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Tag: Biotech

  • STAT+: FDA adcomm members’ ties to industry under scrutiny

    STAT+: FDA adcomm members’ ties to industry under scrutiny

    Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

    Good morning. Yesterday, we got the devastating news that STAT’s infectious disease correspondent, Helen Branswell, passed away. She was a reporter I always looked up to and was also an incredibly generous colleague. Please take the time to read this tribute to her.

    The need-to-know this morning

    • Liquidia and United Therapeutics reached a settlement agreement that resolves their ongoing patent litigation over Liquidia’s treatment for pulmonary arterial hypertension. 

    Researchers in Pittsburgh are launching a novel type of GLP-1 trial — testing not only if the drug will help people with addiction, but also if it will help reduce recidivism while improving other employment, health, and housing outcomes.

    The Center for Addiction Science, Policy and Research (CASPR), a non-profit organizing the effort, and the Allegheny County Department of Human Services are planning to launch the trial in early 2027. They will enroll up to 1,200 adults with alcohol use disorder, opioid use disorder, or both, who are also at high risk of criminal-justice involvement. Half will be randomly assigned to take Novo Nordisk’s Wegovy, according to a press release issued yesterday.

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  • STAT+: Life Biosciences share glaucoma study updates for its cellular reprogramming drug

    STAT+: Life Biosciences share glaucoma study updates for its cellular reprogramming drug

    NIH funding uncertainty thwarts U.S. researchers, Argenx stumbles, and more biotech news

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    Jason is a general assignment reporter, with particular focus on genetic medicine and rare disease. Confidential tips can be sent on Signal at JasonMast.77.

    Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

    This is the Readout. Please read it.

    And don’t miss us too much Monday, when the newsletter will be paused for the holiday. We’ll be back in your inbox Tuesday.

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    1. Meghana Keshavan covers biotech and contributes to The Readout newsletter.

    2. General Assignment Reporter

      Jason is a general assignment reporter, with particular focus on genetic medicine and rare disease. Confidential tips can be sent on Signal at JasonMast.77.

  • STAT+: Roche goes beyond licensing in deal with Chinese biotech

    STAT+: Roche goes beyond licensing in deal with Chinese biotech

    DOJ signals it will start scrutinizing drugmakers, PhrMA sues Trump administration, and more biotech news

    gantenerumab Alzheimer's disease Roche
    Sebastien Bozon/AFP via Getty Images

    Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

    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. Let’s get straight to the news.

    The need-to-know this morning

    Roche goes beyond licensing in deal with Chinese biotech

    Over the past few years, pharma companies have flocked to China to license existing drug candidates. Roche is taking a new approach, partnering with Chinese startup Defand Therapeutics to discover new medicines.

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    1. National Biotech Reporter

      Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

  • STAT+: Roche inks drug discovery deal with Chinese biotech, focused on molecular glue medicines

    STAT+: Roche inks drug discovery deal with Chinese biotech, focused on molecular glue medicines

    Allison covers what hot startups are getting up to, and who’s financing them. She is also co-host of the weekly biotech podcast, “The Readout Loud.” You can reach Allison on Signal at AllisonDeAngelis.01.

    Roche is digging deeper into the biotech industry in China, striking a new partnership with a drug startup there. But rather than licensing the startup’s clinical-stage medicines, Roche is enlisting it to discover new ones, signaling a potential shift in global drug development. 

    Chinese startup Defand Therapeutics said Thursday that it had signed a collaboration deal with Roche to develop molecular glue medicines. Under the deal, Defand will discover and develop multiple drugs for cancer and immune-driven diseases. The financial terms were not disclosed, but a source with knowledge of the agreement said it could be worth close to $1 billion between the upfront fee and payments Defand could get if it meets various preclinical, clinical, and regulatory goals. 

    Molecular glue therapies are a buzzy new area of drug development, designed to create a sticky, more effective connection onto problematic proteins to destroy them. Development of these drugs has just begun to accelerate, thanks in large part to the data from Revolution Medicines, showing its molecular glue treatment Rasonque nearly doubled the survival rate of patients with pancreatic cancer. 

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  • STAT+: Biotech companies are struggling to navigate Trump’s new tariffs

    STAT+: Biotech companies are struggling to navigate Trump’s new tariffs

    WASHINGTON — A broad tariff on imported pharmaceuticals took effect at the end of September, and some biopharma companies and the industry group that represents them say many are being left in the dark on how to get exemptions. 

    The Trump administration announced a 100% section 232 tariff in April, impacting imports of patented drugs and their active ingredients. At the time, the White House offered a number of pathways for companies to reduce their tariff burden, including striking a most-favored nation deal to sell drugs in the U.S. at similar prices to other wealthy countries or agreeing to bring production to the U.S.

    Companies that made MFN agreements would have had start paying tariff costs in July, but now aren’t on the hook for payment until early 2029, per their agreements. That exempts many of the biggest U.S. drugmakers, while leaving smaller biotech firms to face the levies.

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  • STAT+: PhRMA sues over Trump policy mandating lower drug prices in Medicare

    STAT+: PhRMA sues over Trump policy mandating lower drug prices in Medicare

    Pilot program known as GLOBE is intended to test ‘most-favored nation’ policy

    Close up stock news photo of medicare advantage membership cards
    Jenny Kane/AP

    By John Wilkerson

    Oct. 7, 2026

    John Wilkerson, a Washington correspondent, is the author of D.C. Diagnosis, a twice-weekly newsletter about the politics and policy of health and medicine.

    John writes about the politics of health care, and he is the author of the twice-weekly D.C. Diagnosis newsletter. You can reach John on Signal at John_Wilkerson.07.

    WASHINGTON — The brand drug industry’s main trade group is suing the Trump administration over a pilot program tying Medicare drug prices to those in peer countries.

    The Pharmaceutical Research and Manufacturers of America said Wednesday that it had filed a complaint in the U.S. District Court for the District of Columbia asserting that the “most-favored nation” pilot in Medicare Part B exceeds Medicare’s statutory authority. 

    The pilot, called GLOBE, is not expected to have much impact because the administration exempted all but a handful of companies in return for their agreement to voluntary deals to charge Medicaid MFN prices. 

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    1. John writes about the politics of health care, and he is the author of the twice-weekly D.C. Diagnosis newsletter. You can reach John on Signal at John_Wilkerson.07.

  • STAT+: Forbion raises $2.6 billion, its largest fundraise to date

    STAT+: Forbion raises $2.6 billion, its largest fundraise to date

    Promising Duchenne therapies will test FDA flexibility, Doudna-founded Caribou shutting down, and more biotech news

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    Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

    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. Today, STAT released our 2026 Wunderkinds, a group of early-career researchers recognized for doing innovative work in health and medicine. I had the pleasure of speaking with one NIH researcher who has been figuring out how GLP-1 drugs work in the brain. But check out all of the profiles here!

    The need-to-know this morning

    • Cerevance said its experimental pill solengepras reduced Parkinson’s patients’ daily off-time, alongside other symptoms, in a Phase 3 trial. The privately held company, which will now talk to regulators about a potential approval, touts the pill as one of the first potential Parkinson’s drugs that does not act directly on dopamine, sparing patients certain side effects.
    • Henri B. Kagan and Kenso Soai were awarded the 2026 Nobel Prize in chemistry for discovering how to manipulate “mirror image” molecules, paving the way for manufacturing more precise and safer drugs.

    Doudna-founded Caribou is shutting down

    Caribou Biosciences is shutting down after failing to raise enough money to fund a late-stage clinical trial of its off-the-shelf CAR-T therapy for lymphoma.

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    1. National Biotech Reporter

      Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

  • STAT+: In Duchenne muscular dystrophy, a promising therapy is available to a fortunate few

    STAT+: In Duchenne muscular dystrophy, a promising therapy is available to a fortunate few

    By Jason Mast

    Oct. 7, 2026

    General Assignment Reporter

    There’s a boy like you in Minnesota, Yannick’s mom told him a few years ago. He has the same disease. He has the same kind of smile. Maybe you could talk?

    They clicked. After school and on weekends, the two boys boot up their computers, Yannick in San Diego and Brecken in a suburb of St. Paul, Minn. They play Roblox or build virtual worlds on Minecraft: a zoo, for example, like the real-world one 13-year-old Yannick wants to build when he grows up, full of lions, tigers, and giraffes. 

    They seldom talk about Duchenne muscular dystrophy, the rare fatal muscle-wasting disease they live with. But lately it’s all their moms can talk about. In stolen phone calls on the way to coffee or back from school, they compare the two boys: how quickly Yannick is declining and how steadily Brecken is — shockingly — improving.

    Last winter, Brecken, 12, started receiving an experimental drug developed by Avidity Biosciences. The medicine makes the cell’s protein-building machinery “skip” part of the gene, called an exon, behind Duchenne, allowing patients to make a shortened but functional version of a protein essential for muscle survival. In trials, it appeared to virtually arrest the disease in some patients. 

    The approach, however, is out of most patients’ reach. In principle, “skipping” strategies could benefit about 70% of the 10,000 to 15,000 Duchenne boys and men in the U.S. (The disease almost exclusively affects males.) But the medicines have to be targeted to a patient’s specific mutation. Only about 7% of patients — or roughly 900 Americans — are eligible for Avidity’s drug, called Del-zota, which is now under Food and Drug Administration review.

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  • STAT+: AstraZeneca opens new Boston site 

    STAT+: AstraZeneca opens new Boston site 

    Utah pilots AI service to prescribe acne treatment, drug price disclosures are coming, and more biotech news

    HECTOR RETAMAL/AFP via Getty Images

    Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

    Allison covers what hot startups are getting up to, and who’s financing them. She is also co-host of the weekly biotech podcast, “The Readout Loud.” You can reach Allison on Signal at AllisonDeAngelis.01.

    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. From DC to Boston to Utah, we’ve got news from all over today.

    The need-to-know this morning

    • BridgeBio said the FDA granted priority review to its oral treatment for children with achondroplasia, a common form of dwarfism. An approval decision on the drug, called infigratinib, is expected by Feb. 4, 2027. 
    • Japan’s Shionogi has acquired for $2 billion the U.S.-based biotech IntraBio, the maker of an approved drug that treats the neurological symptoms of two rare diseases. 
    • Arrivent Biopharma said its experimental treatment for exon 20-mutated lung cancer failed to delay tumor progression in a Phase 3 study.

    Trump admin says drug price disclosures are coming

    Trump administration officials said yesterday they will start developing a system for health insurers to disclose prescription drug prices, and a “hopeful” final plan will come out by next May.

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    1. National Biotech Reporter

      Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

    2. Biotech Startups and Venture Capital Reporter

      Allison covers what hot startups are getting up to, and who’s financing them. She is also co-host of the weekly biotech podcast, “The Readout Loud.” You can reach Allison on Signal at AllisonDeAngelis.01.

  • STAT+: Are stem cell treatments about to have their day?

    STAT+: Are stem cell treatments about to have their day?

    You’re reading STAT’s D.C. Diagnosis newsletter

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    John writes about the politics of health care, and he is the author of the twice-weekly D.C. Diagnosis newsletter. You can reach John on Signal at John_Wilkerson.07.

    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.

    Celebrity doctor Mike Varshavski has been contacted by The Bachelor for its 30th season. Send news tips and hot physicians to [email protected] or John_Wilkerson.07 on Signal.

    A lame lame-duck

    On Friday, President Trump said he will give $90 to more than 20 million seniors to help pay for Medicare premiums.

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    1. John writes about the politics of health care, and he is the author of the twice-weekly D.C. Diagnosis newsletter. You can reach John on Signal at John_Wilkerson.07.