March 28, 2025

The need-to-know this morning

Advisers to the European Medicines Agency voted to deny the approval of Kisunla, Eli Lilly's treatment for early Alzheimer's disease. The benefits of Kisunla did not outweigh the risks of potentially fatal events due to brain bleeding, the advisers said. Lilly, in a statement, said it intends to appeal the decision.
Milestone Pharmaceuticals said the FDA rejected its application seeking approval for an inhaled drug to treat adults with certain types of abnormal heart rhythm. The FDA cited manufacturing deficiencies as the reason for the rejection, Milestone said.

government

10,000 jobs to be cut at HHS, including 3,500 at FDA

Robert F. Kennedy Jr. is slashing HHS, with plans to cut 10,000 jobs and halve the the agency's divisions in what he is calling an effort to streamline bureaucracy and tackle chronic disease. He says the restructuring will save $1.8 billion a year — 0.1% of HHS's budget — but former officials see the moves amounting to amateur hour and warn that morale is tanking and essential services could crumble.

These cuts will include roughly 3,500 jobs at the FDA, though it's not clear yet which they will be. The cuts will target employees working on policy, human resources, information technology, procurement, and communications. It'll start sending notices to employees on Friday, with terminations coming into effect on May 27.

Meanwhile at the FDA's Oncology Center of Evidence, both deputy directors are on the way out at the door.

OBESITY

Novo Nordisk sets sights on new type of oral obesity drug

Novo Nordisk has signed another obesity pact, this one for an oral drug that works via an uncommon mechanism and could potentially help patients maintain their weight loss when they stop taking Novo's blockbuster obesity drug.

The Danish drugmaker is licensing a drug called LX9851 from Lexicon Pharmaceuticals, according to an announcement this morning. Lexicon could receive up to $75 million in upfront and near-term payments, if it meets certain development goals, and is eligible to earn up to $1 billion from later R&D, regulatory, and sales milestones.

The deal is the latest in both Novo Nordisk's and Eli Lilly's moves to fend off new competitors in the obesity market.

TELEMEDICINE

Lilly to connect patients to telehealth providers of Alzheimer's care

Eli Lilly is expanding its direct-to-consumer telehealth platform, LillyDirect, to include care for Alzheimer's disease. It'll connect patients with Synapticure, another telehealth company, which will arrange for virtual diagnoses and care navigation — but not drug delivery, since treatments like Lilly's new infusion drug Kisunla require in-person administration.

Lilly is framing this as an effort to streamline early diagnosis and access, which is especially important with all the new treatments that are available. At the same time, some lawmakers and experts worry that the growth of pharma and telehealth arrangements may lead to over-prescribing and inadequate care.

"I would not want to compromise the quality of care just to increase capacity," one Alzheimer's researcher told STAT. "I would want to make sure that whoever they're connecting to truly is a dementia expert … and doesn't have a conflict of interest in doing it."

podcast

Artificial intelligence, HHS cuts, and 23andMe's collapse

Can an AI tool be better than the industry standard at predicting which cancer patients will respond to treatment? Will drug companies feel the impacts of new cuts at the Department of Health and Human Services? And what will happen to all of the consumer health data owned by 23andMe?

We discuss all that and more on this week's episode of "The Readout LOUD," STAT's biotech podcast. Our hosts, Adam, Elaine, and Allison, discuss the Trump administration's plan for huge job cuts and a restructuring of the country's top health care agencies, the approval of the first drug to treat a devastating rare disease, and the bankruptcy of 23andMe.

Then, we bring on the chief executive of startup Altis Labs to discuss new data from a study they conducted with AstraZeneca on an AI tool for cancer drug development.

Listen here.

Pharma

Pfizer accused of major tax-dodging scheme

Pfizer pulled off what one senator called "the largest tax-dodging scheme" in pharma history, using a tactic known as "round-tripping" to avoid paying any U.S. income tax on $20 billion in domestic drug sales in 2019.

An investigation by Democratic staff of the Senate Finance Committee concluded that Pfizer funneled profits through offshore subsidiaries in tax havens like Puerto Rico and Ireland — despite selling to American patients — thanks to loopholes created by a 2017 tax law. The company claims it paid $12.8 billion in U.S. taxes over four years, and says documents to back that up have been filed with the SEC.