Terns drug shows strong early efficacy data

Terns Pharmaceuticals reported early but strong data on its next-generation CML drug, TERN-701, at the American Society for Hematology, STAT's Adam Feuerstein writes. Major molecular response rates hit 64% at 24 weeks across four escalating doses — far above what Novartis' Scemblix achieved in its Phase 1 study — in heavily pre-treated patients. Safety looked manageable, with no dose-limiting toxicities or pancreatitis and mostly expected cytopenias.

"CML is a chronic disease where people are likely going to be taking a drug for the rest of their lives, for most of them," Terns CEO Amy Burroughs told STAT. "You want to offer something that is safer and more efficacious."

With investors already eyeing TERN-701 as a potential successor to Scemblix, Terns plans to expand the dataset and launch a Phase 3 trial in 2026.

fda

FDA revolving door rules need modern overhaul

It's long past time to update federal rules meant to curb the FDA's revolving door, two pharmacist-attorneys write in a new STAT First Opinion. As senior officials continue to cycle directly into high-profile industry jobs, public trust is eroding, they argue, and blurring the line between the regulator and the regulated.

Current post-employment restrictions under the Criminal Code's Section 207 — drafted for a different era — are riddled with loopholes. These allow former FDA leaders to lobby at the state level, offer behind-the-scenes advice, and trade on their former titles with little consequence. Authors Lee Rosebush and Marc Wagner call for longer cooling-off periods, stricter enforcement, and a public registry tracking where FDA officials go after they exit.

"The threat of regulatory capture is not unique to the FDA, but the agency's importance in American life makes it a natural place to pilot new reforms," Rosebush and Wagner write. "If we care about safe drugs, trustworthy approvals, then reform of Section 207 is not just necessary — it is overdue."

vaccines

Why the White House shouldn't compare U.S. vaccine policy to Europe's

Shortly after last week's chaotic ACIP meeting, President Trump signed a memorandum directing HHS to align the U.S. vaccine schedule with peer, developed countries.

"To the uninitiated, this might look like a sudden, erratic pivot. It is not," attorney Richard Hughes IV, who used to be vice president of public policy at Moderna, writes in a First Opinion piece for STAT. "It is the culmination of a calculated campaign I have watched unfold all year — a strategy of weaponized incrementalism."

He describes how the committee, now steered by political appointees, has eroded long-standing recommendations by amplifying debunked safety fears, injecting regulatory friction, and ultimately voting to strip the hepatitis B birth dose from the schedule.

"A core argument driving this dismantling — championed by the President and Kennedy — is that the U.S. is an outlier compared to nations like Denmark or Japan that administer fewer doses," he writes. "This argument is a lethal fallacy that relies on the public's lack of knowledge about international health care infrastructure."

fda

FDA leadership's clashing standards deepen oversight risks

Under the current administration, the FDA is operating with striking ideological inconsistency, UC Davis professor Paul Knoepfler writes in a new First Opinion. Regulators are tightening evidence requirements for some products while signaling looser standards for others, he argues, which endangers patients and destabilizes the biomedical ecosystem.

As an example, Knoepfler points to the appointment of Tracy Beth Høeg as acting CDER director. Hoeg has been highly critical of Covid vaccinations while also previously offering patients stem cells and other procedures that were unproven. He notes similar contradictions in CBER chief Vinay Prasad's simultaneous demands for rigorous gene therapy data and support for policies that would lower evidence thresholds elsewhere.

"The inconsistency that has already manifested is bad for biotech and poses risks to the public," Knoepfler writes.

sequencing

DNA sequencing firm Oxford Nanopore names new CEO

Oxford Nanopore Technologies, a U.K. DNA sequencing firm that has made headlines for its ability to decode complex parts of the genome, announced that it appointed Francis Van Parys as its new CEO. Van Parys, who is currently CEO of Radiometer, a Danish acute care diagnostics firm, will start in March. He's replacing Gordon Sanghera, who has led Oxford Nanopore since its founding in 2005 and made clear earlier this year that he'd step down in 2026.

The move comes at a time when the company, like other genomics firms, is dealing with academic customers wary of making purchases due to uncertain research budgets. Shares have fallen by around 40% since August.

More around STAT