LONDON — A U.K. commission on Thursday unveiled its recommendations for how the country should regulate artificial intelligence in medicine, as health authorities globally try to determine how to continuously review ever-changing products after they have been authorized instead of simply clearing them once for the market. 

In its report, the commission sought to strike a balance between ensuring that the U.K. takes advantage of AI’s potential in medicine — the ability to review the millions of scans that are generated each year to track the eye health of patients with diabetes, for example — while prioritizing safety, tracking device performance over time, and treating patients equitably.

The 44 recommendations include some that would allow for the staged authorization of new AI models and others that would build a system for providers to report how tools are performing in their clinics — including when they malfunction or potentially inhibit patient care — as the models learn and adapt and perform differently depending on the setting.  

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NEW YORK — The two measles-related deaths in Pennsylvania last month involved infants, and the virus itself caused one of the deaths, a Pennsylvania coroner confirmed Wednesday.

Lancaster County’s coroner, Dr. Stephen Diamantoni, said he told the Centers for Disease Control and Prevention of his conclusions. CDC officials, however, have not said whether they will count either death as measles-associated, and the agency’s website still carries a disclaimer about them.

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ARPA-H, the government agency that funds cutting-edge health research, plans to commit $62.7 million to develop artificial intelligence bots that direct treatment of heart failure. Among the goals of the program, called ADVOCATE, is to produce partially autonomous AI devices authorized by the Food and Drug Administration to help treat patients, including assessing symptom severity, prescribing drugs, and ordering lab tests. 

ARPA-H on Wednesday announced the first batch of awards to health tech companies Atman Health, UpDoc, Tempus AI, and teams from Stanford University, Duke University, and the Kaiser Permanente health system. ARPA-H may still fund additional teams. The amount committed for the first year is $33.7 million, and the remainder may be renegotiated up or down. 

Many of the 6.7 million Americans with heart failure don’t get optimal treatment because of difficulty accessing specialists, and the hope is that AI agents developed with ARPA-H funding can help address the gap, especially in rural and other underserved settings.

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It’s hard to resist the world’s obsession with productivity and efficiency and to force yourself to be present in a quiet space. I’ve been enjoying the wandering_cassettes Instagram account, which posts videos of Fisher Price cassette players playing songs in different settings. This one is particularly calming, but they’re all timeline cleansers.

The newsletter will be off next week as I work on a big new story, but I’ll be back in your inboxes Sept. 23.

AI scribes only fix a tiny slice of the problem

Today’s AI Prognosis — and my new story — are brought to you by “The Pitt.” Not in any financial way — I just mean that I finally started watching “The Pitt.” (No spoilers! I’m only halfway through season two.)

Everyone is right — it is extremely compelling television. But what struck me the most was how “The Pitt” feels exactly like the ambulance ride-alongs and emergency department shadowing visits I’ve done: Dropping in on the worst day of someone’s life, but doing it over and over every 40 minutes, for eight to 12 hours, without enough resources.

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First came the new teaser for Nathan Fielder’s documentary on Elizabeth Holmes. Now come the memes. Bring it on.

FDA names permanent heads of drug and biologics centers

For the past few months, key centers at the FDA have been led by acting officials. The agency said yesterday it will now make them permanent. Michael Davis will be director of the Center for Drug Evaluation and Research, and Karim Mikhail will be director of the Center for Biologics Evaluation and Research.

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Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a needed cuppa stimulation. Our choice today is ginseng peach, a favorite from our pantry. Meanwhile, here is the latest menu of tidbits to help you on your way. We hope you conquer the world and have a wonderful day. And as always, please do stay in touch. We appreciate feedback, tips and criticism. …

In a pair of late-stage trials, an AstraZeneca drug reduced the dangerous flare-ups that worsen COPD, positioning it as a potential new option for the vast number of patients with the debilitating lung condition, STAT explains. According to data released Tuesday, the results 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 the injectable drug could reap billions in annual sales if approved, both in COPD and in other conditions including asthma. 

The Trump administration permanently filled four key leadership roles at the U.S. Food and Drug Administration on Tuesday, after nominating Heidi Overton to lead the agency late last month, STAT says. Three of the officials are serving in an acting capacity, and will take the same roles permanently. 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. 

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Good morning. I didn’t have space to mention it yesterday, but can you believe Nathan Fielder made an Elizabeth Holmes documentary? Variety called it shameless and fascinating. I may need to see for myself. 

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SAN DIEGO — When Kura Oncology decided to take aim at a protein involved in cell division and signaling, researchers reported a bonus finding: Targeting the protein, menin, didn’t just control the growth of leukemia cells, it also helped control blood sugar levels in animal studies. The biotech on Wednesday announced that it is turning that insight into a new company.

The new firm, Caspian Therapeutics, is launching with $50 million in financing to develop menin inhibitors for diabetes and other cardiometabolic diseases. The initial funding, led by BVF Partners and joined by Eli Lilly and members of Kura’s leadership team, among others, is meant to advance Caspian’s lead small molecule drug through an early-phase clinical trial in diabetes and support the development of a second candidate.

Kura will retain around 50% ownership of Caspian, and Kura CEO Troy Wilson will serve as executive chair of the new biotech’s board. Robert Spencer, who was most recently CEO of Neurommune Therapeutics and has previously led drug discovery programs at Merck, was named Caspian’s head.

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Ezekiel J. Emanuel and Abe Baker-Butler have been debating the proper place for AI in medicine with American Medical Association CEO John Whyte. Now, they are taking their discussion to STAT’s First Opinion. Read Emanuel and Baker-Butler’s essay below and read Whyte’s essay here.

In 1867, Joseph Lister published his research on carbolic acid and antiseptic surgical technique.  In September 1871, he was summoned to Queen Victoria, who had a rapidly growing abscess in her left armpit. Using his antiseptic surgical technique, Joseph Lister successfully drained the pus. Queen Victoria recovered without fever or other complications. The antiseptic technique quickly gained approval in the U.K. and Europe, but not among American physicians.  

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Ezekiel J. Emanuel and Abe Baker-Butler have been debating the proper place for AI in medicine with American Medical Association CEO John Whyte. Now, they are taking their discussion to STAT’s First Opinion. Read Whyte’s essay below and read Emanuel and Baker-Butler‘s essay here.

Would you want artificial intelligence to tell you that you have cancer?

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BOSTON — The building that houses the Brigham and Women’s Hospital emergency department opened in 2022. But by 2025, it was already too small. One early September evening, the emergency room had 59 patients — 152, if you counted everyone in the waiting room. 

“In terms of rooms for acute care, we have 61,” said Christopher Baugh, an emergency physician at the hospital. “You can’t see 152 patients in 61 rooms.” Patient beds lined every possible area, with a full circle of beds surrounding the staff workstations in the center of the bay. Figurines of Star Wars characters R2D2 and C3PO peered over beds 80H and 81H — where “H” stands for “hallway.”

To some, this may look like a scene from another country, Baugh said. But to him, it’s just Thursday.

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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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I hope you all had a good Labor Day weekend. Robots may be able to run extremely fast now, but at least we know how to stop. Run your thoughts to me anytime: bob.herman@statnews.com.

A cash parade for a top House Democrat

UnitedHealth Group’s top executives, including CEO Stephen Hemsley, and board members recently flooded the campaign coffers of Rep. Katherine Clark of Massachusetts, the No. 2 Democrat in the House who just beat two opponents in a closely watched primary.

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House Republicans canceled the last two weeks of their session in September, which means House lawmakers will have gotten at least 15 weeks off between Memorial Day and the midterms on Nov. 3. Send news tips and PTO requests to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.

House Democrats’ agenda takes shape

In the week that the House was in town, a fuzzy outline of the health care agenda that Democrats are considering should they win back the House started to take form.

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Good morning health tech readers!

I hope you had a wonderful long weekend.

Reach me: mario.aguilar@statnews.com

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Today, we delve into how an FDA approval paradoxically complicated access to Revolution Medicines’ new pancreatic cancer drug for some patients, see standout mid-stage results for Roivant’s pulmonary hypertension drug, and more.

Hope you had a lovely long weekend! Estoy trabajando en este Readout de la Biblioteca Vasconcelos en la CDMX.

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Good morning, everyone, and welcome to another working week. We hope the weekend respite — longer than usual thanks to a holiday on this side of the pond — was relaxing and invigorating. Now, though, that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on a cup of stimulation. Our choice today is butter pecan. Feel free to join us. Remember, no prescription is required. Meanwhile, here are a few items of interest. Best of luck accomplishing your goals, and we hope you conquer the world. And, of course, do keep in touch. …

An experimental Novartis drug for a rare neuromuscular condition failed to improve muscle function in a pivotal study, its second major trial collapse in a matter of days, STAT writes. The two study flops will likely stoke concerns about its pipeline and acquisition strategy as it navigates a major patent cliff, though the company did see a victory with a multiple sclerosis drug last week. The stock was down by as much as 10% in early trading in Switzerland. The Phase 3 HARBOR trial was testing the drug del-desiran in a condition called myotonic dystrophy type 1, known as DM1, which causes progressive muscle stiffness and weakness.

Novo Nordisk stopped two trials of a drug that aims to tame inflammation as a way to improve cardiovascular health, another blow for the approach, STAT notes. The company said it had halted the HERMES and ATHENA trials of its drug, ziltivekimab, after a data monitoring committee found they were unlikely to succeed. Novo informed trial investigators on Friday. The move follows the earlier failure of the drug in the ZEUS trial, which showed that the medicine, despite lowering markers of inflammation, did not reduce the risk of major clinical complications, including deaths and heart attacks.

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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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Good morning. An exciting post-Labor Day announcement: While STAT’s Lev Facher is away on a Knight-Wallace Fellowship, I’ll be covering the addiction beat for him! My first story published last week. Send me news tips and story ideas to tackle over the next eight months: theresa.gaffney@statnews.com 

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