December 19, 2025

The need-to-know this morning

BioMarin said it is acquiring Amicus Therapeutics, maker of rare-disease drugs, for $4.8 billion.

exclusive

FDA voucher program enables political influence in science, staffers say

A new FDA program meant to speed drug reviews is becoming a vehicle for political interference, STAT's Lizzy Lawrence reports exclusively.

While some of the products selected for the Commissioner's National Priority Review program were nominated by career staff, final decisions are being made by FDA Commissioner Marty Makary and by the White House, multiple government officials said.

The vouchers, which promise one- to two-month reviews, have in some cases been awarded over career scientists' objections, tied to White House drug-pricing negotiations, and accompanied by pressure to compress standard review timelines.

"There's the risk of not fully vetting something for safety, or that we don't approve a drug that is safe and effective because we do not have sufficient time to fully and thoughtfully vet the data," a drug center employee said. "And if all of the attention is being put on the review of the [voucher] product, there will be less attention to other products that may be equally worthy."

funding

U.K. courts U.S. capital to revive biotech

Facing industry pullback and investor fatigue, the U.K. government is mounting a renewed push to reinvigorate its life sciences sector by courting American biotech venture capital.

The state-backed British Business Bank recently pitched new partnerships during a recent tour in Boston and New York — armed with the capacity to invest £25.6 billion in a handful of sectors, including the life sciences, STAT's Allison DeAngelis writes.

"We're here to say we're really open for business," said Leandros Kalisperas, chief investment officer of the British Business Bank.

The visit came after months of tension over drug pricing that drove companies like Merck, Eli Lilly, and AstraZeneca to pause investments in the U.K. The outreach also comes as life sciences VC fundraising has slumped to decade lows, potentially making British capital an attractive lifeline.

innovation

Former Pfizer R&D chief not so 'optimistic' about biopharma now

After decades of rising productivity in drug discovery, former Pfizer R&D chief John LaMattina argues that recent U.S. policy shifts are undermining the biopharmaceutical ecosystem.

In a New York Times profile nearly two decades ago, LaMattina was labeled "Dr. Optimistic" — but that's simply not the case anymore, he writes. From vaccine skepticism at HHS to the deep funding and staffing cuts at federal science agencies, he warns that innovation will slow considerably and the U.S. will be dangerously unprepared for future pandemics.

"It's very reasonable to worry that things are going to get worse," he writes. "It's pretty hard to be optimistic in such an environment."

Meanwhile, China is rapidly filling the gaps left by floundering U.S. research, and now is responsible for roughly a third of global drug pipelines — a development that may ultimately help patients, he writes, but should be alarming to policymakers if they have any interest in preserving a U.S. lead in biotech.

podcast

Biotech's year in review

Is the biotech industry truly out of its slump? Why are employers dropping coverage of weight loss drugs? And what will the hosts bake for the holidays?

We discuss all that and more on this week's episode of "The Readout LOUD," the last episode of the year. We bring on Bruce Booth, partner at venture capital firm Atlas Venture, to reflect on everything that's happened in the biotech industry this year and to look ahead at the trends next year.

We also chat about Adam's picks for best and worst biopharma CEOs in 2025, and why Eli Lilly and Novo Nordisk's direct-to-consumer offerings may be contributing to employers' decisions to drop coverage of weight loss drugs.

Listen here.

More around STAT