Tag: statnews
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Post-TIGIT flop, iTeos Therapeutics is shuttering
Post-TIGIT flop, iTeos Therapeutics is shuttering 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 look at the implications of BARDA cutting a major vaccine contract with Moderna, hear why former FDA chief Scott Gottlieb thinks agency layoffs will impede…
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STAT+: PillPack founders’ new health care marketplace has deep roots with Amazon
STAT+: PillPack founders’ new health care marketplace has deep roots with Amazon A new digital health care marketplace, launched last week, has a good amount of Amazon in its DNA. General Medicine, with $32 million in funding, came out of stealth with three former Amazon employees as co-founders and investors, a business model that could…
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STAT+: HHS cancels nearly $600 million Moderna contract on vaccines for flu pandemics
STAT+: HHS cancels nearly $600 million Moderna contract on vaccines for flu pandemics This story will be updated The Department of Health and Human Services has notified Moderna that it is canceling a nearly $600 million contract with the company to develop, test, and license vaccines for flu strains that could trigger future pandemics, including…
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Lilly to acquire biotech developing pain drugs
Lilly to acquire biotech developing pain drugs 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’re seeking nominations for our annual Wunderkinds list, which aims to honor some of the most promising early-career scientists out there. If you have someone in mind, submit…
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Amid measles outbreak, Texas is poised to make vaccine exemptions for kids easier
Amid measles outbreak, Texas is poised to make vaccine exemptions for kids easier AUSTIN, Texas — Texas this year has been the center of the nation’s largest measles outbreak in more than two decades, as a mostly eradicated disease has sickened more than 700 in the state, sent dozens to hospitals and led to the death of two children…
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Opinion: Former FDA commissioner: ‘Cost-cutting’ may undo one of Trump’s best drug pricing achievements
Opinion: Former FDA commissioner: ‘Cost-cutting’ may undo one of Trump’s best drug pricing achievements President Trump often touted during his first term that his administration had “approved more affordable generic drugs than any administration in history.” He had good reason to highlight these accomplishments. Over the first two years of his presidency, the Food and…
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RFK Jr. rolls back Covid vaccine recommendations for healthy children, pregnant people
RFK Jr. rolls back Covid vaccine recommendations for healthy children, pregnant people Health secretary Robert F. Kennedy Jr. announced Tuesday that he has unilaterally struck the recommendation that healthy children and healthy pregnant people get Covid-19 booster shots — a move that experts say is unprecedented. Kennedy made the announcement on the social media site X,…
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STAT+: What’s already been lost from CDC layoffs
STAT+: What’s already been lost from CDC layoffs 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. Summer holiday weekends are a challenge. Do I seek a “relaxing” long weekend sitting in traffic…
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STAT+: Young scientists say they may abandon research as their career options shrink amid Trump cuts
STAT+: Young scientists say they may abandon research as their career options shrink amid Trump cuts Becks Padrusch‘s fondest memories growing up were of trips to Boston’s Museum of Science, where the Arlington native got to touch animal organs and watch with fascination as chickens hatched in incubators. As a toddler, Padrusch, who uses they/them pronouns,…
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STAT+: Lawmaker wants to know how FDA can police drug ads after cutting its oversight workforce
STAT+: Lawmaker wants to know how FDA can police drug ads after cutting its oversight workforce Amid ongoing controversy over pharmaceutical advertising, one lawmaker wants to know how the U.S. government will enforce regulations after the Food and Drug Administration let go of numerous employees from the office that oversees prescription drug promotions. In a…
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STAT+: What Baby KJ means for the CRISPR gene editing industry
STAT+: What Baby KJ means for the CRISPR gene editing industry For the ailing gene editing industry, hope came earlier this month in the tiny, smiling, fuzzy-headed form of KJ Muldoon. At just 6 months old, KJ received a gene editing treatment custom-built to correct his unique mutation. He’s not cured, researchers explained at the…
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STAT+: Harvard is the most celebrated university in the world. Will Trump’s international student ban derail that standing?
STAT+: Harvard is the most celebrated university in the world. Will Trump’s international student ban derail that standing? Harvard University has long stood on top of the academic world. Thousands from all over seek a coveted spot every year at the Ivy League school with a reputation for cultivating future leaders, from Nobel Prize recipients to…
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Opinion: I’m a dentist from India. The fluoride debate in the U.S. horrifies me
Opinion: I’m a dentist from India. The fluoride debate in the U.S. horrifies me Florida has just banned fluoride in public water, becoming the second state to do so. It’s part of decadeslong battle that has heated up in recent years. Local governments debate whether it belongs in the water supply. Parents question safety. Pseudoscience…
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STAT+: Reeling from Trump contract cuts, the National Academies prepares for ‘a fairly radical downsizing’
STAT+: Reeling from Trump contract cuts, the National Academies prepares for ‘a fairly radical downsizing’ The National Academies of Sciences, Engineering, and Medicine is headed for a major reorganization as it tries to reduce its overhead amid big losses in funding from the federal government. Facing a shortfall of roughly $40 million in terminated contracts,…
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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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New budget bans Medicaid coverage of trans gender-affirming care
New budget bans Medicaid coverage of trans gender-affirming care Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. Good morning. It’s Liz again, wondering why May looks and feels like March in Boston. Read the rest… Elizabeth Cooney Go to statnews
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STAT+: Pharmalittle: We’re reading about Trump’s drug-pricing claims, FDA’s Covid vaccine directive, and more
STAT+: Pharmalittle: We’re reading about Trump’s drug-pricing claims, FDA’s Covid vaccine directive, 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, but we expect to manicure…
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GSK drug’s new approval sets up competition with Dupixent
GSK drug’s new approval sets up competition with Dupixent 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. Apologies that this newsletter is coming late to you this morning — we had some technical difficulties. But we’ve still got the news…
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STAT+: How Trump’s tax cut bill would reshape health care
STAT+: How Trump’s tax cut bill would reshape health care WASHINGTON — The House passed President Trump’s tax-cutting plan early Thursday morning with the attendant health care measures to partially pay for it. Relative to earlier drafts, GOP lawmakers revised the bill to further cut government spending, discourage Medicaid expansion, and potentially restrict coverage of…
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FDA advisory panel split on whether agency should require updates of Covid-19 vaccine
FDA advisory panel split on whether agency should require updates of Covid-19 vaccine The Food and Drug Administration’s expert vaccine panel appeared split Thursday on whether Covid-19 vaccine manufacturers should be advised to update the strain of the virus that their products target, with some favoring recommending a newer version of the virus and others…
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Opinion: The FDA is circumventing key roles and procedures for licensure and use of Covid vaccines
Opinion: The FDA is circumventing key roles and procedures for licensure and use of Covid vaccines The Food and Drug Administration’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory processes. The first sign of trouble was the failure to rule on the licensure of the Novavax protein-based Covid-19 vaccine…
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Uncertainty in CRISPR world and the start of more M&A
Uncertainty in CRISPR world and the start of more M&A What was the mood like at a big gene therapy conference last week? Why is Novo Nordisk’s CEO stepping down? And why has Adam been in such a good mood? We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s…
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STAT+: Merus drug, with immunotherapy, shows preliminary survival boost for patients with head and neck cancer
STAT+: Merus drug, with immunotherapy, shows preliminary survival boost for patients with head and neck cancer Merus said Thursday that a combination of its experimental drug petosemtamab with the checkpoint inhibitor Keytruda has kept 79% of patients with newly diagnosed metastatic head and cancer alive for at least one year, according to a new analysis…
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STAT+: Five burning questions on the FDA’s new Covid-19 vaccine framework
STAT+: Five burning questions on the FDA’s new Covid-19 vaccine framework WASHINGTON — Food and Drug Administration Commissioner Marty Makary promised stakeholders last week that the agency’s new Covid-19 vaccine framework would answer all of their questions. But the framework has perhaps created as much confusion as clarity. Broadly, the FDA said it will limit approval…
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How do we know mRNA vaccines are safe and effective? An explainer
How do we know mRNA vaccines are safe and effective? An explainer Messenger RNA vaccines fueled the response to the worst pandemic the world has faced in a century and led to a Nobel Prize. This week, they’re set to face intense scrutiny from critics doubtful of the safety and efficacy of these shots. On…
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LGBTQ+ researchers sue HHS, NIH over grant cuts
LGBTQ+ researchers sue HHS, NIH over grant cuts A group of physicians and researchers working on LGBTQ+ health sued the National Institutes of Health and the Department of Health and Human Services Tuesday over the sweeping grant terminations that have impacted medical research on queer people as part of the implementation of President Trump’s executive…
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STAT+: Trump, building on Biden policy, to speed up audits of Medicare Advantage insurers
STAT+: Trump, building on Biden policy, to speed up audits of Medicare Advantage insurers President Trump’s federal Medicare agency will expedite audits of Medicare Advantage insurers, a move that could claw back nearly $500 million a year for taxpayers, according to previous federal estimates. However, the audits remain mired in a two-year-old lawsuit initiated by…
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STAT+: ASCO and Google create ‘walled garden’ AI tool for doctors to query group’s guidelines
STAT+: ASCO and Google create ‘walled garden’ AI tool for doctors to query group’s guidelines The American Society of Clinical Oncology, the largest professional organization in cancer care, announced Wednesday that it had partnered with Google Cloud to develop an AI-based tool to help physicians rapidly question the organization’s guidelines on best practices in diagnosing…
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New FDA framework on Covid vaccines leaves pediatricians confused and concerned
New FDA framework on Covid vaccines leaves pediatricians confused and concerned A new framework for Covid-19 vaccines announced by Food and Drug Administration leaders Tuesday suggests the agency will no longer approve new Covid vaccines for healthy individuals under 65, including babies, without data from new randomized clinical trials showing their benefit. The plan —…
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Blunt Rochester presses RFK Jr. on CDC acting director
Blunt Rochester presses RFK Jr. on CDC acting director Sen. Lisa Blunt Rochester has written a stinging letter to Health Secretary Robert F. Kennedy Jr. demanding that he clarify whether the Centers for Disease Control and Prevention has an acting director. In her three-page missive, Blunt Rochester suggested that Matthew Buzzelli, the person Kennedy said…
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STAT+: Maryland governor signs law to expand powers of the state’s prescription drug affordability board
STAT+: Maryland governor signs law to expand powers of the state’s prescription drug affordability board In a notable development, Maryland Gov. Wes Moore signed a bill that will allow a state board to extend its mandate for lowering prescription drug costs to all residents, not just those employed by government agencies. The move was hailed…
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STAT+: RFK Jr. meets with health tech startups, most backed by Andreessen Horowitz
STAT+: RFK Jr. meets with health tech startups, most backed by Andreessen Horowitz Of the seven health tech companies that met with the government’s most powerful health official on Monday, all but one had something in common: Financial backing from one of Silicon Valley’s top venture capital firms. In a post on the social media…
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STAT+: GOP works through unresolved issues on Medicaid work requirements
STAT+: GOP works through unresolved issues on Medicaid work requirements WASHINGTON — Over the weekend, House Republicans discussed squeezing additional savings from Medicaid to pay for President Trump’s tax cuts. Medicaid policy remains one of the main unresolved areas of House Republicans’ budget reconciliation bill. On late Sunday night, Republicans on the House Budget Committee…
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Opinion: I’ve reported on presidents’ health for 53 years. No public evidence suggests Biden’s doctors mishandled prostate cancer testing
Opinion: I’ve reported on presidents’ health for 53 years. No public evidence suggests Biden’s doctors mishandled prostate cancer testing News of former President Biden’s aggressive and incurable prostate cancer has surprised the public (and presumably him). Based on the public record of Biden’s medical care and standard medical recommendations, as recently as a year ago there was…
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Private funder HHMI pauses postdoc fellowship
Private funder HHMI pauses postdoc fellowship Molecular biologist Chiara Masnovo spent weeks filling out an application for a research fellowship earlier this year — taking it over the finish line as she was 38 weeks pregnant and starting a new job. The chance of getting this fellowship was well worth the toil. The Hanna Gray fellowship,…
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Trump’s science adviser calls for return to ‘gold-standard’ research to kickstart stalled advances
Trump’s science adviser calls for return to ‘gold-standard’ research to kickstart stalled advances President Trump’s science adviser, Michael Kratsios, called for a return to reproducible and transparent research to kickstart what he characterized as years of stalled scientific progress, in his first detailed public remarks on science policy since taking office in March. Kratsios, who…
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Former President Biden diagnosed with aggressive prostate cancer
Former President Biden diagnosed with aggressive prostate cancer WASHINGTON — Former President Joe Biden has been diagnosed with prostate cancer, his office said Sunday. Biden was seen last week by doctors after urinary symptoms and a prostate nodule was found. He was diagnosed with prostate cancer on Friday, with the cancer cells having spread to…
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STAT+: Novavax wins narrowed approval for its Covid-19 shot after delay
STAT+: Novavax wins narrowed approval for its Covid-19 shot after delay The Food and Drug Administration has finally approved Novavax’s Covid-19 vaccine, but in doing so has placed restrictions on it that its two competitors in the U.S. market do not face. The long-awaited license limits use of the vaccine to people 65 and older…
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STAT+: Trump is moving to terminate hundreds of federal grants across Harvard
STAT+: Trump is moving to terminate hundreds of federal grants across Harvard In yet another escalation of its fight against higher education, the Trump administration has moved to terminate hundreds of research grants at Harvard University and its medical school, imperiling dozens of research projects and potentially upending the futures of young scientists. Harvard researchers studying cancer,…
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STAT+: UnitedHealth’s Optum working on Medicare risk scoring system that would use AI
STAT+: UnitedHealth’s Optum working on Medicare risk scoring system that would use AI SAN DIEGO — Optum, the health data and care provider division of UnitedHealth Group, is developing a way to calculate how sick Medicare patients are through artificial intelligence, instead of relying solely on diagnosis codes submitted by physicians. Ken Cohen, a physician…
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FDA clears first blood test for diagnosing Alzheimer’s
FDA clears first blood test for diagnosing Alzheimer’s The Food and Drug Administration approved on Friday the first blood test for diagnosing Alzheimer’s disease, opening up a quicker way for patients to get detected for the neurological condition and receive treatment. The test, developed by Japan-based Fujirebio Diagnostics, uses a blood sample to detect the…
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STAT+: At gene therapy meeting, no one wants to talk about the Vinay Prasad (not) in the room
STAT+: At gene therapy meeting, no one wants to talk about the Vinay Prasad (not) in the room NEW ORLEANS — Last year, hundreds of people poured in to see Peter Marks, the Food and Drug Administration’s head of biologics, speak at the American Society of Gene and Cell Therapy conference. The regulator was seen by…
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Does the CDC have an acting director?
Does the CDC have an acting director? Earlier this week, Lisa Blunt Rochester asked a seemingly simple question of Robert F. Kennedy Jr. during his testimony to the Senate’s Health, Education, Labor, and Pensions Committee: “Who is the acting CDC director?” Kennedy, the secretary of Health and Human Services, offered the name “Matt Buzzelli,” who…
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STAT+: Day 3 at ASGCT: Vinay Prasad speculation, screening newborns, promising data
STAT+: Day 3 at ASGCT: Vinay Prasad speculation, screening newborns, promising data NEW ORLEANS — Greetings from the home stretch of American Society of Gene and Cell Therapy conference, where everyone is still talking about Baby KJ and no one wants to talk about Vinay Prasad. The Vinay Prasad in the room Last year, hundreds…
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STAT+: MAHA has a new think tank. The Trump administration is listening
STAT+: MAHA has a new think tank. The Trump administration is listening The Make America Healthy Again movement is coalescing around a new effort to turn its goals into federal policy. The Trump administration is listening. The MAHA Institute, a policy center launched Thursday, is pushing to change the American health and food systems: from…
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HHS to stop recommending routine Covid shots for children, pregnant people, RFK Jr. ally says
HHS to stop recommending routine Covid shots for children, pregnant people, RFK Jr. ally says Health Secretary Robert F. Kennedy Jr. is set to announce that the Department of Health and Human Services will stop recommending Covid vaccines for children and pregnant people, a close Kennedy ally said Thursday. The news arrived between panels at…
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‘What wouldn’t I be worried about?’: Research leaders discuss threats to U.S. science
‘What wouldn’t I be worried about?’: Research leaders discuss threats to U.S. science Attacks on efforts to diversify the sciences. Research grant terminations. Fear among scientists to speak out against the government. Cuts to international aid. These were some of a long list of concerns shared by three research leaders as they discussed the state…
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Trump’s drug-pricing plan and a potential Theranos 2.0
Trump’s drug-pricing plan and a potential Theranos 2.0 How likely is it for President Trump’s new drug-pricing plan to be implemented? Why have investors seemed unbothered by the proposal? And will we see a return of Elizabeth Holmes’ blood-testing ambitions? We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s…
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STAT+: Day 2 of ASGCT: Good news for Baby KJ and the dream of personalized gene editing
STAT+: Day 2 of ASGCT: Good news for Baby KJ and the dream of personalized gene editing NEW ORLEANS — Greetings from ASGCT, where the gene therapy field had some great news for once, about a highly photogenic infant. Baby KJ gets a custom CRISPR edit to his genome Kiran Musunuru, a researcher at the University of…
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STAT+: Eli Lilly and AstraZeneca top a consultancy’s ranking of drug company R&D
STAT+: Eli Lilly and AstraZeneca top a consultancy’s ranking of drug company R&D A consultancy’s new ranking of drug company R&D shows Eli Lilly has risen to the top of the drug development heap — but when it comes to invention, AstraZeneca, with its wealth of experimental cancer and rare disease therapies, ranks above its…
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Prenatal genetic therapy for SMA shows promise in a mouse study
Prenatal genetic therapy for SMA shows promise in a mouse study Researchers have taken preliminary steps toward treating a devastating neurodevelopmental disorder, spinal muscular atrophy, with a genetic therapy delivered in the womb, before the worst damage to motor neurons can occur. The scientists at the University of California, San Francisco, and Johns Hopkins University…
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STAT+: Day 1 at ASGCT: Missing scientists, a gene editing failure, and a gene editing first
STAT+: Day 1 at ASGCT: Missing scientists, a gene editing failure, and a gene editing first NEW ORLEANS — The mood at the annual meeting of the American Society of Cell and Gene Therapy isn’t amazing. The biotech market has been bad for years. The FDA and NIH are shrouded in uncertainty. But many researchers…
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STAT+: In combative hearings, Kennedy defends HHS cuts, backtracks — and lashes out
STAT+: In combative hearings, Kennedy defends HHS cuts, backtracks — and lashes out WASHINGTON — In hours of combative congressional hearings Wednesday, health secretary Robert F. Kennedy Jr. swung between defending sweeping changes at his agency and backtracking on aspects of a reorganization he nevertheless said would be “painful.” He repeatedly cast doubts on reports about…
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Former FDA head Robert Califf says RFK Jr.’s vaccine rhetoric is ‘doing harm’ to Americans
Former FDA head Robert Califf says RFK Jr.’s vaccine rhetoric is ‘doing harm’ to Americans SAN FRANCISCO — Former Food and Drug Administration Commissioner Robert Califf said health secretary Robert F. Kennedy Jr.’s hesitance to endorse vaccines is harming the American public. “Fundamental vaccination saves millions of lives every year already, and he’s busy eroding public…
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STAT+: Scientific societies call for a moratorium on using CRISPR to create genetically modified children
STAT+: Scientific societies call for a moratorium on using CRISPR to create genetically modified children Leading trade organizations representing the makers of cell and gene therapies are calling for a 10-year international moratorium on the use of CRISPR and other DNA-editing tools to create genetically modified children, according to a draft of the declaration provided…
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STAT+: Trump order on drug pricing appears to issue subtle threat to pharma
STAT+: Trump order on drug pricing appears to issue subtle threat to pharma File this under “Lower your price — or else!” Tucked inside the executive order on drug pricing from President Trump is a sentence that appears to threaten pharmaceutical companies that their medicines may be withdrawn if they do not lower prices. Specifically,…
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STAT+: State AI laws would be banned under clause buried in House budget bill
STAT+: State AI laws would be banned under clause buried in House budget bill A small but powerful nugget is buried in the text of the House budget reconciliation bill released this week: a clause that would ban state and local governments from enforcing any laws on AI, even ones that have already been put…
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Opinion: Can dying people really will their body to stay alive for a final event?
Opinion: Can dying people really will their body to stay alive for a final event? Earlier this spring, Pope Francis was hospitalized for more than five weeks. A pneumonia riddled both of his lungs, and his doctors thought he was in imminent danger of death. But he recovered enough to return to the Vatican and…
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Mental health care may be harder to obtain after HHS rule reversal
Mental health care may be harder to obtain after HHS rule reversal For a recent therapy session, Andria Donaghy’s insurance plan paid her psychiatric nurse practitioner only $11 on a $125 service. “To even put that on paper is insulting,” she said. “These people give their lives [to help others] and that’s what you pay…
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STAT+: Our biggest burning questions on Trump’s order to bring down drug prices
STAT+: Our biggest burning questions on Trump’s order to bring down drug prices WASHINGTON — President Trump’s executive order to lower drug prices through sweeping, cross-agency action left leaders in the pharmaceutical industry scrambling Monday to make sense of what may be ahead — and how to respond. The announcement was long on messaging, but…
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STAT+: Trump’s drug-pricing order takes a hard line against pharma. Investors shrugged
STAT+: Trump’s drug-pricing order takes a hard line against pharma. Investors shrugged President Trump on Monday unveiled his plan to dramatically overhaul the way the U.S. pays for drugs by lowering what he calls “inflated” prices to those paid by other countries. Pharma investors didn’t seem to care. The XBI, a closely tracked index of…
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STAT+: OpenAI leaps into health care with AI benchmark to evaluate models
STAT+: OpenAI leaps into health care with AI benchmark to evaluate models OpenAI on Monday released a large dataset for evaluating how well large language models answer questions related to health care. Experts lauded the open-source data and detailed evaluation rubrics, calling them “unprecedented” in scale and breadth. The project, HealthBench, marks OpenAI’s first foray…
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Elizabeth Holmes rises again — or at least her partner does
Elizabeth Holmes rises again — or at least her partner does She is serving an 11-year prison sentence for misleading investors and is barred from participating in federal health programs for 90 years. But Elizabeth Holmes’ dream of a diagnostic testing revolution is once again the talk of health care. The emergence of Haemanthus, a…
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Opinion: What it’s like to have measles, mumps, whooping cough, and other vaccine-preventable illnesses
Opinion: What it’s like to have measles, mumps, whooping cough, and other vaccine-preventable illnesses When I was recently at the vet’s office, I started eavesdropping a little on the conversation between two older women. When they started talking about the measles outbreak in Texas, I couldn’t help it. I joined in. One of the women,…
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FDA approves Verastem’s ovarian cancer treatment
FDA approves Verastem’s ovarian cancer treatment Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Today, we talk about the FDA’s new artificial intelligence effort in the wake of mass layoffs, see AI darling Insitro cut staff, and more. Read the rest… Meghana…
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STAT+: Pharmalittle: We’re reading about a Trump drug-pricing plan, an AstraZeneca court loss, and more
STAT+: Pharmalittle: We’re reading about a Trump drug-pricing plan, an AstraZeneca court loss, 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 involves saluting our shortest person — aka the…
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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+: Here’s how Trump might approach his drug pricing plan
STAT+: Here’s how Trump might approach his drug pricing plan WASHINGTON — President Trump is widely expected to try to advance a “most-favored nation” policy next week in an effort to reduce U.S. drug prices — a move that is likely to significantly rattle the pharmaceutical industry, cheer his political base, and, possibly, leave open…
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First at-home test kit for cervical cancer approved by the FDA, company says
First at-home test kit for cervical cancer approved by the FDA, company says WASHINGTON — U.S. regulators have approved the first cervical cancer testing kit that allows women to collect their own sample at home before shipping it to a laboratory, according to a medical device company. Teal Health said Friday the Food and Drug Administration approved…
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STAT+: More Medicare plans cover Humira biosimilars, but do little to encourage patient use
STAT+: More Medicare plans cover Humira biosimilars, but do little to encourage patient use Medicare drug plans significantly boosted coverage of biosimilar versions of the Humira rheumatoid arthritis medicine this year, but nearly all of them failed to take steps that would encourage greater use of these alternative treatments, a new government watchdog report finds.…
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STAT+: Insitro, an AI biotech founded by Daphne Koller, lays off staff
STAT+: Insitro, an AI biotech founded by Daphne Koller, lays off staff Insitro, the closely watched AI biotech founded by the Stanford professor and entrepreneur Daphne Koller, said Thursday it was laying off 22% of its staff, or around 60 people. It’s part of a series of cuts that have hit well-backed startups over the…
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STAT+: 5 burning questions about FDA’s ‘aggressive’ deployment of AI for scientific review
STAT+: 5 burning questions about FDA’s ‘aggressive’ deployment of AI for scientific review The Food and Drug Administration said it will rapidly roll out a generative artificial intelligence model to assist scientific reviews across the agency, setting up a high-stakes test of the technology’s use in vetting products used in the care of millions of…
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A firebrand takes oversight of vaccines, gene therapies
A firebrand takes oversight of vaccines, gene therapies What does the appointment of Vinay Prasad as the head of biologic drug evaluation mean for biotechs? Is his fiery public persona suited for government service? We discuss these and other burning questions on a new episode of “The Readout LOUD,” STAT’s biotech podcast. Read the rest……
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RSV sent fewer babies to the hospital last winter, after new treatment and vaccine arrived
RSV sent fewer babies to the hospital last winter, after new treatment and vaccine arrived A new report from the Centers for Disease Control and Prevention shows there was a substantial drop in hospitalizations for respiratory syncytial virus this winter among very young children, who are at the highest risk of becoming severely ill if they contract…
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STAT+: Trump nominates Casey Means, entrepreneurial doctor and MAHA leader, for surgeon general
STAT+: Trump nominates Casey Means, entrepreneurial doctor and MAHA leader, for surgeon general The health entrepreneur and “Make America Healthy Again” leader Casey Means has been nominated to be the U.S. surgeon general after President Trump pulled his prior nominee suddenly on Wednesday. Means, an M.D. and author who runs a holistic wellness blog and…
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White House withdraws nomination of a former Fox News contributor for U.S. surgeon general
White House withdraws nomination of a former Fox News contributor for U.S. surgeon general WASHINGTON — The White House is withdrawing the nomination of former Fox News medical contributor Janette Nesheiwat for U.S. surgeon general, marking at least the second health-related pick from President Donald Trump to be pulled from Senate consideration. The withdrawal was confirmed by two people…
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STAT+: The state of antibiotic development: ‘Deplorable comes to mind’
STAT+: The state of antibiotic development: ‘Deplorable comes to mind’ Four years ago, an ambitious pharmaceutical industry venture to tackle antibiotic resistance launched to invest in small companies that can develop two to four novel antibiotics by 2030 — and replenish the global supply chain with needed treatments. The effort began with $1 billion in backing…
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Francis Collins blasts Trump administration’s ‘slash-and-burn’ actions at science agencies
Francis Collins blasts Trump administration’s ‘slash-and-burn’ actions at science agencies Francis Collins, the former director of the National Institutes of Health, excoriated the Trump administration’s efforts to upend federal scientific agencies on Wednesday, saying the logic behind the moves “escapes any possible explanation.” Speaking on a panel about trust in science and scientific institutions, Collins…
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STAT+: Compounders lose legal battle with FDA over removal of Eli Lilly’s weight loss drug from a shortage list
STAT+: Compounders lose legal battle with FDA over removal of Eli Lilly’s weight loss drug from a shortage list A federal judge has sided with the U.S. Food and Drug Administration over a decision last year to remove two Eli Lilly drugs — the Zepbound weight loss medicine and the Mounjaro diabetes treatment — from…
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STAT+: Vinay Prasad tapped to run FDA center that regulates vaccines, gene therapies
STAT+: Vinay Prasad tapped to run FDA center that regulates vaccines, gene therapies WASHINGTON — Vinay Prasad, an academic and fierce critic of the medical mainstream, will be the next director of the Food and Drug Administration center that oversees the regulation of vaccines, gene therapies, and the blood supply. Prasad, previously an epidemiology professor at…
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STAT+: Few drugmakers embrace a newer test for contamination, placing horseshoe crabs at risk
STAT+: Few drugmakers embrace a newer test for contamination, placing horseshoe crabs at risk Many large drugmakers are still using a decades-old test — derived from horseshoe crabs — as a go-to tool for detecting contamination in medicines and vaccines, rather than switching to a cheaper and equally effective alternative, according to a survey by…
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STAT+: Vinay Prasad, in his own words, outlines the philosophy he’ll bring to the FDA
STAT+: Vinay Prasad, in his own words, outlines the philosophy he’ll bring to the FDA People seeking roles in government are often careful about what they say in public, or at least somewhat hesitant to freely share their opinions. It’s difficult to know exactly what’s going on in their heads. Not Vinay Prasad. The new…
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STAT+: GOP hits resistance on Medicaid cuts, and a brewing plan to lower drug prices
STAT+: GOP hits resistance on Medicaid cuts, and a brewing plan to lower drug prices 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. A horse named Journalism was favored to win the…
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STAT+: Trump signs order in bid to boost pharma manufacturing in the U.S.
STAT+: Trump signs order in bid to boost pharma manufacturing in the U.S. Amid ongoing anticipation over tariffs on pharmaceuticals, President Trump on Monday signed an executive order designed to lower regulatory hurdles and make it faster for drug companies to manufacture their products in the U.S. The move also includes plans to place more…
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20 attorneys general ask federal judge to reverse deep cuts to HHS
20 attorneys general ask federal judge to reverse deep cuts to HHS Attorneys general in 19 states and Washington, D.C., are challenging cuts to the U.S. Health and Human Services agency, saying the Trump administration’s massive restructuring has destroyed life-saving programs and left states to pick up the bill for mounting health crises. The lawsuit was filed in federal…
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Opinion: STAT+: Bristol Myers Squibb CEO: Pharmaceutical innovation requires bold yet predictable U.S. policy
Opinion: STAT+: Bristol Myers Squibb CEO: Pharmaceutical innovation requires bold yet predictable U.S. policy Having grown up in rural Arkansas, I have an acute awareness of the challenges many in our country face when it comes to health care. Quality care wasn’t always accessible, and the decision of whether to pay medical or utility bills…
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STAT+: Charles Lieber, ex-Harvard chemist convicted of lying about ties to China, joins faculty of Chinese university
STAT+: Charles Lieber, ex-Harvard chemist convicted of lying about ties to China, joins faculty of Chinese university Charles Lieber, the former chair of Harvard’s chemistry department and renowned nanoscientist who was convicted of lying to federal agents about his ties to China, was recently announced as a new professor at a Chinese university. Lieber joined the…
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STAT+: Vertex reports an earnings miss and pause on cystic fibrosis trial
STAT+: Vertex reports an earnings miss and pause on cystic fibrosis trial Vertex Pharmaceuticals on Monday reported disappointing first-quarter earnings impacted by weaker-than-expected sales of its drugs for cystic fibrosis, and little or no contributions from a gene therapy for sickle cell disease and a recently launched pain medicine. A “tolerability issue” caused a temporary…
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STAT+: AACR Recap: Excitement about cancer prevention, new immunotherapies and advocacy
STAT+: AACR Recap: Excitement about cancer prevention, new immunotherapies and advocacy CHICAGO — With thousands of abstracts presented at the American Association for Cancer Research annual meeting, it’s hard to keep up with all the latest advances and data. Like every meeting, this year’s conference was full of presentations and posters detailing new innovations in…
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Scientists question NIH project’s use of 20th century technology to make a universal flu vaccine
Scientists question NIH project’s use of 20th century technology to make a universal flu vaccine When word broke this week that the Department of Health and Human Services was investing half-a-billion dollars on a National Institutes of Health project to develop a vaccine platform for pathogens that could trigger pandemics, a number of scientists who…
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STAT+: At AACR, leading cancer researchers urge colleagues to ‘fight for your science’
STAT+: At AACR, leading cancer researchers urge colleagues to ‘fight for your science’ CHICAGO — In the first few weeks of President Trump’s second term, many leaders and top scientists in cancer research found themselves questioning if they could have communicated better to the public. After all, experts told STAT, maybe if people understood how…
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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+: Overseas grants could be ‘closed down’ by NIH under new policy, internal email suggests
STAT+: Overseas grants could be ‘closed down’ by NIH under new policy, internal email suggests A National Institutes of Health policy change on funding of foreign scientists is far more sweeping than described in a Thursday announcement, according to an internal email that indicates international clinical trials and other research will be strictly vetted going…
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CDC reports 216 child deaths this flu season, the most in 15 years
CDC reports 216 child deaths this flu season, the most in 15 years NEW YORK — More U.S. children have died this flu season than at any time since the swine flu pandemic 15 years ago, according to a federal report released Friday. The 216 pediatric deaths reported by the Centers for Disease Control and Prevention eclipse…
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STAT+: Trump proposes billions in cuts to federal health agencies from NIH to CDC
STAT+: Trump proposes billions in cuts to federal health agencies from NIH to CDC WASHINGTON — President Trump on Friday proposed massive cuts to the federal government’s health agencies in his 2026 budget request, arguing that Congress should reduce spending by tens of billions from current levels. The request would be a 26% cut to…