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Good morning. My colleagues and I will be live-blogging the confirmation hearing today for Marty Makary, President Trump’s pick for FDA commissioner. Follow along here.
Let’s get into the rest of the news today.
The need-to-know this morning
- German drugmaker Merck KGaA reported fourth-quarter earnings but management didn’t say anything new about the potential acquisition of Springworks Therapeutics.
Trump’s pick for NIH director aligns with the party
Economist Jay Bhattacharya, who is considered a shoo-in for NIH director, largely toed the party line in a confirmation hearing yesterday.
On the Trump administration’s move to slash NIH funding for indirect costs at research institutions, Bhattacharya said he would look carefully at the issue and suggested that universities were not transparent enough on how they use their money. (Note that yesterday, a federal judge issued a preliminary injunction blocking the Trump administration from slashing this NIH funding, but there’s widespread concern that in the new political climate, academic centers may still end up having to greatly cut back on research.)
Bhattacharya also said he is “convinced” vaccines don’t cause autism, but won’t rule out more studies on the issue, even as Republican Sen. Bill Cassidy countered him, arguing that producing more studies is “plowing over ground that has been plowed over.” If confirmed, Bhattacharya would work under HHS Secretary RFK Jr., who has refused to say that vaccines don’t cause autism.
For an overview and analysis of the whole hearing, read more from STAT’s Eric Boodman.
ITM’s radiopharmaceutical notches late-stage win
ITM Isotope Technologies Munich SE said this morning that it will seek FDA approval for its radiopharmaceutical to treat rare gastrointestinal cancers, after showing that the therapy halted tumor progression for nearly two years.
The drug, called ITM-11, is being developed for gastroenteropancreatic neuroendocrine tumors (or GEP-NETs). In a Phase 3 trial, patients with the earliest forms of this cancer who took the treatment lived for 23.9 months without their tumors growing, while patients taking an existing treatment on the market went a median 14.1 months before their cancer progressed.
Biopharma companies have been racing to develop candidates in the class of cancer drugs called radiopharmaceuticals. Novartis is currently the only company with radiopharmaceuticals on the market, one of which, Lutathera, treats GEP-NET cancers.
Read more from STAT’s Allison DeAngelis.
Novo follows Lilly with direct-to-patient offering
Novo Nordisk said yesterday that it will start selling its obesity drug Wegovy directly to patients at a reduced price, following a similar move from Eli Lilly, though Novo’s offering is broader.
Wegovy normally carries a list price of about $1,350 a month, but Novo will sell the treatment through its new direct-to-consumer offering called NovoCare Pharmacy at $499 a month for all doses to cash-paying patients, meaning patients who are paying on their own without insurance. Meanwhile, Lilly sells all but the highest doses of Zepbound through LillyDirect, and at different prices ranging from $349 to $699 a month.
Novo also said that in the “near future,” it will extend the reduced price to cash-paying patients who fulfill their orders at traditional pharmacies. Lilly hasn’t indicated it will take such a step.
Amgen starts late-stage studies of MariTide
Elsewhere in the obesity space — Amgen has initiated Phase 3 trials of its obesity drug MariTide, one in overweight and obese people without diabetes and another one for people with diabetes.
The company’s chief scientific officer, Jay Bradner, said at a health care conference yesterday that it will study three doses of “low, medium, and high.” He disclosed little about the exact dosing scheme that will be tested, but said that “you can think of a titration scheme as starting lower.”
Recall that late last year, Amgen reported that in a Phase 2 trial, MariTide led to roughly 20% weight loss over a year. Many investors didn’t view the result as competitive enough, especially since executives had said they were “very encouraged” by an interim analysis of that study. Still, though, Amgen’s leadership has said it continues to see the treatment, designed to be dosed monthly, as being “differentiated.”
“The progression of the MariTide Phase 3 program is going very, very well,” Bradner said.
More reads
- Trump’s early actions imperil efforts to improve AI’s performance in medicine, STAT
- New version of Merck’s blockbuster cancer drug threatened by patent battle, Wall Street Journal
- CDC invites back about 180 fired employees, including some who help fight outbreaks, Associated Press