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LOS ANGELES — In the chapel of a homeless shelter, health secretary Robert F. Kennedy Jr. stood behind a lectern with a “Cancel Corruption” sign and lambasted local officials for mishandling the city’s homelessness and substance use crisis.

Just 24 hours earlier, Kennedy was in the Oval Office, standing alongside President Trump, as the president signed an executive order calling for major changes to childhood vaccinations.

The change in tone — from day to day and coast to coast — shows how Kennedy’s sprawling political messages tied to his Make America Healthy Again movement vary depending on the audience he is in front of. 

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The Internal Revenue Service is investigating UnitedHealth Group, with an initial probe determining the health care conglomerate underpaid taxes during a four-year period by funneling money through a foreign subsidiary.

The IRS is “seeking to significantly increase taxable income” from 2017 through 2020 and may force UnitedHealth to pay more “for subsequent years after 2020,” UnitedHealth revealed in a recent regulatory filing. UnitedHealth received the notices, which have not been reported, from the IRS in March. 

These types of audits from the IRS are exceedingly rare and focus on how big companies transfer profits within themselves. Given UnitedHealth’s size as one of the five largest companies in the world by revenue, this examination likely involves substantial sums of money. 

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Every August, Epic Systems founder Judy Faulkner holds court with over 20,000 people, including staff and executives from her most devoted customers, in an auditorium buried five stories into the Wisconsin earth. At the company’s annual meeting, she takes the stage to unveil her company’s latest innovations — products that inevitably form a technological road map for America’s hospitals.

This year, the crowd will also be watching Faulkner’s speech for another reason. 

The company she founded nearly half a century ago, now the nation’s dominant seller of electronic health records software, is facing an unprecedented series of challenges driven by antitrust lawsuits, questions about its artificial intelligence strategy, an exodus of key technology leaders, and, most recently, the disclosure that state and federal investigators are looking into the company’s business practices.

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America’s health care affordability crisis is not a partisan problem. It is bankrupting families, straining state budgets, and overwhelming emergency rooms from rural Appalachia to downtown Seattle.

While it is not a cure-all, we want to share something that worked in the purple state of North Carolina, in some of the most underserved rural communities in America, built with support from both sides of the aisle. We call it the Healthy Opportunities Pilots, and the results recently came in. They are worth everyone’s attention.

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The father cradled his newborn daughter as we reviewed routine infant care. Her mother, still recovering from childbirth, joined by video from home. He held his daughter with the tentative confidence and unmistakable love of a first-time parent. As we wrapped up our visit, he shook his head and said, “I can’t believe I have to go back to work tomorrow.”

As a pediatrician, I am unfortunately familiar with this type of story. Parents want to be present during the first days of their children’s lives. Too often, they cannot afford to be — especially fathers.

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Over a dozen states now have laws enhancing their oversight of private equity deals in health care. A new report says that’s putting a crimp in dealmaking. 

Physician practice management is on track to see about half the number of deals this year as it did in 2025. Investments in the businesses, which run clinics’ billing and operations, have plummeted from a high of 851 deals in 2021 to just 105 in the first half of 2026, according to new data from PitchBook. 

“It’s certainly been a big decrease,” said Paul Pitts, a partner with Reed Smith who works with health care providers. 

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The Federal Trade Commission is examining Epic Systems Corp., the nation’s largest vendor of electronic health records, for potential violations of antitrust law as part of a broad inquiry into the company’s business practices, according to four people who were recently contacted by investigators.

The probe is in its early stages and may never lead to charges against Epic, whose dominant market position and control of Americans’ health data has rapidly accelerated in recent years. But the people contacted by investigators — who work in or advise health care businesses that interface with Epic — said they were asked about a wide range of issues relating to company policies and practices that have generated continual complaints and lawsuits from former employees and rival companies.

One of the people said the government appears to be pursuing two separate lines of inquiry. One is focused on Epic’s agreements that bar its employees from working for a wide swath of health care businesses that directly, or indirectly, compete with the company. Another set of questions focused on Epic’s use of its dominant market position, and leverage over its hospital customers, to block rival technology companies from getting access to patient data and information needed to support their businesses.

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Every parent experiences a unique mix of emotions when caring for a newborn baby. You’re filled with an overwhelming sense of pride, love, and awe for this tiny, precious person in your arms. There are also feelings of nervousness and anxiety at the sudden responsibility of new parenthood. And, of course, you’re exhausted. There’s no instruction manual to refer to, but you’re in charge, and you’re immediately faced with lots of decisions. And people online are more than eager to tell you what to do and how to do it.

I know this feeling well. I’m a parent myself, but I’m also a pediatrician who has talked to thousands of parents navigating their first days and months with a new baby. After caring for children for more than 30 years, what I can say is that one thing hasn’t changed: Every parent wants to do what is best for their child.

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NEW YORK — Luigi Mangione pleaded guilty on Friday to federal stalking charges in the killing of UnitedHealthcare CEO Brian Thompson, admitting matter-of-factly that he trailed the executive to an investor conference in 2024 and gunned him down on a New York City street.

Mangione, 28, said he even used a ruse to glean information about the event, contacting the health insurance company ahead of time under the guise of being an investor at a multibillion-dollar firm.

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Today, we’re looking at a new multiple myeloma approval for Bristol Myers Squibb, PBMs embracing TrumpRx price comparisons, and Novartis winning a key U.K. patent fight over Entresto.

My son built a structurally sound bridge yesterday out of latticed twigs; it supported my weight and also his. It was a moment of great pride. Hire him, he’s 8.

Bristol’s Zenbexus wins accelerated approval in multiple myeloma

The Food and Drug Administration yesterday approved an oral treatment for advanced multiple myeloma made by Bristol Myers Squibb, marking the debut of a new class of medicine for the blood cancer and the first drug cleared by U.S. regulators using a more sensitive measure of remission.

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And so, another working week will soon come to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still taking shape, but we plan on promenading with the official mascots, catching up on our reading, and hanging with a visiting short person. We also hope to have time for our weekly listening party, where the rotation will likely include this, this, this, this and this. And what about you? As noted previously, this is a marvelous time to enjoy the great outdoors. City streets beckon. And beaches and woodsy trails are closer than you think. You could also curl up with a good book if the weather fails to cooperate, tidy around your castle, or get a head start on back-to-school shopping — the economy could always use a boost. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

The U.S. Food and Drug Administration approved an oral treatment for advanced multiple myeloma made by Bristol Myers Squibb, marking the debut of a new class of medicine for the blood cancer and the first drug cleared by U.S. regulators using a more sensitive measure of remission, STAT explains. The drug, which will be sold under the brand name Zenbexus, is part of a Bristol research effort to develop a new and more potent class of blood cancer drugs called CELMoDs that work by redirecting a cell’s natural machinery to eliminate cancer-causing proteins.

A U.S. appeals court ruled that a lower-court judge ‌erred in dismissing a $6.7 billion lawsuit accusing Bristol Myers Squibb of cheating former Celgene shareholders by delaying federal approval for three drugs, Reuters writes. In a 3-0 decision, the appeals court decided UMB Bank was entitled to represent Celgene shareholders as a trustee despite ​an error in how it was appointed. The case arose from Bristol Myers’ purchase of Celgene for $80.3 billion in 2019. Celgene shareholders who ​held “contingent value rights” were entitled to an extra $9 per share in cash if Bristol Myers won timely ​U.S. regulatory approvals for three drugs.

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A laboratory that tussled with regulators over impurities found in some widely used medicines has accused the group U.S. Pharmacopeia of making false and misleading remarks about its methods for uncovering safety problems.

In a lawsuit filed in a U.S. court, Valisure argued that USP, an independent organization that develops standards for medicines, inaccurately claimed it has used “unvalidated methods” for quality testing that can lead to “misleading results” and “unnecessary concern.”

Valisure maintained USP made these remarks in a 2023 white paper as part of an effort to portray its own testing methods as “inherently and universally safe, while suggesting that other testing approaching undermine public confidence” in medicines. Moreover, the lab alleged USP did so to promote trust in a system that “financially benefits” itself.

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The Food and Drug Administration on Thursday approved an oral treatment for advanced multiple myeloma made by Bristol Myers Squibb, marking the debut of a new class of medicine for the blood cancer and the first drug cleared by U.S. regulators using a more sensitive measure of remission. 

The Bristol drug, iberdomide, will be sold under the brand name Zenbexus. It will be used in combination with two other drugs, Darzalex and dexamethasone, to treat patients with multiple myeloma who have received at least one prior line of therapy. 

“With the Zenbexus approval, Bristol is the first company to bring a novel class of drugs to patients with multiple myeloma, opening venues for many more potential combinations,” said Cristian Massacesi, Bristol’s chief medical officer, in an interview with STAT ahead of the approval announcement. 

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The Trump administration’s campaign to eradicate transgender health care for young people has run into a series of legal roadblocks: Judges have ruled against Justice Department subpoenas, a declaration from the health secretary, and parts of the president’s executive order halting all federal support for this care. But a new rule finalized this week by the Centers for Medicare and Medicaid Services may prove more difficult to challenge. 

The agency announced Tuesday it was barring the use of federal Medicaid and CHIP dollars to pay for pediatric gender-affirming medications and surgery. Then on Thursday, the Department of Health and Human Services released a report on diagnostic coding practices among gender-affirming care clinicians and referred hundreds of health care groups to the Justice Department for investigation into those practices. Despite many court losses, the administration has successfully pressured at least dozens of hospitals into closing or pausing gender-affirming care programs. 

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Methadone clinics are finally getting their report card. 

In 2024, with the specialized addiction treatment providers facing backlash from patient groups and scrutiny from lawmakers, the federal government issued a long-awaited overhaul of regulations that determine how the clinics operate. 

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After doing three loops around the parking lot, you finally see a free spot. You step on the gas to claim it, but an SUV cuts in front of you and steals the space. You stomp on the brakes, jerking to a halt. You might forgive the other driver, but your Toyota remembers.

Later, as you drive home, your eyes wander to the restaurant that just opened on the corner. Your car loudly beeps you back to attention, the dashboard scolding, “keep eyes on the road.” Your car is watching you, and that hard stop and brief glance to the side are data sent directly to your car insurer, churning into an algorithm that decides your future premiums.

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At a church on the outskirts of Liverpool, older residents amble in for community lunch. In Sunderland, mothers swap stories as they are guided through play exercises with their babies at a local hub. On the St Matthew’s estate in Leicester, children spill out of school and onto a new football pitch.

These scenes are unremarkable, the everyday rhythms of community life. None of it looks much like health care. But this relational, daily support keeps people healthy and resilient outside of the clinical system — while remaining largely peripheral to how we fund, measure, and debate health.

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Commure, a $7 billion health software company that sells artificial intelligence tools to medical clinics, has terminated a program through which it was paying parties for referrals to new customers, according to company emails obtained by STAT. 

The emails, sent by Commure’s chief legal officer, Dan Brian, inform members of the partnership program that their payment agreements will be terminated 30 days from receipt of the company’s notice. One email, dated Aug. 6, states that anything owed under the agreement as of the termination date will be “paid in full.”

The notice was sent to members of the program six days prior to the publication of a STAT investigation that found the company offers to pay thousands of dollars to customers and other parties to refer its AI products to new business prospects. STAT first asked about the referral arrangements in an email to Brian on June 5.

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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.

Every competitor got a gold medal at Trump’s Freedom 250 Patriot Games, which sounds more like Lake Wobegon than an elite youth sports event. Send news tips and stories about your above-average kids to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.

Kennedy goes west

The day after the White House made another big push to change how Americans get vaccines, health secretary Robert F. Kennedy Jr. was in California pushing to change addiction treatment — and blaming the prior administration for how it previously handled it. My colleague Chelsea Cirruzzo was there with him.

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There’s limited access to California’s cheap insulin, Eli Lilly’s cracking down on black market retatrutide, and new biotech Khartis Therapeutics emerges with $95 million.

Some rather buff fellows at my gym were comparing abdomens today, raving about the bodysculpting wonders of all that illicit “reta.” I imagine they won’t be too pleased about the Lilly news.

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Rise and shine, everyone, another busy day is on the way. And it is getting off to a pleasant start here on the Pharmalot campus, where clear blue skies and comfy breezes are greeting us. As for the official mascots, they are happily snoozing in their respective corners. As for us, we are firing up the trusty kettle for another cuppa stimulation. Our choice today is ginger peach. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few items of interest. As always, do keep in touch. We appreciate feedback, criticism, and tips. …

Novo Nordisk chief executive officer Mike Doustdar believes investors are underestimating the demand for differentiation among obesity drugs, ‌and that new treatment options like pills will keep it from becoming a winner-take-all battle with rival Eli Lilly, Reuters writes. Novo was first to bring a highly effective GLP-1 weight loss injection, Wegovy, to the U.S. market, but is under pressure to regain ground lost to Lilly’s Zepbound in a business that ​analysts expect will be worth more than $100 billion a year by 2030.

Drugmakers are holding back applications for health insurance coverage in Switzerland over concerns that lower prices there could affect their U.S. ​business under drug-pricing policies introduced by the Trump administration, Reuters says, pointing to a new survey. About one-third of new innovative medicines were not submitted for coverage under Switzerland’s mandatory health insurance system between January 2025 and June 2026, potentially limiting patient access to new ​treatments, saccording to the survey ​by Interpharma.

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You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday.

Hello, health tech readers! Next week, the newsletter is going on its annual summer hiatus — we’ll see you back on the 25th.

Today, a deep dive into Commure, a company promising to automate the business of health care with artificial intelligence — and all the levers it’s pulling to make that happen. Let’s get right into it.

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This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.

A drug for a rare disease is evaluated in a small clinical trial. The treatment is modestly effective with manageable side effects. Balanced against the devastating nature of the disease, the drug is benefiting patients more than it is causing harm. Regulators approve it.

Months later, physicians prescribing the drug widely start to note a small number of patients are dying, despite the fact that no deaths were reported in a clinical trial of the drug. Similarly, the frequency of serious side effects rises dramatically, including some so severe that patients require hospitalization. The drug’s real-world safety profile appears worse than what was characterized in the small clinical trial.

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Scroll through the flashy websites of neurotechnology startups and a phrase repeats again and again: “minimally invasive.”

“The term is fuzzy, problematic,” said Anna Wexler, a medical ethics and health policy professor at the University of Pennsylvania Perelman School of Medicine. “Is it physical invasiveness? We’re not sure, it’s a fraught term.”

The fuzziness hasn’t stopped most brain-computer interface startups from deploying it in a bid to differentiate their devices from others in development. Synchron, Motif Neuroscience, Precision Neuroscience, and Merge Labs all use it liberally. Journalists sometimes repeat the spin.

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For hospitals, the promise of artificial intelligence is financial as much as clinical. A hospital might deploy an AI device because it promises to throw up an alert that could save a patient’s life — but the technology is far more likely to stick if it proves it can drive down costs. 

Convincing hospitals and health systems that a new technology will provide that return on investment is tricky, though. So some AI startups have benefited from a temporary sweetener that helps customers get on board: Certain new technologies can apply to get add-on payments from Medicare for two or three years after they come to market. The tax-dollar-funded payments are meant as an incentive to help get new, expensive medical technologies to patients.

If a hospital thinks, “‘Oh, you’re not 100% sure you have the money, or you don’t necessarily believe 100% of the assumptions in the ROI,’ then you know what? You have this safety net, at least for the next few years,” said Tom Valent, chief business officer at Aidoc. 

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I have spent much of my career responding to infectious diseases in places where vaccines were desperately needed but not always available.

In Haiti, I watched a patient die of tetanus, their body seized by violent, agonizing spasms until they could no longer breathe. Watching someone die that way from a disease a simple vaccine can prevent is something I have never forgotten.

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Over the last several years, fearmongering about statins has exploded, as misinformation alleges that they damage the brain, liver, and muscles, among other problems.

Oxford researchers recently published a study in the Lancet Digital Health that should help with one common concern involving muscle disorders. Whether it ultimately does, however, will tell us a lot about the influence of online misinformation, and the scientific community’s ability to counter it.

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Shortly after her wedding four years ago, Jenilee Crowley felt ready to start having kids. Then the 38-year-old found a lump in her breast that upended all her future plans.

Chemotherapy, radiation, and other cancer treatments come with a slew of side effects, including hormone changes and potential organ damage that can risk a person’s fertility.

But Crowley, who was diagnosed with stage one breast cancer in 2022, learned that she had options. After a double mastectomy to remove the cancer, Crowley started hormone therapy to help prevent it from returning. Then, under medical guidance from her team at Dana-Farber Cancer Institute, she paused the treatment so that she and her husband could freeze embryos and try for a baby. Her son, Archer, is now four months old.

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STAT is co-publishing this article by KFF Health News.

SAN FRANCISCO — At a Walgreens in this city’s bustling Japantown neighborhood, pharmacist Margaret On stocks two boxes of long-acting insulin pens from California’s new prescription drug label, CalRx, emblazoned with the state’s iconic grizzly bear.

Although she hasn’t dispensed any, On plans to keep them on hand. “It’s good to have if a patient comes in and doesn’t have health insurance,” she said. “Or just in case of emergencies.”

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The Trump administration on Wednesday unveiled a new framework for helping Americans facing the often-intertwined circumstances of addiction and homelessness. 

In a new toolkit, the White House unveiled a “treatment first” model that boosts faith-based interventions while rejecting harm reduction principles and the “housing first” strategy that characterized the Biden administration’s approach. While the new strategy favors medicalized approaches to treating addiction, it cites abstinence as the ultimate goal as opposed to also celebrating decreased drug use and related harms. 

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A highly anticipated No Surprises Act court decision delivered yet another win for providers, finding that the government erred in its instructions for calculating the amounts health insurers typically pay for services.

Tuesday’s decision from the U.S. Court of Appeals for the Fifth Circuit stems from a 2022 Texas Medical Association lawsuit challenging the government’s rule for calculating the qualifying payment amount, a number that’s used in arbitration to represent health insurers’ contracted rates for services. The trade group for doctors had argued that the methodology yielded numbers that were unfairly low, and the court mostly agreed.

The Fifth Circuit sided with providers against the federal government on two of three points: that the QPAs should not include so-called ghost rates, or placeholder rates that providers don’t actually negotiate, and that they should include bonus and incentive payments. It disagreed with air ambulance providers, finding that a one-off price for transporting a single patient should not factor into QPAs. 

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Young adults’ use of vapes and cannabis hit all-time highs last year, according to the results of a large new national survey conducted at the University of Michigan.

The percentage of young adults who said they’d used nicotine vapes in the past 30 days reached the highest levels since the question was first added to the survey in 2017, more than tripling to 19%. For cannabis, 29% of young adults between the ages of 19-30 said they’d used the drug in the past 30 days — just slightly below the all-time high of 30% the previous year. A record high of 12% reported daily cannabis use. 

The annual Monitoring the Future survey, which is supported by the National Institutes of Health, gathers data from about 20,000 Americans spanning the ages of 19 to 65. Overall, this year’s report presents a mixed picture of substance use trends in the U.S, according to Nora Volkow, director of NIH’s National Institute on Drug Abuse (NIDA).

“It is reassuring to continue to see relatively low smoking rates and a continuing decline in alcohol use among adults,” Volkow said in a press release. “At the same time, rising rates of cannabis, nicotine, and certain other drug use warrant attention. Continued monitoring is vital for understanding the changing drug landscape so that we can develop effective interventions to support public health.”

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Talks are underway between authorities in the Democratic Republic of the Congo and the World Health Organization to expedite the start of a multi-armed Phase 3 clinical trial of vaccines geared towards helping to contain spread of the Bundibugyo virus in the northeast of the country, which the director-general of the global health agency warned Wednesday is on track to become the largest Ebola outbreak on record.

“It’s already the second-biggest Ebola epidemic on record, and it’s moving faster than any previous Ebola outbreak. At its current pace, it’s on track to eclipse the West African Ebola outbreak of 2014 to 2016,” Tedros Adhanom Ghebreyesus said during a news conference in Geneva. 

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Senior officials of the World Health Organization, including Director-General Tedros Adhanom Ghebreyesus, criticized the Trump administration’s newest attempt to trigger an overhaul of U.S. vaccination policy on Wednesday, calling it politically motivated and contradictory to the best available science.

The critique was aimed at an executive order signed by President Trump on Monday. It calls for a reduction in the number of vaccinations recommended for all children in the U.S., and for the use of vaccines targeting single pathogens rather than the combination vaccines now in use, starting with the measles, mumps, and rubella shot.

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Waiting for treatment to start can be an excruciating period for cancer patients. There can be fears that the disease is spreading, or progressing to a point where therapies become less effective. Yet over the last few decades, the time cancer patients are waiting between diagnosis and treatment has steadily grown, according to a new study of more than 2.7 million patients.

“What was striking was the consistency,” said Tim Donahue, the senior author on the study and a surgical oncologist at the University of California, Los Angeles. “Across every cancer we studied, patients are waiting longer today than they were a decade ago.”

Donahue and his colleagues analyzed data from the National Cancer Database, a national data repository from the American College of Surgeons, from 2012 to 2023. They looked only at patients with stage 1 to 3 cancers that were considered eligible for surgery at diagnosis across six different cancers. Then, they compared the time between diagnosis and any first treatment, which included surgery as well as radiation or chemotherapy or other medical therapies. 

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The Lindsay Clancy case has become one of the most painful and polarizing stories in recent American memory. At its center are the unimaginable deaths of three young children and a mother whose mental state has become the subject of intense legal, medical, and public scrutiny. The criminal justice system will determine legal responsibility, but regardless of the trial’s outcome, the case exposes a larger and uncomfortable truth: Our understanding and treatment of postpartum psychiatric illnesses remain profoundly inadequate.

For many observers, the debate has become a binary one. Either Clancy was suffering from a severe postpartum psychiatric disorder, or she was not. Either she is guilty of murder or she is not. Either the system failed her or it did not. And, despite numerous attempts to seek medical care, she was either inappropriately medicated or not.

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Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy. So grab that cup of stimulation and get started. Our flavor today is butter pecan, a pantry favorite. We hope you have a lovely day, and do keep in touch. …

A group of physicians and experts in Prader-Willi syndrome, a rare disease that causes an insatiable desire to eat, notified clinicians of a series of patient deaths and cases of severe side effects potentially associated with Vykat XR, a newly approved drug sold by Neurocrine Biosciences, STAT reports. Vykat was approved by the U.S. Food and Drug Administration last year, but since then, seven people prescribed the drug have died, according to the FDA’s Adverse Event Monitoring System. And more than 100 reports of serious adverse events, mostly cases of patients hospitalized for swelling, respiratory, and heart complications, have been reported to the FDA. 

Eli Lilly filed six lawsuits against U.S. companies it accuses of illegally selling black-market versions of its experimental obesity drug retatrutide, escalating its campaign against unauthorized sellers before the medicine has won regulatory approval, Reuters says. The drugmaker said the lawsuits target a ​range of businesses, including compounding pharmacies, medical spas, and online sellers that allegedly marketed retatrutide ​products to consumers despite the drug remaining under clinical development. Retatrutide is still in ⁠Phase 3 clinical trials for obesity, type 2 diabetes, and other related conditions.

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Definium Therapeutics said Wednesday that its LSD therapy significantly helped patients with generalized anxiety disorder in the first of two large trials.

It’s the second major win for Definium in the past two months, following a Phase 3 success in major depression. 

In the Phase 3 anxiety study, 214 patients were randomly assigned to receive a single dose of DT120 — Definium “proprietary, pharmaceutically optimized” LSD pill — or a placebo. 

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You’re reading the web edition of STAT’s AI Prognosis newsletter, our subscriber-exclusive guide to artificial intelligence in health care and medicine. Sign up to get it delivered in your inbox every Wednesday. 

As you read today’s main item and the associated story, let me know whether you think these are just the typical growing pains of a company trying to live up to its investors’ expectations while transforming health care, or something bigger. You can reply to this email or send a message to aiprognosis@statnews.com.

And if you have tips I should consider for future investigations, email them to me or contact me on Signal (an encrypted messaging app) at btrang.01.

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Over the last five years, German researcher Georg Schett has made a name for himself as a pioneer in autoimmune disease treatment, showing that CAR-T therapy could be used to reset patients’ immune systems. 

He has become a scientific adviser de rigueur for the field, joining a half-dozen startup advisory boards. 

Now, for the first time, he’s co-founding a biotech company. But it has no immediate plans to work in CAR-T. 

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A group of physicians and experts in Prader-Willi syndrome, a rare disease that causes an insatiable desire to eat, on Tuesday notified clinicians of a series of patient deaths and cases of severe side effects potentially associated with Vykat XR, a newly approved drug sold by Neurocrine Biosciences. 

Vykat was approved by the Food and Drug Administration in March 2025 to curb the intense hunger sensation in children and adults with Prader-Willi syndrome, or PWS. But since its clearance, seven people prescribed the drug have died, according to the FDA’s Adverse Event Monitoring System. Additionally, more than 100 reports of serious adverse events, mostly cases of patients being hospitalized for swelling, respiratory, and heart complications, have been reported to the FDA. 

“The intention of this statement is to increase awareness of the risks for people with PWS when starting Vykat XR,” the physicians and experts wrote. Neither the deaths nor the severe side effects have been definitively linked to the drug, the group added. 

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The sky was a smoky grayish-orange and trees a few hundred yards away had turned to ghostly outlines. This July marked the third summer since I’ve lived in Chicago that the city was covered in a suffocating blanket of smoke from Canadian wildfires, and the air quality was breaking records: as high as 753 on the air quality index one afternoon, earning an “extremely hazardous” warning. Even with all our windows closed and two air purifiers running in different rooms, I was still getting headaches, a sore throat, and burning eyes. And my arthritis pain was worsening.

I’ve lived with chronic illnesses for most of my adult life and have racked up six of them at this point (endometriosis, psoriatic arthritis, Celiac disease, Graves and Hashimoto’s diseases, and interstitial cystitis). I know that my joints hurt more in cool, wet weather, that I’m prone to overheating when the temperature spikes above the 90s. I’m not alone: I’ve talked to dozens of people with different chronic conditions about how the weather affects them. Those with lupus need to avoid the sun, while some with psoriasis get relief from it; storms can trigger migraines and joint pain; hot weather worsens postural orthostatic tachycardia syndrome (POTS). Everyone’s body has a unique pattern of interacting with the weather, such that it’s difficult for patients to predict what might cause a flare.

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From its inception, Commure was built on the dream of automation.

The Silicon Valley technology company set out in 2020 to build a new operating system for health care. Its executives began to cast the company as a kind of Robin Hood: It would leverage artificial intelligence to take power and money from massive insurers and other industry giants — and give it back to doctors.

“I would love a world where the market cap of a UnitedHealth is a fifth, but every doctor is a millionaire,” Commure CEO Tanay Tandon said in a recent interview with Y Combinator, an investor in the company, currently valued at $7 billion.

But Commure isn’t just promising to fatten doctors’ wallets with money from insurers. For those willing to talk up its AI, it also offers to kick in compensation of its own.

A STAT investigation found the company offers thousands of dollars, in various forms, to medical clinics and other parties who refer its products to new business prospects. The compensation is part of a strategy to swiftly sell AI tools it says can unburden clinicians burned out by health care’s endless bureaucratic morass.

Based in Mountain View, Calif., Commure is among the most ambitious and all-encompassing efforts to automate the administrative tasks that underlie these businesses. Many of its customers speak of the company in heroic terms. In marketing videos and podcast interviews, they testify that its products for billing, scheduling, and clinical documentation have restored joy, and reliable revenue, to their practices. The company claims its tools are used by more than 500 health care organizations across the country, including “130 of the nation’s largest health systems,” such as for-profit giants HCA Healthcare and Tenet Healthcare.

Continue to STAT+ to read the full story…

President Donald Trump’s administration said that Medicaid will stop paying for gender-affirming surgeries and hormone treatments for transgender minors and the state Children’s Health Insurance Program won’t pay for the treatments for those under 19.

The announcement is the latest in a series of policies from the administration aimed at transgender people that began the day Trump returned to office last year.

Read the rest…

Not long after guidelines shifted to considering statin therapy as early as age 30, new research from France suggests there may be no harm in stopping the cholesterol-lowering drugs at age 75 in people with no history of cardiovascular disease. The lessons, however, may not translate elsewhere. 

The “non-inferiority” study, published Tuesday in the Lancet Healthy Longevity, does not advise doctors to tear up statin prescriptions for older people. Nor does it conclude that going off statin therapy is better than staying on. It does say patients should talk to their doctors to see if they’d be no worse off for dropping the daily pills.

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WASHINGTON — Health industry leaders pushed back on President Trump’s executive order on vaccines this week — including those he may need to rely on for his agenda.

On Monday, Trump signed an order that sought to unilaterally change the federal government’s approach to vaccinating children: recommending fewer shots, spreading them over longer periods, and doing so without evidence to back up the changes.

Trump was particularly interested in breaking up the vaccine that protects against measles, mumps, and rubella into three separate shots, saying — against all current evidence — that the combination shot could be lethal. (Trump later said he had no evidence for the claim; his health officials have repeatedly said they recommend the shot.)

Continue to STAT+ to read the full story…

The White House fact sheet accompanying President Trump’s executive order, which he signed Monday, makes a claim worth examining: that most peer nations sustain high childhood vaccination rates through “public trust and education” rather than mandates.

Let’s use trust as the test.

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Sen. Bill Cassidy (R-La.) is not happy with Trump’s call for the MMR shot to be broken up. If only there had been a way to stop that. Send news tips and your biggest regrets to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.

Trump’s about-face on vaccines

The president thrust controversial vaccine policy matters back into the spotlight on Monday.

Continue to STAT+ to read the full story…

History tells us that President Trump’s executive order calling for the measles, mumps, and rubella vaccine to be split into separate shots could do real harm. If policymakers prevail on vaccine makers, it will mean more missed vaccine doses, and more sick kids. But first a lesson on where the shot comes from.

In March 1963, a 5-year-old girl named Jeryl Lynn woke up with a sore throat at 1 a.m. Her father, a six-foot-one widower who had lost his wife to breast cancer four months earlier, bent down and felt the lumps on her neck. He was a scientist at the pharmaceutical company Merck, and he checked “The Merck Manual,” a medical reference book. “Oh my God,” he said. “You’ve got the mumps.”

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Top of the morning to you, and a fine one it is. Sunny skies and mild breezes are enveloping the Pharmalot campus once again. And to celebrate, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is blackberry hibiscus. Remember, a prescription is not required. So no need to mess with rebates or even TrumpRx. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …

The U.S. Food and Drug Administration rejected a radiopharmaceutical therapy because of manufacturing issues, halting what would have been a competitor for Novartis, STAT notes. The drug had been developed by ITM Isotope Technologies Munich SE, a long-standing player in the field of radiopharmaceuticals, which are an emerging treatment designed to shoot radioactive isotopes directly at tumor cells. The company had been anticipating the FDA would sign off on the drug and last month launched a new division, Lumara Bio, to commercialize and sell it.

Hims & Hers plans to jump into the peptides market before the end of the year, seeing opportunity to seize on a booming corner of the health industry, Bloomberg News says. The telehealth company is preparing to sell already-allowed popular compounds that patients seek for wellness and longevity benefits despite limited clinical evidence. The plan comes as the FDA decides whether to loosen restrictions on seven different compounds. Last month, the agency held a hearing in which outside advisers recommended easing limits on production and expanding access.

Continue to STAT+ to read the full story…

Two years ago, scientists made history with a gene therapy that restored hearing for a small group of children who had been born deaf, allowing some of them to hear for the first time. Indistinct murmurs turned into audible whispers. The robust gains and lack of safety concerns led the Food and Drug Administration to approve Regeneron’s Otarmeni therapy in April for the small group of people with this rare genetic mutation.

“[Otoferlin-related mutations] are more of a Goldilocks. The ear stays completely intact in animal models, even into geriatric models,” said Joe Burns, former senior vice president of research at Decibel Therapeutics, which was acquired by Regeneron in 2023.

Scientists are now eyeing other hearing-loss targets, including the holy grail — the GJB2 gene. Startups in the United States, France, and China are racing to concoct a solution, with Skylark Bio emerging from stealth on Tuesday to announce that they have dosed their first patient with a therapy aimed at restoring hearing in a child with a GJB2 mutation. 

Continue to STAT+ to read the full story…

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday.

Happy Tuesday, health tech readers! Mario is out on a very well-deserved break, so you’ll get dispatches from the rest of STAT’s health tech team this week. 

Today, a word from nurses on how AI really impacts their work. And finally, more details on the RAPID pathway that aims to help medical devices escape the valley of death.

Continue to STAT+ to read the full story…

Biotech companies don’t hide or obfuscate strong data. 

It’s an old saw but one that I have found to be a reliable predictor of future success or failure, particularly when judging clinical trial results. Yet once again, MoonLake Immunotherapeutics has announced “positive” results from a study of its autoimmune drug candidate marred by a level of data obtuseness that renders the word meaningless. 

It’s a subject I keep returning to, because with MoonLake it happens again, and again, and again. 

Continue to STAT+ to read the full story…

Nurses, who make up the largest part of the health care workforce, are getting more vocal about the risks posed by clinical artificial intelligence to their jobs and patient care as the technology makes deeper inroads into the practice of medicine. 

At Montefiore hospital in the Bronx, laid-off nurses have raised the alarm about administrative AI they say is replacing them. Across the country in California, nurses at Kaiser Permanente are striking and picketing against the AI surveilling their work and playing a growing role in patient care. Collectively, the loudest voices have come from unions like National Nurses United, which represents over 200,000 nurses, including those at Kaiser and Montefiore. 

As that workplace advocacy and bargaining continue, educators and researchers also have their eyes on the future: They’re trying to build solutions to support the next generation of nurses through training and involvement in how patient-facing AI is developed and deployed. By giving nurses a voice in AI’s inevitable disruption of health care, they hope to make the current adversarial relationship more collaborative.

Continue to STAT+ to read the full story…

In Venice, Italy, the fabled Bridge of Sighs spans a narrow canal, its small stone-barred windows once offering prisoners a final glimpse of freedom as they were escorted to their cells. The name reflects their resignation, the quiet exhale of those who knew what awaited them.

For many primary care physicians, a similar sigh now accompanies the start of Medicare’s “Bridge” program, which promises discounted access to the GLP‑1 weight loss medications Wegovy, Zepbound, and Foundayo. Despite its admirable goal — making highly effective treatments more affordable — the program risks doing the opposite by creating a complex, burdensome process that could limit access in practice.

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A physician is eating dinner with her family when an encrypted message appears on her phone. A frightened 17-year-old explains that she took misoprostol — one of the medications commonly used to end a pregnancy. Four weeks later, she is still nauseated and her pregnancy test remains positive.

She wants to know: Can she see a doctor without her parents finding out? Could she get into legal trouble for taking abortion pills?

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When Stephen Rosenfeld and Patricia Seymour founded the not-for-profit North Star Review Board, they’d become disillusioned with the scientific oversight system in America. IRBs, or institutional review boards, are supposed to have one priority top of mind: the rights and welfare of human research participants. But after decades as research ethicists, Rosenfeld and Seymour thought the industry had lost its way.

The problem, they said, isn’t just theoretical. Over the last couple of decades, IRB scandals have cast a spotlight on a fundamental problem in the system, experts said. In one such example, the Government Accountability Office in 2009 tested whether a group of for-profit IRBs could successfully detect a bogus unethical research protocol and reject it. One of the three companies tested, Coast IRB in Colorado, approved the fictitious application, even though the fake device had specifications and matched several examples of “significant risk” per FDA guidance. The sting operation revealed what the GAO called a vulnerability to “unethical manipulation” in the IRB system.

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WASHINGTON — The Trump administration, which in recent months had avoided public discussions of vaccine policy because of concern around the political repercussions, is changing course. 

Speaking from the Oval Office, President Trump on Monday unveiled a new executive order as he and his top health officials presented a new, skeptical government approach to vaccines, making extraordinary claims without evidence to support the remade federal agenda.

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The Food and Drug Administration has rejected a radiopharmaceutical therapy due to manufacturing issues, halting what would have been a competitor for Novartis. 

The drug, ITM-11, had been developed by ITM Isotope Technologies Munich SE, a long-standing player in the field. Radiopharmaceuticals are an emerging type of treatment designed to shoot radioactive isotopes directly at tumor cells. 

ITM’s therapy was designed to treat gastroenteropancreatic neuroendocrine tumors, or GEP-NETs, a rare type of cancer that grows in the pancreas, stomach, small intestine, and other parts of the gastrointestinal system. ITM reported in March 2025 that patients with the earliest forms of this cancer who received ITM-11 infusions lived for 23.9 months without their tumors growing. Meanwhile, patients taking another treatment on the market, everolimus, went a median 14.1 months before their cancer progressed. 

Continue to STAT+ to read the full story…

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Radiopharma’s precision promise runs into toxicity problems, China puts new guardrails around its biotech innovation engine, and Grail’s Galleri heads to an FDA advisory panel.

This Readout was partially produced at a sun-splashed kiddie pool party in SoCal. Each matriarch toenail is perfectly shellacked.

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The cyclosporiasis outbreak means a lot of poop has been tested. Spare a thought for the lab professionals who are up to their knees in you-know-what. Feel free to send me samples … of your thoughts and tips only, come on now: bob.herman@statnews.com.

Should prior authorization be eliminated?

Hannah Garden-Monheit is asking for a simple health care policy change: ban prior authorizations (for the most part). 

Continue to STAT+ to read the full story…

WASHINGTON — The Department of Health and Human Services on Monday announced a new effort to catalog the many additives in the U.S. food supply, most of which entered with little oversight. 

Companies looking to add a new substance to human or animal foods will need to notify the Food and Drug Administration, and provide details on how they deemed the additive “generally recognized as safe,” or GRAS. Manufacturers with GRAS substances already on the market would need to let the FDA know for the first time how the additive is used — information that would be made public in a database, HHS officials said. 

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Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because 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 cuppa stimulation. Our choice today is honeybush vanilla turmeric. Feel free to join us. Remember, no prescription is required. Meanwhile, here are some tidbits to help you along. Best of luck accomplishing your goals today and, of course, do keep in touch. …

Sanofi is experiencing shortages of two medicines used to treat Pompe disease, and the problem emerged shortly after the U.S. Food and Drug Administration warned the company over manufacturing issues at the Irish facility where the drugs are made, STAT reports. In recent days, the drugmaker has alerted patient groups and physicians in both the U.S. and Europe that supplies of Myozyme, an older standard of care, and Nexviazyme, a newer treatment, are dwindling due to what has been described as a bottleneck in the final manufacturing phase, as well as quality control issues at its Waterford plant.

Jazz Pharmaceuticals agreed to buy Actio Biosciences in a deal valued at ​up to $1.32 billion, adding an experimental treatment for ‌a rare inherited form of epilepsy that has no approved therapies, Reuters notes. The treatment, called ABS-1230, is being developed for KCNT1-related epilepsy, ​a severe disease that causes frequent seizures ​and developmental problems in children. KCNT1-related epilepsy affects about ​2,500 patients in the U.S., according to the company. ABS-1230 reduced seizures in ‌an ⁠early study of children and is being evaluated in a study intended to support a U.S. approval application.

Continue to STAT+ to read the full story…

Sionna Therapeutics said Monday that its experimental pill for cystic fibrosis did not show any benefit when added onto Vertex Pharmaceuticals’ Trikafta in a Phase 2 trial. 

The company will no longer try to advance the drug, called SION-719, as an add-on therapy for CF patients. And it hinted at potential layoffs, saying it will “take actions to preserve capital while evaluating next steps.”

Monday’s results are a major blow to Sionna. The company was founded in 2019, the same year that Trikafta reached the market, changing the lives of tens of thousands of CF patients and earning Vertex billions of dollars.

Continue to STAT+ to read the full story…

An experimental medicine from Silence Therapeutics stabilized red blood cell levels in patients with a rare blood cancer in a new trial — a result that could position it to compete with a drug nearing approval from Takeda Pharmaceuticals.

The cancer, polycythemia vera, is marked by runaway production of red blood cells and puts patients at risk of life-threatening blood clots, bleeds, and other cancers. 

In the 48-person, Phase 2 trial, 88% of patients who received Silence’s drug, called divesiran, every six weeks or 12 weeks achieved a clinical response, the company said Monday. By contrast, only 19% of patients on placebo did. 

Continue to STAT+ to read the full story…

Tenax Therapeutics reported negative results Monday from a late-stage clinical trial evaluating an experimental treatment for a type of heart failure associated with high blood pressure in the lungs.

Shares of the biotech company plunged 84% to $2 in early trading. 

In the Phase 3 study called LEVEL, Tenax’s drug, an oral formulation of levosimendan, improved exercise capacity by 14 meters on a six-minute walking test compared to an improvement of 10.4 meters for a placebo. The difference was not statistically significant, failing to achieve the study’s primary efficacy goal, the company said. 

Continue to STAT+ to read the full story…

For years, U.S. scientists and biotech companies have watched warily as China has made strides onto the global stage, overtaking them in research spending, patent applications, and clinical trials.

To many observers, it has been a sign that the U.S. needs to urgently modernize a lumbering clinical trial and regulatory system. But now, a key driver of China’s roaring biomedical engine — one that many researchers believe the U.S. should replicate — is being fine-tuned, and a system that was credited with supporting the country’s wild success has come under scrutiny.

That system has been fueled by what are known as investigator-initiated trials, or ITTs, in which researchers were long permitted to launch clinical trials without sign-off from the National Medical Products Administration, China’s equivalent of the Food and Drug Administration, and without the rigorous review that would otherwise come with it. The studies have allowed China to speed up the translation of medical research, encourage physicians to become a part of the country’s drug innovation engine, and help produce billions of dollars in sales of newly approved medicines.

They also appear to have come at a price, raising questions about patient safety, a lack of transparency, and the use of intellectual property.

Continue to STAT+ to read the full story…

When most people hear “Ebola,” they think of a single disease caused by a single virus.

Scientists know better. Ebola virus disease is caused by several distinct virus species capable of causing devastating outbreaks in humans, each with important biological differences that influence diagnostics, vaccines, therapeutics, and outbreak response. Yet for much of the past decade, global preparedness efforts have largely focused on a single species: Zaire ebolavirus (EBOV).

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In cancer treatment, the pitch has been simple: What if, instead of blasting radiation across patients’ bodies, crop-dusting not only malignant cells but also neighboring healthy tissues, we could shoot chemical weapons directly at only the noxious tumors?

That has been the central promise of radiopharmaceuticals, which have grabbed the drug industry’s attention and created a shining new field of drug development. But, as more and more of these therapies move into clinical trials, developers are finding it’s not so clear-cut. 

The isotopes that make up radiopharmaceuticals are just as virulent as the beam radiation patients have begrudgingly tolerated for decades. They are designed to be far more targeted. But while they’re hurtling to biological bull’s-eyes, some are inadvertently zapping patients’ kidneys, liver, or bone marrow along the way. 

Continue to STAT+ to read the full story…

In September, states must start to notify Medicaid enrollees affected by new changes — including work requirements and new twice-yearly eligibility checks — that will begin in 2027.

These changes, introduced by the One Big Beautiful Bill Act of 2025 with a short implementation timetable, are expected to reduce Medicaid enrollment and potentially create confusion and chaos as beneficiaries try to understand whether and how new requirements affect them. States are required to notify people affected by the changing requirements using at least two outreach methods, but the exact methods are up to the state.

Read the rest…

Sanofi is experiencing shortages of two medicines used to treat Pompe disease, and the problem emerged shortly after the Food and Drug Administration warned the company over manufacturing issues at the Irish facility where the drugs are made.

In recent days, the drugmaker has alerted patient groups and physicians in both the U.S. and Europe that supplies of Myozyme, an older standard of care, and Nexviazyme, a newer treatment, are dwindling due to what has been described as a bottleneck in the final manufacturing phase, as well as quality control issues at its Waterford plant.

The site is responsible for what is known as batch release, which refers to the final quality assurance and regulatory process where a manufactured amount of medicine is formally certified, approved, and cleared for distribution and use by patients. This step is supposed to verify the batch of medicine meets safety and potency requirements.

Continue to STAT+ to read the full story…

The Senate committee hearings last week on the origins of the Covid-19 pandemic presented a master class in political distraction from what is important for the nation’s public health. And Thursday the committee held Anthony Fauci in contempt of Congress for invoking his Fifth Amendment defense to a committee chaired by someone who has already said Fauci “should go to prison.”

The Covid-19 pandemic originated in Wuhan, China. The Chinese government vigorously suppressed information about the epidemic in the first weeks and months. It dragged its feet on alerting the international community to the threat. It frustrated the World Health Organization’s attempts to discover basic facts about the transmissibility of the virus, denying the rest of the world crucial weeks to prepare. And once the virus had escaped China and spread to Europe and then North America, it covered up the initial facts about the epidemic, silenced whistleblowers, and prevented investigations into the origin of the virus by refusing international investigations, locking WHO representatives in their hotel rooms on the specious theory that the virus had been imported from abroad. It then denied international access to scientists in Wuhan, their laboratory records, and the records of local public health authorities. Countries that demanded an open investigation were threatened with economic retaliation.

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The National Institutes of Health plans to close the door on one of the few pathways available to international students on visas to forge a career in biomedical research in the United States. 

The agency intends to limit eligibility for its “Pathways to Independence” award to U.S. citizens, permanent residents, and non-citizen nationals, according to an internal presentation viewed by STAT. Historically, it has been one of few programs to offer funding to international scientists on a visa. Without it, experts fear, even the most promising scholars will struggle to find footing to establish themselves in the U.S. 

The pathway, referred to as a K99/R00, includes funding for two years of a researcher’s postdoctoral studies, and three years of funding as an independent lab head. 

Continue to STAT+ to read the full story…

And so, another working week will soon come to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still taking shape, but we plan on promenading with the official mascots, catching up on our reading, escorting Mrs. Pharmalot to a speakeasy and, if time permits, holding another listening party, where the rotation will likely feature this, this, this, this and this. And what about you?  Once again, we will remind you that the great outdoors is beckoning. With this in mind, time to grab your beach gear or strap on your hiking boots. If the weather fails to cooperate, you could always stroll around a museum, check out the new arrivals at your local library or curl up in front of the telly. Or maybe this is an opportunity to sit on the phone and reach out to a few special people. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon…

The U.S. Food and Drug Administration cleared Replimune’s treatment for advanced melanoma, dealing the biotech a major win after a tumultuous saga of trying to seek approval for the controversial treatment, STAT notes. The decision to grant accelerated approval to the drug, which will be marketed as Tudriqev, came after its FDA advisers last week voted in support of the treatment. Even though FDA staff expressed concerns about the design and conduct of the key trial, advisers ultimately believed there was a large enough signal of efficacy and that patients are in urgent need of new treatments.

A little-noticed policy shift by Medicare caused a seven-year delay in choosing a costly AbbVie medicine for price negotiations, a move likely to hurt taxpayers, STAT writes, citing an analysis by a consumer advocacy group. The change occurred as the Centers for Medicare and Medicaid Services readied a new round of talks with drugmakers over prices the agency would pay for a limited number of drugs. The process was created by the Inflation Reduction Act. But CMS modified criteria for selecting drugs for the negotiations, which transformed the process for determining when certain medicines would become eligible for the talks. And it was done in a way that benefited AbbVie and may help other drugmakers in the future.

Continue to STAT+ to read the full story…

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Boston’s biotech identity is under pressure as founders decamp for California, Alzheimer’s researchers uncover more secrets of tau function, and Replimune finally secures a hard-fought FDA approval.

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It’s so hot that it’s open fire hydrant season in New York City.

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Keep your head down. Don’t ask too many questions. Just finish your note and move on.

I heard a version of this command at every level of training and well into my attending practice, from colleagues, seniors, teachers, and administration. Most delivered the advice like it was some sort of hard-won wisdom, though it wasn’t. It was the sound of people who repeated the system’s rules because it felt like control.

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On the afternoon of Aug. 8, 2025, I was in my office at the Centers for Disease Control and Prevention when I heard what sounded like hammering outside. One of my laboratory directors appeared at my door. She shared that her husband, in the 12-story building next door, said his building was shaking. Construction, on a Friday near quitting time? That didn’t fit.

Then she said that people feared it was an active shooter.

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REDWOOD CITY, Calif. — By all rights, Felix Wong and his company should be in Massachusetts.

Wong, 33, was born in Quincy, graduated from Braintree High School, and spent a decade living in Cambridge, where he earned two degrees from Harvard and worked as a post-doc at MIT. His parents still live in Massachusetts, and he now leads a startup in biotech, an industry Boston has owned for the better part of two decades.

But on a recent Wednesday, Wong was in sunny Silicon Valley, walking in the shade of the jacaranda trees near the hiking trail outside his office and reflecting on the creative spirit of California.

Continue to STAT+ to read the full story…

The Food and Drug Administration has cleared Replimune’s treatment for advanced melanoma, dealing the biotech a major win after a tumultuous saga of trying to seek approval for the controversial treatment.

The FDA’s decision to grant accelerated approval to the drug, which is called RP1 and will be marketed as Tudriqev, came after its advisers last week voted in support of the treatment. Even though FDA staff expressed concerns about the design and conduct of Replimune’s key trial, advisers ultimately believed there was a large enough signal of efficacy and that patients are in urgent need of new treatments.

Replimune has not yet disclosed Tudriqev’s price.

Continue to STAT+ to read the full story…

A little-noticed policy shift by the Trump administration caused a seven-year delay in choosing a costly AbbVie medicine for Medicare price negotiations, a move likely to hurt taxpayers, according to an analysis by a consumer advocacy group.

The change occurred as the Centers for Medicare and Medicaid Services readied a new round of talks with drugmakers over prices that the agency would pay for a limited number of medicines. The process was created by the Inflation Reduction Act, which became law in 2022 in response to the rising cost of prescription drugs.

Continue to STAT+ to read the full story…

In the race for new ways to treat Alzheimer’s and other devastating neurologic diseases, the protein tau has become a tantalizing target for drug developers. A new study lends support to those efforts by describing a previously unknown role that tau plays in neurodegeneration — and suggesting a novel way researchers might block the protein’s activity.

A team led by Stanford scientists found that tau can gum up the works of a cell’s mitochondria, its energy-producing powerhouse. The protein sends electrons flowing in the opposite direction of their usual microscopic relay race, a reversal that generates reactive oxygen species, cellular stress, and inflammation. Scientists found that blocking this phenomenon, known as reverse electron transport, reversed many of the harmful effects and improved learning and memory in flies and mice.

Whether the same will hold true in people is for now unclear, though an analysis of human cells grown in the lab and patient brain tissue suggests blocking the retrograde flow of electrons could make neurons healthier. Two of the study’s authors have started a biotech startup to put this idea to the test. 

Continue to STAT+ to read the full story…

On Thursday morning, the Senate Homeland Security and Governmental Affairs Committee voted along party lines to hold Anthony Fauci in contempt of Congress over his recent invocation of the Fifth Amendment during a hearing about his pandemic-era leadership. Fauci will next face a Senate vote.

While watching these congressional proceedings, my mind has gone to two places at once: the spring of 2020 — and, more importantly, to what comes next.

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The Trump administration said Wednesday it will shut down a Kentucky organ donation group accused of continuing plans for organ retrieval from some patients who unexpectedly showed signs of life.

While those surgeries were canceled, the cases made headlines several years ago, prompting a spike in people around the country revoking their organ donor registrations.

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Again, a child dies in a gene therapy trial in China, and STAT has exclusive details. Also, we have encouraging fecal pill results for peanut allergy, and see biotech investor Greg Verdine notch a series of wins.

In other news, it’s been hot out! My backyard tortoise, Philbert, has been most irascible and taken to his fainting couch (cardboard box).

Continue to STAT+ to read the full story…

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday.

Good morning health tech readers!

Today, a story about tech companies and regulators rubbing elbows. Plus: Checking in on ACCESS, one month in.

Continue to STAT+ to read the full story…

Good morning, everyone, and how are you today? We are just fine, thank you. Although gray skies are enveloping the Pharmalot campus, our spirits remain sunny. After all, as the Morning Mayor taught us: “Every new day should be unwrapped like a precious gift.” So go ahead and tug on the ribbon. While you do, we will indulge with another cup of needed stimulation. Our choice today is maple bourbon. Meanwhile, here are some items of interest. Hope your day goes well …

In a move that seemed out of reach just six months ago, the Food and Drug Administration approved Moderna’s influenza vaccine for older adults, the first licensed flu shot made using messenger RNA technology, STAT says. In February, Vinay Prasad, the FDA’s head of biologics at the time, overturned the recommendation of career staff and issued a rare “refusal to file” notice” to the company, saying the agency would not review the vaccine based on available data. A week later, after Moderna disclosed the decision as well as its own displeasure over the agency position, Prasad’s decision was reversed. He left the FDA at the end of April.

The FDA approved a novel type of treatment for narcolepsy made by Takeda, backing a drug class that scientists hope can transform the treatment of sleep disorders and potentially address a broad range of neurologic conditions, STAT writes. The twice-a-day pill, an orexin receptor agonist that will be marketed as Orzeyful, is likely to be very appealing to patients. Current therapies, stimulants and sodium oxybates, carry risk of misuse, and patients still feel sleepy while taking them. Since the orexin system not only regulates the cycle of sleeping and waking but may also boost attentiveness and cognition, the broader goal for drugmakers is to test the treatments in various neuropsychiatric conditions in which patients feel sleepy and fatigued.

Continue to STAT+ to read the full story…

WASHINGTON — A Senate committee voted Thursday to hold Anthony Fauci, who declined to answer questions in a hearing last week about his role in the lead-up and response to the Covid-19 pandemic, in contempt of Congress in a party-line vote, 8-7. 

Now the matter will go before the entire Senate, where the vote would be subject to the filibuster. If the Senate votes to hold Fauci in contempt, it will be up to the Department of Justice to decide whether to prosecute him.

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Once in a while, a scientific paper poses a question that we already know the answer to. That’s the case with a new study in Nature Medicine titled, “Is AI actually improving healthcare?”

Yes, it is. This much we know. The study also offers a big caveat: “In many cases, we do not know.” So many AI tools are so new that it’s still unclear whether they improve patient outcomes.

This distinction is essential. In health care, we have a tendency to treat AI as a monolith — a single, mysterious force. But asking “Is AI actually improving health care?” is a bit like asking “Do lasers improve surgery?” In the hands of a skilled surgeon using a validated tool, they allow for lifesaving precision; in an unproven setting, the question of efficacy is still open.

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Good morning and happy Thursday. FYI: The newsletter is taking a summer break next week, which means today is the last time you’ll hear from me until the 17th. (Rose will still be in your inbox tomorrow with the end-of-week news.) Talk soon! 

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On Wednesday, the Food and Drug Administration’s approved mFlusiva, the first mRNA seasonal influenza vaccine ever licensed in this country. In June the agency’s own advisory committee voted unanimously that its benefits outweigh its risks in adults 50 to 64, then unanimously again for adults 65 and older. Nine independent experts, appointed by this government, could not produce a single vote against it.

Wednesday was also an anniversary. On Aug. 5, 2025, the Department of Health and Human Services killed 22 mRNA vaccine development projects worth roughly $500 million and ordered a halt to federal investment in the platform.

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This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.

Later this month, Tenax Therapeutics will report results from a Phase 3 study evaluating an oral treatment for a type of heart failure associated with high blood pressure in the lungs. The study outcome might be one of the biggest binary stock events remaining on the biotech docket this year. Tenax’s stock price could double or more if the study hits, or sink to cash levels if it fails.

Adding to the fun is the crapshoot nature of the study readout. This is a complicated disease, the proposed mechanism by which Tenax’s drug might work is unproven, and data from a prior study were mixed. Lastly, Tenax’s entire future rests on this one drug and indication. It has no fallback plan.

Continue to STAT+ to read the full story…

Greg Verdine is having a very good year. 

The scientist-turned-biotech entrepreneur has been basking in the knowledge that the science he had tried to propel forward nearly 15 years ago may have changed the landscape for pancreatic cancer patients.

His more recent ventures are taking off. One, Parabilis Medicines, went public in June in one of the industry’s largest IPOs in recent years. The other, LifeMine, has raised $263 million, it announced Thursday, enough to advance a drug that Verdine believes could make organ transplants more viable and potentially help people with autoimmune conditions. 

Continue to STAT+ to read the full story…

Elimination of measles in the United States in 2000 was a landmark public health achievement. Twenty-five years later, the country has already reported more cases this year than it did in all of 2025, a stark reminder that public health victories can be reversed.

In mid-August, colleagues and I will review the evidence and decide whether the U.S. has maintained measles elimination. In many ways, our roles bookend that history. Several of these colleagues helped lead the national effort that ended endemic measles transmission in 2000. And I now chair the committee that must determine whether that hard‑won status still holds — or whether the country is on the verge of losing it. 

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In a move that seemed out of reach just six months ago, the Food and Drug Administration approved Moderna’s influenza vaccine for older adults on Wednesday, the first licensed flu shot made using messenger RNA technology.

In February, Vinay Prasad, the FDA’s head of biologics at the time, overturned the recommendation of career staff and issued a rare “refusal-to-file” notice to the company, saying the agency wouldn’t review the vaccine based on the available data package. A week later — after Moderna disclosed the FDA’s decision as well as its own displeasure over the agency’s position — Prasad’s decision was reversed. He left the FDA at the end of April.

Read the rest…

Federal health officials held closed-door conversations with prominent technology companies last month as the health department and its subagencies aim to safely boost adoption of clinical artificial intelligence.

During a “clinical AI demo day” on July 8 at the Food and Drug Administration’s White Oak headquarters, officials from the FDA and the Centers for Medicare and Medicaid Services hosted leaders from 10 companies, according to an agenda for the event reviewed by STAT: Anthropic, Counsel Health, Curai, K Health, Microsoft AI, Amazon One Medical, Doctronic, Ellipsis Health, Hippocratic AI, and Welldoc.

STAT spoke with four companies that attended, Counsel Health, K Health, Hippocratic AI, and Ellipsis Health, whose leaders summarized their comments to regulators. The meeting was meant to offer federal health officials firsthand experience with AI doctor technology as it exists today. For the assembled companies, including powerful technology giants and startups funded by influential investors such as Andreessen Horowitz and Khosla Ventures, the event offered a significant opportunity to help shape policy as officials wrestle with regulating health AI and how to pay for it.

Continue to STAT+ to read the full story…

The Food and Drug Administration on Wednesday approved a novel type of treatment for narcolepsy made by Takeda, backing a drug class that scientists hope can transform the treatment of sleep disorders and potentially address a broad range of neurologic conditions. 

The twice-a-day pill, which will be marketed as Orzeyful, is an orexin receptor agonist. It’s cleared to treat narcolepsy type 1, a taxing condition in which patients have a deficiency of the orexin neuron and experience bouts of sleepiness and muscle weakness during the day.

The drug is likely to be very appealing to patients. Current therapies, stimulants and sodium oxybates, carry risk of misuse, and patients still feel sleepy while taking them. In two Phase 3 trials, Orzeyful helped patients stay awake during the day for much longer than what’s been seen with current treatments. Throughout the studies, participants also reported less daytime sleepiness, less frequent muscle weakness, and greater attentiveness.

Continue to STAT+ to read the full story…

WASHINGTON — Erica Schwartz was confirmed Wednesday as the director of the Centers for Disease Control and Prevention, making her the second permanent leader of the agency since the second Trump administration took office. 

Her confirmation, approved by the Senate in a 51-44 vote, also ends a nearly yearlong vacancy for the CDC’s top job after health secretary Robert F. Kennedy Jr. fired Schwartz’s predecessor last year. 

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Last year, a little-known Chinese startup took center stage at the American Society for Gene and Cell Therapy annual convention in New Orleans. 

Speaking before a sprawling conference hall for the presidential symposium, HuidaGene CEO Alvin Luk presented data from one of the world’s first trials to test if CRISPR gene editing could cure children with Duchenne muscular dystrophy, an intractable, fatal disease. Similar efforts in the U.S. ran aground amid technical challenges, but HuidaGene had surged ahead, using a regulatory pathway that lets Chinese hospitals start studies without oversight from government regulators. 

The results, from the first two patients, were not impressive. It wasn’t clear the therapy worked at all. But Luk said the data indicated benefit and the company was about to test a higher dose. Hopefully, that would have far better effects. 

Then HuidaGene went dark. For 15 months following that conference, the Shanghai-based company did not issue a single new press release. Luk quietly departed last summer, alongside Chief Technology Officer TJ Cradick, a longtime U.S.-based gene editing executive who had been there less than a year. In February, a listing on a clinical trial registry was updated to announce the study was “complete.” 

What happened to the remainder of patients in the study was unclear. But after a monthslong STAT investigation and repeated questions to the company, HuidaGene on Wednesday issued an update.

Continue to STAT+ to read the full story…

In an early-stage clinical trial, six participants with peanut allergy showed improved tolerance to small peanut exposures up to four months after they received fecal microbiome transplant using stool capsules. 

The results of the phase one clinical trial, published in Science Translational Medicine on Wednesday, suggests fecal microbiome transplant has the potential to be a viable treatment option for peanut allergy, according to experts. 

“We, as the food allergy community, have been waiting for these results,” said Stephen Tilles, an allergist-immunologist and clinical professor at the University of Washington, who was not a part of this study. Tilles described the study findings as “very exciting,” even if it may not be “ready for prime time” yet. 

Continue to STAT+ to read the full story…

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 cup of stimulation. Our choice today is ginseng honey, 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. …

Excluding rare disease drugs from a Medicare pilot program known as GUARD to lower prices would wipe out much of the savings from retail meds, STAT writes. The program applies to retail drugs in Medicare Part D. Biotechs are lobbying the Trump administration to exclude rare disease drugs from the program, which is part of a plan to get drugmakers to lower prices in the U.S. to levels seen in other wealthy countries, an approach known as “most-favored nation.” Thomas Hwang, who heads the Cancer Innovation and Regulation Initiative at Harvard Medical School, said that if all companies that agreed to most-favored nation deals were exempted, potential savings would be cut by 71%.

There are no talks ongoing between AstraZeneca and ​Bristol Myers Squibb over a potential ‌deal, quashing the ​prospect of a mooted mega merger ​between the drugmakers, Reuters reports. “There is no deal ⁠between AstraZeneca and BMS. There never ​was a deal to be done, and ​there are no discussions between the companies,” said a source, speaking on condition of anonymity. On Sunday, The Financial Times reported that the two drug makers had held ‌preliminary ⁠talks about a possible deal that would create a pharmaceutical behemoth with a combined value of nearly $400 billion.

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You’re reading the web edition of STAT’s AI Prognosis newsletter, our subscriber-exclusive guide to artificial intelligence in health care and medicine. Sign up to get it delivered in your inbox every Wednesday. 

In the middle of watching the new Spider-Man movie, I thought I heard a mention of siRNA and made a note to ask STAT’s biotech team about it. But lo and behold, my favorite science content creator Alex Dainis is on the case (caution: spoilers).

Schrödinger’s and Centene’s AI shifts

I’m looking forward to the point in time when people revise their opinions on AI. I think that in five years, we’ll have a better idea of what AI can and can’t do. Bosses will stop forcing people to use AI that doesn’t work, partially helped by AI getting better. There will be less froth, and thus less uncertainty in the job market and in the world (with regard to AI) at large.

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Good morning. We’ve got a busy earnings week. Here’s the latest.

The need-to-know this morning

• Amgen and Gilead Sciences reported earnings last night.
• United Therapeutics reported earnings this morning.

Novo vs. Lilly

The two GLP-1 giants have both reported earnings.

Continue to STAT+ to read the full story…

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Good morning. Thinking about sour cream and onion chips again. 

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WASHINGTON — Excluding rare disease treatments from a Medicare pilot program to lower drug prices would wipe out much of the savings from retail drugs, according to a Harvard University researcher. 

Biotech companies are lobbying the Trump administration to exclude treatments for rare, or “orphan,” diseases from two Medicare pilot programs: Global Benchmark for Efficient Drug Pricing (GLOBE) and Guarding U.S. Medicare Against Rising Drug Costs (GUARD). Those pilots are part of President Trump’s plan to get drugmakers to lower prices in the United States to the levels seen in other rich countries, an approach generally referred to as a “most-favored nation” policy.

The exact scope of those pilot programs has been in question. Some companies that struck most-favored nation pricing deals with the White House — including many of the largest drugmakers globally — have said they were exempted from the pilots, though details of those deals have not been made public. 

Continue to STAT+ to read the full story…

The top Democrat on the Senate Finance Committee launched an inquiry into the Trump administration’s recent actions on flavored vapes and kratom products, alleging a pattern of quid pro quos after the tobacco and kratom industries made large donations to the presidential campaigns of Donald Trump and Robert F. Kennedy Jr.

“Both industries will flood gas stations and convenience stores with products that pique the curiosity of kids and teens and launch them into addiction,” Sen. Ron Wyden (D-Ore.) writes in an Aug. 3 letter to Kennedy, who is now President Trump’s health secretary. Wyden adds, “You have yet to draw a line in the sand and buck corporate interests to Make America Healthy Again.”

The Senate investigation includes Kennedy as well as the heads of Reynolds American and kratom company Botanic Tonics, asking for written responses and documentation by Aug. 31.

Continue to STAT+ to read the full story…

With more than 333,000 new cases every year, prostate cancer is the most frequently diagnosed cancer in the U.S., and by far the most common among men. It is also the least deadly: Only about 4% of prostate cancers end up being lethal, and the 5-year survival rate is about 99%. 

This paradox is in no small part due to the way it is diagnosed. A routine blood test checking for levels of a biomarker called prostate-specific antigen (PSA) is followed, if this protein is elevated, by a systematic biopsy to find cancerous tissue. This two-step process is effective at detecting cancer, even in its earliest stages. It may be too effective, in fact: Up to 70% of new prostate cancer diagnoses are low grade and in no need of treatment, as the risk of the disease turning deadly is negligible. 

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By the time a patient arrives in an emergency room with chest pain, nobody asks whether the physician caring for them trained in an allopathic (M.D.) or osteopathic (D.O.) medical school. Both physicians prescribe medications, perform procedures, lead hospital teams, and practice under the same state licenses.

The credential on the wall does not change the care provided at the bedside.

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On Wednesday, legislation that allows terminally ill New Yorkers to opt for an assisted suicide is set to come into effect. The state’s Medical Aid in Dying Act is the culmination of work by many — and a work of art may have paved the way.

Released in the U.S. in 2025, Pedro Almodóvar’s film “The Room Next Door” tells the story of how Martha (Tilda Swinton), who has terminal cancer, enlists her friend Ingrid (Julianne Moore) to help her die. Set in a fictional New York prior to the legalization of medical aid in dying, assisted death is framed positively, with Martha’s decision to die an act of dignity and self-determination. Ingrid is an honorable and moral friend who facilitates her death while staying in a neighboring room.

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Good morning, health tech readers!

Today, controversy over a regulator’s decision on AI scribes. Plus, a little more detail on Dexcom’s FDA pilot and an enlightening look at how scribes are working their way into medical education.

Continue to STAT+ to read the full story…

BUNIA, Congo — Ebola has killed more than 1,700 people in eastern Congo in what has become the fastest-growing outbreak of the disease, according to data — spreading faster than health officials can track and with patient zero still unidentified.

As of Tuesday, 3,802 cases had been recorded, with 1,707 deaths, the latest government update showed.

Read the rest…

Aurora Therapeutics, a startup focused on building personalized gene-editing drugs, has scrapped its lead program and slashed staff, just seven months after it launched, STAT has learned. 

A company spokesperson declined to say how many employees were laid off, or whether any of the startup’s three-person leadership team would stay on. Aurora’s chief scientific officer left the company earlier this year. 

The company appears to have been undercut by Beam Therapeutics, a larger and more established competitor. Just a month after Aurora launched, Beam announced it was already advancing its own set of custom gene editors for the exact same disease. 

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Good morning. I’ve decided to paint the walls in one of my rooms a dark brown. I may deeply regret this decision. Please send any painting tips!

The need-to-know this morning

• Earnings: Vertex, Pfizer, and Merck.

Lilly will review applications for special access to experimental drug

Over a month ago, STAT reported that Eli Lilly had granted a single 79-year-old patient special access to its next-gen obesity drug retatrutide. Now, the pharma company says it will allow other patients to apply for early access to the therapy as well.  

Continue to STAT+ to read the full story…

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Good morning. I’ve decided to paint the walls in one of my rooms a dark brown. I may deeply regret this decision. Please send any painting tips!

The need-to-know this morning

• Earnings: Vertex, Pfizer, and Merck.

Lilly will review applications for special access to experimental drug

Over a month ago, STAT reported that Eli Lilly had granted a single 79-year-old patient special access to its next-gen obesity drug retatrutide. Now, the pharma company says it will allow other patients to apply for early access to the therapy as well.  

Continue to STAT+ to read the full story…

Rise and shine, everyone, another busy day is on the way. And it is getting off to a pleasant start here on the Pharmalot campus, where clear blue skies and comfy breezes are greeting us. As for the official mascots, they are happily snoozing in their respective corners. As for us, we are firing up the trusty kettle for another cuppa stimulation. Our choice today is ginger peach. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few items of interest. As always, do keep in touch. We appreciate feedback, criticism, and tips. …

After Eli Lilly granted an apparently well-connected 79-year-old patient special access to retatrutide, an unapproved obesity drug, the company confirmed that it will allow other patients to apply for early access, STAT tells us. The move comes six weeks after STAT reported the expanded access and followed up this week about further requests from a handful of doctors who had not yet received a reply from the drugmaker. It marks a striking change in the public posture of the company, which had previously offered little information about the special access program. The initial patient accessed the drug in April via the U.S. Food and Drug Administration’s “compassionate use” program.

The California Supreme Court sided with Gilead Sciences in a closely watched case brought by thousands of patients who argued the company was negligent for slow-walking development of an HIV medicine that was safer than another drug it was already selling, STAT writes. In a 6-to-1 decision, the court overturned a state appeals court ruling two years ago that Gilead could be held liable, raising alarm in the pharmaceutical industry that drug development decisions could be influenced by the fear of legal liability and dissuade innovation.

Continue to STAT+ to read the full story…

A controversial provision in the One Big Beautiful Bill Act, which exempts more so-called orphan drugs from Medicare pricing negotiations in order to encourage further development, may not warrant that protection, according to a new analysis.

At issue is a portion of the Inflation Reduction Act that went into effect three years ago and allows Medicare to negotiate prices for certain drugs. Under that law, orphan drugs, which are used to treat rare diseases, were exempt in the case of drugs granted just one orphan designation and approved by the Food and Drug Administration.

However, the Orphan Cures Act, which was part of the Big Beautiful Bill Act that became law last year, broadened the exception by allowing medicines with multiple orphan indications to remain exempt. The law also delayed the timelines for which an otherwise eligible orphan drug may be considered for price negotiations.

Continue to STAT+ to read the full story…

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Good morning. Thanks for sticking with us in the dog days of August. We’ve got a lot of news for you below. 

Read the rest…

WASHINGTON — Health secretary Robert F. Kennedy Jr. was talking about healthy eating on a farm in Michigan, as part of a national tour he’s taking to promote his Make America Healthy Again agenda, when two hecklers demanded to know why the Trump administration was cutting Medicaid. 

We aren’t cutting Medicaid, he responded. That’s just a “myth people believe,” he said. 

But in Michigan and other battleground states the administration hopes to win over come the November midterms, state officials and Medicaid advocates are bracing for changes to Medicaid that will significantly alter enrollment rates and eligibility. And despite what the administration says, health policy experts say those changes will force people off the program and slow growth in Medicaid over time.

Continue to STAT+ to read the full story…

In the last three decades, as involuntary outpatient treatment for people with serious mental health conditions like schizophrenia have expanded to almost every state, the evidence for these programs’ efficacy has remained murky. 

A new evaluation of New York’s involuntary outpatient treatment program adds another wrinkle to the complex existing scientific literature on this type of care. Assisted outpatient treatment (AOT) reduced hospitalizations, arrests, and more. So did voluntary treatment. The independent authors concluded that the state should funnel more money toward voluntary services, especially after hearing about the coercion and harms that people experienced under AOT orders.

“When people are engaged in services, they have better outcomes,” said Bevin Croft, director of Human Services Research Institute’s Behavioral Health team and one of the study’s authors. “Whether or not that engagement is voluntary doesn’t seem to make a huge difference.”

Continue to STAT+ to read the full story…

On Sept. 11, 1984, Céline Dion found God. At Montreal’s Olympic Stadium, she sang “Une Colombe” (“A Dove”) for 65,000 young people and Pope John Paul II. When the song ended, real doves were released. One landed on the pope’s shoulder and stayed there: a miracle, Céline claimed, that made her a believer.

Josée Lamère was 20 that day. She had helped organize the visit as a youth adviser to the archbishop of Montreal, in a province that had spent 20 years dismantling the church’s grip on its hospitals, schools, and public life. Josée wasn’t watching the doves at Olympic Stadium that day. Instead, she was live broadcasting at Radio-Canada’s Montreal studios, telling the province’s young Catholics they owed the church no automatic loyalty, that their own values had to be part of any new contract with the institution. The dove had landed for Céline. For Josée, it never quite would.

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I have had type 1 diabetes for more than 30 years, which I manage using a glucose monitor connected to an insulin pump. About every five years, I would get upgraded pumps and sensors that were approved by the Food and Drug Administration and covered by my insurance. Still, my glucose control slowly deteriorated.

One day, my physician encouraged me to explore new, open-source software that better manages the sensor and pump system. This new code — written by people who were dissatisfied with the existing, FDA-regulated app — is a revelation. It fine-tunes my insulin delivery in a manner no FDA-approved systems could. I am now meeting guidelines that had previously eluded me, and I’m feeling great. All of this is free and runs on my iPhone.

Read the rest…

DETROIT — Two people have died in the cyclospora outbreak in Michigan, state health officials announced Monday, the first deaths confirmed in the U.S. related to the microscopic parasite.

The Michigan Department of Health and Human Services said both people had underlying health conditions that may have been impacted by the intestinal illness and dehydration. The department said it would not provide additional information about the deaths.

Read the rest…

The California Supreme Court sided with Gilead Sciences in a closely watched case brought by thousands of patients who argued the company was negligent for slow-walking development of an HIV medicine that was safer than another drug it was already selling.

In a 6-to-1 decision, the court overturned a state appeals court ruling two years ago that Gilead could be held liable, raising alarm in the pharmaceutical industry that drug development decisions could be influenced by the fear of legal liability.

The case began after more than 24,000 people claimed in federal and state court lawsuits that they unnecessarily suffered kidney injury and bone loss from the older drug. They maintained that Gilead cynically managed its product pipeline at the expense of people who should have been treated with a safer medicine.

Continue to STAT+ to read the full story…

Six weeks after STAT reported that Eli Lilly granted a single 79-year-old patient special access to retatrutide, an unapproved obesity drug, the company confirmed on Monday that it will allow other patients to apply for early access. 

The announcement comes after STAT asked Lilly about the requests for expanded access from a handful of doctors who had not yet received a reply from the drugmaker.  It marks a striking change in the public posture of the pharmaceutical giant, which had previously offered little information about the special access program. 

“For a limited number of patients who meet specific medical criteria and cannot enroll in a clinical trial, we believe it is medically appropriate to make authentic retatrutide available before FDA approval, consistent with FDA’s guidance,” a Lilly spokesperson told STAT. The company said it is actively reviewing requests from health care providers. 

Continue to STAT+ to read the full story…

Medicare is removing flexibilities that have allowed medical devices designated as “breakthroughs” by the Food and Drug Administration to leapfrog qualifications for extra payments.  

Until now, alternative pathways have allowed authorized breakthrough devices to qualify for supplemental payments without proving their novelty or substantial clinical improvement over alternatives. In its rule for inpatient hospital payments, the Centers for Medicare and Medicaid Services finalized a proposal to repeal those pathways for both inpatient and outpatient settings, starting in fiscal year 2028. 

Such payments are meant to incentivize hospitals to use new, transformative technology while it’s still expensive, and give its makers time to prove their value. Requiring breakthrough devices to demonstrate substantial clinical improvement, the rule reads, “ensures that additional Medicare payments are used to support Medicare beneficiaries’ access to innovations that are demonstrated to improve outcomes compared to the currently available treatment.” 

Continue to STAT+ to read the full story…

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because 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 cuppa stimulation. Our choice today is oolong. Please feel free to join us. Meanwhile, here is the latest menu of tidbits for you to peruse. We hope that your day is absolutely smashing and that you conquer the world. And of course, do keep in touch. We treasure your feedback and insights. …

AstraZeneca stock fell as investors balked at reports of merger talks with Bristol Myers Squibb about forming what would become one of ​the world’s biggest drugmakers, with a combined value of nearly $400 billion, Reuters explains. Shares in AstraZeneca were down 5.5% so far on Monday as ‌investors and analysts noted the U.K.’s biggest drugmaker had little obvious need for a transformative acquisition despite potential financial benefits. Meanwhile, Bristol Myers shares were up about 5% in U.S. premarket trading. Jefferies analyst Michael Leuchten wrote in an investor note that a deal “would be more than a head scratcher.”

Amgen disclosed that hackers stole company data and patient health information in a ​cybersecurity incident involving cloud storage systems run by third-party ‌providers, becoming the latest health care firm to disclose a breach, Reuters writes. On July 29, Amgen determined the incident was material, based on its evaluation of how ​many files appeared to be affected and the possibility that ​the information in those files could be sensitive, according to a regulatory filing. To date, Amgen has not found any impact on its products, manufacturing operations, financial reporting systems, or its ability to ​meet patient needs.

Continue to STAT+ to read the full story…

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Hiya, and welcome back to The Readout. 

Today, we’re getting ready for the FDA’s upcoming decision on Moderna’s mRNA flu shot, and see both a revived fight over 340B rebates and fresh legal scrutiny for Lilly’s insulin pricing.

Continue to STAT+ to read the full story…

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Good morning, and happy August. I hope you’ve been enjoying the summer, because we’re rounding that last corner. The Senate, on its own way to August recess, made news relevant to scientists over the weekend. More matters of interest below. 

Read the rest…

Sandoz agreed to pay $478.5 million to settle allegations by dozens of states and resellers of medicines that the company engaged in a widespread conspiracy to artificially inflate and manipulate prices of generic drugs and harmed consumers by reducing competition.

Under one settlement, the company agreed to pay $400 million over seven years starting in 2027 to resolve all remaining claims by U.S. states in three pending cases and make an additional payment of about $50 million to states that settled earlier. Another $28.5 million will be paid to resolve all remaining class-action litigation brought by indirect resellers. Sandoz did not admit to any wrongdoing.

The agreement marks the latest settlement in a long-running battle between numerous states and many of the largest players in the generic drug industry, which were accused of fixing prices for their medicines. Previously, Glenmark Pharmaceuticals, Lannett, Bausch, Apotex, and Heritage Pharmaceuticals collectively settled lawsuits for nearly $98 million.

Continue to STAT+ to read the full story…

BioNTech on Monday named Guido Oelkers, formerly the leader of the Swedish biopharma company Sobi, as its new CEO, as the Covid-19 vaccine developer continues its shift to oncology.

Oelkers will replace Ugur Sahin as CEO. In March, BioNTech announced that Sahin and his cofounder and wife Özlem Türeci, the company’s chief medical officer, would depart the company to lead a new biotech focused on developing mRNA medicines. 

Oelkers, who has worked in biopharma for more than 30 years, will start by Feb. 1, 2027, the company said. He said that he would continue BioNTech’s work to be a global company with multiple approved medicines by 2030. 

Continue to STAT+ to read the full story…

Top of the morning to you, and a fine one it is. Skies are gray but rain is not expected on the Pharmalot campus today, making it possible for the official mascots to eat breakfast on the deck and take long, luxurious naps. As for us, we are firing up the trusty kettle to make another cuppa stimulation. Our choice today is English breakfast, another old standby from the pantry. Please feel free to join us. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …

A U.S. Food and Drug Administration advisory panel voted 9-to-3 against effectiveness data for a Capricor Therapeutics treatment for Duchenne muscular dystrophy, STAT tells us. The key question centered on whether the drug had shown it could treat Duchenne-related cardiomyopathy. Last year, the agency declined to approve ​the therapy ⁠and sought additional data after saying the treatment did not meet efficacy requirements. During the meeting, the FDA spent a good deal of time calling out Capricor, saying it made major changes to the study’s statistical analysis plan that degraded the robustness of the data and made even seemingly positive outcomes hard to interpret.

The U.S. Federal Trade Commission sued Hims & Hers, continuing a pattern of action against the business practices and use of consumer health data by digital health companies, STAT notes. The agency, along with Utah and California, alleged that Hims misled consumers about sharing sensitive health information with third parties, and that the company is not clear when consumers fill out medical histories and are signing up for a subscription that continually renews and bills them for medicine. Patients also are not given an opportunity to review a provider’s recommended treatment or provide consent. The FTC also alleges the site makes it difficult for users to cancel their subscriptions. 

Continue to STAT+ to read the full story…

Cardiologists see this happen all too often: A patient is waiting in the hospital for a heart transplant, only to be disqualified because their fitness has fallen with each day in bed. 

Dismayed by such cases, Radha Gopalan, a heart transplant cardiologist at Banner–University Medical Center Phoenix, decided to try a twist on other rehabilitation programs.

Read the rest…

Hospitals have been quick to adopt artificial intelligence tools for automating note-taking during patient visits, saying they help lower physician burnout and increase revenues. Medical schools, though, are facing a vexing quandary over AI scribes.

As much as educators want future physicians to be well-versed in the technology, they worry that letting students off-load the struggle of thinking through differential diagnoses to AI could do irreparable harm during the formative years of their medical training.

“The process of deliberately crafting the note forces us to use our brains to really wrestle with what’s happening,” said Jaideep Talwalkar, associate dean of educational technology and innovation at Yale School of Medicine. “There’s an importance in doing that with great repetition.” 

Continue to STAT+ to read the full story…

I have delivered ALS diagnoses. I know the exact weight of those words, the way the room changes when a person hears them, and the composure and presence a physician is trained to maintain. I spent nearly a decade in medical training learning how to sit across from someone and explain, gently but honestly, what their future might look like with a progressive, fatal disease that today has no cure.

Then I found myself where I never expected to be: on the other side of that conversation.

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Artificial intelligence is moving fast — so fast that old questions about whether AI should be licensed to practice medicine, in whole or in part, have become pressing ones. These questions are arriving everywhere, in policy debates, pilot programs, and draft legislation, particularly at the state level.

The safest and most sensible answer today is that AI is not ready to be independently licensed like a physician. Medicine rests on a social contract: Society grants physicians unique privileges because they promise extraordinary duties of competence, ethics, and accountability in return. A medical license, therefore, isn’t just a permit to generate thoughtful and informed answers. It’s a legal and ethical grant of authority tied to human judgment, professional accountability, discipline, transparency, and a duty to put patients first.​

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WASHINGTON — Senate leadership on Sunday released the text  of a bipartisan government funding stopgap measure that would block the White House’s proposal to give political appointees control over federal research grants. 

The continuing resolution  would fund the government until Dec. 11. It would only block the Trump administration’s new grants proposal until that time, but it will be more difficult for Republicans to allow the White House’s plan to take effect now that they’ve agreed to blocking it, even if temporarily. 

The provision emerged from bipartisan discussions in the appropriations committee, to which Republican leadership agreed. The Senate is expected to consider the funding bill this week, after which it will break for August recess. The government funding bill that the House passed two weeks ago does not include a similar provision blocking the grant rule. The House already is in recess. Once they’re back, the two chambers will need to work out their differences before government funding expires at the end of September, and the president would need to sign it.

Continue to STAT+ to read the full story…

A divided Michigan Supreme Court ruled on Friday that the state’s attorney general may investigate Eli Lilly over its pricing practices for insulin.

In its 4-to-3 decision, the court rejected a lower court decision that prevented Michigan Attorney General Dana Nesel from proceeding with a probe that began four years ago. At the time, Nessel cited state consumer protection laws, alleging the drug maker had artificially increased the price of its insulin medication.

Lilly was accused of charging “grossly” excessive prices for three different insulin products — Lispro, Humalog and Basaglar — that forced some patients to ration or forego  insulin, restrict their diets or buy less-effective alternatives. These practices led to “serious disability and even death in some patients,” the state wrote in court documents at the time.

Continue to STAT+ to read the full story…

The Trump administration has revised the terms of a pilot effort that allows some drugmakers to offer rebates to certain hospitals and clinics for purchased medicines, a controversial move that may transform a key tenet of a federal drug discount program.

The anticipated pilot for the 340B Drug Pricing Program, which is slated to go into effect on Jan. 1, 2027, will allow pharmaceutical companies to provide “timely” rebates, rather than offering upfront discounts. The program targets specific drugs and pharmaceutical companies that are involved in the first two rounds of the Medicare Drug Price Negotiation Program.

“This revised pilot helps modernize program oversight by improving visibility into 340B transactions while helping preserve the program’s long-term sustainability for the patients and communities it was created to serve,” said Tom Engels, who heads the Health Resources and Services Administration, the government agency that oversees the program, in a statement.

Continue to STAT+ to read the full story…

And so, another working week will soon come to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still taking shape, but we plan on promenading with the official mascots, catching up on our reading, and manicuring the Pharmalot campus. We also hope to hold still another listening party, where the rotation will likely feature this, this, this, this and this. And what about you? If the weather cooperates, the possibilities are endless — hiking, surfing, sunbathing, strolling, gazing at the stars in the sky. Maybe you want to try a new restaurant. You could also do something meaningful and reach out to someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

A U.S. Food and Drug Administration advisory panel voted 10-to-3 to recommend use of an experimental Replimune treatment for advanced melanoma, STAT writes. The panel determined the company collected sufficient data to allow the FDA to review RP1, an engineered viral immunotherapy. What comes next could be seen by some as a signal of how the FDA, which is under new leadership, weighs potential benefits and risks for investigational drugs. RP1 was initially rejected last year and again this past April. Investors have interpreted the decision to hold an advisory committee meeting as a sign of new lenience.

The weight loss drug boom is beginning to show signs of a slowdown as employers and insurers pull back on coverage, signaling the market could be entering a more restrained phase after years of breakneck expansion, Bloomberg News says. In the past few months, growth in prescriptions for GLP-1 drugs for weight loss have moderated, according to Cigna chief executive officer Brian Evanko. The insurer’s pharmacy benefits manager has seen coverage declines and slower utilization growth compared to prior periods. About 6% of big employers dropped coverage for the drugs in 2026, according to a recent survey from consulting firm Mercer.

Continue to STAT+ to read the full story…

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What dish will health secretary Robert F. Kennedy Jr. make on the first episode of his new cooking show? Wrong answers only.

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Novo Nordisk said Friday that its investigational anti-inflammatory drug did not reduce the risk of major heart events in a pivotal trial, raising questions about the increasingly popular approach of targeting inflammation to prevent cardiovascular complications.

In a Phase 3 study that enrolled over 6,300 people with heart disease, kidney disease, and inflammation, the drug, ziltivekimab, did lower markers of inflammation, Novo said. However, that did not translate into a reduction in risk of major complications, including cardiovascular-related death, heart attack, or stroke.

Novo shares were down about 7% Friday.

Continue to STAT+ to read the full story…

Nine years ago in these pages, we — columnists for STAT at the time — praised the American Diabetes Association for standing up to a researcher in Brazil who had sued the group in U.S. federal court for issuing expressions of concern on four of his published articles. We even named the ADA the inaugural winner of our Doing the Right Thing award. 

Times certainly have changed, and the ADA is no longer what we’d call a profile in courage. The nation’s leading diabetes group now finds itself mired in a self-made mess involving its decision to oust a group of physicians from its annual meeting earlier this year. 

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When I was first diagnosed with limb girdle muscular dystrophy (LGMD), I was devastated to learn there wasn’t any treatment or cure. For those of us living with progressive diseases, time is not neutral. Every month a promising therapy is delayed, we will have irreversible loss of muscle function.

Rare disease drug development is in the midst of an extraordinary era of scientific innovation. Researchers are advancing gene therapies and targeted treatments unimaginable just a decade ago. The Food and Drug Administration has opportunities today with new leadership to modernize, including the utilization of innovative trial designs and tools so the United States continues to lead the world in rare disease drug development.

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First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others.

To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to the Editor received in response to them. You can submit a Letter to the Editor here, or find the submission form at the end of any First Opinion essay.

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SAN DIEGO — She first came to Park Boulevard for the money and the snacks. A friend told her there was a place they could go with free fruit gummies, granola bars, and rice crispy treats — and she could make $20 if she answered some survey questions. It sounded like a dream. GB had been spending her nights crinkling through garbage bags for bottles and cans. Aluminum got $1.66 per pound; to make $20, she had to collect hundreds of empties. As far as she understood, on Park Boulevard, all she had to do was show up. One morning in May, she and her friend walked over from the tent city where they lived.

The place was a research office: sterile, with frosted glass. Sure enough, there was good, strong coffee and a little basket of snacks. She was surprised, though, when the researcher who’d been interviewing her asked if he could draw her blood. She was 47. She’d been using meth since 2021, but she was terrified of needles. She snorted her speed, never did heroin, never injected anything at all. She thought about saying she needed the bathroom and sneaking off. But she liked Carlos Vera, the guy who was asking. He was gentle, and talked to her like a real human being, unlike so many people, who treated her like a bug, like something dirty to be rid of. 

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A group of outside experts convened by the Food and Drug Administration on Thursday voted in favor of Replimune’s experimental treatment for advanced melanoma.

In a 10-3 vote, the advisers determined that the biotech company has collected sufficient data to allow the FDA to review RP1, an engineered viral immunotherapy for melanoma. The agency tends to follow the recommendations of its expert panels but is not bound by them.

What comes next could be seen by some as a signal of how the FDA, under new leadership, weighs potential benefits and risks when it comes to investigational drugs. RP1 was rejected in April, under former FDA leaders Marty Makary and Vinay Prasad. Investors have interpreted the FDA’s decision to hold an advisory committee meeting about the drug as a sign of new lenience. But STAT has reported that earlier resistance to RP1 was based on the views of the FDA’s career staff, not leadership. 

Continue to STAT+ to read the full story…

Is the Food and Drug Administration taking inconsistent approaches to Duchenne muscular dystrophy drugs? How will a new batch of drug executives shake up their companies? And why is Adam talking to a recruiter?

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

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Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.

Good morning. Earlier this week, STAT’s Anil Oza went to our regular sandwich place to get lunch, and the folks working asked him where his friend was. That’s me! I had packed my own lunch — but I might never do that again, now that I know I’m known.

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BOSTON — In an order issued Thursday, a federal judge denied 26 states’ request to postpone the implementation of Medicaid work requirements announced in June.

The case seeks to alter a piece of one of President Trump’s biggest legislative priorities. The suit is focused on the implementation of a work requirement for people who receive Medicaid, the details of which were issued in June with the target of implementing the changes by Jan. 1. But states must also communicate with Medicaid recipients by Aug. 31 regarding how the changes may affect those enrollees.

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WASHINGTON — The Senate health committee approved two Trump administration nominees for key health roles Thursday, including the director of the Centers for Disease Control and Prevention and a pandemic preparedness leader, after an earlier vote was delayed. 

The vote on Erica Schwartz for CDC director was approved by all Republicans and by Tim Kaine (D-Va.), with other Democrats opposed. Sean Kaufman won support from all Republicans to be assistant secretary for preparedness and response, and all Democrats were opposed.

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The war with Iran has driven oil prices up, prompting concern that the supply of some medicines will be disrupted. But there is another consideration. In a new report, Unitaid emphasized that essential medicines are exposed to oil price volatility. Specifically, the global health agency examined the effect rising oil prices could have on one HIV medication and found that manufacturing costs could rise by 15% if oil reaches $120 barrel, and 85% of those higher costs are driven by petrochemical ingredients. To push back, Julien Pouille, who leads the climate and health strategic team and is lead author of the report, argues that lessening reliance on petrochemical products would help mitigate rising medicine costs and improve the climate. This is an edited version of our conversation.

So what prompted this exploration?

As part of our access strategy, we have a climate and health strategy that looks into ways in which basically we can just advance product knowledge that’s good for health, but also good for climate.… And of course, in the context of the Middle East crisis… we thought it was very timely to look into, specifically, the relationship between medicine prices and oil prices, because we were anticipating that that could potentially lead to some risks in terms of access for people and the population we work for.

Continue to STAT+ to read the full story…

This story, published in partnership with The Examination, is part of an investigative collaboration involving The Examination, The Bristol Cable, Daraj, Investico, Paper Trail Media, Der Spiegel, Der Standard, and the Toronto Star.

On a winter morning in a Long Island town about two hours east of New York City’s skyscrapers, a Dutch researcher told local officials that their concerns about mixing heavily caffeinated energy drinks with alcohol were overblown.

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Starting next week, Nebraskans on Medicaid will be at risk of losing their health coverage unless the state can verify that they work, volunteer, or attend school for 80 hours per month. Come January, millions of other low-income Americans will face the same cliff. 

While some working-age people are exempt, including those with young children and those deemed “medically frail,” new rules about who can opt out have led to widespread confusion. For patients with complex medical conditions, the looming requirements may create another barrier to health.

Read the rest…

First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others.

To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to the Editor received in response to them. You can submit a Letter to the Editor here, or find the submission form at the end of any First Opinion essay.

Read the rest…

When I met Tesfaye at Boru Meda General Hospital, he vaguely remembered the thorn. He was 15 when it pricked his foot, out in the fields somewhere in Mekdela, in north-central Ethiopia. He had noticed it in passing, then forgot about it.

Seventeen years later, that prick had severely damaged his foot, destroying its bones.

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Young life scientists have been increasingly abandoning academia, a seismic shift that has fueled calls for rethinking graduate education. On Wednesday, the Trump administration announced that it’s funding a pilot program to test a new strategy: Giving Ph.D. students industry experience — and dollars — as part of their training.

The program is creating four-year Ph.D. programs that are jointly bankrolled by universities and industry partners, with additional support from the National Science Foundation. During their Ph.D. studies, participants will spend at least one year conducting research at a company site.

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A group of outside experts convened Wednesday by the Food and Drug Administration concluded clinical data for a treatment for Duchenne muscular dystrophy from Capricor Therapeutics did not provide “substantial evidence” of efficacy.  

The vote was 9-3, sending to the FDA a recommendation that the Capricor treatment, called deramiocel, should not be approved. 

The FDA is not required to adhere to the expert panel’s stance, but it typically does. The agency review is still underway with a decision expected by Aug. 22. 

Continue to STAT+ to read the full story…

For decades, efforts to develop non-opioid pain drugs were marked by failure. But what was once a graveyard of drug discovery is quickly turning into a race for a multibillion-dollar market, with Latigo Biotherapeutics publishing positive data on Wednesday for a therapy meant to rival a Vertex medicine already on the market.

The startup’s Phase 2 trial enrolled 343 patients who’d gotten tummy tuck surgery; they were randomized to receive a high or low dose of Latigo’s experimental pill, a placebo, or a combination of acetaminophen and the opioid hydrocodone. Those given either dose of Latigo’s oral drug, LTG-001, showed statistically significant pain relief compared to placebo after 48 hours. And while participants in all groups had the option to use the opioid oxycodone if they needed additional pain management, those on a high dose of Latigo’s therapy were significantly less likely to do so than participants on placebo.

The drug was generally safe and well tolerated, with higher overall adverse event rates in the placebo group than in either treatment group. Some adverse events, however, were more common in the treatment groups: 7% of those taking a high dose of LTG-001 had a fever, compared with 2% of people on placebo, and 6% experienced lightheadedness, compared with 1% of the placebo group. 

Continue to STAT+ to read the full story…

On Wednesday, the Federal Trade Commission sued direct-to-consumer telehealth company Hims & Hers, continuing a pattern of action against digital health companies’ business practices and use of consumer health data. The FTC, along with Utah and California, alleged that Hims deceived consumers in several ways when they purchased clinical care and medications through the site. 

The telehealth company misled consumers about sharing their sensitive health information with third parties including Meta and Snap, the suit claims. It also alleges that Hims isn’t clear that when consumers fill out a medical history, they are signing up for a subscription that continually renews and bills them for medication. Patients are given “virtually no opportunity to review the provider’s recommended treatment, much less consent to it,” the lawsuit alleges, while the site also makes it difficult for users to cancel their subscriptions. 

Hims responded to the suit in a statement on the social media platform X. “This lawsuit disregards substantial evidence we provided the FTC during its nearly three-year investigation, ignores established state laws and industry standards in telehealth, and contorts the law to try to manufacture claims,” reads the statement. “This is not enforcement grounded in consumer protection; it is an effort to generate headlines at our expense. We are confident in our position and will vigorously defend ourselves against these baseless claims.” 

Continue to STAT+ to read the full story…

WASHINGTON — The Trump administration will end subsidies for private Medicare drug plans, likely resulting in higher premiums for some older adults right before the midterm elections.

Democrats were already campaigning on the approximately $1 trillion in health care cuts in Republicans’ tax bill from last summer. They immediately seized on the decision to end drug plan subsidies as another opportunity to attack Republicans on affordability. 

Senate Minority Leader Chuck Schumer (D-N.Y.) called the decision  “Heartless, cruel, and completely by choice.”

Continue to STAT+ to read the full story…

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I saw “The Odyssey” during its opening weekend. Ever since then, I have been questioning whether I’m illiterate or whether Christopher Nolan is a poor storyteller. This London Review of Books evaluation of the film, written by the woman whose translation of “The Odyssey” Nolan apparently read, has freed me from my wondering. (h/t to my colleague Matthew Herper)

Hot takes on Homer’s epic, or hot tips about Epic Systems: aiprognosis@statnews.com

Benchmark battle bots

You might recall that in mid-June, there was a Nature Medicine study that pitted clinical AI systems OpenEvidence and UpToDate Expert AI against general LLMs. It set off a reaction in the clinical AI world like no other paper has. “The results rang out like a gunshot,” as STAT health tech correspondent Katie Palmer describes it.

The controversy surrounding the study, and everything that came after, exemplifies the problems I have with benchmarks.

Katie summed it up well when I talked to her yesterday: “The way that benchmarks have been talked about generally, and specifically in clinical AI, tends to summarize them into the headlines,” she said. “Every study needs a headline and every story needs a headline, but as we both know, and as I think most people in the industry know, an individual benchmark doesn’t mean much.”

Continue to STAT+ to read the full story…

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 not-so-appetizing possibilities, we invite you to join us for a needed cuppa stimulation. Our choice today is green tea with ginger. 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. …

When one of Rhode Island’s most-wanted fugitives was discovered last week to have been secretly working under an alias in the biotech industry, the reaction among many was shock, STAT says. How did he evade scrutiny for two decades? And how did the companies that hired him — at least one biotech on a full-time basis and at least two large drugmakers on a contractual basis — not vet him more thoroughly? But to an industry recruiter who spoke with Richard Graydon — the alias used by Ronald Fischer, a former doctor who was convicted of sexual assault and had spent two decades on the run — it wasn’t all that surprising. His stellar academic credentials, board certification, and years of experience leading teams that successfully developed cancer drugs made him an ideal candidate for top jobs. Much of his CV appears to have been fabricated, but it checked the right boxes.

A New Hampshire hospital is challenging a new Eli Lilly policy that requires certain hospitals to submit claims data when dispensing the company’s drugs under the federal 340B drug discount program, Bloomberg Law writes. The lawsuit filed by Mary Hitchcock Memorial Hospital alleges Lilly’s requirement imposes an illegal policy with “non-negotiable terms” and “retaliatory pricing penalties in order to extract commercially valuable data.” The hospital said it refused to comply with the company’s demands, which were announced in February. Earlier this month, Lilly began terminating discounts to dozens of hospitals.

Continue to STAT+ to read the full story…

At a highly anticipated Senate hearing, Anthony Fauci on Wednesday invoked his Fifth Amendment right to refuse to answer questions about the Covid-19 pandemic and its origins, saying he was doing so on the advice of his attorneys.

The former U.S. health official, who achieved rock star status for a time due to his central role in charting the U.S. response to the pandemic, had been subpoenaed to testify before the Senate Homeland Security and Governmental Affairs Committee, a panel headed by Sen. Rand Paul (R-Ky.), who had made no secret of his desire to see Fauci behind bars. Among other allegations, Paul has accused Fauci of covering up the origins of the virus that causes Covid — which the senator believes was caused by a lab leak in China — and lying to Congress.

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Good morning. Might I suggest you order yourself a delicious sandwich for lunch today and join Office Hours with Isa Cueto and Lev Facher, who will be discussing alcohol consumption as a public health crisis, the industry’s lobbying, and potential policy solutions. 1 p.m. EDT. Questions encouraged! 

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Hundreds of thousands of U.S. doctors use clinical large language models, pitched by companies like OpenEvidence, Doximity, and UpToDate as an antidote to the dangers of hallucination-prone generalist models from Big Tech. Yet few studies have pitted them against each other — and this summer brought a high-profile head-to-head. 

Researchers from NYU Langone Health had tested general and clinical models, including OpenEvidence and UpToDate Expert AI, on three sets of clinical questions. The findings, published in Nature Medicine in June: The clinical AI performed worse than the general models. 

The results rang out like a gunshot. “I’ve never seen a single paper trigger the kind of reactions this one has in the health AI community,” wrote Kaiser Permanente’s vice president of AI and emerging technologies on LinkedIn. The paper’s findings, like all science, are subject to interpretation and debate — but many online reactions treated them more like a clear victory for general frontier models.

Continue to STAT+ to read the full story…

When one of Rhode Island’s most-wanted fugitives was discovered last week to have been secretly working under an alias in the biotech industry, the reaction among many was shock. How did he evade scrutiny for two decades? And how did the companies that hired him — at least one biotech on a full-time basis and at least two large pharmaceutical companies on a contractual basis — not vet him more thoroughly?

But to an industry recruiter who spoke with Richard Graydon — the alias used by Ronald Fischer, a former doctor who was convicted of sexual assault and who had spent two decades on the run — it wasn’t altogether surprising. 

Graydon’s stellar academic credentials, board certification, and years of experience leading teams that successfully developed cancer drugs made him an ideal candidate for top jobs at biotech and pharma companies. Much of his CV appears to have been fabricated, according to a STAT review, but it checked the right boxes.

Continue to STAT+ to read the full story…

Biotechnology is rapidly becoming a pillar of national power. The nation that can discover, test, and deploy new therapies most efficiently will not only improve the health of its citizens but also shape global standards, attract investment, strengthen military readiness, and dominate one of the most important industries of the past century.

China understands this reality. Beijing has made biotechnology a strategic priority and is investing aggressively in artificial intelligence, synthetic biology, advanced biomanufacturing, gene therapies, and precision medicine.

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The nurses had warned me not to expect much. They hadn’t seen her smile in weeks, they said, sounding as though they’d already given up.

Her room was undecorated and gray, crowded with machines whose chorus of irritating beeping never ceased. I paused at the entrance, horrified by the numerous plastic tubes penetrating her tiny abdomen. My eyes moved from her stomach to her hands, clenched around a stuffed unicorn, her sole companion on a Friday night.

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The expulsion of five diabetes experts from the American Diabetes Association meeting last month continues to reverberate, with more than 200 members now calling for two ADA leaders to resign. In response, the ADA delivered its own message Tuesday, expressing appreciation for members’ patience while a report is prepared. 

The resignation demand, sent last week in an open letter to the ADA board of directors, calls for the removal of CEO Charles Henderson and chief scientific and medical officer Rita Kalyani. It also urges “an independent investigation into the events of the 2026 Scientific Sessions in New Orleans, a full apology to the five colleagues removed from the meeting, and the restoration of editorial independence at Diabetes Care,” an ADA scientific journal.

“It has now been more than 45 days since the incident at the 2026 Scientific Sessions, and the ADA Board of Directors has still taken no meaningful action to hold leadership accountable, issue a genuine apology, or restore trust with the membership,” the open letter said. “The ADA was founded by physicians and scientists who understood that this organization’s strength flows from the community it serves — not from the administrators who happen to run it. That community is now telling its Board, in the clearest terms available, that the current path is unsustainable. We ask that they change the organization now.”

Continue to STAT+ to read the full story…

WASHINGTON — Senate Republicans, and particularly Rand Paul (R-Ky.), have long been critical of the government’s actions during the Covid-19 pandemic — which began during the first Trump administration — and have sought to pin blame on those they believe played some role in the virus’s outbreak and what they describe as a subsequent coverup of the pandemic’s origins. 

On Wednesday, they will again get another chance to explore the past when Anthony Fauci, the nation’s former top infectious disease expert, testifies before the Senate Homeland Security and Government Affairs Committee following a subpoena issued by Paul.

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For nearly half a century, the federal government encouraged international students and scholars to study in the U.S. by allowing them to stay for the duration of their training — regardless of how many years it took. The Trump administration now plans to tear up that long-standing policy, fueling concerns in the research community that the U.S. could lose out on talented foreign scientists. 

In mid-July, the Department of Homeland Security announced that future international students and postdoctoral researchers will be allowed to stay in the U.S. for no more than four years on nonimmigrant visas unless they apply for and receive an extension from DHS. Those already in the U.S. won’t need an extension if their training is set to end before September 2030, even if they’ve already been in the country for more than four years.

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Denver is holding a Potato Palooza to give away a surfeit of spuds. Send news tips and tater salad tricks to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal. Also, join STAT’s Isabella Cueto and Lev Facher tomorrow at 1 p.m. EDT for Office Hours, a live Q&A about the latest in their series on the U.S. alcohol epidemic.

Fauci subpoenaed to testify before Senate panel

Anthony Fauci is scheduled to testify again tomorrow before Congress, this time at the Senate homeland security committee.

Continue to STAT+ to read the full story…

LONDON — Half a year into taking over the job, GSK CEO Luke Miels on Tuesday laid out his plans to turn the U.K. pharma giant into a more agile company with years of growth ahead. 

A key step, Miels said, will be a three-year campaign to generate 1.9 billion pounds (about $2.5 billion) in annual savings by 2029, much of which will be reinvested to advance the company’s late-stage pipeline. The company also now plans to start at least 20 Phase 3 trials this year, up from the 10 that it had disclosed at the beginning of 2026. 

“We are step-by-step building a set of potential best-in-class products across our core therapy areas,” Miels said, a list that includes some newer target areas — like oncology and liver disease — as well as longtime GSK focuses like vaccines and HIV. Miels would not say Tuesday how many jobs would be cut under the savings drive. 

Continue to STAT+ to read the full story…

Regulators at the Food and Drug Administration have reiterated concerns that Replimune does not have adequate data to support an approval of its investigational skin cancer treatment, as the biotech tries for the third time to seek clearance for its highly controversial drug.

In briefing documents released Tuesday ahead of a meeting of FDA advisers later this week, the agency took issue with the single-arm trial the biotech relies on, in which patients who have already tried a PD1-inhibitor took Replimune’s drug, called RP1, in combination with the PD1-inhibitor Opdivo. The agency argued the study is not enough to properly evaluate the efficacy of the drug itself and whether the treatment, which is injected locally, has systemic benefits.

Replimune counters in its own briefing document that “it is not feasible or ethical” to conduct a study that randomly assigns its drug or placebo on top of PD-1 inhibitors in patients whose cancer has stopped responding to PD-1s, since “there is no evidence that continued anti-PD-1 monotherapy provides any level of clinical benefit” to those patients.

Continue to STAT+ to read the full story…

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Good morning health tech readers!

Today, the latest on tech company pledges to CMS. Plus: ChatGPT Health is now generally available and Whoop’s new CMO answers my questions.

Continue to STAT+ to read the full story…

Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us. Our choice today is witch’s brew. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. …

The U.S. Food and Drug Administration said that a Capricor Therapeutics stem cell treatment for Duchenne muscular dystrophy did not meet the objectives of a Phase 3 trial — contrary to company claims last year, STAT says. Last December, Capricor said its drug, known as deramiocel, met both the primary and secondary endpoints in a large, randomized study. It was a striking result in a fatal, childhood disease that has proven stubbornly difficult to treat, despite immense advances in genetic medicine. But in documents released Monday in advance of a hearing this week where FDA advisers will weigh in on the drug, the agency said the study fell short.

The world risks a resurgence of the HIV epidemic after international financing to combat the infectious disease suffered a “profound shock” last year, STAT writes, citing a new report from UNAIDS, the United Nations agency. Overall, government funding declined by more than $1.5 billion to $7.3 billion in 2025, an 18% drop and the lowest level in nearly two decades. Prevention programs, in particular, have historically relied heavily on donor assistance in most regions, especially in sub-Saharan Africa, where it reached 83% two years ago. Although the U.S. was blamed for funding cuts, it still provides 74% of government donor funding.

Continue to STAT+ to read the full story…

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.

Good morning. We’ve got a pretty juicy story from STAT’s Jason Mast for you today. Pour your coffee and scroll down.

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Biotechs are spending billions to cure a rare liver disorder most Americans have never heard of. The contentious race features dueling technologies, patent wars, a broken alliance, and a boiling competition between the U.S. and Chinese drug industries.

The disease, known as alpha-1 antitrypsin deficiency (AATD), is a slow-moving disaster for patients. Thanks to a single misspelled letter of DNA, their livers produce a mutant version of a protein that normally travels through the bloodstream and protects the lung from damage. 

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An interim look at an Alzheimer’s disease clinical trial evaluating an amyloid-targeting treatment from ProMIS Neurosciences showed low rates of brain bleeding and no incidences of brain swelling — results reported Tuesday that suggest the drug could be safer than approved treatments. 

In a blinded analysis that pooled safety data from patients receiving the ProMIS drug and a placebo, the total rate of ARIA was 4.4%, with all cases mild and asymptomatic, the company said. 

None of the patients experienced ARIA-E, which is the more severe side effect that causes brain swelling. All the cases were characterized as ARIA-H, which involves tiny bleeds in the brain. 

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It was a skit worthy of an Agatha Christie whodunit reveal: Against the perhaps-too-joyous strains of a jazzy “When The Saints Go Marching In,” a gaggle of health IT professionals and Medicare staffers accompanied a Spirit Halloween-style coffin prop onstage at Health and Human Services headquarters on Monday. Some wore black veils, some held white roses. 

The coffin read, “RIP CLIPBOARD,” referring to the decades-old information-gathering staple of health care provider waiting rooms.

“So who killed the clipboard?” asked Zac Jiwa, a federal Medicare official. Health IT officials and experts, reading from cue cards, denied that it was standards implementation, health information exchange networks, electronic health records, or apps — all parts of the various health data initiatives that private industry promised Medicare a year ago that it would improve.

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In the nine years since my last visit to the Docklands’ Excel conference center for the 2017 annual Alzheimer Association International Conference, or AAIC, little of London’s infrastructure has changed. I traveled via the same low-ceilinged, clattering trains with signs advising riders to “mind the gap” and “mind the step.” The center has the same weird jack-o’-lantern-esque façade and forgettable restaurants and hotels. I was even here for the same conference.

Same meeting, in the same place, but what transpired was quite different. In just nine years, how we think about the aging brain has transformed.

One moment captured this. It was a speaker’s remark at a breakfast meeting convened by the Davos Alzheimer’s Collaborative. The 5-year-old organization describes itself as “uniting leading organizations worldwide to build an innovation ecosystem that will accelerate breakthroughs, develop and scale promising solutions and equip every healthcare system to end Alzheimer’s disease everywhere.”

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Bontle Moka-Moliki starts and ends every day in pain. 

The 32-year-old Atlanta resident was diagnosed with endometriosis in 2019. A year later came fibroids. Then in 2024 she was diagnosed with a condition now called polyendocrine metabolic ovarian syndrome. “If someone is at a zero, my pain is at a three every day, and then it’s only up from there,” she said. 

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The world risks a resurgence of the HIV epidemic after international financing to combat the infectious disease suffered a “profound shock” last year, according to a new report from UNAIDS, the United Nations agency.

Overall, government funding declined by more than $1.5 billion to $7.3 billion in 2025 — an 18% decline and the lowest level in nearly two decades. Prevention programs, in particular, have historically relied heavily on donor assistance in most regions, with especially high dependency in sub-Saharan Africa, where it reached 83% two years ago.

Other factors contributing to the worrisome outlook are high debt burdens in countries most affected by the disease and backsliding on human rights and gender equality, the report noted.

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Hello! Wanna drop some cars in an open pasture? The internet does it again. Drop some tips and feedback here: bob.herman@statnews.com.

PhRMA doesn’t want you to look at drug spending

Lobbying groups frequently send news releases and talking points to journalists as a way to influence reporting. Right now, the pharmaceutical industry’s primary lobbying shop, PhRMA, wants everyone to ignore the clear-cut rise in prescription drug spending. 

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Sarepta Therapeutics, the bruised maker of Duchenne muscular dystrophy treatments, on Monday named Michael Severino, formerly the CEO of Tessera Therapeutics, as its new chief executive, starting Tuesday. 

Severino is replacing Doug Ingram, who announced earlier this year that he planned to retire after leading the biotech for nearly a decade. During his tenure, the company got three Duchenne treatments approved, but has faced ongoing questions about how effective they are and run into regulatory scrutiny over the safety of its gene therapy. 

The company’s share price has tanked from where it was at the beginning of 2025.

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The Food and Drug Administration said Monday that Capricor Therapeutics’ stem cell treatment for Duchenne muscular dystrophy did not  meet the objectives of Phase 3 trial — contrary to the company’s claims last year.

Capricor said in December that the drug, known as deramiocel, met both the primary and secondary endpoints in a large, randomized study. It was a striking result in a fatal, childhood disease that has proven stubbornly difficult to treat, despite immense advances in genetic medicine. 

The data were also notable for coming primarily in teenagers and young men who have already lost the ability to walk, a population with few options. The drug appeared to both preserve their upper-arm function and stave off the heart failure most patients eventually experience, Capricor had said. 

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Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because 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 cuppa stimulation. Our choice today is Earl Grey, an old standby. Feel free to join us. Remember, no prescription is required. Meanwhile, here are some items of interest to help you on your journey today, which we hope will be productive and meaningful. Best of luck and, of course, do keep in touch. …

A U.S. Food and Drug Administration advisory panel on Friday recommended that compounding pharmacies be allowed to manufacture the peptides epitalon and semax, but narrowly voted to recommend against manufacturing emideltide, STAT writes. The votes, which followed the panel’s decision on Thursday to recommend allowing pharmacies to make four other peptides, bring U.S. Health and Human Services secretary Robert F. Kennedy Jr. one step closer to his mission of making these unapproved compounds more available for Americans. Peptides have become increasingly popular in the U.S., driven by endorsements from social media influencers.

Amgen submitted new evidence to the FDA ​as it seeks a hearing to challenge the proposed ‌withdrawal of its rare disease drug Tavneos from the U.S. market, Reuters says. In April, the agency proposed withdrawing the drug, which treats a rare autoimmune ​disease that damages blood vessels, citing a lack of proven effectiveness ​and false statements in its original marketing application. Amgen strongly disagrees with the FDA and noted its submission includes more than 70 real-world studies involving over ​2,200 patients supporting the drug’s effectiveness and safety.

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RA Capital and a fleet of other investors are putting $175 million behind Oak Hill Bio, a startup trying to revive an experimental Angelman syndrome drug that Roche shelved. 

Oak Hill is competing with Ultragenyx Pharmaceutical and Ionis Pharmaceuticals, both of which are already running Phase 3 trials of similar drugs for the same disease. Ultragenyx will have results this year.

Oak Hill is betting it has the best molecule.

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Good morning. In a search for silver linings yesterday, I found this: I can finally spell the word “diarrhea” confidently! The latest on cyclosporiasis, measles, and more below. 

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When we were children, it wasn’t unusual to hear about a kid wiping out on a bike, skateboard, or roller skates and coming home with scrapes, bruises, and occasionally broken bones that needed to be fixed. While painful, those injuries generally matched the speed and physics of childhood play and rarely led to permanent injuries.

However, now, with the increasing prevalence of electric bicycles and scooters, known as e-bikes and e-scooters, the equation has changed for children and teens.

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When students return to McGovern Medical School at UT Health Houston this year, they will get to participate in hands-on nutrition experiences, including cooking demonstrations in the teaching kitchen, tours of the campus “holistic garden,” and the opportunity to take a culinary-medicine-focused elective. 

These immersive programs are a response to health secretary Robert F. Kennedy’s call for medical schools to teach more nutrition — part of the Trump administration’s push to address the rising rates of chronic diseases in the United States. Kennedy has blamed the problem, in part, on doctors not routinely discussing diet and nutrition with their patients.

Lessons in culinary medicine are part of the 71 nutrition-related topics that the Department of Health and Human Services wants future physicians to be well versed in. Other topics in the department’s Advancing Nutrition Education push include enhancing nutrient bioavailability through soaking, sprouting, and fermenting foods as well as prioritizing food-based medicine as the primary approach to manage chronic diseases driven by metabolic dysfunction.

The vast majority of 163 M.D.-granting and 48 D.O.-granting schools aren’t yet part of Kennedy’s new initiative, including several leading institutions. So far, some 73 medical schools — 54 M.D. programs, 19 D.O. programs — across 36 states have signed on.

Even as some medical schools heed Kennedy’s call for more nutrition education, several told STAT that they plan to steer clear of topics that aren’t backed by evidence, including some that align with the priorities of the Make America Healthy Again political movement championed by the health secretary. Nutrition experts cautioned that some of those topics could lead to “wellness creep” in medical education.

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In the dimmed light of a hospital room in Nevada, the placenta — blue and shining — has just delivered. I coaxed it gently, spinning the warm, bloody organ and twisting the trailing membranes into a compact coil, leaving nothing behind. Even a small fragment of placenta or membrane can prevent the uterus from contracting properly, failing to squeeze shut the great vessels that have spent 40 weeks surging with blood to feed a growing baby. If those vessels do not abruptly close, blood continues pumping into the empty uterus and a hemorrhage begins.

I am always vigilant for bleeding — but today I am also uneasy. My patient has made it clear that she does not consent to blood products, even in an emergency. She will not risk receiving blood from a donor who has been vaccinated against Covid-19. No hospital or blood bank tracks donor vaccine status, because it poses no known transfusion risk — but no fact will change her mind.

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Argenx said Monday it would buy Forte Biosciences to expand its immunology pipeline, continuing the sector’s acquisition run, as even midsize companies hunt for pick-up targets. 

The deal, worth $2.2 billion in cash, values Dallas-based Forte at $77 per share, a 41% premium to the biotech’s closing price on Friday. 

Argenx, which has its main operations in Belgium, has become a top success story in immunology. Its drug Vyvgart, approved to treat the autoimmune diseases generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, has delivered steady sales increases as its label has been widened to cover more patients.

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WASHINGTON — A Food and Drug Administration advisory panel recommended on Friday that compounding pharmacies be allowed to manufacture the peptides epitalon and semax, but narrowly voted to recommend against manufacturing emideltide. 

The votes, which followed the panel’s decision on Thursday to recommend allowing pharmacies to make four other peptides, bring health secretary Robert F. Kennedy Jr. one step closer to his mission of making these unapproved compounds more available for Americans. Peptides, which are short-chain amino acids, have become increasingly popular in the U.S., driven by endorsements from social media influencers.

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I spent nearly a decade leading FDA’s Center for Food Safety and Applied Nutrition. That role convinced me that food safety and nutrition are interdependent in so many ways, and if we want to make our population healthier, we need to support both.

Over the past few weeks, record numbers of cases of cyclosporiasis have driven that message home broadly, including to consumers. FDA is currently investigating six cyclospora outbreaks, only one of which is currently linked to shredded iceberg lettuce.

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The number of measles cases in the U.S. has surpassed the record-breaking tally for all of 2025, with five more months of 2026 still to come.

The U.S. Centers for Disease Control and Prevention logged 2,318 cases of measles as of Thursday, according to an agency update on Friday.

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Today, a win for RFK Jr., as an FDA panel narrowly voted in favor of allowing compounding pharmacies to produce certain unregulated peptides. Also, in heart-wrenching detail, Science writes of the six-year-old girl who died in China after receiving an experimental, brain-directed CRISPR therapy.

The Readout’s taking a summer break next week, so we’ll see you in August!

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And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still in the works, but we do plan to promenade extensively with the official mascots, stroll the supermarket aisles, and spend time with the Pharmalot ancestor. We also hope to hold yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? The possibilities are endless — you could stop by your favorite restaurant, curl up with a good book, hang with your best friend, or take a long drive to nowhere. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

In a win for peptide proponents and for U.S. Health and Human Services Secretary Robert F. Kennedy Jr., an advisory panel to the U.S. Food and Drug Administration recommended compounding pharmacies be allowed to make the drugs BPC-157, KPV, TB-500, and MOTS-c., STAT says The FDA panel will vote on additional compounds on Friday. The votes are not binding, so the FDA will decide whether to lift restrictions and make them more accessible to people who have been turning to the little-researched but popular drugs. The vote reflects tensions between FDA staff, who recommended against lifting restrictions on the peptides because of safety and efficacy concerns, and the panel, which critics have said was “stacked” by Kennedy with people who stand to benefit from broader peptide access.

People with diabetes who use a popular long-acting insulin pen made by Sanofi have had to become pharmacy scouts in recent weeks as they encounter supply issues, STAT explains. The Lantus Solostar pen containing 3 milliliters of insulin glargine has been running low for several weeks because of increased demand “driven by broader market dynamics,” according to Sanofi. The issue is not technically considered a shortage by the FDA, but patients are having trouble finding the medication. While some diabetes patients have had luck finding the medication at small independent pharmacies or their hospital pharmacy, large pharmacies like CVS and Walgreens are coming up dry.

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Yesterday, my friend who lives in the Bay Area told me that I should be asking people about their peptide “stack,” which is where someone takes multiple peptides for presumably greater health benefit.

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Amid rising concern over efforts to contain HIV, Merck has reached voluntary licensing deals with seven companies to make generic versions of an experimental, once-a-month prevention pill in 129 low- and middle-income countries.

The agreements will allow the manufacturers — three of which are based in Africa and four in India — to sell generic versions to both public and private buyers, which is designed to ensure the medicine becomes available to the widest possible population. Moreover, the deals are royalty free, which makes it easier for the generic companies to predict costs.

The timing of the announcement is notable because Merck is striking these deals while its medicine, known as alimatravir, is currently undergoing a pair of late-stage clinical trials. By doing so now, the company believes it will help the generic makers plan for wide-scale production and the necessary steps to receive regulatory approvals around the world.

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