WASHINGTON — The Trump administration permanently filled four key leadership roles at the Food and Drug Administration on Tuesday, after it nominated Heidi Overton to lead the agency late last month. 

Three of the officials are serving in an acting capacity, and will take the same roles permanently, the administration said. They are Michael Davis, a psychiatrist who will be director of the Center for Drug Evaluation and Research; former Merck official Karim Mikhail, who will be director of the Center for Biologics Evaluation and Research; and Bret Koplow, an attorney who has been at the FDA since 2011 and will serve as director of the Center for Tobacco Products. 

The fourth appointee, Jared Seehafer, will serve as the FDA’s first deputy commissioner for technology and artificial intelligence. He joined the FDA as an adviser in 2025 after founding a life science software company and working in investment advising in biotech, according to his LinkedIn. Under the Trump administration, the agency has pushed its staff to use AI to speed up its review processes. 

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Residue and stains plastered on production walls, floors, and manufacturing equipment. Corrosion on a product line. An employee wearing open-toed sandals.

These were among the unsanitary conditions found last April by a Food and Drug Administration inspector during a visit to Shoolin Pharma in Gujarat, India, where the company makes active pharmaceutical ingredients for more than a dozen medicines, including erectile dysfunction and anti-convulsant pills, that are sold to compounding pharmacies in the U.S., according to the agency.

The concerns about filth and possible contamination in the production and packaging areas — as well as incomplete laboratory testing records — prompted the agency last month to halt all product shipments by the company into the U.S., the FDA disclosed in an Aug. 18 warning letter that was posted on the FDA web site last week.

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In a pair of late-stage trials, a drug from AstraZeneca reduced the dangerous flare-ups that drive the worsening of COPD, positioning it as a potential new option for the vast numbers of patients with the debilitating lung condition, according to data released Tuesday. 

Results from the Phase 3 trials of the drug, called tozorakimab, also amount to a re-assuring victory for AstraZeneca, which is known for its metronomic success in trials but has seen some notable misses in recent months, most dramatically with a heart disease drug. Analysts and the company have projected that “tozo,” as the injectable drug is dubbed, could reap billions in annual sales if approved, both in COPD — which, as the third-leading cause of death globally, remains greatly underserved — and in other conditions including asthma. 

In the trials, tozo reduced COPD exacerbations — any sudden worsening of the disease requiring medical care, whether a severe cough or breathlessness — by about 30% across all patients over a year, according to data presented at the European Respiratory Society’s annual conference in Barcelona and published in the New England Journal of Medicine. That finding makes tozo competitive with other COPD treatments that have reached patients in recent years, but notably, the tozo trials included participants not eligible for the other new drugs. The benefits seen in those patients could give AstraZeneca a large segment of the market to itself.

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RFK Jr. adviser Calley Means and Kennedy’s son Finn attended the Enhanced Games, the pro-doping athletic competition and biohacking extravaganza that took place over the weekend in Las Vegas, according to The Washington Post. Send news tips and personal bests to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.

Ripple effects

For weeks, Republicans have been preoccupied with an immigration funding bill that they’re pushing through Congress, without support from Democrats. I’ve not been writing about that bill because it doesn’t include health care policies. But it’s now becoming relevant to health care, albeit indirectly.

Early last week, Republicans were expected to pass that budget reconciliation bill without much friction. By the end of the week, Senate Republicans adjourned for a week-long recess without voting on it due to an impasse over a new $1.8 billion settlement fund for Trump’s allies. They’d also butted heads with the president over his demands for $1 billion for a White House complex and ballroom.

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WASHINGTON — People in the food world didn’t know what to expect when the Trump administration appointed a little-known Florida attorney as the FDA’s top food official in 2025. 

They knew Kyle Diamantas worked at Jones Day representing food, beverage, and tobacco-industry clients. They saw the picture of him and Donald Trump Jr. holding giant, dead wild turkeys after a hunt. He had no experience in public health, in medicine or science, or in government.

The credentials didn’t scream qualified. And Diamantas was stepping into a center rocked by DOGE layoffs and a defiant resignation by former leader Jim Jones. 

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Sen. John Cornyn: How many patents do you [have?]
AbbVie CEO Richard Gonzalez: … A hundred and thirty-six patents.
Cornyn: A hundred and thirty-six patents on one drug?
Gonzalez: But, well, remember, Humira is like nine different drugs, or 10 different drugs. So —
Cornyn: I thought you said to Sen. [Debbie] Stabenow it was the same
molecule.
Gonzalez: It is the same molecule, but it treats different conditions. And if you look at that patent portfolio —
Cornyn: So you use the same molecule to treat different conditions and you can get a patent on that treatment?
Gonzalez: Certainly.

The above exchange comes from a 2019 congressional hearing. Sen. John Cornyn, a Republican from Texas, was asking AbbVie’s CEO, Richard Gonzalez, to explain to the Senate Committee on Finance how his company had amassed so many patents on this single drug called Humira. Gonzalez, who was no stranger to controversy, chose to respond by likening it to multiple drugs. After AbbVie had received the first regulatory approval for Humira to treat rheumatoid arthritis, a condition that causes inflammation of the joints, it thought the drug might also work on inflammatory bowel disease. In fact, AbbVie would eventually test, obtain patents for, and get FDA approval of the drug for several inflammation-related conditions. For Gonzalez, the 136 patents AbbVie had accumulated up until that point were justified. They were “innovations they had created,” he said. This would mean another 18 years of patent protection beyond the expiry of Humira’s original patent in 2016.

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Eli Lilly said Monday that a high dose of its gene-editing therapy reduced cholesterol levels by 62% in participants in a clinical trial, an early but encouraging test of whether a one-time treatment may one day help people seeking to lower their LDL, or “bad,” cholesterol.

Lilly acquired the therapy, VERVE-102, in its $1 billion buyout of Verve Therapeutics last year. Executives tout it as a potential treatment to broadly prevent heart disease, the world’s leading killer, as many patients struggle to stay on existing, more conventional medicines for reducing cholesterol levels.

There were no treatment-related serious adverse events in the Phase 1 study — a notable finding, given that Verve had to shelve its first candidate due to safety concerns. 

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Below is a lightly edited, AI-generated transcript of the “First Opinion Podcast” interview with Patricia Bencivenga and Adriane Fugh-Berman. Be sure to sign up for the weekly “First Opinion Podcast” on Apple Podcasts, Spotify, or wherever you get your podcasts. Get alerts about each new episode by signing up for the “First Opinion Podcast” newsletter. And don’t forget to sign up for the First Opinion newsletter, delivered every Sunday.

Torie Bosch: Brain fog and weight gain and hair loss and insomnia — those are the calling cards of perimenopause. At least that’s what the new perimenopause awareness movement claims. But what’s real and what’s just social media misinformation?

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Retro Biosciences, the longevity startup backed by OpenAI CEO Sam Altman, has raised more money at a $1.8 billion valuation, it announced Friday. 

Retro has a big mission: Add 10 healthy years to the human lifespan. It is seeking to do that by using a variety of technologies, including in vivo gene therapies, cell replacement therapies, and other approaches to spur younger, healthier cells into aging tissues. 

The company is currently running its first clinical trial — testing a pill designed to enhance the body’s ability to better clear out protein aggregates in patients with Alzheimer’s disease. Retro CEO Joe Betts-LaCroix told the audience at STAT’s Breakthrough Summit West on Tuesday that the trial is going “super good” and that researchers haven’t seen any dose-limiting toxicities. He said he anticipates releasing some data from the trial around August. 

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The Food and Drug Administration on Friday rejected — again — an experimental treatment for advanced skin cancer developed by Replimune Group. 

Replimune’s treatment, an engineered virus designed to rev up the immune system against melanoma, has been a flashpoint in a simmering debate over shifting standards at the agency.

The drug was initially rejected in July, just two months after Vinay Prasad was appointed the FDA’s head of biologics. As an academic oncologist, Prasad criticized regulators for approving drugs with limited data, and the Replimune decision was viewed as a possible sign of the stricter stance he might take at the agency.

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Why is old exon science getting new traction? What’s unsettling biotech VCs? And who will be the next CEO of PhRMA?

We discuss all that and more on the latest episode of “The Readout LOUD,” STAT’s weekly biotech podcast.

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In which RFK Jr. says the “government lies to us” while sitting in front of an HHS seal. Send news tips and podcast recommendations to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.

First, control health care costs

Last month, a group of 12 Senate Democrats proposed a framework for rebuilding the health care system. The idea was to spur input from others ahead of when Democrats might get a chance to act on those plans.

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Georg Schett had two things: a young patient deathly ill with lupus, and a couple of mouse studies raising the possibility that special T cells could tame the condition.

The German physician-scientist could produce the cells — chimeric antigen receptors, or CARs — at his institution, which was half the battle. Another hurdle: The patient’s parents. “They were like, ‘Don’t do that. You’re crazy,’” recalled Fabian Müller, Schett’s collaborator at the University of Erlangen-Nuremberg. A widespread fear at the time was that T cells would trigger or worsen autoimmune disease. 

The rest of the story is the rare scientific fairy tale: The patient got better. Five years on, she is still in remission, and working in the very clinic where she was treated. Her case upended the world of autoimmune disease, driving a flood of experimentation and investment and offering new hope to millions of patients. 

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You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays.

The 2026 STAT Madness competition was stacked with research on topics like smart dental floss that monitors stress, Baby KJ’s personalized gene therapy, and an artificial intelligence model designed to predict cell behavior. Check out the winner, unveiled this morning. And as always, send news tips to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.

Budget reruns

The 2027 budget that the Trump administration released on Friday is in many ways a repeat of last year’s proposal: It includes deep cuts to the National Institutes of Health, the elimination of a health research agency, and the creation of a new agency devoted to chronic diseases called the Administration for a Healthy America.

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An experimental HIV prevention pill being developed by Merck could be mass produced for less than $5 per patient a year according to a new analysis. Advocates argue the low cost means the company should find it easier to license the drug so that low- and middle-income countries can gain easy access.

The pill, dubbed MK 8527, is currently undergoing a pair of late-stage clinical trials that are expected to determine whether the medicine can lower HIV transmission when given to people at high risk of infection. The results are due in the latter half of 2027, according to separate postings on ClinicalTrials.gov.

Already, the pill is generating considerable interest after Merck released mid-stage results last summer showing its drug holds promise. In addition to being safe and effective, the study found it could protect against infection, a form of prevention known as pre-exposure prophylaxis or PrEP, within 24 hours after being taken. Merck noted the pill works in a novel way.

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WASHINGTON — The Food and Drug Administration used the president’s budget to propose policies aimed at encouraging domestic development and manufacturing of drugs.  

FDA Commissioner Marty Makary has said the agency needs “giant, big ideas” to counter China’s dominance in early-stage clinical development of drugs. Among the FDA’s ideas are proposals to make it easier to run early-stage trials in the U.S. and to hand an advantage to U.S.-based generics manufacturers.

The Trump administration has been using a variety of policy levers to try and bring drug manufacturing to the U.S. For example, many of the brand drugmakers that struck deals to lower U.S. prices also promised to increase domestic manufacturing, under the threat of tariffs.

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For the second time in two years, a bill is moving through the Colorado legislature that would exempt orphan drugs, which are used to treat rare diseases, from pricing caps that might be pursued by the state’s Prescription Drug Affordability Board — a panel whose work is being closely watched elsewhere in the country.

The effort reflects concerns that patients may lose access to these drugs if pharmaceutical companies halt sales of such treatments in the state. But opponents argue exemptions would unnecessarily extend to numerous big-selling medicines for common conditions that — thanks to regulatory endorsements — also happen to have an orphan designation.

As a result, consumer advocates complain the maneuver would only increase the risk that countless patients could have trouble paying for a wide variety of medicines. They further argue that the legislation would preserve profits for drug companies at the expense of the state government — and its taxpayers — as it tries to cope with budgetary strains.

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