mailitics

Category: biotechnology

  • STAT+: The FDA, urged to avoid controversy, creates a new headache with attack against UniQure

    STAT+: The FDA, urged to avoid controversy, creates a new headache with attack against UniQure There was a telling exchange during a Thursday media call set up by the Food and Drug Administration to enable a “senior FDA official” — he could only be quoted anonymously — to attack UniQure and its experimental treatment for…

  • 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…

  • 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…

  • Breaching the IBD efficacy ceiling, and sham surgeries

    Breaching the IBD efficacy ceiling, and sham surgeries Will drugmakers finally be able to breach the efficacy ceiling in inflammatory bowel disease? And is the Food and Drug Administration being flexible enough with rare disease treatments? We discuss all that on this week’s episode of “The Readout LOUD.” Read the rest… Allison DeAngelis, Adam Feuerstein,…

  • 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…

  • 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…

  • 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…

  • 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…

  • Listen: FDA turmoil, election intrigue, AI, and more

    Listen: FDA turmoil, election intrigue, AI, and more On “The Readout LOUD” this week: Adam Feuerstein, solo. His usual co-hosts Allison DeAngelis and Elaine Chen took some time off, so Adam manned the podcast mic himself.  Adam thought, quite understandably, that our cherished listeners wouldn’t want to hear him drone on for 30 minutes, so…

  • STAT+: A rare disease drug was approvable, then it wasn’t. Inside a surprise rejection by the FDA

    STAT+: A rare disease drug was approvable, then it wasn’t. Inside a surprise rejection by the FDA An experimental therapy for a rare blood cancer was on the path toward approval by the Food and Drug Administration last year — with internal reviewers recommending it be cleared — before the agency rejected the drug last…

  • 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…

  • 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…

  • 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?…

  • 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…

  • 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…

  • 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…

  • 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…

  • STAT+: Key study of Grail’s cancer detection test fails in setback for company

    STAT+: Key study of Grail’s cancer detection test fails in setback for company A blood test for detecting cancer early being developed by the diagnostics firm Grail failed to meet its main goal in a giant study being conducted with England’s National Health Service, the company said Thursday. Grail’s test has been the standard bearer…

  • Hims’ Super Bowl fallout, and the FDA reverses course

    Hims’ Super Bowl fallout, and the FDA reverses course Was Hims’ Super Bowl ad the final straw for regulators? Is the bar being lowered for psychedelic medicines? And what’s happening behind-the-scenes with Moderna and the Food and Drug Administration? We discuss all that on this week’s episode of “The Readout LOUD.” STAT’s Katie Palmer joins…

  • 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…

  • 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,…

  • STAT+: FDA rejects rare disease therapy from Disc Medicine, early recipient of commissioner’s voucher 

    STAT+: FDA rejects rare disease therapy from Disc Medicine, early recipient of commissioner’s voucher  WASHINGTON — The Food and Drug Administration on Friday rejected bitopertin, a therapy developed by Disc Medicine to treat the rare blood disorder porphyria, which makes patients extremely sensitive to sunlight.  It’s the first experimental drug to go through FDA Commissioner…

  • 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…

  • 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…

  • 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…

  • STAT+: NIH redefines ‘clinical trials,’ dividing researchers 

    STAT+: NIH redefines ‘clinical trials,’ dividing researchers  In a long-debated move, the National Institutes of Health will no longer characterize basic experimental studies involving humans as clinical trials, a step that was cheered by many researchers, but is also raising transparency concerns because the work will no longer have to be registered with — or…

  • STAT+: FDA refuses to review Moderna’s influenza vaccine

    STAT+: FDA refuses to review Moderna’s influenza vaccine The Food and Drug Administration refused to review Moderna’s application for a new influenza vaccine, the company said Tuesday, a surprise decision that could  raise concerns about the agency’s posture toward drug companies and the Trump administration’s policies on vaccines. Moderna, revealing the rejection, took the unusual…

  • 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…

  • STAT+: FDA rejects Regenxbio’s rare-disease gene therapy

    STAT+: FDA rejects Regenxbio’s rare-disease gene therapy The Food and Drug Administration has rejected a rare-disease gene therapy from Regenxbio, the company said Monday.  The one-time treatment, called RGX-121, is designed to replace a malfunctioning gene that causes mucopolysaccharidosis type II, also known as Hunter syndrome, an ultra-rare disorder that causes physical and cognitive impairments. …

  • 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…

  • 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…

  • STAT+: ‘Moonshot’ agency ARPA-H lays off staff meant to commercialize breakthroughs

    STAT+: ‘Moonshot’ agency ARPA-H lays off staff meant to commercialize breakthroughs ARPA-H, the “moonshot” biomedical agency established under the Biden administration, laid off staff last week, according to two people familiar with the matter.   The cuts largely hit staff responsible for operations and for commercializing the technologies the agency supports, the people said, leaving scientific…

  • 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…

  • STAT+: A rival goes after Ocular Therapeutix on eve of pivotal readout on eye treatment

    STAT+: A rival goes after Ocular Therapeutix on eve of pivotal readout on eye treatment Ocular Therapeutix and Eyepoint Pharmaceuticals are developing competing treatments for wet age-related macular degeneration, a common cause of vision loss in older people. Their CEOs don’t particularly like each other. So, with Ocular in a self-imposed quiet period ahead of…

  • 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%…

  • 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…

  • STAT+: FDA officials push for long-term monitoring of autoimmune patients receiving CAR-T therapy

    STAT+: FDA officials push for long-term monitoring of autoimmune patients receiving CAR-T therapy Food and Drug Administration officials are advising drug developers to study the long-term effects of using CAR-T to treat patients with autoimmune conditions, out of concern the therapies could cause cancer or fertility issues.  The recommendations were outlined in an op-ed published…

  • 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…

  • 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…

  • The high stakes for Huntington’s patients

    The high stakes for Huntington’s patients Biotech company UniQure is set to meet with the Food and Drug Administration to discuss the path forward for its gene therapy for Huntington’s disease, and the outcome could be potentially devastating for patients. That’s what patient advocate Lauren Holder says on the latest episode of “The Readout LOUD,”…

  • STAT+: AI biotech founded by ex-Google CEO Eric Schmidt is raising $150 million

    STAT+: AI biotech founded by ex-Google CEO Eric Schmidt is raising $150 million Hologen, a secretive AI startup co-founded by former Google CEO Eric Schmidt, is seeking to raise $150 million in a Series A fundraising round, STAT has learned.  Hologen describes itself as a “frontier medical AI company, a drug development & diagnostics company,…

  • 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…

  • 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…

  • 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…

  • A measles outbreak and hospitals’ financial troubles

    A measles outbreak and hospitals’ financial troubles Why is the U.S. at risk of losing its measles elimination status? How are health officials reacting to the measles outbreak? And what did top Centers for Medicare and Medicaid Services official Mehmet Oz tell hospital executives at a fancy yacht party in San Francisco? We discuss all…

  • STAT+: The number of new drug shortages in U.S. hits lowest level in 20 years, but myriad problems remain

    STAT+: The number of new drug shortages in U.S. hits lowest level in 20 years, but myriad problems remain The number of ongoing prescription drug shortages rose slightly in the last quarter of 2025, but remained significantly lower than the all-time high reached in the beginning of 2024. Moreover, the number of new shortages identified…

  • 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…

  • 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…

  • 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…

  • Breaking down JPM 2026: the mood, the big interviews — and all the AI billboards

    Breaking down JPM 2026: the mood, the big interviews — and all the AI billboards In last week’s STATus Report episode, we heard from STAT reporters Allison DeAngelis and Damian Garde, who shared what they would be keeping an eye out for at this year’s J.P. Morgan Healthcare Conference. Top of mind was predicting this…

  • 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…

  • STAT+: On Day 4 of JPM, a chat with Regeneron’s George Yancopoulos, an IPO forecast, and all eyes on J&J

    STAT+: On Day 4 of JPM, a chat with Regeneron’s George Yancopoulos, an IPO forecast, and all eyes on J&J This is the online version of The Readout, STAT’s flagship biotech newsletter. Sign up to get it in your inbox. We have made it! And so have you. This is Adam, Elaine, Matt, and Allison preparing to sign…

  • STAT+: On Day 3 of JPM, pharma threads a needle with the White House, and Novo Nordisk has an eye on M&A

    STAT+: On Day 3 of JPM, pharma threads a needle with the White House, and Novo Nordisk has an eye on M&A This is the online version of The Readout, STAT’s flagship biotech newsletter. Sign up to get it in your inbox. It’s Day 3 of JPM and all of us — Matt, Elaine, Adam, and Allison — are…

  • Live from JPM 2026, a sit-down with Novo Nordisk’s CEO and VC Bob Nelsen

    Live from JPM 2026, a sit-down with Novo Nordisk’s CEO and VC Bob Nelsen How did an office clerk become CEO of a major pharmaceutical company? What’s “Project Prometheus”? And what’s next in drug R&D? Allison, Adam, and Elaine are asking those questions live from the J.P. Morgan Healthcare Conference in San Francisco. Read the…

  • STAT+: Secretive Project Prometheus takes VC Bob Nelsen beyond just health care

    STAT+: Secretive Project Prometheus takes VC Bob Nelsen beyond just health care SAN FRANCISCO — Venture capitalist Bob Nelsen believes his latest project will be “one of the most important companies in the world.” But, unusually for the longtime biotech investor, it’s not strictly in health care. Nelsen has been quietly working on a new…

  • Kennedy adds two OB-GYNs to vaccine advisory panel amid review of shots for pregnant women

    Kennedy adds two OB-GYNs to vaccine advisory panel amid review of shots for pregnant women WASHINGTON — Health secretary Robert F. Kennedy Jr. appointed two new members to the main federal vaccine advisory board, his latest change to a group that has made a series of controversial recommendations and upended the usual processes for vaccine…

  • STAT+: Watch: At JPM, former drug regulator Richard Pazdur rings the alarm about politics at FDA

    STAT+: Watch: At JPM, former drug regulator Richard Pazdur rings the alarm about politics at FDA Richard Pazdur, a veteran regulator at the Food and Drug Administration until last month, joined STAT in San Francisco on Monday evening to make his first public remarks about the circumstances leading up to his abrupt departure. At an…

  • STAT+: On Day 2 of JPM, Gilead lays outs it next test, a VC looks to raise funds, and one firm has FDA whiplash

    STAT+: On Day 2 of JPM, Gilead lays outs it next test, a VC looks to raise funds, and one firm has FDA whiplash This is the online version of The Readout, STAT’s flagship biotech newsletter. Sign up to get it in your inbox. You’re back. We’re sort of back. It’s Day 2 of JPM and we’re…

  • 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…

  • 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…

  • STAT+: Alnylam charts ambitious five-year plan as sales of key drug miss expectations

    STAT+: Alnylam charts ambitious five-year plan as sales of key drug miss expectations SAN FRANCISCO — On Sunday, Alnylam, the gene-silencing company that notched one gigantic accomplishment after another over the past five years, set out a plan for the next five years built on yet more innovation and growth. At the same time, it announced…

  • STAT+: Why the JP Morgan conference is important — but not make-or-break

    STAT+: Why the JP Morgan conference is important — but not make-or-break This is the online version of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. My advice for JPM week: chill SAN FRANCISCO — The super-sized gathering of the biopharma universe is important, but it’s…

  • STAT+: FDA puts off Stoke’s request for faster filing of severe epilepsy drug

    STAT+: FDA puts off Stoke’s request for faster filing of severe epilepsy drug SAN FRANCISCO — Stoke Therapeutics and the Food and Drug Administration were unable to reach agreement on an expedited submission for the company’s severe epilepsy treatment, the company said Sunday.  Following a meeting in December, the FDA did not shut the door…

  • STAT+: Key scientist from Baby KJ team launches startup to scale personalized CRISPR medicines

    STAT+: Key scientist from Baby KJ team launches startup to scale personalized CRISPR medicines In between bites of thin, crispy slices of pizza at Berkeley’s Pizzeria da Laura, gene editing researcher Fyodor Urnov and venture capitalist Johnny Hu began hatching a plan for a different kind of CRISPR company. It was spring 2024 and Urnov,…

  • 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…

  • 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…

  • JPM to bring more deals and happy CEOs

    JPM to bring more deals and happy CEOs What news happened over the holidays? Why will pharma CEOs be greeted warmly in San Francisco next week? And who will buy Revolution Medicines? We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s weekly biotech podcast. We bring on former co-host…

  • 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,…

  • 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…

  • 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.…

  • With political savvy and outrage over drug prices, advocate David Mitchell was ahead of his time

    With political savvy and outrage over drug prices, advocate David Mitchell was ahead of his time About a dozen years ago, I was interviewing for a job at The Wall Street Journal when I was asked by an editor what I thought would be the most important story in the coming year for the pharmaceutical…

  • 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…

  • 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…

  • 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…

  • 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…

  • Best of STAT 2025

    Best of STAT 2025 What a year! Yes, it was our 10th anniversary, but it also brought an unprecedented blizzard of news, and while we weren’t added to a Signal chat on war plans, we did have a giant health insurer email us internal strategy documents by mistake. Our coverage featured everything from a piece…

  • 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…

  • 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…

  • 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…

  • 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…

  • 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…

  • 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…

  • STAT+: Cytokinetics heart drug wins FDA approval, the biotech’s first

    STAT+: Cytokinetics heart drug wins FDA approval, the biotech’s first It took 27 years, but Cytokinetics secured its first U.S. drug approval. On Friday, the Food and Drug Administration cleared the new medicine, called Myqorzo, to treat patients with obstructive hypertrophic cardiomyopathy, an inherited heart disorder.  Cytokinetics said it will begin selling Myqorzo in late…

  • Biotech’s year in review

    Biotech’s year in review Is the biotech industry truly out of its slump? Why are employers dropping coverage of weight loss drugs? And what will the hosts bake for the holidays? We discuss all that and more on this week’s episode of “The Readout LOUD,” the last episode of the year. We bring on Bruce…

  • 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…

  • 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…

  • 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…

  • 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…

  • The future of American science and a dispatch from ASH

    The future of American science and a dispatch from ASH How did Terns Pharmaceuticals and its “hodgepodge” pipeline grab attention at the American Society of Hematology conference? Is Eli Lilly’s new drug making people lose too much weight? And what, exactly, is the Trump administration’s plan for reforming the National Institutes of Health? We discuss…

  • STAT+: In a first, a nonprofit wins FDA approval for rare disease gene therapy

    STAT+: In a first, a nonprofit wins FDA approval for rare disease gene therapy The Food and Drug Administration this week granted approval to a new gene therapy for a rare immune disorder, the maker of which is notably not a drug company, but an Italian charity.  The authorization of Waskyra on Tuesday for Wiskott-Aldrich…

  • 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…

  • 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…

  • STAT+: Results in Terns leukemia drug study suggest it could be a successor to Novartis blockbuster

    STAT+: Results in Terns leukemia drug study suggest it could be a successor to Novartis blockbuster ORLANDO, Fla. — Terns Pharmaceuticals reported an update Monday on its targeted leukemia drug that maintained and even boosted molecular response rates in advanced-stage patients.  The study results, while still early, are likely to draw even more positive attention…

  • STAT+: New data from Gilead, Arcellx multiple myeloma CAR-T suggest benefit over rival treatment

    STAT+: New data from Gilead, Arcellx multiple myeloma CAR-T suggest benefit over rival treatment ORLANDO, Fla. — With sales of its existing blood cancer CAR-T therapies weakening, Gilead Sciences needs anito-cel, its next CAR-T therapy for multiple myeloma — to succeed more than ever.  On Saturday at the annual meeting of the American Society of…

  • STAT+: Fulcrum study suggests improved efficacy for higher dose sickle cell pill

    STAT+: Fulcrum study suggests improved efficacy for higher dose sickle cell pill Fulcrum Therapeutics said Sunday that a higher dose of its experimental pill for sickle cell disease was more effective at inducing an alternative form of the oxygen-carrying molecule hemoglobin — boosting hopes it could one day provide a simple and effective treatment for…

  • STAT+: Incyte study results suggest a new approach to treating myelofibrosis

    STAT+: Incyte study results suggest a new approach to treating myelofibrosis ORLANDO, Fla  — An experimental drug from Incyte achieved meaningful spleen response rates and improvements in disease symptoms in patients with advanced myelofibrosis, according to study results reported Sunday.  The data, while preliminary, should bolster the company’s efforts to develop a new type of…

  • 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…

  • 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…

  • 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…

  • 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…