February 7, 2025

The need-to-know this morning

Bain Capital said this morning it will buy Mitsubishi Chemical's pharma business for $3.37 billion, in one of the private equity firm's largest life science deals. Bain will acquire a centuries-old drugmaking division currently developing medicines for neurological and immune disorders, among other kinds of conditions, allowing Mitsubishi to focus on its core chemical business.

government

White House reportedly plans for sweeping cuts across health agencies

The White House is preparing an executive order to cut thousands of jobs at the Department of Health and Human Services, including the FDA, CDC, and NIH, the Wall Street Journal reports — though final decisions have not been made. The plan would require agencies to lay off a certain percentage of workers, potentially impacting drug approvals, disease tracking, and medical research. Agency officials have been told to compile lists of essential and non-essential workers, sources told the Journal. That said, the White House has denied that there's an executive order of this nature underway.

Employees across the federal government have been offered buyouts, with more than 40,000 workers expressing intent to resign — though a judge has paused the deadline for them to make a decision while considering litigation that challenges the program.

DRUG DEVELOPMENT

Lilly expands GLP-1 research to hypertension, neuro conditions

From STAT's Elaine Chen: Eli Lilly plans to test weight loss drugs in even more disease areas outside of obesity.

On the company's earnings call yesterday, Chief Scientific Officer Dan Skrovronsky said it plans to start a Phase 3 trial of its GLP-1 pill, orforglipron, in hypertension. Lilly also plans to study incretin drugs (treatments that target hormones like GLP-1 and GIP) in areas that could include brain health, pain, and neuropsychiatry, he said.

This adds to the broad swath of conditions that Lilly has already planned to test its obesity drugs in. It's already reported data on the use of its obesity drug Zepbound to treat sleep apnea and heart failure. It's also announced plans to study obesity drugs in inflammatory conditions and substance use disorders.

There's been growing data showing that GLP-1 drugs can enter and exert effects on the brain. Some research suggests these treatments may help patients with neurodegenerative diseases such as Alzheimer's and mental health disorders like severe depression and bipolar, though larger studies are needed.

Lilly's competitor Novo Nordisk is running two large trials of the obesity drug Wegovy in Alzheimer's that are expected to report data this year.

government

Lawmakers call out Hims & Hers Super Bowl

Late last month the telehealth company Hims & Hers released an eyebrow-raising Super Bowl commercial saying the weight loss industry was keeping patients "sick and stuck" and that the industry's new wave of GLP-1 drugs were "priced for profits, not patients."

Now, lawmakers want the FDA to determine whether the commercial breaks any pharmaceutical advertising rules.

In a letter to acting FDA commissioner Sarah Brenner, Sens. Dick Durbin (D-Ill.) and Roger Marshall (R-Kan.) said they worried that the ad, which will be seen by millions of people during the Super Bowl this coming Sunday, "risks misleading patients by omitting any safety or side effect information" about the compounded weight loss drugs that the company promotes. They added that they "believe FDA may already have the authority to take enforcement action against marketing that may mislead patients about this company's products."

DEI

FDA trial inclusivity remains important

The FDA's Diversity Action Plan was meant to ensure that new drugs were tested in a broader spectrum of people before approval, but it's been sidelined in the wake of the Trump presidency.

Suzanne B. Robotti, who has served on an FDA advisory committee for drug safety and risk management, opines it's imperative to preserve diversity efforts in clinical trial design. She points out that clinical trials still overwhelmingly feature white men, which means we don't always know how well a drug will work for women, Black people, older adults, or other underrepresented groups.

"Modern medicine is a miracle," she writes. "But it can't be a miracle that works for only part of the population and leaves the balance in the dark."

podcast

Crisis in CRISPR world

Why are CRISPR companies not OK? Will Robert F. Kennedy Jr. keep his promises if he's confirmed to lead the Department of Health and Human Services? And how do you pronounce Journavx?

We discuss all that and more on this week's episode of "The Readout LOUD," STAT's biotech podcast. We bring on our colleague Jason Mast to discuss the dramatic downturn in the once-swaggering field of CRISPR gene editing.

We also talk about the advancement of RFK Jr.'s nomination to be HHS secretary, the latest pharma earnings, and the approval of a non-opioid pain drug from Vertex Pharmaceuticals.

Listen here.

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