Category: Biotech
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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…
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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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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,…
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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+: 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+: 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…
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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+: 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+: 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+: 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…
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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+: 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…
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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+: 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+: 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…
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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+: 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. …
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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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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…
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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+: 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…
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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+: 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…
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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+: 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,…
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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+: 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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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…
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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…
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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…
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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…
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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…
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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…
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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+: 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…
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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…
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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…
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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,…
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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+: 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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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…
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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+: 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+: 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…
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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+: 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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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+: 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…
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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+: 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+: 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…
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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…
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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…
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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…
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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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STAT+: Cancer detection firm Freenome to go public via $330 million SPAC deal
STAT+: Cancer detection firm Freenome to go public via $330 million SPAC deal Freenome, a Bay Area biotech that is part of the increasingly competitive race to accurately detect cancer early through blood-based tests, announced Friday that it plans to go public to advance the development of tests that can spot individual cancers and several…
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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+: Hair loss drug succeeds in Phase 3, but data underwhelms experts
STAT+: Hair loss drug succeeds in Phase 3, but data underwhelms experts A topical hair loss medication successfully built up hair in a Phase 3 trial, according to the results of two late-stage trials released Wednesday. Cosmo Pharmaceuticals, which is based in Dublin, ran the studies on men with a common form of hair loss…
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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+: 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+: 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+: 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+: Many poor countries where experimental drugs are tested fail to benefit after approval, analysis finds
STAT+: Many poor countries where experimental drugs are tested fail to benefit after approval, analysis finds Numerous medicines are not accessible in many of the countries where they were tested before approval by the Food and Drug Administration, raising concerns about whether pharmaceutical companies are adhering to ethical standards, a new study finds. The researchers reviewed 172…
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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…
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STAT+: Pfizer closes $10 billion Metsera deal
STAT+: Pfizer closes $10 billion Metsera deal Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! If you’re still wondering “What the heck happened with Moderna?” the latest episode of the video series STATus Report spells it out quite nicely. Also, a KFF…
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STAT+: Makary, Prasad outline pathway for bespoke gene therapy
STAT+: Makary, Prasad outline pathway for bespoke gene therapy 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 learn AbbVie has ended its partnership with Calico, the FDA outlines how bespoke gene-editing treatments can make it through the regulatory pipeline,…
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STAT+: Kura Oncology secures approval for leukemia drug, its first
STAT+: Kura Oncology secures approval for leukemia drug, its first The Food and Drug Administration on Thursday approved a drug made by Kura Oncology to treat patients with a certain type of genetically altered leukemia. The medicine will be sold under the brand name Komzifti. The FDA cleared the drug to treat patients with relapsed…
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STAT+: AbbVie cuts ties with Google-backed longevity company, lays off scientists
STAT+: AbbVie cuts ties with Google-backed longevity company, lays off scientists AbbVie is ending a decade-long partnership with Calico Life Sciences, an Alphabet-funded biotech company focused on aging research, and laying off chemists working on discovering new drugs. The moves, detailed in internal emails sent Tuesday and viewed by STAT, come as the pharmaceutical giant…
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STAT+: FDA chiefs offer roadmap to expand custom gene-editing treatments like Baby KJ’s
STAT+: FDA chiefs offer roadmap to expand custom gene-editing treatments like Baby KJ’s Top Food and Drug Administration officials on Wednesday detailed a roadmap for approving the world’s first personalized gene-editing treatments. The perspective, published in the New England Journal of Medicine, comes six months after researchers announced they had crafted a custom gene-editing treatment…
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STAT+: Why is Eli Lilly worth nearly $1 trillion?
STAT+: Why is Eli Lilly worth nearly $1 trillion? 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 big FDA news to get into today — let’s get straight into it. FDA names Richard Pazdur as top drug regulator The…