STAT+: FDA adcomm members’ ties to industry under scrutiny
Good morning. Yesterday, we got the devastating news that STAT’s infectious disease correspondent, Helen Branswell, passed away. She was a reporter I always looked up to and was also an incredibly generous colleague. Please take the time to read this tribute to her.
The need-to-know this morning
- Liquidia and United Therapeutics reached a settlement agreement that resolves their ongoing patent litigation over Liquidia’s treatment for pulmonary arterial hypertension.
New trial to test effect of GLP-1s on social outcomes
Researchers in Pittsburgh are launching a novel type of GLP-1 trial — testing not only if the drug will help people with addiction, but also if it will help reduce recidivism while improving other employment, health, and housing outcomes.
The Center for Addiction Science, Policy and Research (CASPR), a non-profit organizing the effort, and the Allegheny County Department of Human Services are planning to launch the trial in early 2027. They will enroll up to 1,200 adults with alcohol use disorder, opioid use disorder, or both, who are also at high risk of criminal-justice involvement. Half will be randomly assigned to take Novo Nordisk’s Wegovy, according to a press release issued yesterday.
STAT+: The startup chasing ‘general biological intelligence’
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I’m looking forward to “When the Promise of AI Doesn’t Pan Out,” which is scheduled for just after noon ET today, and STAT executive editor Rick Berke’s interview with Katelyn Jetelina, better known as “Your Local Epidemiologist,” whom I’m still starstruck by.
STAT+: Pharmalittle: We’re reading about Sanofi settling an EU antitrust probe, ‘pharma bro’ Shkreli, and more
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, which we hope to find shortly since we are on the road. Perhaps we can meet? Meanwhile, here is the latest menu of tidbits to help you on your way. We hope you conquer the world and have a wonderful day. And as always, please do stay in touch. We appreciate feedback, tips, and criticism. …
Martin Shkreli is back, but the U.S. Federal Trade Commission is not happy, STAT says. The agency and seven states asked a U.S. court to hold Shkreli in contempt for “flagrantly and repeatedly” violating a court order banning him from working in the pharmaceutical industry. Shkreli, known as “pharma bro” for imperiously defending his decision to raise the price of a drug by 5,000%, was sentenced to seven years in prison for defrauding investors in 2018. Before his release in 2022, a court banned him from ever working in the industry again, saying he illegally tried to prevent generic competition to the drug. Since then, he became a prolific trader in pharma stocks, broadcasting his analysis in posts and livestreams on X and other platforms.
European Union antitrust regulators accepted concessions from Sanofi to settle an investigation into an allegedly “misleading” campaign that disparaged the only rival flu vaccine recommended for vulnerable patients at risk for developing the illness, STAT tells us. In doing so, the company avoided being fined. The European Commission had suggested that Sanofi portrayed the Fluad vaccine marketed by CSL Seqirus as inferior to its own Efluelda vaccine in a communication campaign that primarily targeted health care professionals in Germany and France. Sanofi holds a dominant position in both countries, according to the EC.
STAT+: Sanofi avoids fine as EU accepts offer to end antitrust probe over disparaging rival vaccine
European Union antitrust regulators accepted concessions from Sanofi to settle an investigation into an allegedly “misleading” campaign that disparaged the only rival flu vaccine recommended for vulnerable patients at risk for developing the illness. In doing so, the company avoided being fined.
The European Commission had suggested that Sanofi portrayed the Fluad vaccine marketed by CSL Seqirus as inferior to its own Efluelda vaccine in a communication campaign that primarily targeted health care professionals in Germany and France. Sanofi holds a dominant position in both countries, according to the EC.
To resolve the probe, Sanofi committed to a corrective communication campaign rectifying its “possible disparaging behavior” and to refrain from such behavior in the future, according to Teresa Riberta, the European Commission executive vice president for Clean, Just and Competitive Transition. The agreement is legally binding.
New study examines GLP-1 impact on interactions with criminal justice system, employment, housing stability
We got devastating news yesterday. The inimitable Helen Branswell has died at age 69. We’ll miss her so much.
A huge loss for science, journalism, and STAT
Helen Branswell — STAT’s renowned infectious diseases reporter, our best baker, and the biggest hater of the email function “reply-all” — died yesterday due to complications from cancer. Please read Andrew Joseph’s beautiful obituary all the way to the end.
STAT+: Lobbyists and trade groups fight to shape how states regulate medical AI
Influential lobbying groups for doctors and hospitals, a health insurer, technology companies, and representatives from state governments met behind closed doors in Washington, D.C., in early October to develop guidelines for how to regulate artificial intelligence in the practice of medicine.
Executives from the American Medical Association, American Hospital Association, artificial intelligence giant Anthropic, and insurer Elevance Health are part of a 22 member AI workgroup convened by the Federation of State Medical Boards, or FSMB, a national organization that advocates for state boards. A spokesman said the workgroup “was built to balance expertise across medical regulation, AI development, care delivery, academic medicine, state AI policy, and patient safety,” and that its recommendations would be open for feedback before being formally adopted.
The discussions within workgroup meetings are being kept confidential, but the goal is to draft guidelines to aid local medical boards, with “particular attention … to AI tools that perform clinical functions with limited or no direct physician supervision,” Humayun Chaudhry, the FSMB’s president and CEO, told STAT. A draft of the recommendations could be made public in “weeks to months,” said Chaudhry. They could ultimately form the basis of legislation in states, which individually regulate medical licensure and the practice of medicine.
Opinion: How states can resist the potential Trump vaccine shortages
Vaccine skepticism has worked its way from the fringes of the public to the highest levels of the federal government. The Trump administration is reportedly considering changes to a critical policy, the Vaccine Injury Compensation Program, that has protected domestic vaccine supply for 40 years, which could further jeopardize vaccine access and even create shortages in the United States. These attacks on vaccines could have much more far-reaching impacts than may appear at first blush: They could effectively blow up a key pillar of the industrial policy that has maintained stable vaccine access in the U.S. for four decades.
This could create a situation where Americans who want vaccines can no longer get them. But as I explain in a new paper, the Trump administration doesn’t have to have the final word. Policymakers at the state level can step in to directly produce vaccines to prevent shortages and harm to the American people.
Opinion: We think a baby’s gut microbiome could be key to lifelong brain health
Picture a baby sleeping in a crib.
Every second, her brain is forming more than a million new neural connections. The scaffolding for language, memory, attention, and thought is going up in real time, wire by wire. We don’t yet know who she will become; yet much of her future self depends on what reaches her now, in the earliest months of her life.
STAT+: BlackRock to buy majority stake in Humana’s CenterWell clinics for $2.8 billion
Humana is swapping out private equity sponsors for its CenterWell Senior Primary Care clinics. Good bye, Welsh, Carson, Anderson & Stowe. Hello, BlackRock.
The health insurer announced Tuesday that BlackRock is buying out Welsh Carson’s majority stake in its network of 150 Medicare Advantage-focused clinics in a transaction valued at $2.8 billion. Over the next two years, Humana said the deal would help the company fund existing clinic operations, add new clinics, and make other strategic acquisitions.
It’s been more than six years since Welsh Carson’s initial investment in CenterWell, making this precisely the time you’d expect a private equity firm to head for the exit. Welsh Carson has poured at least $1.8 billion into the venture since 2020.
STAT+: Many patient, consumer reps on FDA advisory panels have ties to groups funded by pharma, analysis finds
Nearly 40% of Food and Drug Administration advisory committee meetings held over a recent 20-year period included either a patient or consumer representative with active ties to an advocacy group funded by pharmaceutical companies, according to a new analysis. And for several committees, the number of such reps exceeded 50%.
In addition, more than one in 10 advisory committee meetings included a rep who was affiliated with an organization that received funding from the drugmaker whose medicine was being reviewed by the committees. Yet most of these organizational ties were not disclosed at the meetings, raising questions about voting behavior.
The analysis, which was published in Health Affairs Scholar, noted the FDA has well-established conflict-of-interest policies for its scientific advisory committee members, but policies concerning patient and consumer reps are not as well developed, especially concerning industry funding of advocacy groups whose members appear on committees.
Helen Branswell, whose reporting on infectious diseases and public health drew acclaim, dies at 69
Helen Branswell, a renowned infectious disease reporter who earned the respect of experts and public health officials around the world with her accessible, prescient dispatches on scourges from influenza to polio and Ebola to Covid-19, becoming a vital source of information for the public during the most chaotic of times, died Tuesday at age 69.
The cause was complications from cancer, said her sister, Brenda Branswell.
STAT+: Doctors are giving generously to doctors running for office
The most influential names in health and medicine will take the stage this Wednesday and Thursday at the STAT Summit in Boston. Be there (virtually or in person) or be square. Send news tips and the panels for which you’re most eager to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.
Doctors give big
The next two years could be a crucial time for doctors as Congress considers the first major overhaul of how Medicare pays physicians, and the left flank of the Democratic party rallies around Medicare for all.
With so much on the line, doctors are showing up for candidates with medical degrees.
STAT+: Animosity in North Carolina, and MA shooting stars
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Hello! We’re here a day later due to Indigenous Peoples’ Day. A big thanks to everyone who emails in. I read all of them. And keep ’em coming: bob.herman@statnews.com.
A fireworks display
One way employers can save money on health care is by making it cheaper for their workers to visit specific hospitals and doctors. An extremely contentious example of this is playing out in North Carolina, and now is moving into the courts.
STAT+: FTC demands Martin Shkreli divest his pharma stocks
Martin Shkreli is back. The Federal Trade Commission isn’t happy.
The FTC and seven states on Tuesday asked a federal court to hold Shkreli in contempt for “flagrantly and repeatedly” violating a court order banning him from working in the pharmaceutical industry.
Shkreli, who became known nationwide as “pharma bro” in the 2010s for imperiously defending his decision to raise the price of an anti-parasitic drug called daraprim by 5,000%, was sentenced to seven years in prison for defrauding investors in 2018. Before he was released in 2022, a court banned him from ever working in the drug industry again, saying he illegally tried to prevent generic competition to daraprim.
STAT+: Pharmalittle: We’re reading about concerns over a rare disease drug, pharma payments to docs, and more
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 cup of stimulation. Our choice today is butter pecan. 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. …
Two months after the release of an open letter on potential safety issues tied to a rare disease drug sold by Neurocrine Biosciences, patient advocates and some experts are expressing growing alarm over the perceived risks of the therapy, STAT reports. The drug, approved to treat Prader-Willi syndrome, which can cause an insatiable feeling of hunger, has been linked to the deaths of seven people and the hospitalization of nearly 100 others — all since the treatment, called Vykat XR, was approved 18 months ago. Case reports on those deaths and hospitalizations that were submitted to regulators do not prove causality; many of the Vykat cases involved complex medical issues and multiple medications. But some experts say the evidence is sufficient to conclude Vykat is causing unacceptable harm.
The gifts and payments that doctors receive from drugmakers increased inappropriate prescribing and the number of prescriptions written, likely leading to rising health care costs, STAT writes, citing a Cochrane review of dozens of previous studies that have explored the influence the pharmaceutical industry has on medical practice. In addition, pharmaceutical advertising or education aimed at doctors may also increase inappropriate prescribing, probably increases the number of prescriptions written, and may increase the costs of prescriptions. But conflict-of-interest policies that restrict or manage interactions between companies and doctors probably improved prescribing practices.
STAT+: Takeaways from an evaluation of Google’s diagnostic chatbot, AMIE
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Good morning health tech readers!
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How many ways can the Trump administration clamp down on international researchers?
Good morning! You can still buy passes to the STAT Summit — kicking off tomorrow in Boston — if you act fast. The agenda is chock full of fascinating panels and conversations about the state of health care, moderated by some of the newsletter’s familiar faces. Register here.
How many ways can the Trump administration clamp down on international researchers?
In the span of two days last week, the Trump administration issued two sweeping announcements meant to crack down on international students and scholars, who make up a sizable portion of the nation’s biomedical research workforce. On Wednesday, the Department of Homeland Security announced a proposed $70,000 fee for a work authorization program that many foreign students use to gain professional experience. The next day, the Labor Department revealed that it is investigating nine universities — including Harvard, Stanford, and Yale — for alleged fraud related to visas awarded to postdoctoral researchers.
Opinion: Lethal injection will never be the same after Christa Pike’s botched execution
For the first time in medical and legal history, a prisoner has “survived a complete execution attempt in the U.S.” According to the Death Penalty Information Center, Christa Pike’s failed execution was “the worst we’ve seen and unlike any other botched execution in the modern era (since 1976). There is no precedent.” This game-changing bioethics case may even end lethal injection.
About 7,000 people were executed in the U.S. between 1900 and 1976, and 1,683 people after 1976. Ultimately, since 1900, only 0.6% (55) have been women. Pike is now the second woman on death row the U.S. Supreme Court declined to rescue from a botched execution.
STAT+: Concerns grow on safety issues tied to Neurocrine Biosciences rare disease drug
Two months after the release of an open letter on potential safety issues tied to a rare disease drug sold by Neurocrine Biosciences, patient advocates and some experts are expressing growing alarm over the perceived risks of the therapy.
The drug, approved to treat Prader-Willi syndrome, which can cause an insatiable feeling of hunger, has been linked to the deaths of seven people and the hospitalization of nearly 100 others — all since the treatment, called Vykat XR, was approved 18 months ago.
Case reports on those deaths and hospitalizations that were submitted to regulators, and that were obtained by STAT through the Freedom of Information Act, do not prove causality; many of the Vykat cases involved complex medical issues and multiple medications. But some experts say the evidence is sufficient to conclude Vykat is causing unacceptable harm.
Opinion: STAT+: The epidemic of learned helplessness in physicians
Welcome to Chief Complaint, a new STAT+ column from Frances Mei Hardin, M.D. A former ear, nose, and throat surgeon, she writes about the many challenges facing those who practice medicine in a time of great change.
In some clinical settings, resident physicians have to ask for permission to use the restroom. You read that correctly: Many of these people are approaching or in their 30s, they all have M.D.s and other graduate degrees, and they are still requesting permission to accommodate basic tasks in Maslow’s hierarchy, such as leaving to grab a bite of food or drink, or use the restroom.
And when the beginning of training is marked by infantilizing treatment, even as their responsibility for patient lives quickly grows, it can often lead to something plaguing medicine: learned helplessness, a psychological state wherein a person stops trying to change an unfavorable or unsavory situation because they believe that they have no control over the outcome, even when they do.
Your service area is not your market
Americans trust science more than peers around the world, survey shows
Americans have more trust in science than most of the rest of the world, according to a new survey of people in 140 countries, a finding that may seem difficult to explain in a country deeply divided by issues such as the benefits and harms of vaccines.
According to the newest edition of the Wellcome Global Monitor, 52 percent of Americans report having “a lot” of trust in science. Across the globe, that number is a mere 26 percent.
STAT+: Biotech leader, leading lab leak theorist no longer in consideration for top infectious disease role
An early advocate for the theory that the Covid-19 virus was engineered in and leaked from a lab in China is no longer the leading choice to be America’s top infectious disease expert, a source with knowledge of the decision told STAT.
Steven Quay, a biopharmaceutical executive with no background in infectious diseases, was being considered for an appointment as director of the National Institute for Allergy and Infectious Diseases at the National Institutes of Health, a role once held by Anthony Fauci, according to one person familiar with the discussions. However, Quay instead is expected to take on more of a consulting role for the center, the source said.
Neither the White House nor the Department of Health and Human Services responded to requests for comment. Quay also did not respond.
STAT+: Hospitals sue – again – to halt Trump administration’s 340B rebate pilot
The American Hospital Association is once again suing the Trump administration over its plan to test revamping a federal drug discount program into one that provides after-the-fact rebates instead of upfront discounts for certain drugs.
It’s the second time the powerful hospital lobbying group has sued over such a plan. The first time, in 2025, a judge agreed to temporarily halt a more limited version from taking effect, and the Health and Human Services Department voluntarily withdrew the plan after losing on appeal. In February, the agency announced an expanded version, set to take effect Jan. 1, 2027, that would target 25 of the costliest, most widely used drugs covered under Medicare. The original plan included 10 drugs.
The AHA’s argument is largely the same as in the first case: the government failed to accurately account for the costs hospitals would incur by having to pay market prices for drugs and then apply for rebates. The lawsuit says that the Health Resources and Services Administration, the HHS division that administers 340B, received more than 2,400 comments on the rebate model’s second iteration, including hospitals describing in “granular detail the catastrophic impact” it would have.
STAT+: Pharma’s free lunches for doctors boost inappropriate prescribing, analysis finds
The gifts and payments that doctors receive from drugmakers increased inappropriate prescribing and the number of prescriptions written, likely leading to rising health care costs, according to a Cochrane review of dozens of previous studies that have explored the influence the pharmaceutical industry has on medical practice.
In addition, pharmaceutical advertising or education aimed at doctors may also increase inappropriate prescribing, probably increases the number of prescriptions written, and may increase the costs of prescriptions. But conflict-of-interest policies that restrict or manage interactions between companies and doctors probably improved prescribing practices, the analysis found.
However, there was not enough evidence to draw clear conclusions on whether free drug samples and other promotions affect decisions to place specific drugs on hospital formularies. These are the list of medicines approved for use and routinely stocked in a hospital or health system.
STAT+: Medicare Advantage star ratings trigger new bonuses, and uncertainty
The federal government has released new quality ratings for Medicare Advantage insurers for 2027, with Humana emerging as the biggest winner.
But deep uncertainty remains around Medicare Advantage quality measures, which come with tens of billions of dollars in extra revenue for the highest-performing plans. One health insurance company, Alignment Healthcare, has already threatened to sue the government after its star ratings were downgraded — a now-common occurrence for almost any insurer that is unhappy with its grades.
Nearly 71% of Medicare Advantage enrollees are currently in a plan that will have at least four out of five stars for quality, according to the Centers for Medicare and Medicaid Services. Getting at least four stars triggers bonuses, which total $13 billion across the industry annually. Ratings for 2027 lead to bonus payouts in 2028.
STAT+: Life Biosciences share glaucoma study updates for its cellular reprogramming drug
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STAT+: Pharmalittle: We’re reading about a setback for Argenx, Lilly suits over copycat versions of an obesity drug, and more
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, so far, rather modest. We plan to catch up on our reading, promenade with the official mascots and celebrate the turning of another page on the calendar with our remaining Pharmalot ancestor. We also hope to hold another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This is the time of year when apples and pumpkins grow lonely, waiting for someone to take them to a nice home. So perhaps a drive in the country is in order. This may also be an opportunity to simply enjoy the great outdoors, given the lovely change of scenery that is taking place. Or you could keep busy by strolling city streets and watching life go by. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon…
Argenx disclosed that its blockbuster drug Vyvgart failed to outperform placebo in a Phase 3 trial of patients with Sjögren’s disease, a chronic autoimmune disorder, marking an unusual setback for the company, STAT says. Argenx has racked up a series of wins in autoimmune disorders en route to becoming one of the world’s largest biotechs based on market cap. William Blair analysts had projected $1.4 billion in peak sales from Vyvgart in Sjögren’s disease but described the trial as high risk, in part because Sjögren’s patients often have high placebo responses. The trial was supposed to be completed next year, but it was stopped early after a data monitoring committee determined the primary endpoint would not be met.
The Food and Drug Administration flagged a potential safety signal after four deaths were reported among patients with treatment-resistant schizophrenia who received investigational evenamide in clinical trials, MedPage Today informs us. In April, the agency halted patient enrollment in a Phase 3 trial for the Newron Pharmaceuticals medicine after the sudden death of a participant. That hold remains in place at U.S. study centers but enrollment continues in other countries, and additional clinical sites are being added. The FDA concern relates to the risk that some sodium channel blockers may trigger arrhythmias that can lead to serious cardiovascular events or seizures.
How these census changes could threaten public health
Hi there, it’s Sarah. Last night, STAT scored an awards hat trick, taking home a Gerald Loeb — the most prestigious honor in business journalism — for the third year in a row! This year’s Loeb recognized Lizzy Lawrence for her exceptional beat reporting on the Food and Drug Administration. This is also STAT’s fourth Loeb overall in our 11-year history. Not too shabby, y’all.
Does MAHA still matter to voters?
The Make America Healthy Again movement has been credited with helping to propel Donald Trump to a second term at the White House. But as midterm elections draw near, MAHA is nearly invisible on the campaign trail.
STAT+: Will MAHA survive the midterms?
WASHINGTON — Health secretary Robert F. Kennedy Jr.’s Make America Healthy Again movement rushed into American politics with a promise: Let an unlikely coalition of activists reach the masses, and they will deliver revolutionary gains for the Republican Party.
Yet as midterm elections draw near, the movement is nearly invisible on the campaign trail and struggling to find a financial or messaging foothold in key races. To some of its most vocal supporters, the very soul of MAHA is at stake come Nov. 3.
These problems are showing even as some of Kennedy’s ideas, including his critiques of the American food supply and corporate influence, continue to have widespread appeal. MAHA has yet to figure out how to turn those broadly popular themes into tangible policies or causes with political heft.
Opinion: Proposed U.S. census changes could be catastrophic for public health
In 2030, U.S. mortality and morbidity rates will suddenly jump. This will happen not because there is a new pandemic or a sudden rise in cases of existing diseases or injuries, or a sudden decline in access to health care. These jumps in rates will occur throughout the U.S., more in some states than others. Within states, these rate changes will be especially noticeable among four groups: college-age people, retirement-age people, people of color, and immigrants.
Even more remarkable, these shocking changes in U.S. health statistics could be averted without any new treatments or changes in access to or quality of health care.
Opinion: 50 years ago, my colleagues and I pursued basic research science that became revolutionary
September marked 50 years since my colleagues and I published a paper describing what became known as interleukin-2, or IL-2, one of the first cytokines to be discovered and a protein essential to the growth and regulation of T cells. Science marked that anniversary with a perspective by renowned immunologists Rafi Ahmed and Steven Rosenberg examining the discovery. Their perspective prompted me to reflect on a question I’ve been asked many times over the years: What has been IL-2’s greatest legacy?
My answer depends on how you define importance.
The fall of Roe dramatically changed abortion access. This researcher used Reddit to capture how
Betsy Pleasants was studying one historic disruption to abortion access when a more seismic one emerged.
In spring 2022, as a graduate student at UC Berkeley School of Public Health, Pleasants was researching the effects of the Covid-19 pandemic on abortion services when a leaked draft opinion indicated that the U.S. Supreme Court would overturn Roe v. Wade. The court finalized its decision that June, ending the nearly 50-year-old constitutional right to abortion and ushering in an era of rapid change and increased state restrictions.
Trump administration investigates 9 universities for alleged visa fraud
The Trump administration announced Thursday that it is investigating nine universities for alleged fraud related to visas commonly used by postdoctoral researchers, a core part of the nation’s biomedical workforce.
Vice President JD Vance announced during a press briefing that Harvard, Yale, Stanford, Brown, the California Institute of Technology, Arizona State University, the Massachusetts Institute of Technology, the University of Pittsburgh, and UC Davis are under investigation by the Department of Labor. During the briefing, Vance asserted that these schools are improperly using J-1 visas, the main class of visa used by international postdocs, to bring in cheap labor rather than relying on domestic researchers.
STAT+: House Democrat seeks to scrap No Surprises Act’s costly arbitration process
A new proposal in Congress to scrap a surprise billing ban’s controversial arbitration system will need to to survive an onslaught of attacks from provider groups, for whom arbitration has been a gold mine.
After Rep. Frank Pallone (D-.N.J.) unveiled his Lower Premiums, Faster Payments Act on Thursday, it quickly garnered praise from academics and consumer advocates, as well as condemnation from provider groups. It would dismantle the problem-plagued process that’s currently used to resolve disputes between health insurers and out-of-network providers and replace it with a payment system based on median in-network rates.
Pallone, one of the authors of the No Surprises Act, said in a statement that the law has been an “overwhelming success” when it comes to protecting patients from surprise bills.
NIH funding uncertainty thwarts U.S. researchers
How has the National Institutes of Health been spending its budget? Why are biotech investors feeling gloomy? And what is the most quintessential Boston movie?
We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast. We bring on STAT reporter Anil Oza and Heather Pierce, senior director of science policy at the Association of American Medical Colleges, to discuss the how the NIH distributed its money in the latest funding cycle and the effects on U.S. biomedical research.
STAT+: The fresh faces that may shake up key Senate committees ahead of midterms
STAT has announced its tenth class of Wunderkinds. It’s an impressive group of researchers and clinicians who are making an impact in science and medicine early in their careers. Send news tips and go-getters to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.
Fresh faces
Dozens of Democrats are vying for seats on the House Energy and Commerce and Ways and Means committees in anticipation of Democrats winning back control of that chamber.
Several members from both parties are either leaving or in close races. If Republicans lose the House, most of the departing Republicans will not be replaced by GOP colleagues. But it’s a major opportunity for Democratic lawmakers to get a seat on the high-profile committees, both of which have broad jurisdiction over health care policies.
STAT+: AI for breast cancer risk prediction goes DTC, regulatory cloud over Utah sandbox, and AI psychosis
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Good morning health tech readers!
I had the pleasure of profiling Yasha Ektefaie, a fellow at the Broad Institute, who is newly announced STAT Wunderkind. Check out our annual list of promising young researchers here.
FDA says its safety review of abortion pill will continue into next year
WASHINGTON — The Food and Drug Administration says its ongoing safety review of the nation’s main abortion pill will continue into next year, a timeline that was quickly condemned by abortion opponents hoping to see the drug’s use curtailed.
The FDA gave a court-ordered update on its progress in a legal filing late Wednesday, providing the first substantive information about the controversial reevaluation ordered by Health Secretary Robert F. Kennedy Jr.
STAT+: Roche goes beyond licensing in deal with Chinese biotech
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Good morning. Let’s get straight to the news.
The need-to-know this morning
- Bristol Myers Squibb said Zenbexus, recently granted FDA accelerated approval to treat multiple myeloma, reduced the risk of disease progression by 51% compared to standard therapy in a Phase 3 trial.
- Generic drugmaker Viatris said it will acquire Pacira Biosciences, maker of non-opioid pain therapies, for $1.65 billion.
Roche goes beyond licensing in deal with Chinese biotech
Over the past few years, pharma companies have flocked to China to license existing drug candidates. Roche is taking a new approach, partnering with Chinese startup Defand Therapeutics to discover new medicines.
STAT+: Argenx sees unusual setback with failure of late-stage study of drug for autoimmune disease
Argenx said Thursday that its blockbuster drug Vyvgart didn’t outperform placebo in a Phase 3 trial of patients with Sjögren’s disease, a chronic autoimmune disorder.
It’s an unusual setback for Argenx, which has racked up a series of wins in autoimmune disorders en route to becoming one of the world’s largest biotechs by market cap.
Argenx’s stock slipped 13% Thursday morning.
STAT+: Pharmalittle: We’re reading about PhRMA suing Trump, biotech frustration over tariffs, and more
Top of the morning to you, and a fine one it is. Clear blue skies are hovering over the Pharmalot campus, where a cool breeze is wafting by and the official mascots are bounding about the grounds in search of critters. As for us, we are engaged in the usual ritual of brewing a cuppa stimulation — our choice today is English breakfast — and foraging for items of interest. On that note, please enjoy the latest menu of tidbits we have assembled for you. As always, we hope your journey is meaningful and productive, and that you conquer the world. And of course, do keep in touch. Our settings make it possible to accept postcards and telegrams …
The trade group representing brand-name drug makers in the U.S. is suing the Trump administration over a pilot program tying Medicare drug prices to those in peer countries, STAT notes. PhRMA filed a lawsuit asserting that the “most-favored nation” pilot in Medicare Part B exceeds Medicare’s statutory authority. The pilot, called GLOBE, is not expected to have much impact because the administration exempted all but a handful of companies in return for their agreement to voluntary deals to charge Medicaid MFN prices. But it would set a precedent that the industry wants to nip in the bud. PhRMA says the voluntary agreements are acceptable, but the mandatory GLOBE program is not.
The Trump administration is crafting plans that would allow the temporary sale of certain previously restricted peptides as federal health officials hammer out new regulations around the controversial products, The Washington Post reports. Such a move would allow some compounding pharmacies to dispense certain peptides marketed as new medical treatments and wellness products even as the claims for what they treat have not been fully safety tested. The plan has not yet been announced and timing was unclear, meaning it could still change.
STAT+: Roche inks drug discovery deal with Chinese biotech, focused on molecular glue medicines
Roche is digging deeper into the biotech industry in China, striking a new partnership with a drug startup there. But rather than licensing the startup’s clinical-stage medicines, Roche is enlisting it to discover new ones, signaling a potential shift in global drug development.
Chinese startup Defand Therapeutics said Thursday that it had signed a collaboration deal with Roche to develop molecular glue medicines. Under the deal, Defand will discover and develop multiple drugs for cancer and immune-driven diseases. The financial terms were not disclosed, but a source with knowledge of the agreement said it could be worth close to $1 billion between the upfront fee and payments Defand could get if it meets various preclinical, clinical, and regulatory goals.
Molecular glue therapies are a buzzy new area of drug development, designed to create a sticky, more effective connection onto problematic proteins to destroy them. Development of these drugs has just begun to accelerate, thanks in large part to the data from Revolution Medicines, showing its molecular glue treatment Rasonque nearly doubled the survival rate of patients with pancreatic cancer.
The Nobel boys club (again)
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If you’re into online gambling, I think it’s worth mentioning that STAT predicted optogenetics’ success and a potential Nobel almost a decade ago. We said, “it hasn’t won a Nobel yet, but it’s been on some informal watchlists for a few years.” Skip Kalshi, subscribe to STAT, instead.
STAT+: Biotech companies are struggling to navigate Trump’s new tariffs
WASHINGTON — A broad tariff on imported pharmaceuticals took effect at the end of September, and some biopharma companies and the industry group that represents them say many are being left in the dark on how to get exemptions.
The Trump administration announced a 100% section 232 tariff in April, impacting imports of patented drugs and their active ingredients. At the time, the White House offered a number of pathways for companies to reduce their tariff burden, including striking a most-favored nation deal to sell drugs in the U.S. at similar prices to other wealthy countries or agreeing to bring production to the U.S.
Companies that made MFN agreements would have had start paying tariff costs in July, but now aren’t on the hook for payment until early 2029, per their agreements. That exempts many of the biggest U.S. drugmakers, while leaving smaller biotech firms to face the levies.
STAT+: Dozens of Democrats vie for slots on key House health committees
WASHINGTON — Two powerful House committees with jurisdiction over health care policies are expected to get several fresh faces after the midterms.
The combined impact of a potential wave election and multiple departing lawmakers could open up plenty of seats on the Energy and Commerce and Way and Means committees. Similar jockeying is going on for key Senate committee roles, as STAT previously reported.
The new cast of characters will mean that lobbyists will be busy visiting the offices of lawmakers with which they might not have had much interaction.
Opinion: How CMS plans to fix a major flaw in the 340B drug discount program
Some Medicare patients owe more in coinsurance than the hospital paid for their drug. That arithmetic sounds impossible. It is a consequence of the 340B drug discount program and Medicare’s payment formula. Now the Department of Health and Human Services, where I work, is proposing to narrow that gap.
Congress created the 340B drug discount program in 1992 to financially support safety net hospitals that serve low-income patients. Drug manufacturers must give them steep discounts. But Medicare, Medicaid, and commercial insurers generally reimburse them at the full amount, allowing these hospitals to keep the spread above the discounted purchasing costs.
Opinion: England and other nations are on the path toward eliminating hepatitis C. Why not the U.S.?
In September, “Baywatch” star Pamela Anderson opened up about her hepatitis C diagnosis in the 1990s. “It was a death sentence,” she said while accepting the Award of Courage from amfAR, an organization supporting HIV/AIDS research and advocacy. When she was diagnosed, she said, her doctor told her that she might only live another 10 years.
Her story is a good reminder of the amount of global progress that has been made in preventing and treating hepatitis C in just the last decade — and how far the U.S. has to go to catch up to our European neighbors.
STAT+: Why this startup is taking its AI to predict breast cancer risk directly to patients
“Don’t wait. Choose to be informed.”
That’s the call to action that patients will find on the site for digital health company Everlywell, which has offered at-home lab tests directly to consumers for a decade. But last week, it wasn’t marketing a prick to measure blood glucose or screen for celiac disease: It was launching one of a new generation of AI-based risk prediction algorithms for medical images.
For $249 in cash, eligible patients can now come to the site, share a recent mammogram, and receive a prediction of their five-year breast cancer risk. It’s generated by an AI algorithm called Clairity Breast, which received de novo authorization from the Food and Drug Administration last May.
A mother-daughter quest to find fellow members of an ultra-rare genetic community
“Don’t Google,” the pediatric geneticist warned us on a sunny October afternoon in 2020.
She had just diagnosed our 11-year-old daughter, Maya, with Nicolaides-Baraitser syndrome, a genetic condition so rare there were only 61 cases in the scientific literature.
Breast cancer can behave differently in older women. This physician is making more tailored treatments a reality
Of all the factors that can increase a person’s risk of breast cancer, age is among the most significant. Almost half of people diagnosed with breast cancer are at least 65, and about 20% are 75 or older. Despite these rates, older women are frequently excluded from clinical trials; one study of breast cancer trials found that only 9% of participants were 65 or older, leaving physicians with a poorer understanding of how drugs behave in older adults and fewer guidelines with which to treat them.
There’s increasing evidence that these patients could benefit from more tailored treatments. Neil Carleton, a cancer biologist and first-year resident physician at Brigham and Women’s Hospital, said that breast tumors can develop and grow differently in older patients than in younger ones because of hormone levels and inflammation.
STAT+: Pharmalittle: We’re reading about U.S.-funded psychedelic trials, an AstraZeneca R&D center, and more
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 honeybush vanilla turmeric. 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. …
The Trump administration is advancing the first government-funded clinical trials of the psychedelic drug ibogaine to treat opioid addiction and post-traumatic stress disorder, Reuters says. The initiative follows an executive order signed last April by President Trump that dedicated $50 million to the federal ibogaine research, as well as recent calls by experts and veterans for strict safety standards on psychedelic treatments. The U.S. Food and Drug Administration said it has opened a public docket seeking feedback on trial design, dose selection, patient eligibility, safety monitoring, study-stopping rules, and oversight by Nov. 20.
AstraZeneca’s pivot towards the U.S. market has continued with the opening of a new R&D center in the biotech hotspot of Cambridge, Mass., the centerpiece of a $1 billion investment program in the state, Pharmaphorum explains. The new facility in the Kendall Square area — which is one of the densest biotech clusters in the world, with hundreds of small and large biopharma companies present — covers 570,000 square feet of lab and office space over 18 stories. The center is part of a major investment program by the U.K.-based company that was first announced in 2024 and dramatically expanded to around $50 billion last year.
STAT+: In small trial, optogenetics restores some vision lost to retinitis pigmentosa
Retinitis pigmentosa is a genetic disorder that causes degeneration of the light-sensing cells in the retina. Generally diagnosed in childhood or early adolescence, patients gradually lose peripheral and night vision, often becoming legally blind by young adulthood.
With the exception of a subset of patients who present a specific genetic mutation and can be treated with gene therapy, there is no cure for the condition. Cases are addressed by measures to slow degeneration and preserve what is left of the vision.
Optogenetics — the technology just recognized with a Nobel Prize — could offer hope, according to a new paper published on Wednesday in the New England Journal of Medicine.
STAT+: Trump administration proposes $70,000 fee for popular international student work program
As part of its ongoing bid to more tightly regulate international students, the Trump administration on Wednesday announced a proposed $70,000 fee for a popular work authorization program meant to give students professional experience.
The Department of Homeland Security said the fee would help combat alleged fraud and abuse in the work program, known as Optional Practical Training, which allows students to get hands-on work experience related to their field of study while still on a student visa. The department also said the restrictions would help U.S. citizens compete against international applicants in the job market.
“Optional Practical Training was never meant to be a back door into the American workforce, a subsidy for cheap labor, or a prize for those who game the system,” said a department spokesperson in a press release. “American workers should not have to compete against a program that has been turned into a pipeline for cheap foreign labor.”
STAT+: PhRMA sues over Trump policy mandating lower drug prices in Medicare
WASHINGTON — The brand drug industry’s main trade group is suing the Trump administration over a pilot program tying Medicare drug prices to those in peer countries.
The Pharmaceutical Research and Manufacturers of America said Wednesday that it had filed a complaint in the U.S. District Court for the District of Columbia asserting that the “most-favored nation” pilot in Medicare Part B exceeds Medicare’s statutory authority.
The pilot, called GLOBE, is not expected to have much impact because the administration exempted all but a handful of companies in return for their agreement to voluntary deals to charge Medicaid MFN prices.
Highmark Health taps Karen Hanlon as CEO
STAT+: Merck suffers a setback in Europe over its new Keytruda formulation
In a setback for Merck, a Dutch court ruled that the company infringed on a patent pertaining to a subcutaneous formulation of its Keytruda cancer treatment and was ordered to halt manufacturing and marketing the medication in several European countries, including France, Italy, Sweden, Switzerland, and the Netherlands.
The ruling came as part of a widening patent infringement dispute with Halozyme Therapeutics over the best-selling cancer treatment. Patients requiring Keytruda will still have access to the existing intravenous version, which is not affected by the patent dispute or court order.
We asked Merck for comment and will update you accordingly.
STAT+: Why health AI pilots in Utah may be on a collision course with the FDA
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I have refused to read or watch “The Love Hypothesis” — I referred to it as the “Title IX movie” the other day when I forgot its name. But the clips are inescapable on my Instagram feed, and the science gaffes seem … real bad. Absolute butchering of how academia works? The impossible chemistry on the poster? Wearing miniskirts in the lab? Vortexing a test tube? *shudders*
Once again: I firmly believe STAT would allow me to consult on science-related elements on film sets. Offers for Hollywood gigs, health tech story tips, comments: aiprognosis@statnews.com
STAT+: Forbion raises $2.6 billion, its largest fundraise to date
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Good morning. Today, STAT released our 2026 Wunderkinds, a group of early-career researchers recognized for doing innovative work in health and medicine. I had the pleasure of speaking with one NIH researcher who has been figuring out how GLP-1 drugs work in the brain. But check out all of the profiles here!
The need-to-know this morning
- Cerevance said its experimental pill solengepras reduced Parkinson’s patients’ daily off-time, alongside other symptoms, in a Phase 3 trial. The privately held company, which will now talk to regulators about a potential approval, touts the pill as one of the first potential Parkinson’s drugs that does not act directly on dopamine, sparing patients certain side effects.
- Henri B. Kagan and Kenso Soai were awarded the 2026 Nobel Prize in chemistry for discovering how to manipulate “mirror image” molecules, paving the way for manufacturing more precise and safer drugs.
Doudna-founded Caribou is shutting down
Caribou Biosciences is shutting down after failing to raise enough money to fund a late-stage clinical trial of its off-the-shelf CAR-T therapy for lymphoma.
STAT+: Forbion raises $2.6 billion, its largest fundraise to date
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.
Good morning. Today, STAT released our 2026 Wunderkinds, a group of early-career researchers recognized for doing innovative work in health and medicine. I had the pleasure of speaking with one NIH researcher who has been figuring out how GLP-1 drugs work in the brain. But check out all of the profiles here!
The need-to-know this morning
- Cerevance said its experimental pill solengepras reduced Parkinson’s patients’ daily off-time, alongside other symptoms, in a Phase 3 trial. The privately held company, which will now talk to regulators about a potential approval, touts the pill as one of the first potential Parkinson’s drugs that does not act directly on dopamine, sparing patients certain side effects.
- Henri B. Kagan and Kenso Soai were awarded the 2026 Nobel Prize in chemistry for discovering how to manipulate “mirror image” molecules, paving the way for manufacturing more precise and safer drugs.
Doudna-founded Caribou is shutting down
Caribou Biosciences is shutting down after failing to raise enough money to fund a late-stage clinical trial of its off-the-shelf CAR-T therapy for lymphoma.
STAT+: Pharmalittle: We’re reading about WHO obesity guidelines for kids, DOJ targeting pharma, and more
Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a needed cuppa stimulation. Our choice today is ginseng peach, a favorite from our pantry. Meanwhile, here is the latest menu of tidbits to help you on your way. We hope you conquer the world and have a wonderful day. And as always, please do stay in touch. We appreciate feedback, tips, and criticism. …
The World Health Organization released its first guidelines addressing the sharp rise in obesity among children and adolescents, Health Policy Watch says. In 2024, 170 million children and adolescents aged 5–19 years were living with obesity, including 70 million children aged 5 to 9 years and 100 million adolescents aged 10 to 19 years. Obesity prevalence in this age group quadrupled since 1990, rising from 2% to 8%. But the WHO does not recommend pharmacological treatment, bariatric surgery, or weight loss devices for children aged 0 to 9 years. For adolescents aged 10 to 19 years, treatment with approved drugs may be considered only when a supervised multimodal lifestyle program has not achieved desired results.
Caribou Biosciences is shutting down after failing to raise the money necessary to fund a late-stage clinical trial of its off-the-shelf CAR-T therapy for lymphoma, STAT notes. The biotech, borne from the research lab of CRISPR scientist and Nobel laureate Jennifer Doudna, will discontinue clinical development of its two CRISPR-based CAR-T therapies, including vispa-cel for the treatment of advanced B-cell non-Hodgkin lymphoma. Over the past year, Caribou had worked successfully with the Food and Drug Administration to finalize the design of a Phase 3 trial for vespa-cel. Unfortunately, raising the money to pay for the study proved too difficult.
STAT+: Justice Department targets drugmakers in new directive on combating white-collar fraud
In a warning to life sciences companies, the U.S. Department of Justice last week issued a new directive for combating fraud that made a point of noting the agency will pursue violations of a federal law that tightly regulates the pharmaceutical industry.
Typically, the agency has pursued health fraud cases centered on providers, clinics, home health agencies, and hospices. By expressly including the Federal Food, Drug, and Cosmetic Act in the directive, the National Fraud Enforcement Division appears to be placing drug and device makers, among others, more clearly in its crosshairs.
“This is a subtle but significant expansion of their jurisdiction,” said Kevin Lowell, a member of the Miller & Chevalier law firm, who spent a decade at the DOJ, where he most recently had been a deputy chief in the National Fraud Enforcement Division’s health care fraud section.
ER visits from people born outside the U.S. dropped after ICE raids
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Good morning. We’ve got a heartbreaking story from Jason Mast today on two friends with Duchenne muscular dystrophy. Read that now, and if you need a pick-me-up afterward, read about our 2026 class of Wunderkinds.
2026 Nobel Prize in chemistry awarded for ‘mirror image’ molecule research, with impact on pharmacology
Henri B. Kagan and Kenso Soai were awarded the 2026 Nobel Prize in chemistry on Wednesday for “the discovery of non-linear effects and autocatalysis in asymmetric organic synthesis.”
Kagan, 95, and Soai, 76, solved a chemical mystery: Some molecules exist in the world that are mirror images of one another. This is a phenomenon known as chirality, from the Greek word from hand (as hands are mirror images of one another). Amino acids are among chiral molecules, and a living organism can only contain one of the versions. The other mirror molecule is found rarely elsewhere in nature. How such imbalance could occur was not understood.
STAT+: Caribou Biosciences, biotech co-founded by Jennifer Doudna, is shutting down
Caribou Biosciences is shutting down after failing to raise the money necessary to fund a late-stage clinical trial of its off-the-shelf CAR-T therapy for lymphoma, the company said Tuesday.
The Berkeley, Calif.-based biotech, borne from the research lab of CRISPR scientist and Nobel laureate Jennifer Doudna, will discontinue clinical development of its two CRISPR-based CAR-T therapies, including vispa-cel for the treatment of advanced B-cell non-Hodgkin lymphoma.
Over the past year, Caribou had worked successfully with the Food and Drug Administration to finalize the design of a Phase 3 trial for vespa-cel. Unfortunately, raising the money to pay for the study proved too difficult, Caribou CEO Rachel Haurwitz told STAT.
STAT+: In Duchenne muscular dystrophy, a promising therapy is available to a fortunate few
There’s a boy like you in Minnesota, Yannick’s mom told him a few years ago. He has the same disease. He has the same kind of smile. Maybe you could talk?
They clicked. After school and on weekends, the two boys boot up their computers, Yannick in San Diego and Brecken in a suburb of St. Paul, Minn. They play Roblox or build virtual worlds on Minecraft: a zoo, for example, like the real-world one 13-year-old Yannick wants to build when he grows up, full of lions, tigers, and giraffes.
They seldom talk about Duchenne muscular dystrophy, the rare fatal muscle-wasting disease they live with. But lately it’s all their moms can talk about. In stolen phone calls on the way to coffee or back from school, they compare the two boys: how quickly Yannick is declining and how steadily Brecken is — shockingly — improving.
Last winter, Brecken, 12, started receiving an experimental drug developed by Avidity Biosciences. The medicine makes the cell’s protein-building machinery “skip” part of the gene, called an exon, behind Duchenne, allowing patients to make a shortened but functional version of a protein essential for muscle survival. In trials, it appeared to virtually arrest the disease in some patients.
The approach, however, is out of most patients’ reach. In principle, “skipping” strategies could benefit about 70% of the 10,000 to 15,000 Duchenne boys and men in the U.S. (The disease almost exclusively affects males.) But the medicines have to be targeted to a patient’s specific mutation. Only about 7% of patients — or roughly 900 Americans — are eligible for Avidity’s drug, called Del-zota, which is now under Food and Drug Administration review.
STAT+: Democrats plot a midterms push for MAHA voters
WASHINGTON — Democrats are building bridges to a major new constituency: the Make America Healthy Again voter.
As the midterms near, leaders across the party have been meeting with MAHA activists, discussing potential openings with consultants, and rolling out food and environmental agendas meant to entice these voters.
But the MAHA agenda Democrats are offering differs from that of health secretary Robert F. Kennedy Jr., the leader of the movement. Left-leaning candidates are focusing on food and disregarding one of Kennedy’s signature (if relatively fringe, according to pollsters) issues: vaccine injuries.
Opinion: My oncologist recommended active surveillance for prostate cancer. Life insurers called it ‘untreated cancer’
When my term life insurance policy expired in 2013 and I had to get a new one, I thought my widow-maker heart attack in 2005 might be a sticking point. Instead, eight insurers turned me down because they said I had “untreated cancer.”
They were referring to the tiny amount of prostate cancer found three years earlier.
STAT+: Pharmalittle: We’re reading about a Vaxcyte pneumococcal shot, increasing pharma M&A, and more
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating. Now, though, that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? After all, the world — such as it is — continues to spin. So to nudge it in a better direction, we are relying, as always, on a cuppa stimulation. Our choice today is blueberry hibiscus. Of course, you are welcome to join us. Meanwhile, here are a few items of interest. Best of luck accomplishing your goals, and we hope you conquer the world. And, of course, do keep in touch. …
Vaxcyte disclosed that its experimental pneumococcal vaccine hit the primary endpoints in a Phase 3 clinical trial, setting up a competition with Pfizer and Merck, STAT writes. Vaxcyte’s shot, VAX-31, is designed to protect against 31 serotypes, or strains, of bacteria that can cause pneumococcal disease, including pneumonia, compared to 20 strains for Pfizer’s Prevnar and 21 strains for Merck’s Capvaxive. The company needs two more trials to deliver results before it can file for approval: a study looking at VAX-31 administered alongside an influenza vaccine and a study in adults who previously received a different pneumococcal shot.
The U.S. Food and Drug Administration has extended its review of an experimental hemophilia A drug from Novo Nordisk due to ongoing remediation work at a manufacturing facility, Reuters notes. Novo had submitted the application for the drug, called denecimig, in September 2025 and was expecting an FDA decision in the third quarter of 2026. While the regulator has not yet set a new timeline for its decision, Novo said the FDA did not raise any concerns regarding the safety or effectiveness data from the drug’s clinical trials. Novo added that the manufacturing site issues do not impact any of its other medicines currently on the market.
Opinion: Infectious disease expert: The mysterious pneumonia in Russia deserves attention, not panic
Welcome to the debut of ID Consult, a new STAT column from infectious disease physician Krutika Kuppalli about diseases, outbreak response, global health, and health policy.
A 28-year-old laboratory worker in Siberia develops severe pneumonia and dies. She worked at an institute that studies plague and other high consequence infectious diseases. At least one hospital is placed under quarantine with close to 200 contacts reportedly being monitored. Simultaneously Russian public health officials descend on the region.
What are hospital longevity programs, and what can they tell you about your health?
For patients willing to pay thousands of dollars out of pocket, prestigious hospitals across the country are offering a new speciality: longevity. Cash-pay longevity clinics promise to monitor all sorts of health indicators and provide guidance on how to live a longer, healthier life.
A couple of weeks ago, I tagged along with STAT commercial determinants of health reporter Sarah Todd as she tested out one of these new clinics at Weill Cornell Medicine in New York City. At Weill, Sarah underwent a battery of physical, written, and blood tests, performed frog jumps, ran down a hallway, and wore a VO2 Max mask that made her feel “like an elephant.”
STAT+: Are stem cell treatments about to have their day?
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Celebrity doctor Mike Varshavski has been contacted by The Bachelor for its 30th season. Send news tips and hot physicians to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.
A lame lame-duck
On Friday, President Trump said he will give $90 to more than 20 million seniors to help pay for Medicare premiums.
STAT+: AstraZeneca opens new Boston site
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Good morning. From DC to Boston to Utah, we’ve got news from all over today.
The need-to-know this morning
- BridgeBio said the FDA granted priority review to its oral treatment for children with achondroplasia, a common form of dwarfism. An approval decision on the drug, called infigratinib, is expected by Feb. 4, 2027.
- Japan’s Shionogi has acquired for $2 billion the U.S.-based biotech IntraBio, the maker of an approved drug that treats the neurological symptoms of two rare diseases.
- Arrivent Biopharma said its experimental treatment for exon 20-mutated lung cancer failed to delay tumor progression in a Phase 3 study.
Trump admin says drug price disclosures are coming
Trump administration officials said yesterday they will start developing a system for health insurers to disclose prescription drug prices, and a “hopeful” final plan will come out by next May.
STAT+: FDA spells out 2027 AI guidance plans
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Good morning health tech readers!
Just one week until the STAT Summit in Boston. I’ll be on stage. If you are interested in coming but are on the fence, give me a shout.
Top healthcare conferences to attend in 2027
Deciding when to get your flu shot? Consider these factors
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Today’s newsletter answers some pressing questions — what is optogenetics? When should I get my flu shot, as cases rise in parts of the United States? And perhaps most importantly — why do longevity clinics include scratch-and-sniff smell tests as part of their treatments? All will be revealed if you read on.
In this hospital, pulse oximeters went from overestimating to underestimating blood oxygen. Why?
Pulse oximeters gained prominence during the Covid-19 pandemic, offering anyone a handheld tool to take stock of their blood oxygen level.
But their newfound popularity also brought new attention to their limitations — several studies have shown that pulse oximeters overestimate blood oxygen levels when used on darker skin tones. This can make patients of color appear more healthy than they really are, resulting in worse health outcomes and exacerbated inequality.
Opinion: I’m a doctor. Here’s what I want the public to know about AI tools and health care costs
When Blue Cross Blue Shield recently published research suggesting that hospitals use artificial intelligence tools to extract more money from insurers without providing additional care, people were mad. Amid growing concerns about AI, one glimmer of hope has been its potential to improve health — and yet, here it was: inflating health care costs without yielding any benefits.
As a doctor who has used the kinds of tools being criticized, I’m frustrated, too: We can document honestly and still wind up inflating hospital bills. This is because comorbidities function as an on-off switch with respect to billing, even though they affect patient care in nuanced ways.
Opinion: Why the FDA should not approve an ineffective multicancer screening test
There must be some mistake. A company studies its cancer blood test in a randomized trial of 140,000 people using a suboptimal surrogate endpoint, fails to meet that endpoint, yet is recommended for approval by a Food and Drug Administration advisory panel. And because of the Medicare Multi-Cancer Early Detection Screening Coverage Act passed earlier this year, the company appears to be on track to have taxpayers foot the bill.
How does this happen?
STAT+: Can you live longer for $5,500? Longevity clinics are the buzzy new trend at nonprofit hospitals
CHICAGO — I was walking briskly on a steep treadmill, wearing a mask that evoked the villain Bane from “Batman.” Prince crooned back-handed compliments over an iPad speaker to keep my energy up, promising I had to be neither rich nor cool to be his girl. Every so often, the woman standing next to me asked me to point at the color-coded sheet ranking my state of exertion from 1 (roughly, “I could do this all day”) to 10 (“I not only hate this but am about to keel over if you don’t slow this thing down”). The goal was to get to 10. Pushing myself to achieve difficult physical goals does not come naturally. I can’t go on, I thought. I went on.
This was the VO2 Max test, which shows how efficiently the body uses oxygen (“V” stands for volume, “O2” for oxygen) and is considered medicine’s most accurate measure of cardiorespiratory fitness. It was the last in a barrage of assessments I’d undertaken at a shiny longevity clinic affiliated with Northwestern University — part of a $5,500 annual package.
The quest to defeat the indignities of aging has long provoked costly and questionable practices, from the 1920s doctors who believed in the rejuvenating power of grafted monkey testicles to Bryan Johnson’s since-abandoned blood transfusions from his teenage son. Now some of the nation’s most prestigious health systems are jumping into the growing business of longevity. They promise a rigorous scientific approach to helping people preserve their youthful vigor for as long as they can, with assessments that give patients more detailed pictures of their current physical conditions and aging trajectories than they’d get at a typical doctor’s visit.
Some critics, however, question how to reconcile the clinics’ high out-of-pocket costs with hospitals’ nonprofit status and charitable missions, and warn that in their zeal to attract paying customers, they’re offering tests that lack sufficient evidence showing they actually improve people’s health.
STAT+: Nobel-winning optogenetics research has led to experimental treatments for blindness and Alzheimer’s
It is probably impossible to overstate how complex a brain is: A network of billions of intertwined neurons forming an intricate anatomy, capable of working on the millisecond scale to perceive reality, detect sensations, create plans, and take actions.
“All of this is incredibly complicated, and so of course the challenge that we face as neuroscientists and as physicians treating brain disorders is how can we hope to make headway without tools that match the complexity and the precision of the brain?” said Karl Deisseroth, a Stanford University and Howard Hughes Medical Institute researcher who on Monday won the 2026 Nobel Prize for Medicine, alongside German colleagues Peter Hegemann and Georg Nagel, for work developing such tools.
“Our perception of reality and all our inner subjective states come from cells, and so the appropriate tool that would be matched to how the brain works would be something that was fast and could be targeted to individual cells or individual types of cells,” he said in an interview after the announcement.
STAT+: Judges skewer HHS arguments in hearing over Medicare Advantage audits lawsuit
Federal appeals court judges didn’t take kindly to the Trump administration’s arguments Monday in a hearing on Humana’s lawsuit against the government over its rules for auditing Medicare Advantage plans.
The country’s second largest Medicare Advantage insurer argued in its 2023 lawsuit, Humana v. Kennedy, that the Health and Human Services Department’s final rule for auditing Medicare Advantage plans diverged significantly from its proposed rule and that stakeholders weren’t given proper notice and opportunity to comment on the change, which they said would be detrimental to insurers.
In September 2025, a federal judge agreed and invalidated the rule, called the risk adjustment data validation, or RADV, rule. HHS appealed in November. During Monday’s oral arguments, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit seemed poised to toss the rule out, again.
STAT+: New Trump regulations would clean up health care pricing disclosures
The Trump administration released new regulations Monday that will force health insurance companies to publish cleaned-up spreadsheets of the prices that they pay hospitals and doctors, while stripping out meaningless data that clogged up the files.
Trump officials also said they will start developing the system for disclosing prescription drug prices next month. A “hopeful” final plan for drug pricing data will come out by next May, said Mehmet Oz, the head of Medicare and Medicaid, at an event Monday. The government will enforce those requirements by the end of 2027.
Last year, the Trump administration punted on finalizing drug price disclosure rules, in a victory for drug companies and pharmacy benefit managers that have fiercely guarded their prices.
STAT+: Utah plows ahead with more health AI pilots for prescriptions, women’s health
Utah regulators on Monday announced a plan to allow an artificial intelligence product to evaluate patients and write new drug prescriptions without prior human review.
A startup called Nolla Health will launch an AI-powered service in the state that will assess a patient for mild-to-moderate acne treatment using a structured intake and by analyzing photos of their skin. The product may determine whether one of a list of low-risk drugs is appropriate. In the first stages of the pilot, the decisions of the AI will be reviewed by a licensed clinician who will sign off on prescriptions, but Nolla may eventually be allowed to prescribe drugs without this review. The company last year announced it raised $4.5 million from investors including General Catalyst, and Nolla aspires to direct treatment for a host of conditions using AI.
The new pilot is part of a significant expansion of a closely watched “AI sandbox” program that allows Utah’s Office of Artificial Intelligence Policy, or OAIP, to waive regulations for companies that want to test AI products under state supervision.
STAT+: Lilly’s Jaypirca approved as first-line CLL therapy
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I’m hanging out with my 8-year-old pal, Silas Mirza-Ladd, who wants to be featured in a newspaper one day. So, Silas, you’re the inspiration for today’s Readout — along with stem cell hijinx and drug pricing woes.
“Meow,” Mirza-Ladd says.
Could we one day vaccinate against every cancer?
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The winner of the Nobel Prize for medicine was announced early this morning. Did you win your office pool? Do you think another research team was robbed? Send me all your hot takes at amanda.erickson@statnews.com.
STAT+: Vaxcyte claims success in bid to beat Pfizer and Merck in lucrative vaccine market
Vaxcyte said Monday that its experimental pneumococcal vaccine hit the primary endpoints in a Phase 3 clinical trial, setting up the California-based biotech to compete with Pfizer and Merck.
Vaxcyte’s shot, VAX-31, is designed to protect against 31 serotypes, or strains, of bacteria that can cause pneumococcal disease, including pneumonia, compared to 20 strains for Pfizer’s Prevnar and 21 strains for Merck’s Capvaxive.
In the trial, just over 3,500 adults age 50 and older were randomized to receive VAX-31, Prevnar, or Capvaxive. Investigators then measured the strength of their antibody responses against different strains.
STAT+: Hospital and pharmaceutical prices are smothering America’s businesses
Workers and employers are drowning in their health insurance premiums. The reason for that deluge: the health care industry’s high and inscrutable prices.
Health insurers don’t set their premiums in a vacuum. The biggest factor is the care people receive. And the biggest factor driving the cost of that care, STAT has found, is not how often people are going to the hospital or doctor’s office, but the out-of-control prices charged by every part of the health care industry, which workers and businesses are often powerless to stop.
For Gerard Anderson, America’s high prices are as obvious, yet unnoticeable, as the oxygen we breathe. He has studied health care spending and policy for the past four decades, even helping design Medicare’s hospital payment system in the 1980s. He co-wrote a seminal paper in 2003, and again in 2019, that blared the culprit of America’s outlier health spending figures: “It’s the prices, stupid.”
“Some things don’t change,” Anderson, a professor at Johns Hopkins, told STAT.
2026 Nobel Prize in Medicine awarded for brain research tool called optogenetics
Karl Deisseroth, Peter Hegemann, and Georg Nagel are the joint recipients of the 2026 Nobel Prize in Physiology or Medicine “for their discoveries concerning light-gated ion channels and optogenetics,” the Karolinska Institutet in Stockholm, Sweden announced on Monday.
Deisseroth, 55, a professor at the Howard Hughes Medical Institute and Stanford University; Hegemann, 72, a professor at Humboldt University in Berlin; and Nagel, 73, a professor at the University of Würzburg, Germany, developed a method that uses light, combined with genetic modifications of neurons, to switch on or off individual cells in a living brain. This makes it possible to show how nerve cells shape memories, feelings and behavior in the brain, and is being studied as a treatment for disease.
STAT+: Are stem cells the next peptides? These advocates think RFK Jr. could make it happen
WASHINGTON — Stem cell entrepreneur Chuck Meeker is bullish about his industry’s prospects with the Food and Drug Administration nowadays.
“If I were a betting man, I would say before the end of the year we have a series of FDA roundtables happening,” Meeker told STAT at PepMed 2026, a conference for regenerative health businesses held by the American Academy of Peptide Medicine. (The FDA declined to say whether such events were imminent.)
That stem cells made an appearance at a conference centered on peptides isn’t a coincidence. Peptides and stem cells are two peas in the pod of regenerative medicine, which focuses on therapies that claim to trigger the body’s natural healing mechanisms. But while compounded peptides are having a bit of a moment with the FDA, commercially available, unapproved stem cell therapies have remained a black sheep for the agency.
Meeker and others at PepMed told STAT they believe that’s about to change. The stem cell industry sees the FDA’s tentative embrace of peptides as its chance to get a foot in the door — and bring stem cells from the grey market to millions of Americans.
Opinion: Will Claude ever win a Nobel Prize for medicine?
On Monday morning, the Nobel Prize for medicine was announced. This year, I wonder: Will Claude or a future artificial intelligence agent ever win the most prestigious award for medical discovery?
Imagine a future AI agent responding to a scientist’s insightful prompt by successfully identifying a completely novel approach to curing cancer, along with a detailed and actionable plan for implementing it. Given the toll of cancer on our species, I suspect few today would consider that a bad outcome.
STAT+: Divergent trial results on cancer vaccines have the field grappling with hard questions
The recent success of a late-stage mRNA cancer vaccine, showing the drug stopped the return of melanoma, has boosted hopes that the approach can be successfully harnessed to attack other cancers.
The question now is which ones — and whether mRNA is up to the task.
Merck and Moderna reported in August that adding their mRNA cancer vaccine to an existing treatment slowed the return and spread of melanoma. The field had been waiting “with bated breath” for the news on the drug, called intismeran autogene, said Karen Knudsen, the CEO of the Parker Institute for Cancer Immunotherapy, the research organization founded by tech entrepreneur Sean Parker. The results suggested that the idea of using messenger RNA to train the immune system to attack cancer cells — an approach first devised decades ago — was ripe for further drug development.
Opinion: Energy drinks’ new college sports partnerships make them more dangerous than ever
In a single generation, energy drinks have conquered the beverage world. Starting as an upscale version of the humble NoDoz pill, then sugared up for guzzling, they are now the caffeine jolt of choice for the sluggish and the sleep-deprived. In an odd commercial convergence, they have also hooked up with the burgeoning wellness movement by adding favorites like ginseng, vitamins, and amino acids to the mix, making the energy drink seem like a friendly sports drink. Presto! An $85-billion-a-year (and growing) global market is upon us.
Which is fine. Caffeine in whatever form, be it in coffee or tea or Coca-Cola, has long been a staple of the American kitchen table.
Trump announces $90 payments for seniors’ Medicare premium costs ahead of midterm elections
President Donald Trump is promising more payments to voters just ahead of the Nov. 3 midterm elections — this time, to more than 20 million seniors, giving them $90 each to help pay for Medicare premiums.
The announcement, made late Friday night by Trump on social media, comes after the president last month said about 1 million people would get rebate checks of $500 for Affordable Care Act premiums. He has also promised on the campaign trail to send every American adult $5,000 if Republicans retain control of the House and Senate in the midterm elections.
NIH rolling out streamlined website to help public find information more easily
Finding information from the National Institutes of Health about human health, disease, and biomedical research is about to look a lot different. On Monday, the NIH will unveil a new version of its website that shifts attention away from individual institutes and centers and towards eight thematic hubs focused on health, research, data, clinical studies, rare diseases, technology, cancer, and grants.
Agency officials say the redesign — which is part of an ambitious project to consolidate the NIH’s digital footprint — is intended to streamline what was a sprawling and fractured information ecosystem, requiring users to understand NIH’s organizational structure, into an intuitive experience that more closely reflects what type of information people seek out most often.
What it’s like to wait for the call from the Nobel Prize committee
Some 20 years ago, Mary-Claire King was asked to hold a seminar at the Karolinska Institutet in Stockholm.
The invite, the geneticist soon learned, was code for: You are being considered for a Nobel Prize. She traveled to Sweden, held the seminar, then spoke about her work with interested experts who she later understood to be the prize committee.
STAT+: Lilly bypasses Australian pharmacies with DTC model
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Mosquitos are eating us alive into October; I just annihilated an Aedes albopictus that was supping on my shoulder. Is there a Kalshi market for wagers on when dengue will hit SoCal?
The need-to-know this morning
- Novartis is paying $575 million upfront to license an experimental mRNA-based autoimmune therapy from the Chinese firm Abogen Biosciences, the latest case of a large pharma company looking to China to restock its pipeline.
NIH dollars are flowing, but uncertainty persists
The National Institutes of Health spent the $34 billion it was allocated by Congress for research grants in the 2026 fiscal year, but a slower and increasingly opaque funding process is now making it harder to actually do science, a STAT analysis shows.
An Ebola treatment center was burned down as the death toll in Congo passes 4,000
BUNIA, Congo — Congo’s Ebola outbreak has killed more than 4,000 people, authorities said, as they struggle to contain what has become the fastest-growing Ebola outbreak in history.
The latest figures released by the Health Ministry on Thursday showed that 4,018 people have died among 8,300 cases recorded since the outbreak was declared in eastern Congo on May 15.
Access to addiction meds for young people has improved — but retention hasn’t
In 2016, the American Academy of Pediatrics issued a policy statement urging doctors to offer medications for opioid use disorder to adolescent and young adult patients who needed them.
New national data show that more young people with an opioid use disorder diagnosis did start receiving addiction medications like buprenorphine and methadone, but the increase was small. And the number of young people who stayed on medication for six months — already quite low — may have actually decreased.
STAT+: Pharmalittle: We’re reading about the 340B drug pilot program, an obesity drug disappointment, and more
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 to tidy up around the castle, promenade extensively with the official mascots, and escort Mrs. Pharmalot to a roadside tavern. We also hope to have time for another listening party, where the rotation will likely include this, this, this, this, this and this. And what about you? The world is at your fingertips, you know, so this might be a lovely time to enjoy the great outdoors as the seasons turn. If the weather fails to cooperate, you could gather with friends and play a board game — remember those? — or put on your chef’s hat and cook a good meal. You could also plan the rest of your life, before an AI bot does it for you. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
An obesity drug from Boehringer Ingelheim and Zealand Pharma helped patients with diabetes shed as much as 13.1% of their weight, a disappointing result, Bloomberg News tells us. Boehringer has pitched the medicine as a way to help patients lose fat while preserving muscle, but without an edge, the drug becomes just one more contender in an increasingly crowded market dominated by Eli Lilly and Novo. Boehringer pushed back at the idea that the drug might only be a niche product, saying that upcoming studies in heart and liver health will more clearly show its potential.
The upcoming midterm elections are setting the stage for unusually significant changes to key Senate committees that play an important role in health care, STAT explains. Both the finance and health committees could undergo major changes, though for different reasons. Of course, if Democrats take control of the Senate, they would get to run the committees, though the GOP membership changes could still influence the panels’ directions. Specifically, five or more of the Senate Finance Committee’s 14 Republicans are set to leave. And the outlook for the Senate’s Committee on Health, Education, Labor, and Pensions, or HELP, is even more difficult to predict with the departure of chairman Bill Cassidy.
Novartis signed a licensing deal worth about $7.8 billion with Chinese biotech company Abogen to advance RNA-based therapy, Reuters says. Novartis will gain exclusive rights to Abogen’s experimental drug, ABO2203, and options to license other therapies based on Abogen’s RNA technology. It will also have the option to license additional experimental medicines developed using Abogen’s RNA platform. The drug is designed to treat autoimmune diseases by targeting B cells, a type of immune cell that causes disease in conditions like lupus and rheumatoid arthritis.
How big is Pennsylvania’s measles outbreak?
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Hi, it’s Sarah subbing in. I have some embarrassing memories of struggling to do even a single pull-up for the Presidential Fitness Test as a kid, so it is with great interest that I’m following the Trump administration’s efforts to revive the test for today’s unsuspecting schoolchildren. Send me your 10-minute-mile tales at sarah.todd@statnews.com.
STAT+: NIH awarded all its grant funding, but delayed and opaque decisions stymied researchers
A STAT analysis of National Institutes of Health spending shows that in the 2026 fiscal year, which ended Wednesday, the agency continued reducing grant awards involving health disparities, race, and ethnicity but made little progress toward other Trump administration priorities, including disbursing funds more evenly across the country and expanding support for early-career scientists.
While the agency, like last year, spent its entire external grants budget of roughly $34 billion after a slow start, the manner in which it did so is sowing deep uncertainty among researchers. In a survey and interviews, they said delays in the grant review process are slowing down the pace of their work, and making it difficult for them to propose and conduct the sort of innovative, impactful science that the NIH exists to support.
Overall, the agency funded around 58,000 projects, a slight drop from the 61,000 awarded during the 2025 fiscal year and well below the roughly 63,700 grants awarded annually in the years before the second Trump administration. Though this number may increase somewhat in the coming weeks because of reporting lags in the NIH grants database, the smaller number of grants potentially resulted from the White House’s push to fully fund more multiyear grants in advance, which meant that there was less funding on hand to issue new awards.
Opinion: The law has to catch up on orphan-designated drugs with multiple uses
As sure as the sun rises, Crohn’s disease is most definitely not juvenile idiopathic arthritis. But government policy doesn’t seem to understand that.
I’m a pharmacist, and I started a specialty pharmacy in the small town of Sidney, Neb. My pharmacy patients drive miles and hours across the sun-drenched Nebraska prairie to see me at my pharmacy. They are often overjoyed to arrive at my counter to pick up medications like Rinvoq. No longer do they have to deal with remote mail-order pharmacies — they can come to my pharmacy anytime to speak with me and pick up their medications for things like Crohn’s disease in person.
Opinion: I treated heat stroke at the NYC Marathon. Marathons need to prepare for a climate-changed world
Though I have treated thousands of patients since, Nov. 6, 2022 — the day of a record hot New York City Marathon — still weighs on me. Around the three-and-a-half-hour mark of the race, the finish-line medical tent filled. Inside, I was volunteering as a medical provider and an amateur runner, assigned to a row of cots in the moderate-severity zone. The unseasonably climbing temperatures were taking a visible toll on athletes of all levels.
A volunteer wheeled into my zone a middle-aged man — I’ll call him John — who had collapsed at the finish line. I asked him his name; he answered without hesitation.
STAT+: Medicare Advantage plans shift more costs onto seniors in 2027
People who have a Medicare Advantage plan — and wind up needing care and prescriptions next year — are in for a rude awakening.
Medicare Advantage insurers are raising out-of-pocket costs for enrollees, drastically cutting money for dental work and other benefits, and eliminating plans that have broad networks of hospitals and doctors, according to federal data released this week and analyzed by STAT and several investment firms. That could result in more shock for older adults, like discovering their doctor is no longer accepted by their plan, if they don’t shop carefully during Medicare’s annual enrollment period for 2027 plans, which starts Oct. 15.
Big companies like UnitedHealth Group, Humana, and others are chasing higher profits by pruning benefits, after investors grew dissatisfied with margins that were smaller than the insurers had promised. The changes in plans even come even after the industry won a payment increase and delayed reforms from the Trump administration in April.
Top journal’s special issue on women’s health casts spotlight on menopause and pain
Ovulation. Endometriosis. And especially: menopause. These once taboo words — among others — have become part of our daily vocabulary and conversations, a sign of greater interest in, and knowledge of, women’s health.
Yet even as women’s health has been receiving more attention than perhaps ever before, women remain poorly represented in clinical trials, and female health poorly understood compared to male health. Much of the attention remains focused on the reproductive aspects of women’s health.
As CDC redesigns annual health survey, it removes questions about disabilities
A proposed redesign of the federal government’s annual health survey would result in significant undercounting of Americans with intellectual and developmental disabilities, according to advocates for the vulnerable population.
The National Health Interview Survey has historically undercounted people with disabilities, but the changes are a “head-scratcher,” said Katy Neas, CEO of The Arc, an advocacy group. “If we don’t have the government as a trusted source of data, asking questions about real people and what their real experiences are, we’re never going to get better [health outcomes],” she said.
Mistrust in science and a juicy gene-editing lawsuit
On this week’s episode of “The Readout LOUD”: Why have so many Americans lost trust in science? And how have our policy leaders fueled that mistrust? We speak to STAT’s new trust-in-science reporter Nicholas Florko about the impact of Americans’ growing skepticism of science.
Your co-hosts also chat about a clinical update from UniQure on its gene therapy for Huntington’s disease, a juicy lawsuit filed by the gene-editing company Beam Therapeutics against a Chinese competitor, and a shift in the way pharma companies like Novo and Eli Lilly are talking about their GLP-1 products.
STAT+: A journey to witness China’s biotech boom up close
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I am newly enamored with Hans Zinsser, a Harvard bacteriologist who in 1935 wrote “Rats, Lice and History,” a rather charming “biography” of typhus. Got it for a buck at an estate sale.
Favorite line: “there is no arsphenamin for the psychic treponema” — which, in context, basically means, “pretension has no cure.”
STAT+: A major insurer on how it may replicate Medicare’s chronic-care experiment
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Blue Shield of California is one of 17 major health plans that has committed to adopting payment models inspired by the Medicare Innovation Center’s ACCESS Model.
The insurer’s chief medical officer Ravi Kavasery told me that it’s still figuring out details of what this will look like, including whether it will adopt CMS payment amounts and what organizations it will work with. He said Blue Shield of California, which serves 6 million members, expect to launch similar models in commercial plans in 2027.
STAT+: Pharmalittle: We’re reading about a plan to lower Medicare drug prices, a Lilly obesity drug, and more
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 advise that “Every new day should be unwrapped like a precious gift.” While you tug on the ribbon, we are brewing still more cups of stimulation and invite you to join us. Remember, a prescription is not required. Our choice today is butter pecan — spiked with bourbon honey. Yummy. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. …
The Trump administration published a final rule aimed at lowering Medicare prices for drugs administered in doctor offices, but it applies to only four companies and saves 96% less than initial proposal, STAT notes. The Global Benchmark for Efficient Drug Pricing, or GLOBE, is one of two mandatory pilot programs that are part of President Trump’s plan to get drugmakers to lower prices in Medicare to levels charged in other rich countries, a policy generally referred to as most-favored nation pricing. The other pilot, called GUARD, is still in the proposed stage.
An investigational combination therapy from Eli Lilly led to significant weight loss in a mid-stage study, but high rates of people stopping the treatment may raise questions about its tolerability, STAT writes. Lilly tested different combinations of its blockbuster GLP-1 drug Zepbound with eloralintide, a candidate that targets the amylin hormone, in people with obesity and type 2 diabetes. After 48 weeks, participants who stayed on the treatment at the highest dose of the combination therapy lost 23.3% of their weight. That is more than the weight loss seen with those taking only Zepbound and those taking only the highest dose of eloralintide — 14.8% and 11.1%, respectively.
Trump administration appeals ruling blocking limits on international student visas
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Happy October! Lots of stories! You’re going to love them!
STAT+: Invivyd’s pursuit of a Covid vaccine alternative gets a lift, but an FDA hurdle may await
This story first appeared in Adam’s Biotech Scorecard, a STAT newsletter. Sign up here to get it delivered to your inbox. And subscribe to STAT+ to get an unabridged version, with exclusive content.
An update on Invivyd, the small biotech company developing an injectable, low-dose monoclonal antibody to protect against Covid-19 infection like a vaccine does, but without the real or perceived limitations of vaccines. I last wrote about Invivyd in this newsletter in August 2025.
On Tuesday, Invivyd reported the results from a Phase 3 study called LIBERTY that demonstrated the superior safety and tolerability of its antibody candidate, VYD2311, compared against Comirnaty, the established mRNA-based Covid vaccine marketed by Pfizer. After six days, 57% of study participants who had VYD2311 injected into the muscle of their upper arm reported headaches, chills, fatigue or pain at the injection site — the typical side effects associated with vaccinations. In the Comirnaty arm of the study, 91% of participants reported the same side effects. The difference was statistically significant. The same study showed VYD2311 was also better tolerated at 56 days, and could be combined safely with Comirnaty.
STAT+: Why a Huntington’s patient isn’t fazed by the waning effect of UniQure’s gene therapy
This story first appeared in Adam’s Biotech Scorecard, a STAT newsletter. Sign up here to get it delivered to your inbox. And subscribe to STAT+ to get an unabridged version, with exclusive content.
Lauren Holder is an advocate for the Huntington’s disease community who is also living with the early stages of the progressive and fatal neurodegenerative condition. I called her Tuesday to get her reaction to UniQure’s gene therapy clinical update.
The UniQure treatment, called AMT-130, slowed the progression of Huntington’s by 44%, based on a four-year analysis of 12 treated patients. Last year, the company reported a three-year update showing a 75% slowing of disease progression. The treatment effect of AMT-130 seems to have waned from year three to four, for reasons that don’t alarm UniQure but that have raised some outside questions about the therapy’s durability.
STAT+: In Shanghai’s ‘Science City,’ China’s ascendant biotechs make their pitch to the world
SHANGHAI — The biotech executives appeared triumphant.
It was a balmy, overcast Sunday here in the glimmer-and-glass “Science City” district, and the four leaders were on stage at the ballroom level of the five-star Hilton, joking about how much faster, cheaper, and more efficient drug development was here in China than anywhere else — certainly than the United States. (And God help Europe.)
Zhui Chen, co-founder of the now $6 billion Shanghai-based biotech Abbisko, recalled running a trial on a drug licensed to the German pharma Merck KGaA. Abbisko’s trial finished in 11 months, so quickly that Merck executives asked if Abbisko could train their staff.
STAT+: Can a top Republican from a bygone political era fix pharma’s woes in Washington?
WASHINGTON — Eric Cantor has been here before.
In 2013, the House Republican, who had become the party’s de facto “chief political strategist,” was at a Virginia resort with his colleagues, working to shift the GOP away from its stereotype as a party focused on the rich and their corporate interests, according to a New Yorker profile of him at the time.
The party needed to prove, amid growing populist currents, that it wanted to improve the lives of everyday people — and Cantor, then the majority leader, was seen as the strategist to make it happen.
STAT+: Two key Senate health committees face major shake-ups
WASHINGTON — The upcoming midterm elections are setting the stage for unusually significant changes to key Senate committees that play an important role in health care.
Both the finance and health committees could undergo major changes, though for different reasons. Of course, if Democrats take control of the Senate, they would get to run the committees, though the GOP membership changes could still influence the panels’ directions.
At least five Republicans set to leave Senate Committee on Finance
The finance committee faces significant turnover as five or more of the panel’s 14 Republicans are set to leave:
Opinion: I studied GLP-1 use in children. The results are reassuring
I am a transplant surgeon, and my patients are getting younger. Many are in their 30s and 40s — adults whose organ failure can be traced back to childhood obesity. And obesity itself can be a barrier to transplant, compounding the crisis it created.
The data confirm what I see clinically. Adolescents with severe obesity are up to nine times more likely to develop chronic kidney disease in young adulthood, even without diabetes or hypertension. Childhood fatty liver disease increases mortality risk 40-fold and has become the fastest-growing cause of liver transplants in young adults.
Opinion: Claude analyzed my genome in 30 minutes. Now we need standards for the results
Unpacking from vacation a couple months back, I decided to give artificial intelligence a task. I paused folding my laundry, sat down with Claude, and asked it to analyze the entirety of my genome.
Back in 2009, this was a task that quite literally took a village of 30 people — including me — working together to interpret the whole genome sequence of a colleague, friend, and fellow scientist named Stephen Quake. This endeavor brought together experts in genetics, computer science, pharmacology, and clinical medicine.
STAT+: Sanofi, Regeneron expand partnership after Dupixent success
Sanofi and Regeneron Pharmaceuticals, the duo behind the hugely successful drug Dupixent, are re-upping their partnership, with the companies announcing Thursday an expanded collaboration on a new series of antibodies for immunological diseases.
As part of the pact, Sanofi is paying Regeneron $1 billion upfront, with possible milestone payments of up to $7 billion more. The deal involves Regeneron taking the lead on research and development, with Sanofi spearheading commercial efforts. Profits on the medicines would be split evenly.
“By combining Regeneron’s world-class scientific discovery and antibody development expertise with Sanofi’s global capabilities and reach, we hope to once again deliver the next wave of innovation in immunology,” George Yancopoulos, Regeneron’s chief scientific officer, said in a statement.
STAT+: Trump’s watered-down Medicare drug pricing rule saves 96% less than initial proposal
WASHINGTON — The Trump administration published a final rule aimed at lowering Medicare prices for drugs administered in doctor offices. It applies to only four companies.
The Global Benchmark for Efficient Drug Pricing, or GLOBE, is one of two mandatory pilot programs that are part of President Trump’s plan to get drugmakers to lower prices in Medicare to levels charged in other rich countries, a policy generally referred to as most-favored nation pricing. The other pilot, called GUARD, is still in the proposed stage.
The pilots are tied to Trump’s separate voluntary deals with drugmakers to offer MFN prices to drugs for Medicaid recipients. The companies that struck those deals are exempt from the GLOBE pilot, according to the model’s final rule.
STAT+: UnitedHealth investor lawsuit moves forward on allegations it ‘manufactured earnings’ to hide declining profits
An investor lawsuit against UnitedHealth Group will move forward after a federal judge on Wednesday declined the company’s motion to dismiss allegations that it juiced its earnings to the tune of $3.3 billion in 2024 to conceal weakness in its Medicare Advantage business.
It wasn’t all good news for the California Public Employees’ Retirement System, or CalPERS, though. U.S. District Judge Jeffrey Bryan dismissed most of the pension fund’s allegations that UnitedHealth’s leaders deceived investors about multiple aspects of their business in order to artificially inflate the company’s stock. Bryan agreed with UnitedHealth that most of the company statements CalPERS cited weren’t specific enough or represented typical promotional “puffery” that investors wouldn’t act on.
One of the lawsuit’s central allegations was that the Minnesota-based conglomerate concealed an illegal practice of making its Medicare Advantage patients appear sicker on paper to siphon more money from the government. On that front, CalPERS cited the company’s statements that home visits kept its members healthy and that its clinicians made independent clinical decisions. In fact, reporting has since shown that UnitedHealth used those visits to add diagnoses to patients’ records for which they received no follow-up care and pressured its doctors to do the same using bonuses. .
STAT+: HHS announces new efforts to speed up, expand clinical trials with AI
WASHINGTON — The Department of Health and Human Services announced a set of new initiatives aimed at speeding up clinical trials by incorporating more artificial intelligence and computational models and moving away from sharply delineated trial phases.
The centerpiece five-year program, dubbed SURPASS — “Simulation-augmented, Real-time Platform Adaptive Seamless Trials” — will kick off later this fall by accepting “ground-breaking ideas from cross-disciplinary teams in statistics, AI, and clinical trial design, operations, and regulation,” reads a website about the program.
HHS is launching the program through the Advanced Research Projects Agency for Health. The initial announcement did not note how much funding was designated for the new initiatives, nor did it provide details on whether participants would be offered more flexibility or resources.
Oura delays IPO
U.S. poised to boot legal immigrants from Medicaid, including refugees and sex-trafficking victims
Many lawfully present immigrants will be among the first people to lose Medicaid coverage under congressional Republicans’ One Big Beautiful Bill Act, which is expected to cut spending by more than $900 billion through 2034 for the state-federal health program for people with low incomes or disabilities. The law will strip many more immigrants of their Affordable Care Act plan subsidies and Medicare coverage next year.
STAT+: What health tech leaders are talking about in Washington policy circles
This is the web edition of STAT’s AI Prognosis newsletter, our guide to artificial intelligence in health care and medicine. Sign up to get it delivered in your inbox every Wednesday.
It never crossed my mind that there would be a Cookie Monster AI satire piece in the New Yorker, but it does exist and I love it so much. h/t to my colleague Sarah Todd for sharing “Cookie Monster Tries to Meet His A.I. Mandate.”
News I missed, story tips, comments: aiprognosis@statnews.com
Rural MAHA followers say Trump hasn’t improved health of their communities, poll finds
WASHINGTON — About half of rural voters identify with Make America Healthy Again, a sprawling political movement championed by the Trump administration, but most said President Donald Trump’s health care policies have not benefited their communities, according to a new poll from The Associated Press in partnership with KFF.
About 8 in 10 rural voters — an important voting bloc for Trump and fellow Republicans — said the Trump administration’s policies have had a negative effect or no impact on the health of people where they live. Most MAHA supporters, 68%, also feel this way, according to the national survey of more than 2,000 rural registered voters.
STAT+: Eli Lilly’s Zepbound combined with amylin drug led to significant weight loss in mid-stage trial
An investigational combination therapy from Eli Lilly led to significant weight loss in a mid-stage study, but high rates of people stopping the treatment may raise questions about its tolerability.
Lilly, which is racing to bring next-generation obesity drugs to the market, tested different combinations of its blockbuster GLP-1 drug Zepbound with eloralintide, a candidate that targets the amylin hormone, in people with obesity and type 2 diabetes.
After 48 weeks, participants who stayed on the treatment at the highest dose of the combination therapy lost 23.3% of their weight, according to results presented Wednesday at the annual meeting of the European Association for the Study of Diabetes. That’s more than the weight loss seen with those taking only Zepbound and those taking only the highest dose of eloralintide — 14.8% and 11.1%, respectively.
The results were also notable because patients with diabetes don’t tend to lose as much weight on medications as those who don’t have diabetes.
STAT+: Pharmalittle: We’re reading about Beam suing over IP theft, a Trump rule on importing meds, and more
Top of the morning to you, and a fine one it is. Clear blue skies are hovering over the Pharmalot campus, where a cool breeze is wafting by and the official mascots are bounding about the grounds in search of critters. As for us, we are engaged in the usual rituals of brewing cups of stimulation — our choice today is orange creme — and foraging for items of interest. On that note, please enjoy the latest menu of tidbits we have assembled for you. As always, we hope your journey is meaningful and productive, and that you conquer the world. And of course, do keep in touch. Secret dossiers and saucy secrets are especially welcomed. …
The gene-editing company Beam Therapeutics is alleging that one of its scientists stole intellectual property and used it to co-found a Chinese company that made a deal with venture capital firms, STAT tells us. The allegation comes at a time of escalating tensions between American biotech companies and their Chinese counterparts. Beam filed a lawsuit late last week accusing one of its former scientists, Zi Jun “Emma” Wang, of accessing the company’s electronic laboratory notebooks late at night and on weekends, then using the information she gleaned to start a company called YolTech Therapeutics.
Eric Cantor, a former GOP House majority leader, will be the next chief executive of the Pharmaceutical Research and Manufacturers of America, or PhRMA, STAT notes. As head of the brand-name drug industry’s top lobbying group, Cantor will face mounting political pressure on drug prices and an increasingly populist mood from both political parties. He starts work on Nov. 9 and arrives as the Trump administration tries to codify into law voluntary deals that were struck with more than two dozen companies to lower U.S. medicine prices to levels in peer countries.
STAT+: Three biotech updates, including accusations of theft and and a new lobbying leader
Good morning. I have a gallon of apple cider I don’t know what to do with. Please send any good recipes you have!
The need-to-know this morning
- Moderna appointed Juan Andres as its new chief operating officer, a new executive role for the company as it prepares to expand into oncology. This is Andres’ second stint with Moderna. He previously served as its top executive in charge of manufacturing and quality control.
- Pierre Fabre Pharmaceuticals and Atara Biotherapeutics said their drug Ebvallo was refiled with the FDA. The companies are seeking approval to treat patients with an ultra-rare and fatal type of blood cancer that can develop in people who have received a stem cell or solid organ transplant. In May, the FDA agreed to review Ebvallo again after previously rejecting the drug.
Beam alleges Chinese company stole its IP
Beam Therapeutics has filed a lawsuit alleging one of its former scientists stole intellectual property and used it to co-found a Chinese company that recently made a deal with prominent VC firms.
The allegations by Beam, based in Cambridge, comes amid escalating tensions between American biotechs and their Chinese counterparts. A growing number of U.S. investors and pharma companies are looking to China to license new drugs at lower costs, but American entrepreneurs and scientists have countered that Chinese biotechs are creating copycats of U.S drug candidates.
CDC measles death count still lags Pennsylvania’s
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Good morning. In Monday’s newsletter, Amanda wrote about a study on rising mortality rates for treatable surgical conditions like appendicitis. If you were looking for the right link for that, here it is. Scroll down past the first five abstracts for the research in question.
Opinion: America’s biotech race with China must be won at home
Last week, President Trump welcomed Chinese President Xi Jinping to Washington for the first time in a decade. Tariffs, Iran, and rare earth minerals were among the issues that dominated their summit. But another arena of competition deserves Washington’s attention: biotechnology.
The United States remains the global leader in biotech, but China is rapidly narrowing the gap. Yet Washington remains focused on containing China’s rise rather than investing in the strengths of America and our allies. If U.S. leaders want to preserve America’s leadership and protect our national security, they must focus first and foremost on making U.S. biotech stronger.
Kratom and 7-OH should be regulated, experts agree. They’re split on how
Kratom leaf products, often used to ease chronic pain, anxiety, or withdrawal from opioids, have been sold in the U.S. for decades, largely skirting any regulatory restrictions despite a known risk for physical dependence. But increasingly, Americans are turning to newer, more potent products made with a semi-synthetic kratom derivative, 7-hydroxymitragynine, or 7-OH.
Clinicians and recovery advocates warn that highly-concentrated 7-OH could be even more addictive than kratom, though research is scarce. Most people agree that some sort of guardrails need to be put into place. They disagree, however, on what those regulations should be.
Opinion: STAT+: What to think about those mice with half-human brains
What would happen if you generated a new type of lab mouse whose brain was substantially human? Would they be really smart or somehow have a different consciousness?
Until now, such trains of thought mostly were chugging through fictional realms such as “Flowers for Algernon” or the cartoon “Pinky and the Brain.” However, science is catching up with fiction.
A team led by Stanford professor Sergiu Pașca just reported in Nature on the development of a mouse with a cortex made of human brain cells. Reading this paper initially gave me a combination of “wow” and “whoa” reactions. After all, the unique cortex of our brains is the major factor in what makes us human and is the center of complex thought.
STAT+: At MAHA Summit, a grassroots movement goes corporate
WASHINGTON — The Make America Healthy Again movement has changed, if Tuesday’s MAHA Summit is any indication.
The insurgent movement that coalesced around mistrust of the health system and corporate influence put on a summit where industry leaders promoted their work under the MAHA banner, whether as insurers controlling costs or pharma companies developing the next breakthrough.
In a morning panel about health care affordability, for instance, executives at two of the nation’s largest insurers, UnitedHealth Group and Elevance, highlighted their artificial intelligence initiatives while emphasizing the need for prior authorization — an administrative hurdle known to infuriate patients and providers alike.
STAT+: Lawmakers urge Trump to rethink new rule that could restrict imported meds from Canada and overseas
A growing number of congressional lawmakers are urging the Trump administration to rethink a federal rule going into effect next month over concerns it will prevent Americans from obtaining prescription medicines from licensed international pharmacies.
The pending rule requires medicines mailed from abroad to go through a customs process that will mandate a licensed customs broker and a financial guarantee in the form of an entry bond. This is an added burden — and cost — for Americans who, for years, have been able to receive prescriptions from Canada and other countries with relatively little difficulty as they sought to save money on expensive drugs.
Indeed, the clamor for imports began two decades ago as prices rose, prompting some Americans to take bus rides to Canada. Under current law, though, it is illegal to import a medicine into the U.S. for personal use under most circumstances because the drugs often have not been approved by the U.S. Food and Drug Administration as being safe and effective.
STAT+: Beam Therapeutics sues Chinese biotech, VC-backed startup, alleging theft of intellectual property
The gene-editing company Beam Therapeutics is alleging that one of its scientists stole intellectual property and used it to co-found a Chinese company that made a deal with VC firms. The allegation comes at a time of escalating tensions between American biotech companies and their Chinese counterparts.
Beam, which is based in Cambridge, Mass., filed a lawsuit late last week accusing one of its former scientists, Zi Jun “Emma” Wang, of accessing the company’s electronic laboratory notebooks late at night and on weekends, then using the information she gleaned there to start a company called YolTech Therapeutics.
YolTech, which is based in Shanghai, recently made a deal with VC firms RA Capital and RTW to form a new startup called Serapha Bio. Both YolTech and Serapha are named as defendants in the case.
STAT+: PhRMA taps Eric Cantor as new CEO
WASHINGTON — Eric Cantor, a former GOP House majority leader, will be the next CEO of PhRMA, the lobbying group announced Tuesday.
As head of the brand drug industry’s top lobbying group, Cantor will face mounting political pressure on drug prices and an increasingly populist mood from both political parties.
The Trump administration is trying to codify into law voluntary agreements that it struck with more than two dozen companies to lower U.S. pharmaceutical prices to levels in peer countries. Democrats also are interested in that most-favored nation pricing approach and are considering adding international prices to the list of criteria Medicare uses to negotiate prices.
STAT+: Overton won’t get a vote before midterms
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Love is Blind is coming to Boston to spill some tea. Send news tips and casting suggestions/exes to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.
The need-to-know this week
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Wednesday is the deadline for states to decide whether to participate in GENEROUS, a pilot program offering drugs in Medicaid at prices available abroad.
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The Senate health committee will vote Wednesday on three HHS nominees. Heidi Overton, the nominee to lead the Food and Drug Administration, is not among them. (More on that below.)
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CMS Administrator Mehmet Oz will be in Texas to talk up CHOICE arrangements, in which employers can give workers money tax-free to buy ACA Marketplace insurance.
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The annual U.S. Alcohol Policy Alliance conference is taking place in Arlington. It’s the main group advocating for stronger alcohol regulation.
Why no Overton?
It would take just one Republican to sink Overton’s nomination in committee, and last week’s hearing didn’t shed much light on how hard-to-get Republicans might vote. Now we will not know until after the elections. This is the last week the Senate is in session until Nov. 9., and the Senate’s health committee doesn’t have a vote scheduled on the nominee to run the FDA.
Clinician shortage to double by 2040
STAT+: Anthropic joins ARPA-H clinical AI moonshot, will hold closed-door health care event
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Good morning health tech readers!
Anthropic has been loudly warning that AI might one day lead to catastrophe. And yet, the company is moving aggressively into health care, even as AI regulation is in a state of flux.
STAT+: AstraZeneca invests $2 billion in Summit Therapeutics
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I have banned screens for my broken-legged 8-year-old. As a result, I’m hearing all about newly discovered ancient runes on my ceiling, along with endless varietals of bathroom rhymes.
The need-to-know this morning
- Novo went shopping in China for a new obesity pill. The Danish drugmaker has licensed from Hengrui Pharma a once-weekly, oral GLP-1/GIP receptor agonist that is ready for Phase 1 clinical development. Novo paid Hengrui $300 million upfront for global rights (outside China) to the drug. Total deal value if all future milestones are met: $2.6 billion.
- Invivyd said its experimental monoclonal antibody designed to protect against Covid infection demonstrated superior safety and tolerability compared to a currently approved mRNA-based Covid vaccine, achieving the goal of a clinical trial.
- Immix Biopharma said its experimental CAR-T therapy induced complete remissions in 89% of patients with AL Amyloidosis, a rare autoimmune disorder in which toxic proteins build up in organs like the heart and kidneys.
UniQure’s Huntington’s benefit is less pronounced four years in
UniQure’s experimental Huntington’s gene therapy AMT-130 continued to slow disease progression four years after treatment. But the magnitude of the benefit declined from a year earlier — which could potentially complicate the therapy’s regulatory review, STAT’S Adam Feuerstein writes.
STAT+: Pharmalittle: We’re reading about Novo licensing a Chinese obesity pill, Merck pulling an antibiotic, and more
Top of the morning to you and a fine one it is. Blue skies, cool breezes, and plenty of chirping birds are enveloping the comfy Pharmalot campus, which is cause to fire up the coffee kettle for yet another cup of stimulation. Our choice today is pecan pie — sweets for the sweet, you know. Meanwhile, we have assembled the latest menu of tidbits for you to peruse. We hope you have a wonderful day, and please do keep in touch. Once again, we will note that our settings have been changed to accept postcards and telegrams. …
Novo has agreed to pay up to $2.6 billion to license an experimental, weekly weight loss pill from China’s Hengrui Pharma as it seeks to shore up its position in the oral obesity drug market, The Financial Times writes. The deal is Novo’s second since its investor day last week, when its pledges to boost growth with new drugs fell flat. The company, which is trying to regain ground lost to rival Eli Lilly in the obesity drug market, announced last week it agreed to license a technology from Nanexa that could allow patients to take one weight loss injection every few months. Analysts said a weekly pill would be a significant entrant to the market.
Roche stopped work on one of its obesity drug candidates, after clinical-trial data suggested the medicine did not hit internal targets, The Wall Street Journal tells us. The company said it returned rights to the medicine, emugrobart, to Chugai Pharmaceutical, which Roche largely owns and originally discovered the drug before licensing it to Roche. Roche had previously estimated the drug had potential to reach annual peak sales of between $1.21 billion and $2.41 billion. The company is also developing two obesity injections and a pill, and sees potential for each of them to exceed $3.6 billion in peak sales.
Researchers slow neurodegeneration in mice by barring T cells from the brain
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Good morning! To start, a postscript on Anthropic’s biological breakthrough. Last week, the AI company said Claude had discovered a new enzyme system with a series of repeats in DNA “reminiscent of CRISPR.” It turns out University of Copenhagen professor Mario Rodríguez Mestre has been studying the same set of enzymes, using Anthropic’s AI to write code and draft manuscripts as he prepares to publish his findings. “For me, the most important question is not ‘Were [these molecules] already known?’ They were,” the professor told The New York Times. What he wonders is whether AI relied partly on his work for its insights.
STAT+: UniQure’s gene therapy continues to slow Huntington’s progression after four years
An experimental gene therapy for Huntington’s disease, developed by the biotech company UniQure, continued to slow the progression of the neurodegenerative disease four years after it was surgically implanted into the brains of patients, the company reported Tuesday.
However, the magnitude of the treatment’s benefit has waned compared to a similar analysis conducted one year ago, which may raise questions about its durability just as the Food and Drug Administration begins to review UniQure’s marketing application.
In the new analysis, a high dose of UniQure’s one-time gene therapy called AMT-130 slowed the progression of Huntington’s by 44% compared to matched participants in an external control group based on a large, natural history study. The difference was not statistically significant.
Why MAHA wants to make health data much more accessible
WASHINGTON — The Make America Healthy Again movement wants your health data.
The MAHA Institute, a think tank formed by allies of Robert F. Kennedy Jr. after his appointment as health secretary, held an event on Monday that emphasized the benefits of opening up health data sharing in the United States. In particular, the event highlighted how sharing patients’ health records with federal researchers could benefit the study of the origins of chronic diseases.
She’s spent two decades talking to parents who don’t vaccinate their children. Here’s what she’s learned
Parents who decline to vaccinate their children have been called selfish and stupid. They’ve even been accused of child abuse. But what if they’re actually acting logically?
That’s the conclusion of Jennifer Reich, a sociologist at the University of Colorado, who has spent the better part of two decades studying these families’ immunization decisions. Reich is not anti-vaccine; her children received vaccines according to the Centers for Disease Control and Prevention schedule. But she sees parents’ decisions to go a different way as a logical outgrowth of the push for them to be savvy consumers in an increasingly complex world, to make informed decisions about everything that could affect their children’s health.
STAT+: The last ‘breakthrough’ devices to get special treatment from Medicare
In the last month, manufacturers have announced “breakthrough” status from the Food and Drug Administration for a menagerie of devices: triage algorithms for abdominal CT scans, diagnostic panels for urinary tract infections, and thrombectomy robots, to name a few.
They’re coming in just under the wire: As of October, new breakthrough-designated devices will no longer be eligible for special treatment when it comes to qualifying for extra Medicare payments. These devices, and more than a dozen others, are included in the latest update of STAT’s Breakthrough Device Tracker, which since 2022 has captured nearly 800 devices reported to have FDA breakthrough status.
In August, the Centers for Medicare and Medicaid Services finalized the removal of pathways that have made it easier for breakthrough devices to qualify for supplementary Medicare payments for both inpatient and outpatient use. Since 2020, devices that received the designation from the FDA have been able to qualify for new technology add-on payments and transitional pass-through payments without proving they provide a substantial clinical improvement over alternatives, or that they are new.
STAT+: Drug pricing, Medicaid, and research funding: The key policy issues at stake in the midterms
WASHINGTON — Health industry leaders, still contending with the new rules of President Trump’s Washington, are about to face another shift.
November’s midterm elections are likely to shake up key health policy debates, from Medicaid funding to the price of medication. That’s especially true if Democrats seize control of a chamber of Congress, though any major policymaking would still need Trump’s signature.
Drawing on interviews with nearly a dozen leaders and lobbyists representing the health industry, these are the most important questions about federal policy after the midterms. How they are answered will have wide-ranging impacts for America’s health system, science, and patients.
Opinion: Child health is the national security crisis we keep ignoring
Concerns about military readiness, workforce shortages, rising health care costs, affordability, and America’s ability to compete in an increasingly challenging world seem to play on a loop without any sign of progress. Maybe that’s because these challenging and seemingly intractable problems are usually treated as separate crises requiring separate solutions. They are not.
The root cause they share is the declining health and well-being of America’s children, a situation that threatens our future safety and security militarily, economically, and globally.
Opinion: Massive SNAP cuts could mean more children are separated from their families
As the largest SNAP cuts in the program’s history have taken effect around the country, at least 1.5 million children have stopped receiving food assistance. The consequences go beyond hunger. Research suggests that when families lose access to food assistance, they may face a greater risk of investigation by child protective services — and, ultimately, being separated.
That is because poverty and neglect are too often conflated in America’s child welfare systems. When parents cannot afford enough food, stable housing, child care, or other necessities, the conditions created by poverty can bring them to the attention of child protective services. Cutting material support can therefore create a perverse and devastating cycle: The government takes away resources families need to care for their children, and then the child welfare system may intervene because families don’t have the resources to provide for their children.
STAT+: Merck discontinues a crucial antibiotic despite concerns over superbug resistance
In an unexpected move, Merck discontinued an important antibiotic from the U.S. market earlier this month, underscoring concerns about the commitment large pharmaceutical companies are willing to make to a field that is crucial to public health.
The drugmaker is no longer supplying Recarbrio, which was approved seven years ago and is used to treat serious infections in adults and children, such as pneumonia that develops from a hospital or ventilator, as well as complicated urinary tract and stomach infections in patients with limited or no alternative treatment options.
The company did not explain its decision, but the antibiotic — a three-drug combination injection — was pegged from the outset as a treatment of last resort by the Food and Drug Administration in hopes of mitigating antibiotic resistance. However, this also limits market and sales potential. Merck did not disclose Recarbrio sales in its regulatory filings.
Risk from toxic metals can persist months after wildfires, Maui study finds
Metal mixtures found in the leftover smoke, ash and debris from the deadly 2023 Maui wildfires were harmful to the lung health of people living nearby long after the burning ended, a new study says.
The work shows that major wildfires, which are worsening with the planet’s warming, could have lasting effects beyond immediate exposure.
Trump administration asks Supreme Court to allow transgender medical care restrictions in prison
WASHINGTON — The Trump administration asked the Supreme Court on Monday to let it enforce, for now, restrictions on gender-affirming care in federal prison.
The emergency appeal comes after lower courts blocked officials from immediately carrying out the policy adopted after an executive order from President Donald Trump.
STAT+: It really is bleak out there, and list prices matter
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Hello, gang. This past December, I was begging for another season of the game show “99 to Beat.” Well, great news: It’s BACK. If you’ve never seen it, give it a try. You’ll be rooting for strangers in wacky games. Ken Jeong and Erin Andrews have infectious energy as hosts. What’s not to like? As always, send your wackiness here: bob.herman@statnews.com.
Employer-sponsored nightmare fuel
Our “Out of Pocket, Out of Reach” series has been detailing the bleak state of health insurance that workers get through their employers. Experts have told me 2027 will be even worse than this year, and recent developments at sizable public-sector employers are reinforcing just how catastrophic things are becoming.
STAT+: AbbVie wins FDA nod for Parkinson’s pill
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This newsletter was composed from a pediatric emergency department. Hot tip, all: Don’t jump off 6-foot playground equipment. You will scare your mother, and wind up in a cast.
The need-to-know this morning
- Kodiak Sciences said Zenkuda, its experimental vision-sparing treatment for a common cause of age-related blindness, achieved statistical equivalence to Eylea, a standard therapy, in a Phase 3 clinical trial.
- Merck said it paid $400 million upfront to China’s SciBrunch Therapeutics, for global license rights to a preclinical cancer drug that targets tumors with KRAS G12D mutations. The deal is valued at $2.13 billion if all future milestones are achieved.
Novo turns GLP-1 drugs into consumer products
Novo Nordisk is increasingly marketing its GLP-1 drugs less as treatments for a chronic disease and more as consumer products for people who simply want to lose weight, STAT’s Elaine Chen writes. It’s a shift that comes as insurance coverage for these obesity medicines remains limited.
STAT+: Pharmalittle: We’re reading about GLP-1s becoming lifestyle drugs, a setback for Merck and Daiichi, and more
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating. Now, though, that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on a cuppa stimulation. Our choice today is honeybush vanilla turmeric. 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. …
Once promoted as tools to address obesity as a medical issue, GLP-1 drugs are increasingly being seen — and marketed — as a way to look and feel better generally, STAT explains. And, as the pioneer in the field, Novo Nordisk, in particular, has leaned into the shift. This is no accident. While early efforts to market GLP-1s by Novo and Eli Lilly were designed to convince payers and society in general that obesity was a disease that needed treatment, the companies have seen the expansion of insurance coverage stall due to the high price and usage of the drugs. In turn, they began selling their products directly to patients.
Merck and Daiichi Sankyo withdrew their U.S. application seeking accelerated approval for an experimental lung cancer therapy, marking the second pullback under their multibillion-dollar cancer alliance, Reuters notes. The decision followed discussions with the U.S. Food and Drug Administration, which determined the data from a mid-stage clinical study testing the therapy did not satisfy requirements needed to support an early green light. The therapy was under review to treat adults with aggressive, extensive-stage small cell lung cancer. Last year, the companies pulled the application for another lung cancer candidate after it failed to extend the lives of patients in a late-stage study.
Trump uses ‘contested’ power to cut more funding to HHS
Hello and good morning! I hope everyone stayed dry and got some good binge watching in. Speaking of which, The New York Times has finally released its full ranking of the top 100 TV shows of the 21st century. A lot of my favorites made the list, including “Fleabag,” “Gilmore Girls,” (for the fall nostalgia) and “House.” Did your favorite shows (medical or otherwise) make the list? What’s missing? And what’s on your mind this week? Reach out!
Are GLP-1s medications or lifestyle drugs? Yes
“Live lighter” and “summer glow up” sound like magazine cover taglines. They are also, it turns out, slogans Novo Nordisk has used to promote its GLP-1s.