Category: STAT+
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STAT+: What’s in Congress’ sweeping health care deal: PBM reform, telehealth, science funding
STAT+: What’s in Congress’ sweeping health care deal: PBM reform, telehealth, science funding WASHINGTON — Congress has reached a deal on several health care policies, including a crackdown on drug-industry middlemen, transparency measures for hospital billing, pediatric cancer research measures, and Medicare coverage of multi-cancer screening tests. Those measures are part of a bill to…
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STAT+: How accurate is HBO’s ‘The Pitt’? Mass. ER doctors and nurses describe the reality of their jobs
STAT+: How accurate is HBO’s ‘The Pitt’? Mass. ER doctors and nurses describe the reality of their jobs Emergency room staff cut the clothes off an unresponsive homeless man, and several rats leap from his body onto the floor. Doctors examine a child who won’t wake up and discover he ate one of his father’s cannabis…
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STAT+: Former AMA president says the U.S. health care system will implode without an overhaul
STAT+: Former AMA president says the U.S. health care system will implode without an overhaul When artificial intelligence medical imaging company Aidoc asked Jesse Ehrenfeld to be the company’s new chief medical officer, he said no. At 47, Ehrenfeld has already had a distinguished career: He was a commander in the U.S. Navy Medical Corps…
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STAT+: Behind new dietary guidelines: Industry-funded studies, opaque science, crushing deadline pressure
STAT+: Behind new dietary guidelines: Industry-funded studies, opaque science, crushing deadline pressure WASHINGTON — In early May, Health and Human Services Secretary Robert F. Kennedy Jr. had good news for the President: updated dietary guidelines, which were due at the end of 2025, would be delivered ahead of schedule. “We are working very, very fast…
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STAT+: Limit on multiyear funding of NIH grants is a sticking point in Senate budget talks
STAT+: Limit on multiyear funding of NIH grants is a sticking point in Senate budget talks Last year, the country’s biomedical researchers watched with apprehension as the National Institutes of Health’s grant awards lagged billions of dollars behind the pace of previous years. Fears grew that the Trump administration would impound funds appropriated by Congress…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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STAT+: Supreme Court agrees to review ‘skinny labeling’ and generic drug access
STAT+: Supreme Court agrees to review ‘skinny labeling’ and generic drug access The Supreme Court has agreed to review a controversy over so-called skinny labels for medicines, a decision that will be closely watched for its implications for the availability of generic medicines. Skinny labeling refers to moves by generic companies that seek regulatory approval…
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STAT+: Pharmalittle: We’re reading about FDA voucher worries, weight loss drugs and jet fuel, and more
STAT+: Pharmalittle: We’re reading about FDA voucher worries, weight loss drugs and jet fuel, 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 still shaping up as we weigh…
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STAT+: On Day 4 of JPM, a chat with Regeneron’s George Yancopoulos, an IPO forecast, and all eyes on J&J
STAT+: On Day 4 of JPM, a chat with Regeneron’s George Yancopoulos, an IPO forecast, and all eyes on J&J This is the online version of The Readout, STAT’s flagship biotech newsletter. Sign up to get it in your inbox. We have made it! And so have you. This is Adam, Elaine, Matt, and Allison preparing to sign…
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STAT+: Former Emergent BioSolutions CEO sued for insider trading, company reaches $900K settlement in N.Y.
STAT+: Former Emergent BioSolutions CEO sued for insider trading, company reaches $900K settlement in N.Y. The former chief executive officer of Emergent BioSolutions was accused of insider trading by the New York attorney general in connection with a contract the company had to manufacture a Covid-19 vaccine for AstraZeneca. Robert Kramer allegedly sold more than…
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STAT+: Trump releases health care plan amid pressure over affordability
STAT+: Trump releases health care plan amid pressure over affordability WASHINGTON — President Trump on Thursday released a hodgepodge of health care policies that would create new price-control power over pharmaceutical companies, but that otherwise wouldn’t fundamentally overhaul America’s existing system, as he faces mounting pressure to address the cost of insurance and care. The…
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STAT+: On Day 3 of JPM, pharma threads a needle with the White House, and Novo Nordisk has an eye on M&A
STAT+: On Day 3 of JPM, pharma threads a needle with the White House, and Novo Nordisk has an eye on M&A This is the online version of The Readout, STAT’s flagship biotech newsletter. Sign up to get it in your inbox. It’s Day 3 of JPM and all of us — Matt, Elaine, Adam, and Allison — are…
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STAT+: Secretive Project Prometheus takes VC Bob Nelsen beyond just health care
STAT+: Secretive Project Prometheus takes VC Bob Nelsen beyond just health care SAN FRANCISCO — Venture capitalist Bob Nelsen believes his latest project will be “one of the most important companies in the world.” But, unusually for the longtime biotech investor, it’s not strictly in health care. Nelsen has been quietly working on a new…
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STAT+: Watch: At JPM, former drug regulator Richard Pazdur rings the alarm about politics at FDA
STAT+: Watch: At JPM, former drug regulator Richard Pazdur rings the alarm about politics at FDA Richard Pazdur, a veteran regulator at the Food and Drug Administration until last month, joined STAT in San Francisco on Monday evening to make his first public remarks about the circumstances leading up to his abrupt departure. At an…
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STAT+: On Day 2 of JPM, Gilead lays outs it next test, a VC looks to raise funds, and one firm has FDA whiplash
STAT+: On Day 2 of JPM, Gilead lays outs it next test, a VC looks to raise funds, and one firm has FDA whiplash This is the online version of The Readout, STAT’s flagship biotech newsletter. Sign up to get it in your inbox. You’re back. We’re sort of back. It’s Day 2 of JPM and we’re…
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STAT+: HHS dismisses member of vaccine injury advisory panel
STAT+: HHS dismisses member of vaccine injury advisory panel WASHINGTON — At least one member of a committee that advises the federal government on its vaccine injury compensation program has had her term prematurely ended, potentially foreshadowing further changes to the federal apparatus that reviews vaccine injuries and compensates patients. Veronica McNally, an attorney who…
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STAT+: With a grin — and tight lips — Revolution Medicines’ CEO faces questions about acquisition
STAT+: With a grin — and tight lips — Revolution Medicines’ CEO faces questions about acquisition SAN FRANCISCO — Investors attending the J.P. Morgan Healthcare Conference packed themselves into a hotel meeting room Monday to hear Revolution Medicines CEO Mark Goldsmith explain why Merck — or some other pharma buyer — should pay $30 billion…
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STAT+: On Day 1 of JPM, no blockbuster headlines, but biotech newsmakers still move markets
STAT+: On Day 1 of JPM, no blockbuster headlines, but biotech newsmakers still move markets This is the online version of The Readout, STAT’s flagship biotech newsletter. Sign up to get it in your inbox. Hello from sunny San Francisco, where #BiotechVibeWatch2026 has begun. This is Allison DeAngelis, joined here by STAT’s Adam Feuerstein, Matthew Herper, and…
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STAT+: At JPM, doctors’ darling OpenEvidence says it’s pursuing ‘medical super-intelligence’
STAT+: At JPM, doctors’ darling OpenEvidence says it’s pursuing ‘medical super-intelligence’ OpenEvidence has rapidly become a household name among physicians, with a chatbot that answers their day-to-day clinical questions. Last year, it raised $200 million — twice — valuing the company at more than $6 billion. Its next reported round, yet to be confirmed, would…
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STAT+: UnitedHealth has turned Medicare Advantage coding into ‘profit-centered strategy,’ Senate report finds
STAT+: UnitedHealth has turned Medicare Advantage coding into ‘profit-centered strategy,’ Senate report finds UnitedHealth Group’s colossal size has helped the conglomerate turn the way patients are coded in the Medicare Advantage program into “a major profit-centered strategy, which was not the original intent of the program,” according to a new report released Monday from the…
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STAT+: Trump administration indicates it will drop appeal of a court order blocking a 340B pilot program
STAT+: Trump administration indicates it will drop appeal of a court order blocking a 340B pilot program The Trump administration has signaled plans to drop its appeal of a court order that blocked a pilot program from changing payment terms for a controversial federal drug discount program. In a Monday court document, the Department of…
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STAT+: Alnylam charts ambitious five-year plan as sales of key drug miss expectations
STAT+: Alnylam charts ambitious five-year plan as sales of key drug miss expectations SAN FRANCISCO — On Sunday, Alnylam, the gene-silencing company that notched one gigantic accomplishment after another over the past five years, set out a plan for the next five years built on yet more innovation and growth. At the same time, it announced…
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STAT+: Why the JP Morgan conference is important — but not make-or-break
STAT+: Why the JP Morgan conference is important — but not make-or-break This is the online version of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. My advice for JPM week: chill SAN FRANCISCO — The super-sized gathering of the biopharma universe is important, but it’s…
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STAT+: FDA puts off Stoke’s request for faster filing of severe epilepsy drug
STAT+: FDA puts off Stoke’s request for faster filing of severe epilepsy drug SAN FRANCISCO — Stoke Therapeutics and the Food and Drug Administration were unable to reach agreement on an expedited submission for the company’s severe epilepsy treatment, the company said Sunday. Following a meeting in December, the FDA did not shut the door…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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STAT+: Key scientist from Baby KJ team launches startup to scale personalized CRISPR medicines
STAT+: Key scientist from Baby KJ team launches startup to scale personalized CRISPR medicines In between bites of thin, crispy slices of pizza at Berkeley’s Pizzeria da Laura, gene editing researcher Fyodor Urnov and venture capitalist Johnny Hu began hatching a plan for a different kind of CRISPR company. It was spring 2024 and Urnov,…
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STAT+: Pharmalittle: We’re reading about a potential Merck purchase, a J&J pricing deal with Trump, and more
STAT+: Pharmalittle: We’re reading about a potential Merck purchase, a J&J pricing deal with Trump, 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…
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STAT+: House passes ACA subsidy extension as bipartisan negotiations heat up in Senate
STAT+: House passes ACA subsidy extension as bipartisan negotiations heat up in Senate WASHINGTON — The House voted 230 to 196 to pass a three-year extension of enhanced Affordable Care Act premium subsidies, with 17 Republicans joining all Democrats in favor. Five Republicans did not vote. That the House considered the matter at all shows…
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STAT+: Eli Lilly’s Zepbound, on top of immunology drug, helped reduce psoriatic arthritis symptoms
STAT+: Eli Lilly’s Zepbound, on top of immunology drug, helped reduce psoriatic arthritis symptoms Eli Lilly said Thursday that adding its weight loss drug Zepbound on top of its immunology therapy Taltz helped obese patients with an autoimmune condition that causes joint pain more than Taltz did alone. The data suggest the GLP-1 drug Zepbound,…
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STAT+: Panel behind new dietary guidelines had financial ties to beef, dairy industries
STAT+: Panel behind new dietary guidelines had financial ties to beef, dairy industries A group of researchers that formed the scientific basis of new dietary guidelines included people with financial ties to the beef and dairy industries, as well as food companies and other groups. Meat and dairy products received prime placement in new dietary…
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STAT+: AI Prognosis readers’ predictions for health AI in 2026. What’s on your bingo card?
STAT+: AI Prognosis readers’ predictions for health AI in 2026. What’s on your bingo card? You’re reading the web edition of STAT’s AI Prognosis newsletter, our subscriber-exclusive guide to artificial intelligence in health care and medicine. Sign up to get it delivered in your inbox every Wednesday. Hope you had a great holiday season. I’m starting off…
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STAT+: FDA announces sweeping changes to oversight of wearables, AI-enabled devices
STAT+: FDA announces sweeping changes to oversight of wearables, AI-enabled devices LAS VEGAS — The Food and Drug Administration announced Tuesday that it will ease regulation of digital health products, following through on the Trump administration’s promises to deregulate artificial intelligence and promote its widespread use. FDA Commissioner Marty Makary indicated that one of the…
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STAT+: HHS slashes vaccine recommendations
STAT+: HHS slashes vaccine recommendations You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. We’re almost healthy again, according to RFK Jr., though I’m certainly not in top form after my holiday break.…
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STAT+: Pharmalittle: We’re reading about the U.S. launch of a Wegovy pill, a Chinese biotech incubator, and more
STAT+: Pharmalittle: We’re reading about the U.S. launch of a Wegovy pill, a Chinese biotech incubator, and more Good morning, everyone, and welcome to another working week. We have returned from an extended break, which perhaps many of you enjoyed as well. In any event, we hope that any down time was relaxing and invigorating,…
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STAT+: A new drug allowed them to go in the sun for the first time. They’re terrified they may have to give it up
STAT+: A new drug allowed them to go in the sun for the first time. They’re terrified they may have to give it up It was particularly cold and windy for a November day, but that didn’t matter to Ginger Gonsalves and Becky Kelliher. The sun was out, and no one counted the seconds in…
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STAT+: Three major health care policy issues to watch in 2026
STAT+: Three major health care policy issues to watch in 2026 WASHINGTON — Health care figured prominently in the first year of President Trump’s second term, and it’ll likely play an even bigger role leading up to the 2026 midterm elections. The shift back to health care politics has been somewhat surprising. Although Republicans were…
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STAT+: CMS divvies up first payments from $50B rural health fund, with an eye toward MAHA goals
STAT+: CMS divvies up first payments from $50B rural health fund, with an eye toward MAHA goals WASHINGTON — The Trump administration on Monday announced the distribution of the first payments from a new $50 billion rural health fund — but not all states are getting equal payouts. The administration is giving larger awards to…
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STAT+: With the Wegovy pill, Novo Nordisk undercuts Eli Lilly in direct-to-consumer market
STAT+: With the Wegovy pill, Novo Nordisk undercuts Eli Lilly in direct-to-consumer market Novo Nordisk plans to sell its newly approved obesity pill directly to patients at a lower price than a competing medicine from Eli Lilly, as the Danish drugmaker tries to seize market share among consumers paying cash for blockbuster GLP-1 therapies. Novo…
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STAT+: Director of NIH neurological disorders institute is ousted, adding to leadership churn
STAT+: Director of NIH neurological disorders institute is ousted, adding to leadership churn Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, will soon be leaving his role, STAT has learned. His departure in the coming days means nearly half the 27 NIH divisions will have interim leaders. Koroshetz sent an email…
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STAT+: Brain-computer implants are coming of age. Here are 3 trends to watch in 2026
STAT+: Brain-computer implants are coming of age. Here are 3 trends to watch in 2026 Brain-computer interface startups are surging — and poised to expand technologically and geographically. After early feasibility studies and securing breakthrough device designations from the Food and Drug Administration, for several companies’ the future is looking less like a mirage and…
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STAT+: The 3 biggest issues to watch in vaccine policy in 2026
STAT+: The 3 biggest issues to watch in vaccine policy in 2026 WASHINGTON — Vaccine policy has become a key issue for the Trump administration, especially under the leadership of health secretary Robert F. Kennedy Jr., who himself once led an anti-vaccine group. In less than a year, Kennedy has bulldozed vaccine policy precedent and…
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STAT+: Trump moves to require lower drug prices in Medicare
STAT+: Trump moves to require lower drug prices in Medicare You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. The NIH director did the Pete & Bobby fitness challenge, but I didn’t see…
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STAT+: Rolling back health AI transparency rule will shift the burden of vetting to health systems
STAT+: Rolling back health AI transparency rule will shift the burden of vetting to health systems A Trump administration proposal to deregulate artificial intelligence products used in health care would shift the burden of vetting those tools onto health systems that would have to work harder to prove the technology is trustworthy, experts said. In…
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STAT+: Major pharma companies may avoid Medicare experiments’ forced price cuts
STAT+: Major pharma companies may avoid Medicare experiments’ forced price cuts Many of the largest drugmakers may be exempt from Medicare pilot programs intended to force them to lower some of their prices, potentially undermining the effort and depriving American patients of cheaper drugs. Several of the 14 pharmaceutical companies that have struck individual drug-pricing…
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STAT+: Trump administration proposes Medicare pilots to lower drug prices on par with peer countries
STAT+: Trump administration proposes Medicare pilots to lower drug prices on par with peer countries WASHINGTON — The Trump administration proposed two Medicare pilot programs to reduce prices for branded drugs bought at pharmacy counters and administered in doctor offices. If the administration moves forward, the programs could slash Medicare spending on prescription drugs by…
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STAT+: Pharmaceutical industry evades drug price transparency, again
STAT+: Pharmaceutical industry evades drug price transparency, again Drug manufacturers and pharmacy benefit managers received a holiday gift from President Trump on Friday: They still will not have to publicly post the actual prices of prescription drugs, more than five years after federal law required them to do so. Net drug prices — the amounts…
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STAT+: Mass General Brigham bolstered its bottom line. Other Mass. hospital groups reported multimillion losses
STAT+: Mass General Brigham bolstered its bottom line. Other Mass. hospital groups reported multimillion losses Despite uncertainty and concern buffeting Massachusetts hospitals, the state’s largest health system saw its finances improve last year, turning a small operating surplus and receiving a boon from investment income. Mass General Brigham on Friday reported a $59.2 million operating gain…
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STAT+: Drugmakers promise to stockpile certain drugs as part of new drug pricing deals
STAT+: Drugmakers promise to stockpile certain drugs as part of new drug pricing deals WASHINGTON — Brand drugmakers have agreed to donate bulk ingredients to a national stockpile as part of deals with the Trump administration focused on lowering U.S. drug prices to levels available to other wealthy countries. The administration announced Friday that nine…
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STAT+: Cytokinetics heart drug wins FDA approval, the biotech’s first
STAT+: Cytokinetics heart drug wins FDA approval, the biotech’s first It took 27 years, but Cytokinetics secured its first U.S. drug approval. On Friday, the Food and Drug Administration cleared the new medicine, called Myqorzo, to treat patients with obstructive hypertrophic cardiomyopathy, an inherited heart disorder. Cytokinetics said it will begin selling Myqorzo in late…
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STAT+: UnitedHealth proclaims audits show it has ‘robust’ procedures, in contrast to findings of independent reviews
STAT+: UnitedHealth proclaims audits show it has ‘robust’ procedures, in contrast to findings of independent reviews UnitedHealth Group said Friday that the consultants it hired to audit its operations, including its practice of applying lucrative diagnosis codes to older adults’ records, found they’re not only “robust,” but “industry leading.” While the reports give a veneer…
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STAT+: Kennedy vaccine adviser to take a new role at CDC on children’s health research
STAT+: Kennedy vaccine adviser to take a new role at CDC on children’s health research WASHINGTON — A vaccine adviser at the Centers for Disease Control and Prevention with ties to health secretary Robert F. Kennedy Jr. is being given a new portfolio that will have him overseeing research into adverse childhood experiences, according to…
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STAT+: NIH funding rates for early-career researchers plunged in 2025, new data show
STAT+: NIH funding rates for early-career researchers plunged in 2025, new data show A Trump administration change to how the National Institutes of Health awards grants has reduced early-stage investigators’ odds of securing funding, new data from the agency show. During the 2025 fiscal year, 18.5% of early-stage researchers who applied for grants equivalent to…
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STAT+: FDA approves brain tumor warning on Depo-Provera label as court battle grows over side effects
STAT+: FDA approves brain tumor warning on Depo-Provera label as court battle grows over side effects The Food and Drug Administration has approved a change to the labeling for a Pfizer birth control shot that warns patients of the risk of meningioma, a tumor in the layers of tissue that cover the brain and spinal…
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STAT+: Meta is urged by state attorneys general to boost enforcement of weight loss drug advertising
STAT+: Meta is urged by state attorneys general to boost enforcement of weight loss drug advertising More than three dozen state attorneys general are urging Meta to better enforce its policies to thwart a “surge of misleading” pharmaceutical and wellness ads for weight loss drugs on Instagram and Facebook. And the state officials also want…
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STAT+: House set to vote on bills to ban gender-affirming care for young people
STAT+: House set to vote on bills to ban gender-affirming care for young people Republicans in Congress are making a renewed push before the end of the year to pass major federal restrictions to gender-affirming care for trans minors. The House is set to consider two bills this week, before lawmakers depart for their holiday…
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STAT+: More drugmakers set to sign pricing deals with Trump on Friday
STAT+: More drugmakers set to sign pricing deals with Trump on Friday WASHINGTON — Several drugmakers are expected to sign pricing agreements with the Trump administration on Friday, according to four people familiar with the plans, who were not authorized to speak publicly. The agreements would be the latest in a series of deals in…
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STAT+: House juggles options for extending ACA subsidies
STAT+: House juggles options for extending ACA subsidies You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. Since the election, Cheryl Hines hasn’t spoken to Larry David, her on-screen husband of 24 years…
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STAT+: Two rare diseases added to newborn screening recommendations
STAT+: Two rare diseases added to newborn screening recommendations Health secretary Robert F. Kennedy Jr. on Tuesday added two deadly rare diseases, Duchenne muscular dystrophy and metachromatic leukodystrophy (MLD), to the list of conditions the government recommends states screen newborns for. The announcement came eight months after Health and Human Services, under Kennedy, disbanded the…
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STAT+: Pharmalittle: We’re reading about obesity drug lawsuits, Ramaswamy’s latest startup, and much more
STAT+: Pharmalittle: We’re reading about obesity drug lawsuits, Ramaswamy’s latest startup, and much more Rise and shine, another busy day is on the way. We can tell because the official mascots got an early start chasing down cats, squirrels, and other creatures darting about the Pharmalot campus. And then there is the noisy parade of…
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STAT+: NIH specifies how grant reviewers should ensure alignment with Trump priorities
STAT+: NIH specifies how grant reviewers should ensure alignment with Trump priorities Signaling a move toward the next phase of change, leaders at the National Institutes of Health have sent new guidance to its staff on how to further move its $39 billion portfolio in alignment with the Trump administration’s priorities. The seven-page guidance, sent…
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STAT+: Trump order blocking state AI laws could slow health AI adoption, leave patients vulnerable
STAT+: Trump order blocking state AI laws could slow health AI adoption, leave patients vulnerable President Donald Trump’s new executive order to block state laws governing artificial intelligence could help the tech industry but hurt health systems looking to adopt AI safely, and leave patients without protection. This order, aimed at maintaining U.S. dominance in…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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STAT+: Medicare routes $16 billion to insurers to offset high drug costs
STAT+: Medicare routes $16 billion to insurers to offset high drug costs The federal government has sent a record $16 billion to health insurers that sell Medicare drug plans, a flashing red sign that prescription drug spending is blowing up far beyond what government officials and insurance experts had expected. The good news for Medicare…
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STAT+: As superbug fears grow, sales of antibiotics used in food-producing livestock rose dramatically last year
STAT+: As superbug fears grow, sales of antibiotics used in food-producing livestock rose dramatically last year Amid fears of superbugs, the sale of medically important antibiotics given to food-producing livestock rose by 16% overall in the U.S. in 2024 from the year before, an increase that prompted advocates to complain that not enough is being…
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STAT+: Acting head of beleaguered mental health agency to depart this week
STAT+: Acting head of beleaguered mental health agency to depart this week Art Kleinschmidt, the official serving as the de facto head of the federal agency overseeing mental health and addiction treatment, is leaving his post on Friday, according to an email reviewed by STAT. Kleinschmidt has led the Substance Abuse and Mental Health Services…
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FDA approves first new gonorrhea drug in decades
FDA approves first new gonorrhea drug in decades The bacterium that causes gonorrhea has been steamrolling its way through all the antibiotics available to treat it, with a single drug, ceftriaxone, left struggling to quell infections. On Thursday, help arrived. Read the rest… Helen Branswell Go to statnews
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STAT+: Europe’s pharma policy shakeup moves forward toward enactment
STAT+: Europe’s pharma policy shakeup moves forward toward enactment LONDON — European policymakers on Thursday unveiled a compromise framework for the biggest shakeup to E.U. pharmaceutical policy in two decades, as they try to strike a balance between expanding faster access to drugs across the continent while encouraging drugmakers to invest. A key point of…
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STAT+: ACA premium spike looms as Senate votes fail, House bill faces long odds
STAT+: ACA premium spike looms as Senate votes fail, House bill faces long odds WASHINGTON — Senators on Thursday failed to pass legislation aimed at controlling health insurance costs for people with Affordable Care Act plans after dueling partisan bills were voted down mostly along party lines. Four Republicans voted for the Democratic bill, while…
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STAT+: Major health insurers to skip J.P. Morgan conference, again
STAT+: Major health insurers to skip J.P. Morgan conference, again For a second straight year, the nation’s largest health insurance companies will not be formally presenting at January’s J.P. Morgan Healthcare Conference, the industry’s premier investor event. Centene, Cigna, CVS Health, Humana, Molina Healthcare, and Oscar Health are not on the initial agenda for the…
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STAT+: Top HHS official evades discussing Trump plan to block state AI laws
STAT+: Top HHS official evades discussing Trump plan to block state AI laws WASHINGTON — During wide-ranging comments on technology Wednesday, deputy health secretary Jim O’Neill demurred when asked about a controversial proposal to prevent states from enforcing local artificial intelligence laws. “I’ll evade, if that’s alright,” said O’Neill. President Trump on Monday indicated in…
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STAT+: In a first, a nonprofit wins FDA approval for rare disease gene therapy
STAT+: In a first, a nonprofit wins FDA approval for rare disease gene therapy The Food and Drug Administration this week granted approval to a new gene therapy for a rare immune disorder, the maker of which is notably not a drug company, but an Italian charity. The authorization of Waskyra on Tuesday for Wiskott-Aldrich…
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STAT+: J&J’s two-drug combo blocked tumors in advanced multiple myeloma
STAT+: J&J’s two-drug combo blocked tumors in advanced multiple myeloma This is the web version of ASH in 30 Seconds, STAT’s report from the American Society of Hematology meeting. And on the last day of ASH, the sun shone once again. Thanks for joining us on this hematology-oncology journey. We hope you’ve enjoyed our coverage.…
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STAT+: Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access
STAT+: Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access In a closely watched case, the U.S. solicitor general has urged the Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs. Skinny labeling refers to…
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STAT+: Biosecure Act advances, but extra ACA subsidies are still up in the air
STAT+: Biosecure Act advances, but extra ACA subsidies are still up in the air You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. The only nice thing about airport downtime is that I…
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STAT+: At ASH, Terns looks like rival to Novartis with drug for chronic myeloid leukemia
STAT+: At ASH, Terns looks like rival to Novartis with drug for chronic myeloid leukemia This is the online version of ASH in 30 Seconds, STAT’s report from the American Society of Hematology meeting. Sign up for the email version here. It rains in Florida. A lot. This ASH meeting started sunny and wonderful, but quickly…
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STAT+: Results in Terns leukemia drug study suggest it could be a successor to Novartis blockbuster
STAT+: Results in Terns leukemia drug study suggest it could be a successor to Novartis blockbuster ORLANDO, Fla. — Terns Pharmaceuticals reported an update Monday on its targeted leukemia drug that maintained and even boosted molecular response rates in advanced-stage patients. The study results, while still early, are likely to draw even more positive attention…
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STAT+: New data from Gilead, Arcellx multiple myeloma CAR-T suggest benefit over rival treatment
STAT+: New data from Gilead, Arcellx multiple myeloma CAR-T suggest benefit over rival treatment ORLANDO, Fla. — With sales of its existing blood cancer CAR-T therapies weakening, Gilead Sciences needs anito-cel, its next CAR-T therapy for multiple myeloma — to succeed more than ever. On Saturday at the annual meeting of the American Society of…
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STAT+: Fulcrum study suggests improved efficacy for higher dose sickle cell pill
STAT+: Fulcrum study suggests improved efficacy for higher dose sickle cell pill Fulcrum Therapeutics said Sunday that a higher dose of its experimental pill for sickle cell disease was more effective at inducing an alternative form of the oxygen-carrying molecule hemoglobin — boosting hopes it could one day provide a simple and effective treatment for…
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STAT+: Incyte study results suggest a new approach to treating myelofibrosis
STAT+: Incyte study results suggest a new approach to treating myelofibrosis ORLANDO, Fla — An experimental drug from Incyte achieved meaningful spleen response rates and improvements in disease symptoms in patients with advanced myelofibrosis, according to study results reported Sunday. The data, while preliminary, should bolster the company’s efforts to develop a new type of…
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STAT+: A promising sickle cell pill and a new way to treat myelofibrosis
STAT+: A promising sickle cell pill and a new way to treat myelofibrosis This is the online version of ASH in 30 Seconds, STAT’s report from the American Society of Hematology meeting. Sign up for the email version here. It’s Day 2 of the ASH meeting. Let’s get straight into the news. Fulcrum study suggests…
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STAT+: Hengrui, BeOne top new analysis of Chinese drug development
STAT+: Hengrui, BeOne top new analysis of Chinese drug development A new report is peeling back the curtain on Chinese pharmaceutical innovation, assessing which companies are best at driving the drug development that’s captured the attention of pharmaceutical executives and investors worldwide. On Sunday, IDEA Pharma and parent company SAI MedPartners released their inaugural China…
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STAT+: ‘Remarkable’ drug results against an aggressive leukemia
STAT+: ‘Remarkable’ drug results against an aggressive leukemia This is the online version of ASH in 30 Seconds, STAT’s report from the American Society of Hematology meeting. Sign up for the email version here. We hear most of the country is freezing. We wouldn’t know. We’re in Orlando, Fla. where the temps are in the…
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STAT+: Cancer detection firm Freenome to go public via $330 million SPAC deal
STAT+: Cancer detection firm Freenome to go public via $330 million SPAC deal Freenome, a Bay Area biotech that is part of the increasingly competitive race to accurately detect cancer early through blood-based tests, announced Friday that it plans to go public to advance the development of tests that can spot individual cancers and several…
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STAT+: Boehringer Ingelheim prepares schizophrenia app for FDA submission after trial results
STAT+: Boehringer Ingelheim prepares schizophrenia app for FDA submission after trial results HANOVER, N.H. — Boehringer Ingelheim this week provided more details about a late stage clinical trial of an app designed to treat under-addressed symptoms of schizophrenia and revealed the company is preparing to submit the app to the Food and Drug Administration for…
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STAT+: Up and down the ladder: The latest comings and goings
STAT+: Up and down the ladder: The latest comings and goings Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is…
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STAT+: In radiology, an early adopter of AI, technology is advancing faster than the field can keep up
STAT+: In radiology, an early adopter of AI, technology is advancing faster than the field can keep up In the massive demonstration arena of Chicago’s McCormick Place conference complex this week, hundreds of computer monitors lit up with every body part and radiological image: fractures in X-rays, breast cancer in mammograms, brain atrophy in MRIs,…
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STAT+: Lawmakers are still far apart on a deal to extend ACA tax credits, and time is running out
STAT+: Lawmakers are still far apart on a deal to extend ACA tax credits, and time is running out WASHINGTON — There was a lot of talk among lawmakers on Thursday about extending the enhanced Affordable Care Act premium tax credits next year. But the prospects of passing legislation still seem dim. The focus on…
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STAT+: Ashish Jha to step down as Brown University public health dean
STAT+: Ashish Jha to step down as Brown University public health dean PROVIDENCE — Ashish K. Jha, one of the nation’s leading public health experts who became a household name during the Covid pandemic, is leaving his post as the dean of the Brown University School of Public Health at the end of this year. Jha, a practicing physician…
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STAT+: Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks
STAT+: Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks NEW YORK — Vinay Prasad, the Food and Drug Administration’s top vaccines regulator, blamed “misleading media narratives” for the escalating criticism of his leadership amid turmoil and plummeting morale at the agency. Prasad’s remarks, delivered Thursday at a New York investor conference closed…
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STAT+: Why so many primary care doctors are switching between two Harvard-affiliated hospital systems
STAT+: Why so many primary care doctors are switching between two Harvard-affiliated hospital systems Six primary care providers at a single Mass General Brigham practice are moving to rival Beth Israel Lahey Health in January, raising to at least 18 the total number of such defections from the state’s largest health care system to the second largest…
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STAT+: Hair loss drug succeeds in Phase 3, but data underwhelms experts
STAT+: Hair loss drug succeeds in Phase 3, but data underwhelms experts A topical hair loss medication successfully built up hair in a Phase 3 trial, according to the results of two late-stage trials released Wednesday. Cosmo Pharmaceuticals, which is based in Dublin, ran the studies on men with a common form of hair loss…
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STAT+: FDA removes longtime over-the-counter drugs regulator from her position
STAT+: FDA removes longtime over-the-counter drugs regulator from her position WASHINGTON — The Food and Drug Administration removed the longtime director of the office of over-the-counter drugs from her position on Wednesday, six agency sources told STAT. Theresa Michele, director of the Office of Nonprescription Drugs, has worked at the FDA since at least 2015.…
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STAT+: Top drug regulator Richard Pazdur set to leave the FDA
STAT+: Top drug regulator Richard Pazdur set to leave the FDA WASHINGTON — Top drug regulator Richard Pazdur has filed papers to retire from the Food and Drug Administration at the end of this month, adding to the turmoil atop the agency. Pazdur informed leaders at the FDA’s drug center of his intention to leave…
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STAT+: ACA tax credits cool, while BIOSECURE heats up
STAT+: ACA tax credits cool, while BIOSECURE heats up You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. MAHA Action has a holiday shop for all your MAHA gift giving needs. Or you can click over…
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STAT+: Top contributors to leading psychiatry journals fail to disclose industry payments, analysis finds
STAT+: Top contributors to leading psychiatry journals fail to disclose industry payments, analysis finds Amid ongoing concern over conflicts of interest that may affect medical practice, a new study found that 14% of the $4.5 million paid to authors in two leading psychiatry journals was undisclosed and nearly all of the payments were made to…
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STAT+: Medicare Advantage plans to gain $13 billion under Trump changes to star ratings
STAT+: Medicare Advantage plans to gain $13 billion under Trump changes to star ratings Medicare Advantage insurers scored a Thanksgiving gift, as President Trump’s Medicare agency added back a bonus system that rewards health plans with consistently high marks. The Centers for Medicare and Medicaid Services also is proposing to eliminate a dozen star ratings…