Category: Pharma
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STAT+: Moderna’s reset hinges on oncology
STAT+: Moderna’s reset hinges on oncology Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Seems as though investors are still rewarding sheer weight loss over tolerability in the obesity drug race. The FDA moved at a rapid clip with a new myeloma…
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STAT+: FDA warns more telehealth firms about compounded GLP-1s
STAT+: FDA warns more telehealth firms about compounded GLP-1s 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. Moderna is avoiding what would have been a high-profile trial, but will still have to pay up. That and more news below. Let’s…
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STAT+: Pharmalittle: We’re reading about Moderna’s $2.25 billion settlement, FDA warning letters, and more
STAT+: Pharmalittle: We’re reading about Moderna’s $2.25 billion settlement, FDA warning letters, and more Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While…
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STAT+: Moderna to pay Roivant up to $2.25 billion to settle patent lawsuit behind mRNA vaccines
STAT+: Moderna to pay Roivant up to $2.25 billion to settle patent lawsuit behind mRNA vaccines Moderna has agreed to pay Roivant up to $2.25 billion to settle claims that the mRNA vaccine developer infringed on Roivant’s patents in its Covid-19 shot. Roivant will receive $950 million and then another $1.3 billion if Moderna’s attempts…
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STAT+: Prime Medicine to seek approval for gene-editing treatment after two-patient trial
STAT+: Prime Medicine to seek approval for gene-editing treatment after two-patient trial Prime Medicine said Tuesday it will ask the Food and Drug Administration to approve a gene-editing treatment that has been given to only two patients. The application will test an agency that has promised to speed new gene-editing treatments to patients but has…
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STAT+: A Merck cancer drug to watch
STAT+: A Merck cancer drug to watch Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! The impact of President Trump’s “most-favored nation” drug-pricing push can be hard to decipher, but the policy is starting to look less like a slogan and…
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STAT+: Pharmalittle: We’re reading about Trump’s MFN deals, 340B program controversies, and much more
STAT+: Pharmalittle: We’re reading about Trump’s MFN deals, 340B program controversies, and much more Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has predictably returned. You knew this would happen, though, so being a little…
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STAT+: Trump most-favored nation drug pricing deals end after three years for some companies
STAT+: Trump most-favored nation drug pricing deals end after three years for some companies WASHINGTON — President Trump often brags that the “most-favored nation” deals he struck with drugmakers have set the country on a new path to no longer paying more than its fair share for prescription drug costs. But many details of the…
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STAT+: Novo doubles down on oral peptides
STAT+: Novo doubles down on oral peptides 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. By the time this newsletter sends, I’ll be on a plane headed towards vacation. See you next week! The need-to-know this morning Alkermes CEO Richard…
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STAT+: Will Novo Nordisk’s slashing of obesity drug prices save patients’ money? It depends
STAT+: Will Novo Nordisk’s slashing of obesity drug prices save patients’ money? It depends Novo Nordisk made headlines Tuesday by announcing it would slash the list prices of its GLP-1 drugs and arguing that doing so would expand access. For insured patients who have to pay coinsurance — a certain percentage of the list price…
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STAT+: Pharmalittle: We’re reading about an FDA plan for ultra-rare drugs, Novo cutting GLP-1 drug prices, and more
STAT+: Pharmalittle: We’re reading about an FDA plan for ultra-rare drugs, Novo cutting GLP-1 drug prices, and more Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where we have clear blue skies and chilly breezes greeting us today.…
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STAT+: Novo reports ‘triple G’ obesity drug study results
STAT+: Novo reports ‘triple G’ obesity drug study results 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. I hope everyone on the East Coast is staying warm. Let’s get into the news today. How low can obesity drug prices go?…
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STAT+: Drugmakers lay out their legal arguments against Trump’s drug pricing experiments
STAT+: Drugmakers lay out their legal arguments against Trump’s drug pricing experiments WASHINGTON — The pharmaceutical and biotech industries are pushing back against two Trump administration proposals that would test plans to lower drug prices in Medicare by aligning them with the prices paid in other rich countries. Their comments preview arguments that they might…
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STAT+: FDA unveils rules for bespoke gene therapies, predicting flood of rare disease applications
STAT+: FDA unveils rules for bespoke gene therapies, predicting flood of rare disease applications The Trump administration on Monday released detailed guidance for approving the first bespoke medicines crafted to treat patients’ individual mutations. Food and Drug Administration Commissioner Marty Makary and biologics chief Vinay Prasad had already previewed the new approach, known as the plausible mechanism…
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STAT+: Novo’s next-gen obesity drug stumbles in Lilly comparison study
STAT+: Novo’s next-gen obesity drug stumbles in Lilly comparison study Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. We’ve got some big acquisition news today, and also some politics — specifically a look at how pharma lobbyists, who have longed considered the…
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STAT+: Pharmalittle: We’re reading about an FDA official’s speech, a Grail cancer blood test, and much more
STAT+: Pharmalittle: We’re reading about an FDA official’s speech, a Grail cancer blood test, and much more And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up as we…
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STAT+: Element Biosciences launches table-top sequencer capable of $100 genome
STAT+: Element Biosciences launches table-top sequencer capable of $100 genome Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Grail’s Galleri blood test just failed a make-or-break NHS trial, missing its primary endpoint and reviving the uncomfortable question: Does earlier detection actually change…
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STAT+: In first speech to her FDA staff, Høeg says she’ll scrutinize RSV shots and SSRIs in pregnancy
STAT+: In first speech to her FDA staff, Høeg says she’ll scrutinize RSV shots and SSRIs in pregnancy WASHINGTON — Tracy Beth Høeg, the top drug regulator at the Food and Drug Administration, indicated in her first address to staff that she’ll scrutinize antidepressants and the shots used to protect babies from RSV. Høeg told…
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STAT+: Psilocybin data could be good enough for approval
STAT+: Psilocybin data could be good enough for approval Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good day! Today: A look at growing GLP-1 competition in China, a drug reviewed as part of the FDA’s shiny new fast-track voucher hits a roadblock,…
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STAT+: Pediatricians confront HHS in vaccine showdown
STAT+: Pediatricians confront HHS in vaccine showdown Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. The FDA’s surprise refusal to even review Moderna’s mRNA flu vaccine is sending a chill through biotech: Companies are openly wondering whether the regulatory goalposts are shifting…
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STAT+: FDA’s rejection of Moderna threatens to stifle broader vaccine industry
STAT+: FDA’s rejection of Moderna threatens to stifle broader vaccine industry The Food and Drug Administration’s refusal to review Moderna’s flu vaccine this month has renewed fears that Trump administration policies could paralyze the vaccine industry, dissuading companies from developing new shots in the U.S. and leaving the country flat-footed in the event of future…
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STAT+: Trump administration is urged to use a federal law to authorize generic versions of GLP-1 drugs
STAT+: Trump administration is urged to use a federal law to authorize generic versions of GLP-1 drugs Public Citizen petitioned the Trump administration to use a federal law to authorize generic competitors for GLP-1 drugs for treating obesity and diabetes, arguing that prices are “unjustifiably high” for too many Americans. In arguing its case, the…
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STAT+: A change at the top of Sanofi
STAT+: A change at the top of Sanofi Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Vinay Prasad is tightening the screws at the FDA, overruling staff and signaling a tougher stance on vaccines and gene therapies — which, as Adam Feuerstein…
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STAT+: The messaging war over Medicaid cuts
STAT+: The messaging war over Medicaid cuts 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 seems to have invited Jeffrey Epstein to a Valentine’s Day party in 2016, about eight…
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STAT+: TrumpRx: Hype or real savings?
STAT+: TrumpRx: Hype or real savings? 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. Did you snack on HHS-approved MAHA-mole while shaking to Bad Bunny’s Spanish-language celebration of Puerto Rican and Latin…
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STAT+: Hims faces mounting regulatory pressure
STAT+: Hims faces mounting regulatory pressure 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! Hope you enjoyed yesterday’s Bad Bunny performance. My son’s take on the Super Bowl: “Why would anyone want to watch something so boring?” Today, we get…
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STAT+: TrumpRx claims to offer the lowest prices. But many drugs have cheaper generics
STAT+: TrumpRx claims to offer the lowest prices. But many drugs have cheaper generics WASHINGTON — President Trump said the administration’s new TrumpRx website will offer the cheapest prices in the world for 43 brand-name drugs, and counting. But about half of them are already available as generics, usually for much less. The website is…
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STAT+: White House looks for more drug pricing deals to add to TrumpRx
STAT+: White House looks for more drug pricing deals to add to TrumpRx WASHINGTON — After striking 16 deals with pharmaceutical giants and launching a direct-to-consumer drug purchasing platform, the Trump administration is looking to expand its efforts to lower drug prices to more companies. Federal officials on Thursday unveiled the administration’s TrumpRx drug purchasing…
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What to know about TrumpRx, the Trump administration’s prescription drug platform
What to know about TrumpRx, the Trump administration’s prescription drug platform President Trump on Thursday night is planning to announce the launch of TrumpRx, the website that he and his aides have touted for months as a platform aimed at lowering prescription drug prices. The website, which uses technology from health care company GoodRx, is…
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STAT+: Novo Nordisk sees lower sales, profits as Wegovy faces growing competition
STAT+: Novo Nordisk sees lower sales, profits as Wegovy faces growing competition Novo Nordisk on Tuesday said it expects sales and profits to decline this year, as the maker of Wegovy faces growing competition in the obesity market. The Danish pharma giant said it expects sales to decrease in the range of 5% to 13%…
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STAT+: Pfizer unveils data on Metsera drug
STAT+: Pfizer unveils data on Metsera 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. Did Pfizer overpay for the obesity biotech Metsera? It’s probably still too early to tell, but we have some new data this morning. The need-to-know this…
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STAT+: New rule would force PBMs to disclose drug rebates and other fees
STAT+: New rule would force PBMs to disclose drug rebates and other fees Pharmacy benefit managers face new, sweeping requirements to disclose all the different ways they get money from providing drug coverage. The proposed rule from the Department of Labor published on Thursday would be a significant change for an industry that shields prescription…
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STAT+: Pharmalittle: We’re reading about TrumpRx questions, drugmakers lowering some prices, and more
STAT+: Pharmalittle: We’re reading about TrumpRx questions, drugmakers lowering some prices, and more And so, another working week will soon come to an end. This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest. Other than enjoying a symphony, we plan to sharpen our shovels and dig…
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STAT+: AstraZeneca looks to China for obesity drug candidates
STAT+: AstraZeneca looks to China for obesity drug candidates Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Oh, hi. Today, we discuss delays in the launch of TrumpRx. Also, Sanofi is deprioritizing its mRNA flu vaccine. The need-to-know this morning Regeneron Pharmaceuticals…
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STAT+: States are the next vaccine battleground
STAT+: States are the next vaccine battleground 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’d call it a xeet-down, but I can’t tell who won this heated exchange on X between…
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STAT+: Launch of Wegovy pill looks to be going strong so far
STAT+: Launch of Wegovy pill looks to be going strong so far 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 see a new synthetic biology startup, backed by Frances Arnold and Bob Langer. Plus, it’s still early, but Novo…
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STAT+: Insurers blame drugmakers, hospitals for high prices
STAT+: Insurers blame drugmakers, hospitals for high prices 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 see insurers telling Congress that hospital and drugmakers are to blame for health care pricing issues, and read about ways in which some drug…
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STAT+: Health insurance execs shift blame for costly, confusing health care system
STAT+: Health insurance execs shift blame for costly, confusing health care system Health insurance executives agree that the U.S. health care system is overpriced, wasteful, and confusing. And they also agree that those problems are someone else’s fault. On Thursday, the CEOs of America’s largest health insurance companies appeared before Congress to both justify their…
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STAT+: Novo strikes deal for diabetes cell therapies
STAT+: Novo strikes deal for diabetes cell therapies 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 breaking down some of the key parts of a sweeping new health care bill today. The need-to-know this morning Johnson & Johnson kicked…
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STAT+: FDA delays reviews for two drugs in new voucher program
STAT+: FDA delays reviews for two drugs in 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. Hello hello! Hope you survived JPM week and are now recuperating with some electrolytes and a sleep mask. (But don’t forget our virtual…
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STAT+: Pharmalittle: We’re reading about FDA voucher worries, weight loss drugs and jet fuel, and more
STAT+: Pharmalittle: We’re reading about FDA voucher worries, weight loss drugs and jet fuel, and more And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up as we weigh…
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STAT+: Trump releases health care plan amid pressure over affordability
STAT+: Trump releases health care plan amid pressure over affordability WASHINGTON — President Trump on Thursday released a hodgepodge of health care policies that would create new price-control power over pharmaceutical companies, but that otherwise wouldn’t fundamentally overhaul America’s existing system, as he faces mounting pressure to address the cost of insurance and care. The…
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STAT+: HHS dismisses member of vaccine injury advisory panel
STAT+: HHS dismisses member of vaccine injury advisory panel WASHINGTON — At least one member of a committee that advises the federal government on its vaccine injury compensation program has had her term prematurely ended, potentially foreshadowing further changes to the federal apparatus that reviews vaccine injuries and compensates patients. Veronica McNally, an attorney who…
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STAT+: With a grin — and tight lips — Revolution Medicines’ CEO faces questions about acquisition
STAT+: With a grin — and tight lips — Revolution Medicines’ CEO faces questions about acquisition SAN FRANCISCO — Investors attending the J.P. Morgan Healthcare Conference packed themselves into a hotel meeting room Monday to hear Revolution Medicines CEO Mark Goldsmith explain why Merck — or some other pharma buyer — should pay $30 billion…
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STAT+: On Day 1 of JPM, no blockbuster headlines, but biotech newsmakers still move markets
STAT+: On Day 1 of JPM, no blockbuster headlines, but biotech newsmakers still move markets This is the online version of The Readout, STAT’s flagship biotech newsletter. Sign up to get it in your inbox. Hello from sunny San Francisco, where #BiotechVibeWatch2026 has begun. This is Allison DeAngelis, joined here by STAT’s Adam Feuerstein, Matthew Herper, and…
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STAT+: Pharmalittle: We’re reading about a potential Merck purchase, a J&J pricing deal with Trump, and more
STAT+: Pharmalittle: We’re reading about a potential Merck purchase, a J&J pricing deal with Trump, and more And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, so far, rather modest. We…
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STAT+: Former NIH genomics director Eric Green to join Illumina as CMO
STAT+: Former NIH genomics director Eric Green to join Illumina as CMO Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. The Readout heads to the J.P. Morgan Healthcare Conference next week, which means it will hit your inboxes in the afternoon instead…
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STAT+: Eli Lilly’s Zepbound, on top of immunology drug, helped reduce psoriatic arthritis symptoms
STAT+: Eli Lilly’s Zepbound, on top of immunology drug, helped reduce psoriatic arthritis symptoms Eli Lilly said Thursday that adding its weight loss drug Zepbound on top of its immunology therapy Taltz helped obese patients with an autoimmune condition that causes joint pain more than Taltz did alone. The data suggest the GLP-1 drug Zepbound,…
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STAT+: China expected to soon surpass U.S. in bio innovation
STAT+: China expected to soon surpass U.S. in bio innovation 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. It’s an exciting week not only for biotech M&A, but also for my city (Chicago) as we gear up for our big game…
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STAT+: HHS slashes vaccine recommendations
STAT+: HHS slashes vaccine recommendations You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. We’re almost healthy again, according to RFK Jr., though I’m certainly not in top form after my holiday break.…
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STAT+: Pharmalittle: We’re reading about the U.S. launch of a Wegovy pill, a Chinese biotech incubator, and more
STAT+: Pharmalittle: We’re reading about the U.S. launch of a Wegovy pill, a Chinese biotech incubator, and more Good morning, everyone, and welcome to another working week. We have returned from an extended break, which perhaps many of you enjoyed as well. In any event, we hope that any down time was relaxing and invigorating,…
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STAT+: Insilico inks cancer drug deal with Servier after IPO
STAT+: Insilico inks cancer drug deal with Servier after IPO Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Welcome back and happy new year! We have plenty of fresh coverage to start the week. We can also report that our upcoming STAT@JPM…
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Federal health officials slash recommended childhood vaccinations under Trump’s directive
Federal health officials slash recommended childhood vaccinations under Trump’s directive WASHINGTON — Federal health officials are unilaterally reducing the number of recommended pediatric immunizations in response to an order from President Trump, the most significant reshaping of the vaccine schedule since Trump took office and empowered health secretary Robert F. Kennedy Jr., a longtime critic…
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STAT+: Three major health care policy issues to watch in 2026
STAT+: Three major health care policy issues to watch in 2026 WASHINGTON — Health care figured prominently in the first year of President Trump’s second term, and it’ll likely play an even bigger role leading up to the 2026 midterm elections. The shift back to health care politics has been somewhat surprising. Although Republicans were…
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STAT+: With the Wegovy pill, Novo Nordisk undercuts Eli Lilly in direct-to-consumer market
STAT+: With the Wegovy pill, Novo Nordisk undercuts Eli Lilly in direct-to-consumer market Novo Nordisk plans to sell its newly approved obesity pill directly to patients at a lower price than a competing medicine from Eli Lilly, as the Danish drugmaker tries to seize market share among consumers paying cash for blockbuster GLP-1 therapies. Novo…
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In 2026, Kennedy’s MAHA vision gets put to the test. Here are 3 issues to watch
In 2026, Kennedy’s MAHA vision gets put to the test. Here are 3 issues to watch In many ways, it’s been a banner year for chronic disease. America’s enduring ailments became a central theme of the Trump administration, with health secretary Robert F. Kennedy Jr. wielding his influence over the president. Trump created a commission…
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STAT+: The 3 biggest issues to watch in vaccine policy in 2026
STAT+: The 3 biggest issues to watch in vaccine policy in 2026 WASHINGTON — Vaccine policy has become a key issue for the Trump administration, especially under the leadership of health secretary Robert F. Kennedy Jr., who himself once led an anti-vaccine group. In less than a year, Kennedy has bulldozed vaccine policy precedent and…
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STAT+: Trump moves to require lower drug prices in Medicare
STAT+: Trump moves to require lower drug prices in Medicare You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. The NIH director did the Pete & Bobby fitness challenge, but I didn’t see…
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STAT+: Major pharma companies may avoid Medicare experiments’ forced price cuts
STAT+: Major pharma companies may avoid Medicare experiments’ forced price cuts Many of the largest drugmakers may be exempt from Medicare pilot programs intended to force them to lower some of their prices, potentially undermining the effort and depriving American patients of cheaper drugs. Several of the 14 pharmaceutical companies that have struck individual drug-pricing…
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Trump administration’s plan to shrink vaccine schedule sends health sector scrambling
Trump administration’s plan to shrink vaccine schedule sends health sector scrambling WASHINGTON — A possible Trump administration effort to change the childhood vaccine schedule has left hospital leaders, health policymakers, and pediatricians scrambling to navigate what could be the most significant changes to the American vaccine program in decades. The administration had planned to announce…
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FDA approves pill version of Novo Nordisk’s Wegovy, possibly widening access
FDA approves pill version of Novo Nordisk’s Wegovy, possibly widening access The Food and Drug Administration on Monday approved the oral version of Novo Nordisk’s injectable weight loss drug Wegovy, making it the first GLP-1 pill to be cleared by regulators for obesity and possibly allowing many more Americans to get access to a highly…
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STAT+: Trump administration proposes Medicare pilots to lower drug prices on par with peer countries
STAT+: Trump administration proposes Medicare pilots to lower drug prices on par with peer countries WASHINGTON — The Trump administration proposed two Medicare pilot programs to reduce prices for branded drugs bought at pharmacy counters and administered in doctor offices. If the administration moves forward, the programs could slash Medicare spending on prescription drugs by…
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STAT+: Pharmaceutical industry evades drug price transparency, again
STAT+: Pharmaceutical industry evades drug price transparency, again Drug manufacturers and pharmacy benefit managers received a holiday gift from President Trump on Friday: They still will not have to publicly post the actual prices of prescription drugs, more than five years after federal law required them to do so. Net drug prices — the amounts…
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STAT+: More drugmakers set to sign pricing deals with Trump on Friday
STAT+: More drugmakers set to sign pricing deals with Trump on Friday WASHINGTON — Several drugmakers are expected to sign pricing agreements with the Trump administration on Friday, according to four people familiar with the plans, who were not authorized to speak publicly. The agreements would be the latest in a series of deals in…
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STAT+: Pharmalittle: We’re reading about obesity drug lawsuits, Ramaswamy’s latest startup, and much more
STAT+: Pharmalittle: We’re reading about obesity drug lawsuits, Ramaswamy’s latest startup, and much more Rise and shine, another busy day is on the way. We can tell because the official mascots got an early start chasing down cats, squirrels, and other creatures darting about the Pharmalot campus. And then there is the noisy parade of…
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STAT+: FDA initiates priority voucher for J&J’s ‘Tec-Dara’ combo
STAT+: FDA initiates priority voucher for J&J’s ‘Tec-Dara’ combo 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. Apparently the drunk raccoon I mentioned a few weeks ago is a repeat offender. Onto the biotech news today. Continue to STAT+ to read the…
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STAT+: Sobi bets big on next-gen gout drug
STAT+: Sobi bets big on next-gen gout drug 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 the implications of a child’s tragic death after receiving a brain-focused gene therapy, hear Siddhartha Mukherjee opine on why the next frontier in…
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FDA approves first new kind of drug to target gonorrhea in decades
FDA approves first new kind of drug to target gonorrhea in decades A new kind of oral antibiotic to treat gonorrhea has secured Food and Drug Administration approval, the second time in two days that a new drug for the common sexually transmitted infection has come through licensure. Neisseria gonorrhoeae, the bacterium that causes gonorrhea,…
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Myocarditis is a rare but real Covid vaccine side effect. A new study sheds light on what might cause it
Myocarditis is a rare but real Covid vaccine side effect. A new study sheds light on what might cause it While extensive studies have found Covid-19 vaccines to be safe, effective, and to have saved millions of lives during the pandemic, these shots come with a rare but real risk of inflamed heart muscle, or…
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STAT+: J&J’s two-drug combo blocked tumors in advanced multiple myeloma
STAT+: J&J’s two-drug combo blocked tumors in advanced multiple myeloma This is the web version of ASH in 30 Seconds, STAT’s report from the American Society of Hematology meeting. And on the last day of ASH, the sun shone once again. Thanks for joining us on this hematology-oncology journey. We hope you’ve enjoyed our coverage.…
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STAT+: Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access
STAT+: Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access In a closely watched case, the U.S. solicitor general has urged the Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs. Skinny labeling refers to…
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STAT+: Terns leukemia drug could succeed Novartis blockbuster
STAT+: Terns leukemia drug could succeed Novartis blockbuster 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 discuss why comparing U.S. vaccine policy to Europe’s is a red herring, why the revolving door at the FDA between government and industry needs modernized…
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STAT+: At ASH, Terns looks like rival to Novartis with drug for chronic myeloid leukemia
STAT+: At ASH, Terns looks like rival to Novartis with drug for chronic myeloid leukemia This is the online version of ASH in 30 Seconds, STAT’s report from the American Society of Hematology meeting. Sign up for the email version here. It rains in Florida. A lot. This ASH meeting started sunny and wonderful, but quickly…
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STAT+: Early update shows Wave’s RNA drug cut visceral fat
STAT+: Early update shows Wave’s RNA drug cut visceral fat Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! With STAT reporting from ASH this year, we have some stories in the blood space. Also, a potential Dupixent competitor is in the…
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STAT+: A promising sickle cell pill and a new way to treat myelofibrosis
STAT+: A promising sickle cell pill and a new way to treat myelofibrosis This is the online version of ASH in 30 Seconds, STAT’s report from the American Society of Hematology meeting. Sign up for the email version here. It’s Day 2 of the ASH meeting. Let’s get straight into the news. Fulcrum study suggests…
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STAT+: Hengrui, BeOne top new analysis of Chinese drug development
STAT+: Hengrui, BeOne top new analysis of Chinese drug development A new report is peeling back the curtain on Chinese pharmaceutical innovation, assessing which companies are best at driving the drug development that’s captured the attention of pharmaceutical executives and investors worldwide. On Sunday, IDEA Pharma and parent company SAI MedPartners released their inaugural China…
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STAT+: ‘Remarkable’ drug results against an aggressive leukemia
STAT+: ‘Remarkable’ drug results against an aggressive leukemia This is the online version of ASH in 30 Seconds, STAT’s report from the American Society of Hematology meeting. Sign up for the email version here. We hear most of the country is freezing. We wouldn’t know. We’re in Orlando, Fla. where the temps are in the…
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RFK Jr.’s vaccine panel is laying the groundwork for more scrutiny of childhood shots
RFK Jr.’s vaccine panel is laying the groundwork for more scrutiny of childhood shots WASHINGTON — Federal vaccine advisers, through a freewheeling, and at times combative two-day meeting, recommended a major change to childhood vaccinations that runs counter to the medical consensus — and began setting the stage for a larger rethink in the future. …
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STAT+: Boehringer Ingelheim prepares schizophrenia app for FDA submission after trial results
STAT+: Boehringer Ingelheim prepares schizophrenia app for FDA submission after trial results HANOVER, N.H. — Boehringer Ingelheim this week provided more details about a late stage clinical trial of an app designed to treat under-addressed symptoms of schizophrenia and revealed the company is preparing to submit the app to the Food and Drug Administration for…
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CDC panel recommends delaying birth dose of hepatitis B vaccine
CDC panel recommends delaying birth dose of hepatitis B vaccine A panel that advises on U.S. vaccine policy voted on Friday to recommend a delay in when most babies begin to be vaccinated against hepatitis B, overturning a 30-year-old policy that has contributed to a massive decline in cases of the virus. The Advisory Committee…
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STAT+: Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks
STAT+: Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks NEW YORK — Vinay Prasad, the Food and Drug Administration’s top vaccines regulator, blamed “misleading media narratives” for the escalating criticism of his leadership amid turmoil and plummeting morale at the agency. Prasad’s remarks, delivered Thursday at a New York investor conference closed…
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STAT+: FDA removes longtime over-the-counter drugs regulator from her position
STAT+: FDA removes longtime over-the-counter drugs regulator from her position WASHINGTON — The Food and Drug Administration removed the longtime director of the office of over-the-counter drugs from her position on Wednesday, six agency sources told STAT. Theresa Michele, director of the Office of Nonprescription Drugs, has worked at the FDA since at least 2015.…
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STAT+: Top drug regulator Richard Pazdur set to leave the FDA
STAT+: Top drug regulator Richard Pazdur set to leave the FDA WASHINGTON — Top drug regulator Richard Pazdur has filed papers to retire from the Food and Drug Administration at the end of this month, adding to the turmoil atop the agency. Pazdur informed leaders at the FDA’s drug center of his intention to leave…
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STAT+: A drug that was ‘engineered with AI’ enters Phase 3 testing
STAT+: A drug that was ‘engineered with AI’ enters Phase 3 testing 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. My colleagues will be in Orlando later this week for the American Society of Hematology meeting. Sign up for their newsletter…
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STAT+: Sarepta cleared to test new safety regimen for Duchenne drug
STAT+: Sarepta cleared to test new safety regimen for Duchenne 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. We discuss some big news that the Trump administration dropped last night. And we’ll be taking a break this Thursday and Friday. We’ll…
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STAT+: Pharmalittle: We’re reading about Medicare-negotiated drug prices, an FDA voucher program, and more
STAT+: Pharmalittle: We’re reading about Medicare-negotiated drug prices, an FDA voucher program, and more Happy Thanksgiving Eve, Pharmalittle readers. This is Allison, filling in for Mr. Pharmalot. I recently hosted a mini Thanksgiving dinner for friends, and was stumped trying to pick music to play in the background. Why aren’t there any real Thanksgiving songs?…
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STAT+: FDA approves Otsuka kidney disease therapy
STAT+: FDA approves Otsuka kidney disease therapy The Food and Drug Administration on Tuesday approved the first drug from an emerging class of medicines for patients with chronic, autoimmune kidney disease, according to a notice on the agency’s website. The new drug, called Voyxact, is made by Otsuka, the Japanese pharmaceutical company. U.S. regulators cleared…
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STAT+: Pharmalittle: We’re reading about a Novo next-gen diabetes drug, a Novartis gene therapy, and more
STAT+: Pharmalittle: We’re reading about a Novo next-gen diabetes drug, a Novartis gene therapy, and more Hello there and happy Tuesday from STAT’s London outpost, with Andrew Joseph here filling in for Mr. Pharmalot for the day. While it feels like things are slowing down stateside ahead of the Thanksgiving holiday, this place is busy…
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STAT+: J&J’s novel Alzheimer’s drug fails in key trial, dimming hopes for a hot target
STAT+: J&J’s novel Alzheimer’s drug fails in key trial, dimming hopes for a hot target A promising Alzheimer’s disease treatment from Johnson & Johnson failed to slow the progress of the disease in a closely watched study, news that could dampen enthusiasm for a new class of potential medicines. J&J terminated its mid-stage study of…
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STAT+: Lilly hits trillion-dollar valuation as GLP-1 era peaks
STAT+: Lilly hits trillion-dollar valuation as GLP-1 era peaks Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! We’re closing in on CMS’s deadline for 2027 Medicare-negotiated drug prices. Plus, we see a break from precedent in how the FDA selects priority review…
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STAT+: Recursion seeks to deliver results, and a VC sees a wave of M&A coming
STAT+: Recursion seeks to deliver results, and a VC sees a wave of M&A coming 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 some spicy comments from Mark Cuban, and a pair of biotech Q&As. Let’s get to…
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STAT+: FDA review staff was excluded from voting on whether to approve first priority voucher drug
STAT+: FDA review staff was excluded from voting on whether to approve first priority voucher drug WASHINGTON — The Food and Drug Administration has promised companies that earn a Commissioner’s National Priority Voucher a one- to two-month drug review, culminating in a one day “tumor board” style meeting where leaders decide whether to approve the drug. …
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STAT+: Novo Nordisk’s $199 Ozempic deal shows what telehealth platforms can do for pharma
STAT+: Novo Nordisk’s $199 Ozempic deal shows what telehealth platforms can do for pharma On Monday, Novo Nordisk announced a discount on its popular drugs for diabetes and obesity, Ozempic and Wegovy, cutting prices for the lowest doses to $199 when patients pay cash through Novo’s pharmacy NovoCare. Patients searching for those deals online, though,…
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Judge approves opioid settlement for Purdue Pharma and Sackler family members who own the company
Judge approves opioid settlement for Purdue Pharma and Sackler family members who own the company A federal bankruptcy court judge on Tuesday formally approved OxyContin maker Purdue Pharma’s plan to settle thousands of lawsuits over the harms of opioids. U.S. Bankruptcy Judge Sean Lane gave reasoning Tuesday for approving the plan, which requires members of the Sackler…
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STAT+: A revelatory profile of RFK Jr.
STAT+: A revelatory profile of RFK Jr. 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 haven’t read Olivia Nuzzi’s new book, but I dare say my favorite line about her relationship…
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STAT+: FDA’s stronger warning on Sarepta gene therapy raises new questions about heart risk
STAT+: FDA’s stronger warning on Sarepta gene therapy raises new questions about heart risk New warnings and restrictions placed on Sarepta Therapeutics’ gene therapy last week by the Food and Drug Administration have cast a spotlight on an important but overlooked heart-safety risk. “Acute, serious, and life-threatening” cases of heart inflammation called myocarditis and elevations…
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STAT+: Johnson & Johnson acquires Halda Therapeutics for $3 billion, a big win for a buzzy new technology
STAT+: Johnson & Johnson acquires Halda Therapeutics for $3 billion, a big win for a buzzy new technology Johnson & Johnson said Monday it will purchase Halda Therapeutics and its experimental prostate cancer drugs for $3.05 billion, marking the first major buyout for a startup built around a field that has attracted significant investment but not…