Category: STAT+
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STAT+: AbbVie to buy Gilgamesh’s psychedelic drug for up to $1.2 billion
STAT+: AbbVie to buy Gilgamesh’s psychedelic drug for up to $1.2 billion AbbVie on Monday said it will buy Gilgamesh Pharmaceuticals’ investigational psychedelic drug to treat major depression, a sign that pharma companies are warming up more to the burgeoning field. The pharma giant will acquire the treatment, called bretisilocin, for up to $1.2 billion,…
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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+: He was 21 when he programmed MyChart. Now he’s the president of Epic
STAT+: He was 21 when he programmed MyChart. Now he’s the president of Epic VERONA, Wis. — Employees at electronic health records giant Epic are occasionally asked to complete an exercise in which they list three people who could replace them. It’s a way of identifying future leaders hidden in the ranks. Does CEO Judy…
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STAT+: FDA says it will publish reports of adverse events tied to drugs on daily basis
STAT+: FDA says it will publish reports of adverse events tied to drugs on daily basis WASHINGTON — The Food and Drug Administration announced Friday that it has begun publishing reports of adverse events concerning drugs and biological products on a daily basis. Previously, the database of the reports, called the FDA Adverse Event Reporting…
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STAT+: Major U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, FDA finds
STAT+: Major U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, FDA finds Cat hair, pests, bacteria, and equipment failures. These were among the concerns of a recent regulatory inspection of a key, but historically troubled, manufacturing plant that Novo Nordisk bought last year as part of its parent company’s…
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STAT+: How Trump may use Democrats’ drug-price negotiation law
STAT+: How Trump may use Democrats’ drug-price negotiation law 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. I’m happy to report that Last Week Tonight with John Oliver did a segment on…
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STAT+: Elevance loses lawsuit over Medicare Advantage quality ratings
STAT+: Elevance loses lawsuit over Medicare Advantage quality ratings A federal judge in Texas struck down Elevance Health’s lawsuit that argued the government unfairly lowered its Medicare Advantage quality ratings — a decision that could cost Elevance $375 million in bonus revenue. U.S. District Judge Mark T. Pittman, appointed by President Trump in 2019, chastised…
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STAT+: Pharmalittle: We’re reading about conflicts on U.S. vaccine panels, pharma DTC sales, and much more
STAT+: Pharmalittle: We’re reading about conflicts on U.S. vaccine panels, pharma DTC sales, and much more Top of the morning to you, and a fine one it is. Blue skies and unusually cool breezes for this time of year are enveloping the Pharmalot campus, where the official mascots are bounding about the grounds in search…
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STAT+: Conflicts among CDC and FDA vaccine panel members are not as numerous as you think, study finds
STAT+: Conflicts among CDC and FDA vaccine panel members are not as numerous as you think, study finds Conflicts of interest on federal government vaccine panels have declined to “historically low levels” in recent years according to a new study, findings that are likely to increase debate over a contentious issue pushed by Health and…
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STAT+: Pharmalittle: We’re reading about a setback for Pfizer, a boost for Novo Nordisk, and much more
STAT+: Pharmalittle: We’re reading about a setback for Pfizer, a boost for Novo Nordisk, and much more Good morning everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of deadlines, online meetings, and phone calls has predictably returned. But what can you do?…
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STAT+: Novo Nordisk’s obesity drug Wegovy cleared to treat MASH
STAT+: Novo Nordisk’s obesity drug Wegovy cleared to treat MASH Novo Nordisk’s obesity drug Wegovy was cleared by U.S. regulators on Friday to treat an increasingly common liver disease, adding to the list of conditions for which the blockbuster therapy is now approved. The Food and Drug Administration granted accelerated approval to Wegovy for patients…
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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+: MIT president Sally Kornbluth responds to Globe report on academic fraud case at Duke
STAT+: MIT president Sally Kornbluth responds to Globe report on academic fraud case at Duke MIT President Sally Kornbluth responded in a statement Wednesday to a Globe report detailing her time as an administrator at Duke amid a cancer research scandal more than a decade ago, saying she learned lessons from the case that “have powerfully shaped my approach to…
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STAT+: Eli Lilly says it will raise drug prices in Europe to ‘make them lower’ in U.S.
STAT+: Eli Lilly says it will raise drug prices in Europe to ‘make them lower’ in U.S. Eli Lilly said Thursday that it would increase the prices of medicines in Europe and other developed markets “in order to make them lower” in the U.S., an apparent response to the Trump administration’s calls to do so.…
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STAT+: Drugmakers form new group to lobby on impact of Medicare drug price negotiations
STAT+: Drugmakers form new group to lobby on impact of Medicare drug price negotiations WASHINGTON — A handful of drug companies have formed a group to present lawmakers with research on what the industry sees as the negative impacts of Medicare drug price negotiations, according to lobbying records. The group is called the IRA Watchdog…
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STAT+: OpenAI can’t have it both ways on GPT-5 and health
STAT+: OpenAI can’t have it both ways on GPT-5 and health 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. Last week, I noticed that something had punched a hole through the roof overhang…
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STAT+: Duke scientists seemed to have developed a ‘Holy Grail’ of cancer treatment. Then the truth came out
STAT+: Duke scientists seemed to have developed a ‘Holy Grail’ of cancer treatment. Then the truth came out By the time Walter and Juliet Jacobs went to see Dr. Anil Potti, Juliet’s lung cancer was spreading through her torso. She was short of breath, could no longer play tennis, and was afraid she wouldn’t make…
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STAT+: Insmed’s lung disease drug approved in the U.S.
STAT+: Insmed’s lung disease drug approved in the U.S. Insmed on Tuesday received Food and Drug Administration clearance for the first treatment for a chronic lung disease, opening the biotech up to what could be a multibillion-dollar product. Insmed will sell the daily pill, brensocatib, under the brand name Brinsupri for bronchiectasis. The approval comes…
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STAT+: As AI spreads through health care, is the technology degrading providers’ skills?
STAT+: As AI spreads through health care, is the technology degrading providers’ skills? The AI colonoscopy tool rolled out across four health centers. As endoscopists snaked a camera through patients’ large intestines, the algorithm would draw a square around precancerous polyps known as adenomas. The more adenomas detected and removed, the less likely the patient…
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STAT+: Challenges mount for RFK Jr. and his MAHA agenda
STAT+: Challenges mount for RFK Jr. and his MAHA agenda WASHINGTON — A deadly shooting at one of the public health agencies that Robert F. Kennedy Jr. vilified during his rise to power is proving to be a unique test of his leadership, at a time when fractures are emerging in his Make America Healthy…
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STAT+: Prasad returns to the FDA, Attack on the CDC
STAT+: Prasad returns to the FDA, Attack on the CDC 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. Normally I keep the intro to this newsletter light-hearted. But today I feel compelled…
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STAT+: Scientific panel puts new guardrails around stem cell-based embryo models
STAT+: Scientific panel puts new guardrails around stem cell-based embryo models An influential scientific panel is pumping the brakes on stem cell-based embryo models — an umbrella term for the increasingly complex structures researchers are building from stem cells and growing in the lab to mimic aspects of embryonic development. In new guidelines released Monday,…
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STAT+: Dear Vinay: Please embrace dissent and fade into the background
STAT+: Dear Vinay: Please embrace dissent and fade into the background Dear Vinay: My editors asked me to explain your return to the Food and Drug Administration to readers. But I’m more interested, right now, in giving advice to you. Look, any claim I have to clairvoyance is void. I was surprised as anyone by…
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STAT+: After years of close mentorship, Harvard’s president and Jay Bhattacharya enter dramatic new territory
STAT+: After years of close mentorship, Harvard’s president and Jay Bhattacharya enter dramatic new territory In early May, Harvard president Dr. Alan Garber received a letter from the National Institutes of Health notifying him that hundreds of scientific grants had been rescinded, as the next step in the escalating battle between Harvard and the Trump…
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STAT+: Vinay Prasad returns to the FDA, weeks after his ouster
STAT+: Vinay Prasad returns to the FDA, weeks after his ouster WASHINGTON — Vinay Prasad is returning to the Food and Drug Administration to resume his role overseeing vaccine, gene therapy, and blood product regulation. “At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” Health and…
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STAT+: Trump administration launches investigation into Harvard’s federally funded research patents
STAT+: Trump administration launches investigation into Harvard’s federally funded research patents The U.S. Department of Commerce is opening an investigation into Harvard’s federally funded research programs amid allegations that it failed to follow the law, according to a senior administration official. In a letter sent to Harvard President Alan Garber on Friday, Commerce Secretary Howard…
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STAT+: Advocates urge South Africa to reopen antitrust probe into Vertex Pharmaceuticals
STAT+: Advocates urge South Africa to reopen antitrust probe into Vertex Pharmaceuticals Patient advocacy groups are urging the South African government to reopen an antitrust investigation into Vertex Pharmaceuticals over allegations the company misled authorities into closing a high-profile case last year over access to a cystic fibrosis treatment. Last December, the Competition Commission ruled…
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STAT+: Trump executive order seeks to centralize control of grantmaking under political appointees
STAT+: Trump executive order seeks to centralize control of grantmaking under political appointees A sweeping new executive order seeks to transform how the federal government awards billions of dollars in research grants by giving President Trump’s political appointees unprecedented power over the projects agencies fund. The order issued Thursday night, titled “Improving Oversight Of Federal…
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In internal FDA town hall, employees raise concerns about staffing, impromptu expert meetings
In internal FDA town hall, employees raise concerns about staffing, impromptu expert meetings WASHINGTON — Top drug regulator George Tidmarsh assured Food and Drug Administration staff this week that he and other leaders are trying to bring operations back to normal. “I know that I’m coming in here at a challenging time,” Tidmarsh said at…
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STAT+: Dewpoint Therapeutics, biotech startup in a once-buzzy field, cuts 70% of staff
STAT+: Dewpoint Therapeutics, biotech startup in a once-buzzy field, cuts 70% of staff Dewpoint Therapeutics, a startup working in the once-buzzy field of biomolecular condensates, laid off most of its staff Thursday. The biotech is cutting around 70% of its workforce, a source told STAT. Dewpoint declined to provide the number of employees who were…
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STAT+: DOJ and UnitedHealth reach settlement on $3.3 billion Amedisys deal
STAT+: DOJ and UnitedHealth reach settlement on $3.3 billion Amedisys deal The Department of Justice and state officials have reached a proposed settlement agreement with UnitedHealth Group and Amedisys that would allow the companies to complete their $3.3 billion combination so long as they agree to sell 164 home health and hospice locations across 19…
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STAT+: Kennedy’s rejection of mRNA vaccines thwarts scientific progress — and threatens national security, experts say
STAT+: Kennedy’s rejection of mRNA vaccines thwarts scientific progress — and threatens national security, experts say Health secretary Robert F. Kennedy Jr.’s decision this week to discontinue funding of the development of messenger RNA vaccines has alarmed scientists, who have warned that it will leave the country far less prepared for future pandemics. But it is…
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STAT+: Unpacking Trump’s approach to health care oversight
STAT+: Unpacking Trump’s approach to health care oversight 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. I was reminded recently of why I dig mass transit upon overhearing the train conductor and…
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STAT+: Exact Sciences acquires rights to rival Freenome’s blood-based colon cancer test
STAT+: Exact Sciences acquires rights to rival Freenome’s blood-based colon cancer test Exact Sciences announced on Wednesday that it acquired the rights to a blood-based colon cancer screening test from rival firm Freenome. Exact is paying Freenome $75 million for exclusive rights in the United States to current and future versions of the Bay Area…
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STAT+: Sarepta hired a Trump-connected firm to lobby on Duchenne treatment
STAT+: Sarepta hired a Trump-connected firm to lobby on Duchenne treatment WASHINGTON — Sarepta Therapeutics, which has come under regulatory pressure over its gene therapy for Duchenne muscular dystrophy, hired a Trump-connected lobbying firm after the death of a teenage boy treated with the drug, according to lobbying disclosure reports. Continue to STAT+ to read…
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STAT+: Health secretary RFK Jr. shuts door on U.S. investment in mRNA vaccine research
STAT+: Health secretary RFK Jr. shuts door on U.S. investment in mRNA vaccine research This is a developing story. It will be updated. Health secretary Robert F. Kennedy Jr. on Tuesday announced that the government’s emergency preparedness agency will no longer fund work on messenger RNA vaccines, delivering a crippling blow to the country’s capacity…
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STAT+: Vertex next-generation pain candidate fails Phase 2 trial
STAT+: Vertex next-generation pain candidate fails Phase 2 trial Vertex Pharmaceuticals said Monday afternoon that its next-generation non-opioid pain reliever failed to significantly outperform placebo in a Phase 2 trial. The experimental drug, codenamed VX-993, is similar to the company’s recently approved pill Journavx but could potentially be given at higher doses and formulated as…
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STAT+: In health insurers’ race to offload unprofitable members, winners begin to emerge
STAT+: In health insurers’ race to offload unprofitable members, winners begin to emerge If you’ve followed health insurance earnings over the past few weeks, you might be experiencing some whiplash. Four of the biggest players — top names like UnitedHealth Group and Elevance — lowered their profit expectations for the year, while two others —…
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STAT+: AIDS activists sue HHS to obtain Gilead settlement over patents for HIV prevention pills
STAT+: AIDS activists sue HHS to obtain Gilead settlement over patents for HIV prevention pills A patient advocacy group is suing the Trump administration for failing to disclose details of a recent settlement with Gilead Sciences over the patent rights to a pair of HIV prevention pills. The deal, which was reached last January, capped…
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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+: Senators leave RFK Jr.’s MAHA agency out of 2026 budget in apparent snub
STAT+: Senators leave RFK Jr.’s MAHA agency out of 2026 budget in apparent snub WASHINGTON — Senate appropriators seemingly snubbed an effort by health secretary Robert F. Kennedy Jr. to reorganize certain primary care and chronic health programs into a new agency known as the Administration for a Healthy America. Instead, a fiscal 2026 budget…
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Trump escalates demands that pharma companies lower their drug prices
Trump escalates demands that pharma companies lower their drug prices President Trump escalated his demands that pharma companies lower U.S. drug prices in line with what other countries pay, sending letters to 17 major drug companies Thursday that called on them to take actions by Sept. 29. He specifically asked the firms to: provide their…
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STAT+: Senate committee endorses NIH budget increase, rebuking Trump administration’s proposed 40% cut
STAT+: Senate committee endorses NIH budget increase, rebuking Trump administration’s proposed 40% cut WASHINGTON — Senators from both parties endorsed a $400 million increase to the budget of the National Institutes of Health on Thursday, in an Appropriations Committee vote that represents a clear rebuke of President Trump’s plan to dramatically reduce the agency’s spending.…
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STAT+: Health care and tech companies promise CMS they’ll make patient data more accessible
STAT+: Health care and tech companies promise CMS they’ll make patient data more accessible On Wednesday, over 60 health tech companies signed a pledge orchestrated by the Centers for Medicare and Medicaid Services to make health data-sharing easier and to build apps for patients to access and act on their health data. CMS Administrator Mehmet…
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STAT+: Using mRNA, scientists overcome a key challenge to HIV vaccines
STAT+: Using mRNA, scientists overcome a key challenge to HIV vaccines The decades-long push to develop an HIV vaccine has been riddled with setbacks. But researchers reported on Wednesday that they have managed to circumvent one of the longstanding challenges to developing protective shots against this complex and crafty virus. Scientists used a messenger RNA-based…
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STAT+: Vinay Prasad was not good for the FDA. But his ouster makes things worse
STAT+: Vinay Prasad was not good for the FDA. But his ouster makes things worse Vinay Prasad’s three-month tenure as one of the top officials at the Food and Drug Administration was bad for medicine. But his forced departure is probably worse. It will likely be celebrated in many corners: by the many people who…
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STAT+: Inside the fall of Vinay Prasad at the FDA
STAT+: Inside the fall of Vinay Prasad at the FDA Vinay Prasad had a problem. Several, actually. His staff at the Food and Drug Administration kept leaking to the press. He was under attack by President Trump’s allies after moving to pull a gene therapy off the market. Democrats were not happy with his Covid…
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STAT+: Top White House pandemic preparedness official resigns, officials say, in sign of broader disarray
STAT+: Top White House pandemic preparedness official resigns, officials say, in sign of broader disarray When reports circulated in February that the White House had selected biosecurity expert Gerald Parker as the head of its Office of Pandemic Preparedness and Response Policy, there was palpable relief among infectious disease experts. As former commander of the…
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STAT+: Preventive care panel could be restructured ‘imminently’ as RFK Jr. vets new members
STAT+: Preventive care panel could be restructured ‘imminently’ as RFK Jr. vets new members WASHINGTON — Health secretary Robert F. Kennedy Jr. could “imminently” overhaul a key federal advisory panel that recommends which preventive services insurers must pay for, according to a person familiar with the plans. The person said that federal health officials are…
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STAT+: UC San Diego Health’s Karandeep Singh on how Trump’s ‘woke AI’ executive order weaponizes DEI
STAT+: UC San Diego Health’s Karandeep Singh on how Trump’s ‘woke AI’ executive order weaponizes DEI In late July, President Trump signed three executive orders relating to artificial intelligence as part of the administration’s push to deregulate AI and promote its use. One of those executive orders, titled “Preventing Woke AI in the Federal Government,”…
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STAT+: U.S. judge blocks first-in-the-nation law barring companies from owning PBMs and pharmacies in Arkansas
STAT+: U.S. judge blocks first-in-the-nation law barring companies from owning PBMs and pharmacies in Arkansas In a closely watched case, a U.S. federal court judge has temporarily blocked a first-in-the-nation law that would prohibit companies that own pharmacy benefit managers from also operating both retail and mail-order pharmacies in Arkansas. The state law is designed…
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STAT+: Pharma firms will face 15% tariffs in Trump’s E.U. trade deal
STAT+: Pharma firms will face 15% tariffs in Trump’s E.U. trade deal WASHINGTON — President Trump’s tariffs on pharmaceuticals coming from the European Union will be set at 15% and will not go into effect until a national security investigation has been completed, according to a White House official familiar with the plans. Once the…
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STAT+: FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt
STAT+: FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt In a sharp reversal, the Food and Drug Administration on Monday said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular dystrophy to some patients. The therapy, called Elevidys, will once…
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STAT+: Hospitals boost their profit expectations for 2025 as health insurers stumble
STAT+: Hospitals boost their profit expectations for 2025 as health insurers stumble Two major investor-owned hospital chains upped their 2025 revenue and profit forecasts this week, in stark contrast to health insurers, who’ve been doing the opposite. HCA Healthcare and Tenet Healthcare, for-profit chains that collectively own 240 hospitals, both said their revenue and profit…
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STAT+: Pharmalittle: We’re watching Europe moving to reject Elevidys, a FDA panel on SSRI risks, and more
STAT+: Pharmalittle: We’re watching Europe moving to reject Elevidys, a FDA panel on SSRI risks, and more Good morning dearest readers, this is Allison, filling in for Mr. Pharmalittle. I’m coming to you with a little bit of coffee envy — yesterday, one of the investors I follow on LinkedIn revealed that he was recently…
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STAT+: HHS orders thimerosal out of all flu vaccines
STAT+: HHS orders thimerosal out of all flu vaccines 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. Alex Hogan did yeoman’s work of taste testing beef-tallow-fried chicken wings and fries, soda pop…
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STAT+: For many Duchenne families, halt to gene therapy is heartbreak upon heartbreak
STAT+: For many Duchenne families, halt to gene therapy is heartbreak upon heartbreak Jennifer Hill Blair recognized the Cincinnati number on her buzzing phone and slipped out of the school meeting, excited to finally learn when her son Cayse would receive a therapy she believed would change his life. Blair, a second-grade teacher in southern…
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STAT+: What’s hot in health AI investing, what’s not…and what’s venture capital?
STAT+: What’s hot in health AI investing, what’s not…and what’s venture capital? 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. I’m finally admitting that I 1) travel a lot — for work and…
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STAT+: After explosive federal report, Congress fears plummeting trust in organ donation
STAT+: After explosive federal report, Congress fears plummeting trust in organ donation WASHINGTON — Members of a congressional oversight committee said Tuesday that they fear public trust in organ donation has been fractured after a federal report found that an organ procurement organization ignored signs of life in patients when authorizing attempted organ removals. The…
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STAT+: Pharmalittle: We’re reading about Sarepta conceding to the FDA, the U.S. transplant system, and more
STAT+: Pharmalittle: We’re reading about Sarepta conceding to the FDA, the U.S. transplant system, and more Good morning everyone, it’s Jason Mast, filling in for Ed again. Here’s a fun fact about drugs, pulled from Anne Harrington’s “The Mind Fixers,” a fascinating history of psychiatry I’ve recently picked up: After Albert Hoffman synthesized LSD, Sandoz…
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STAT+: FDA’s new top drug regulator hails from industry
STAT+: FDA’s new top drug regulator hails from industry 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. I scream! You scream! We all scream for ice cream without artificial dyes! Tell us…
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STAT+: Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says
STAT+: Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says Sarepta Therapeutics, the maker of a gene therapy for Duchenne muscular dystrophy that is being temporarily shelved because of safety concerns, faces an “arduous and treacherous path” to try to get it back onto the market, a senior Food and…
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STAT+: Basic science publications have been falling for a decade. NIH budget cut would likely accelerate the decline
STAT+: Basic science publications have been falling for a decade. NIH budget cut would likely accelerate the decline The number of basic science papers published by recipients of National Institutes of Health grants has been falling since 2013, the year the agency’s budget was cut by 5%, according to a new analysis. President Trump’s budget…
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STAT+: AlphaFold developer Google DeepMind to fund CASP as NIH funding falls short
STAT+: AlphaFold developer Google DeepMind to fund CASP as NIH funding falls short CASP, the protein structure prediction contest that launched DeepMind’s AlphaFold to international fame and a Nobel Prize, has secured temporary funding to continue operations. The organization’s current funding — from the National Institutes of Health — is set to run out in…
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STAT+: The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear
STAT+: The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear In a matter of a few days last week, Sarepta Therapeutics announced major layoffs, acknowledged the death of another patient receiving one of its gene therapies, and was urged by the Food and Drug Administration to suspend shipments of a…
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STAT+: 10 million expected to lose health insurance under Trump’s tax cut law, CBO says
STAT+: 10 million expected to lose health insurance under Trump’s tax cut law, CBO says WASHINGTON — President Trump’s major domestic policy law will result in nearly 10 million more people going without health insurance by 2034, according to the Congressional Budget Office’s estimate on the final law. The law, which included significant cuts 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+: Sarepta Therapeutics crisis is huge blow to Duchenne families, company
STAT+: Sarepta Therapeutics crisis is huge blow to Duchenne families, company Sarepta Therapeutics confronted one of the most serious crises in its history on Friday, as the Food and Drug Administration prepared to ask the company to halt all shipments of its gene therapy for Duchenne muscular dystrophy — a treatment that had been a…
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STAT+: What the GOP’s cuts to public broadcasting have to do with health care policy
STAT+: What the GOP’s cuts to public broadcasting have to do with health care policy WASHINGTON — Congressional Republicans early on Friday morning passed legislation to take back money they had already appropriated for this year, enacting steep cuts to foreign aid and to public broadcasting. And while none of the funding was for domestic…
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STAT+: Judge dismisses Humana’s case over downgraded Medicare Advantage ratings
STAT+: Judge dismisses Humana’s case over downgraded Medicare Advantage ratings A federal judge on Friday tossed out a lawsuit from Humana that attempted to reinstate higher quality ratings to its 2025 Medicare Advantage plans. The ruling jeopardizes billions of dollars in taxpayer-funded bonuses that Humana gets from the government’s star ratings program. However, Humana said…
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STAT+: Kennedy dismisses two top HHS aides
STAT+: Kennedy dismisses two top HHS aides WASHINGTON — Two top aides to Health and Human Services Department Secretary Robert F. Kennedy Jr. were dismissed from their roles this week after just months on the job. Both Heather Flick Melanson, chief of staff, and Hannah Anderson, deputy chief of staff for policy, were let go,…
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STAT+: Sarepta Therapeutics lays off one-third of workforce in drastic cost-cutting move
STAT+: Sarepta Therapeutics lays off one-third of workforce in drastic cost-cutting move Sarepta Therapeutics laid off more than one-third of its workforce, or approximately 500 employees, the company announced Wednesday — a drastic cost-cutting move following the deaths of two teenagers that forced the company to restrict usage of its gene therapy for Duchenne muscular…
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STAT+: RFK Jr. gives vaccine skeptics plum HHS posts
STAT+: RFK Jr. gives vaccine skeptics plum HHS posts 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. Mr. Medicare Dr. Oz suggests 10 minutes of yoga straight out of bed, preferably with…
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STAT+: A troubled Sun Pharma plant fails yet another FDA inspection
STAT+: A troubled Sun Pharma plant fails yet another FDA inspection A Sun Pharmaceutical plant in India that has been repeatedly cited by the U.S. Food and Drug Administration for serious quality control issues failed another inspection last month over concerns the company was not doing enough to prevent medicines from becoming contaminated. The problems…
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STAT+: ViiV expands licensing deal for its HIV drug in low-income countries
STAT+: ViiV expands licensing deal for its HIV drug in low-income countries Once again, ViiV Healthcare has announced steps to widen access to a sought-after HIV medicine in low- and middle-income countries, reflecting ongoing pressure to respond to criticism. Under the latest arrangement, the company is expanding a licensing agreement reached three years ago with…
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STAT+: Pharmalittle: We’re reading about GLP-1 drugs for addiction, FDA funding, and lots more
STAT+: Pharmalittle: We’re reading about GLP-1 drugs for addiction, FDA funding, and lots more Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so-familiar routine of meetings, deadlines, and messages has returned. But what can you do? There is no pause button to stop…
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STAT+: Bionic knee developed by MIT researchers gives amputees a new world of motion
STAT+: Bionic knee developed by MIT researchers gives amputees a new world of motion Thomas Gee, a former gymnast, used to do handstands, perform wheelies on his skateboard, and run around with his three young children. But in 2001, a marble-sized bump on his left leg swelled to the size of a football. Gee was…
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STAT+: Pharmalittle: We’re reading about a FDA offer on drug reviews, a Moderna Covid approval, and more
STAT+: Pharmalittle: We’re reading about a FDA offer on drug reviews, a Moderna Covid approval, 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+: 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+: FDA won’t pay 2024 bonuses to workers who are getting laid off
STAT+: FDA won’t pay 2024 bonuses to workers who are getting laid off 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. I thought the news would slow down after Republicans passed their…
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STAT+: FDA publishes rejection letters sent to drugmakers, with a big caveat
STAT+: FDA publishes rejection letters sent to drugmakers, with a big caveat The Food and Drug Administration on Thursday published more than 200 letters that it sent to companies when it rejected their medicines, focusing attention on what’s often an opaque part of the drug review process. The agency only highlighted letters that went to…
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STAT+: Kennedy abruptly cancels preventive care committee meeting
STAT+: Kennedy abruptly cancels preventive care committee meeting WASHINGTON — Health secretary Robert F. Kennedy Jr. has abruptly canceled a meeting of a key expert panel that evaluates the nation’s preventive care recommendations, according to an email viewed by STAT. The email did not cite a reason. The cancellation of the Thursday meeting of the U.S.…
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STAT+: HHS backtracks on pledge to disclose new vaccine advisers’ conflicts of interest
STAT+: HHS backtracks on pledge to disclose new vaccine advisers’ conflicts of interest WASHINGTON — The Department of Health and Human Services is sitting on information about new vaccine advisers’ conflicts of interest, and seemingly backtracking on its vow to make key disclosure documents public. Agency officials previously said they would release ethics forms for…
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STAT+: Claims of Microsoft’s ‘super-intelligent’ AI diagnosis agent miss the mark, say experts
STAT+: Claims of Microsoft’s ‘super-intelligent’ AI diagnosis agent miss the mark, say experts Over the past few years, many researchers have tried to test large language models’ medical capabilities using questions from the U.S. medical licensure exam, or by feeding them clinical vignettes containing a set amount of information about a given case. Other researchers…
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STAT+: Fed-up and demoralized, FDA staff are leaving.
STAT+: Fed-up and demoralized, FDA staff are leaving. 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. Between innings of the July 4 Chesapeake Baysox game against the Richmond Flying Squirrels there was…
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STAT+: How Republicans sidelined the health care industry and pushed through historic Medicaid cuts
STAT+: How Republicans sidelined the health care industry and pushed through historic Medicaid cuts WASHINGTON — Republicans swiftly approved President Trump’s tax cut bill last week, despite a full-court press from doctors, hospitals, and patients to beat back some of the largest health care cuts in American history — more than $1 trillion in all…
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STAT+: Pharmalittle: We’re reading about Medicare drug negotiations, a Novartis malaria drug, and more
STAT+: Pharmalittle: We’re reading about Medicare drug negotiations, a Novartis malaria drug, and more Rise and shine, another busy — and steamy — day is on the way. We can tell because the official mascots are spending less time on the dusty Pharmalot grounds and, instead, have curled up by the indoor cool-air blowing machines.…
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STAT+: Cogent Biosciences drug improves symptoms of chronic immune disorder, study results show
STAT+: Cogent Biosciences drug improves symptoms of chronic immune disorder, study results show Cogent Biosciences said Monday that its experimental drug reduced the symptoms of a chronic immune disorder called indolent systemic mastocytosis. The results mean the drug achieved the goals of a Phase 3 study, but a comparison to a rival treatment from Blueprint…
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STAT+: HHS devises legal playbook for future grant terminations, internal memo shows
STAT+: HHS devises legal playbook for future grant terminations, internal memo shows As the National Institutes of Health recently paused its campaign to terminate billions of dollars in grants, its parent agency was starting to lay out a more cautious and legally rigorous strategy for canceling research deemed out of step with Trump administration priorities,…
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STAT+: How the tax-cut bill that just passed the Senate would upend health care
STAT+: How the tax-cut bill that just passed the Senate would upend health care WASHINGTON — Senate Republicans passed President Trump’s landmark tax bill Tuesday morning, putting transformational health provisions a major step closer to enactment. The bill slashes health care spending by more than $1 trillion over a decade, cuts that would affect patients,…
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STAT+: Memo said to describe biotech industry meeting calls RFK Jr. a ‘direct threat to public health’
STAT+: Memo said to describe biotech industry meeting calls RFK Jr. a ‘direct threat to public health’ A memo that purports to summarize a meeting held by members of a leading biotech trade group suggests deep concern about health secretary Robert F. Kennedy Jr.’s stance on vaccines, and describes him as a “direct threat to…
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Why this activist is putting her body on the line for Americans with disabilities
Why this activist is putting her body on the line for Americans with disabilities Flanked by her friends as lawmakers debated the future of a 60-year-old health care plan, Latoya Maddox raised her voice, shouting, “No cuts to Medicaid! No cuts to Medicaid!” The chanting, during a meeting of the House Energy and Commerce Committee…