U.S."

trade wars

Pfizer CEO warns U.S. risks biopharma lead

From STAT's Daniel Payne: Pfizer CEO Albert Bourla said China was on track to be the global leader in biopharmaceutical innovation unless the United States invests further in the industry, a pointed message for Washington as drugmakers await word on expected tariffs.

Speaking at an event hosted by Semafor on Friday, Bourla, who is also chairman of the trade group PhRMA, said the U.S. has been hindering drug development over the past four years instead of supporting it, in part with policies like the Medicare drug price negotiations.

At the same time, China has been advancing. "Unless we reverse that, we should understand that China will become the indisputable leader in biomedical innovation," he said. Bourla said he was talking with President Trump, lawmakers across Congress, and international leaders about how he believes "pro-innovation, pro-patient access policies" can be advanced.

That kind of argument may be persuasive to an administration that has touted an agenda of American dominance in key industries. Critics, however, say its spending cuts so far are moving the country in the wrong direction.

glp-1 drugs

Novo wins key ruling against compounders

Novo Nordisk scored a major legal victory last week as a federal judge denied a compounding trade group's bid to block the FDA from cracking down on pharmacies that make copies of semaglutide, sold as Ozempic and Wegovy. With the ruling, STAT's Elaine Chen writes, the FDA can now immediately target compounders, escalating enforcement starting May 22.

The Outsourcing Facilities Association, which argues semaglutide shortages persist, vowed to keep fighting. Novo and Eli Lilly have aggressively pursued compounders and telehealth firms, warning that unregulated GLP-1 copies pose safety risks — even as patients seek cheaper, accessible alternatives amid insurance gaps.

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