Tag: statnews
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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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Vinay Prasad’s return, animal testing alternatives, and mRNA upended
Vinay Prasad’s return, animal testing alternatives, and mRNA upended Have investors soured on mRNA biotechs? How will Vinay Prasad approach his role at the Food and Drug Administration the second time around? And how do you pronounce “bronchiectasis”? We address all that and more on this week’s episode of “The Readout LOUD.” We discuss the…
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Deconstructing RFK Jr.’s explanation for the cancellation of mRNA vaccine contracts
Deconstructing RFK Jr.’s explanation for the cancellation of mRNA vaccine contracts Last week, health secretary Robert F. Kennedy Jr. announced the cancellation of $500 million in contracts to help develop RNA vaccines. Kennedy explained his reasoning for the cuts in a video posted to X. The video is only 2½ minutes long, but in that…
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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+: Stoke Therapeutics release new data on Dravet syndrome drug
STAT+: Stoke Therapeutics release new data on Dravet syndrome drug 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. As AI becomes more widely used in health care, could it actually lead doctors to lose some of their skills? One new…
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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+: 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+: 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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CDC leaders attempt to reassure staff after shooting, but meeting is brief
CDC leaders attempt to reassure staff after shooting, but meeting is brief The newly installed director of the Centers for Disease Control and Prevention on Tuesday sought to reassure employees their mission would continue and efforts to ensure their safety would be stepped up following a gunman’s attack on the agency’s headquarters last Friday. The…
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NIH director: mRNA vaccine contracts were canceled because public lacks trust in technology
NIH director: mRNA vaccine contracts were canceled because public lacks trust in technology The head of the National Institutes of Health has offered a new explanation for why the federal government canceled $500 million in contracts to help develop messenger RNA vaccines, saying the platform is not viable because the public doesn’t trust it. The…
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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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In internal call, CDC employees recount shooting, ask about RFK Jr.’s response
In internal call, CDC employees recount shooting, ask about RFK Jr.’s response WASHINGTON — Leaders of the Centers for Disease Control and Prevention on Saturday told staff that the agency’s campus had reopened in the wake of the Friday attack by a gunman — and suggested more security measures would be put in place. On…
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CDC shaken after gunman attacks its headquarters
CDC shaken after gunman attacks its headquarters This article was updated on Aug. 9. A gunman attacked the main campus of the Centers for Disease Control and Prevention in Atlanta on Friday, further shaking an agency in the midst of a tumultuous year. Read the rest… Daniel Payne Go to statnews
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Opinion: Trump’s firing of the Bureau of Labor Statistics commissioner puts crucial health data at risk
Opinion: Trump’s firing of the Bureau of Labor Statistics commissioner puts crucial health data at risk In early July, I began teaching a summer course: introductory biostatistics for an accelerated master’s of public health program. Most of the students are clinicians, and biostatistics is (understandably) not often the favorite course. On day one, I told…
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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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Opinion: Former surgeon general: The CDC shooting must be a wakeup call
Opinion: Former surgeon general: The CDC shooting must be a wakeup call At approximately 4:50 p.m. on Friday, a gunman opened fire at the Centers for Disease Control and Prevention headquarters in Atlanta. The attack left bullet holes in office windows and claimed the life of DeKalb County police officer David Rose. Authorities believe the…
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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+: 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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HHS cites list of studies as scientific justification for cancellation of mRNA vaccine contracts
HHS cites list of studies as scientific justification for cancellation of mRNA vaccine contracts WASHINGTON — Federal health officials are citing an extensive list of studies purported to document harms caused by messenger RNA vaccines as scientific justification for canceling hundreds of millions of dollars in investment in the technology. Health secretary Robert F. Kennedy…
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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+: 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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Closing a zombie biotech, and Lilly’s disappointing obesity readout
Closing a zombie biotech, and Lilly’s disappointing obesity readout How does a biotech company decide to shut itself down? Why does Eli Lilly have so much riding on its oral obesity candidate? And what’s the outlook for Vertex’s pain franchise? We discuss that and more on this on this week’s episode of “The Readout LOUD,”…
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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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Lithium, a treatment for bipolar disorders, might be a key to Alzheimer’s disease
Lithium, a treatment for bipolar disorders, might be a key to Alzheimer’s disease A new study finds that the element lithium plays a crucial role in healthy brain function and suggests it could be used to treat Alzheimer’s disease. In a Nature study published on Wednesday, researchers found that the brain produces lithium, and that…
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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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Opinion: Trump deserves the Nobel Peace Prize for Operation Warp Speed’s global impact
Opinion: Trump deserves the Nobel Peace Prize for Operation Warp Speed’s global impact Cambodia recently announced that it plans to nominate President Trump for the Nobel Peace Prize. In response, White House press secretary Karoline Leavitt, naming other conflicts that Trump has “ended,” said that, “It’s well past time that President Trump was awarded the…
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Scientific innovation is driving hope for progress in women’s health, but experts warn of headwinds
Scientific innovation is driving hope for progress in women’s health, but experts warn of headwinds Scientific breakthroughs — from next-generation vaccines to long-acting medications to prevent HIV — are fueling new hope in women’s health. But experts warn that persistent gaps in funding and access could stall that progress. At a STAT event this week, Ruanne…
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STAT+: MAGA social media influencers meet dark money
STAT+: MAGA social media influencers meet dark money 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. Dr. Oz was on Martha Stewart’s podcast to discuss Medicare’s 60th anniversary. She baked a birthday…
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Trump administration violated impoundment law by canceling NIH grants, slowing new awards, GAO finds
Trump administration violated impoundment law by canceling NIH grants, slowing new awards, GAO finds In a scathing report issued Tuesday, the Government Accountability Office found that the Trump administration, by abruptly canceling National Institutes of Health grants, had violated a 1974 law blocking presidents from withholding funding Congress has approved. The independent congressional watchdog said…
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Why record numbers of readers are flocking to STAT
Why record numbers of readers are flocking to STAT Dear Readers, The news seems unrelenting these days, and when it comes to health and medicine, it’s all the more relevant to our daily lives than ever before — affecting the prices of the drugs we take, the potential of the next medical innovation to change…
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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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Gates Foundation pledges $2.5 billion to women’s health initiatives
Gates Foundation pledges $2.5 billion to women’s health initiatives The Gates Foundation said Monday that it would commit $2.5 billion through 2030 to support dozens of different approaches for improving women’s health, from new medicines to prevent maternal mortality to vaccines to curb infections that disproportionately affect women. The figure represents an increase of about…
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How healthy are ‘good-for-you’ ultra-processed foods?
How healthy are ‘good-for-you’ ultra-processed foods? Not all ultra-processed foods are bad for you. But if you’re trying to lose weight, it’s still probably better to opt for nutritious minimally processed foods over protein bars and high-fiber breakfast cereals, according to a new study. The study, published Monday in Nature Medicine, builds on a growing…
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Screening guideline change led to more colorectal cancers being detected early in younger adults
Screening guideline change led to more colorectal cancers being detected early in younger adults Over the last decade, researchers began to notice a sharp increase in the number of young patients coming in with colorectal cancer — often with more advanced disease. The trend spurred organizations like the U.S. Preventive Services Task Force to eventually…
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Opinion: STAT readers debate involuntary commitment, Sarepta, and more
Opinion: STAT readers debate involuntary commitment, Sarepta, and more First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others. To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to the Editor…
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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+: Trump demands drugmakers slash U.S. price now
STAT+: Trump demands drugmakers slash U.S. price now 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, and happy birthday to me! Today, we see the Senate Appropriations Committee look to increase NIH funding, despite the Trump administration’s request to slash…
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FDA to stress opioids’ risk of overdose, death in new medication safety labels
FDA to stress opioids’ risk of overdose, death in new medication safety labels The Food and Drug Administration will soon require prescription opioid manufacturers to include stronger language on the medications’ labels warning that higher doses and longer-term use carry risks including overdose and death. The action, announced Thursday, comes nearly three months after a…
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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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What Vinay Prasad’s ouster means for biotech and the FDA
What Vinay Prasad’s ouster means for biotech and the FDA This week’s show is focused on a single topic — the ouster of Food and Drug Administration official Vinay Prasad from his job running the agency’s biologics division. This surprising development came after a series of controversial decisions he made on Sarepta’s gene therapy for…
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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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Opinion: Vinay Prasad is my former student and friend. His departure from FDA is a loss for American medicine
Opinion: Vinay Prasad is my former student and friend. His departure from FDA is a loss for American medicine A version of this piece first appeared in Sensible Medicine. Vinay Prasad, Marty Makary, and Adam Cifu, among others, were founding members of Sensible Medicine. After news came out that Vinay Prasad would be leaving the…
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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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Tobacco use, binge drinking decrease as Americans consume more marijuana, survey finds
Tobacco use, binge drinking decrease as Americans consume more marijuana, survey finds Americans are binge drinking and smoking tobacco less but consuming marijuana significantly more, according to a new federal survey on drug use and mental health. Overall, roughly 48.4 million Americans, or 16.8% of the population, met the criteria for a substance use disorder…
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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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Major Alzheimer’s group says some blood tests may be used in place of brain scans for diagnosis
Major Alzheimer’s group says some blood tests may be used in place of brain scans for diagnosis A major Alzheimer’s disease medical group is recommending that specialists may use certain blood tests to help diagnose patients with cognitive impairment in lieu of more complex and invasive tests, a move that could lead more people to…
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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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Kennedy, disability advocates paint very different realities as ADA turns 35
Kennedy, disability advocates paint very different realities as ADA turns 35 Stirring speeches filled the tall, fluorescent room on Monday morning as members of the disability community and federal officials celebrated the 35th anniversary of the passage of the Americans with Disabilities Act. They spoke at length about how the landmark law birthed critical protections…
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Judge blocks Trump administration’s efforts to defund Planned Parenthood
Judge blocks Trump administration’s efforts to defund Planned Parenthood A federal judge on Monday ruled Planned Parenthood clinics nationwide must continue to be reimbursed for Medicaid funding as the nation’s largest abortion provider fights President Donald Trump’s administration over efforts to defund the organization in his signature tax legislation. The new order replaces a previous…
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Trump targets supervised consumption of drugs and harm reduction in executive order
Trump targets supervised consumption of drugs and harm reduction in executive order President Trump is threatening to withhold funds from supervised drug consumption sites and potentially pursue criminal penalties against them, offering his clearest stance yet against the philosophy of harm reduction and marking a significant escalation of his rhetoric on substance use and addiction. …
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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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Trump eyes involuntary commitment to end homelessness
Trump eyes involuntary commitment to end homelessness Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. Saturday marks the 35th anniversary of the Americans with Disabilities Act. Some folks in the disability community are spending it at a 60-hour rally pushing back against Medicaid cuts in honor…
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STAT+: FDA panel stirs backlash for SSRI use during pregnancy
STAT+: FDA panel stirs backlash for SSRI use during pregnancy Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we discuss how Duchenne patients and their families are responding to the shelving of Sarepta Therapeutics’ gene therapy, see an FDA panel…
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Safety of fluoride supplements, and freedom of choice, debated at FDA meeting
Safety of fluoride supplements, and freedom of choice, debated at FDA meeting As Robert F. Kennedy Jr. has advocated for the removal of fluoride from water, he has framed it as an issue of medical freedom. “We shouldn’t be demanding that parents accept something for their children and in their homes that is essentially a…
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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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Opinion: The U.S. must reconsider its decision to reject amendments to a global health treaty
Opinion: The U.S. must reconsider its decision to reject amendments to a global health treaty Last week, the Trump administration rejected the 2024 amendments to the International Health Regulations (IHR) — a global treaty that the United States has been a part of since 2007. The rejection cited concerns about sovereignty, scientific freedom, and World…
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A mother’s perspective on Sarepta’s gene therapy halt
A mother’s perspective on Sarepta’s gene therapy halt How are families of patients reacting to the removal of Sarepta’s gene therapy from the market? Why are investors excited about narcolpesy drugs? And why has there been less financing in oncology startups? We chat about all that and more on this on this week’s episode of…
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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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HHS Secretary RFK Jr. accepts recommendations to drop thimerosal from U.S. flu vaccines
HHS Secretary RFK Jr. accepts recommendations to drop thimerosal from U.S. flu vaccines Health and Human Services Secretary Robert F. Kennedy Jr. on Tuesday formally accepted recommendations that would require all vaccine manufacturers to discontinue using the preservative thimerosal in influenza vaccines. A statement issued by the department on Wednesday called the move the fulfillment…
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New study advances theory on why most U.S. bird flu cases have so far been mild
New study advances theory on why most U.S. bird flu cases have so far been mild The H5N1 bird flu virus has historically extracted a heavy toll when it infects humans, with nearly half of confirmed cases ending in death over the past three decades. But of the 70 cases reported in the United States…
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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+: FDA opens applications for new voucher program
STAT+: FDA opens applications for new voucher program 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. We’ve got more developments with Sarepta today. My colleagues got exclusive comments from a senior FDA official — read on for what the official said.…
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Researchers sequence complex parts of human genome, expanding the future of precision medicine
Researchers sequence complex parts of human genome, expanding the future of precision medicine Complex regions of the human genome remained uncharted, even after researchers sequenced the genome in its entirety. That is, until today. Researchers decoded DNA segments involved in the development of diseases like diabetes and spinal muscular atrophy that had previously been considered…
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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+: 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+: 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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For people with diabetes, even a little activity every week is tied to better health
For people with diabetes, even a little activity every week is tied to better health Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. Good morning! It’s Lev Facher, filling in for Theresa. Let’s get to today’s news. Read the rest… Lev Facher Go to statnews
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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+: 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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Opinion: A sloppy report on mifepristone is being used to undermine the FDA — and the biotech industry
Opinion: A sloppy report on mifepristone is being used to undermine the FDA — and the biotech industry For decades, the Food and Drug Administration has partnered with clinicians and industry to deliver evidence-based medical innovations using a gold-standard framework for drug development and oversight. The agency has the authority to review any approved drug,…