The Latest

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    Trump administration

    5 FDA decisions to watch in the fourth quarter of 2026

    The next three months will feature anticipated decisions on a new kind of cancer immunotherapy, as well as medicines important to the futures of Roche, GSK and Gilead.

    FDA
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    Sponsored by PCL Construction

    How AI is transforming biopharma manufacturing facilities of the future

    As AI accelerates drug discovery, here are the ways pharmaceutical manufacturing facilities are adapting.

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    Deep Dive // IPO window

    Biotech IPOs are the industry’s lifeblood. Track how they’re performing.

    Lycia Therapeutics, a developer of protein-degrading immune drugs, outlined IPO plans on Monday while TRex Bio and Retension Pharmaceuticals cued up offerings that could price Thursday night.

    Updated 9 hours ago
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    News roundup

    Optogenetics researchers win a Nobel Prize; Roche bets on Alector brain drug

    The Nobel laureates “laid the foundation” for a new field of brain research, the award committee wrote. Elsewhere, Roche and CSL cut licensing deals and the FDA endorsed broader use of a Lilly medicine.

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    Shionogi pays $2B to acquire a rare disease startup

    The acquisition of Texas-based IntraBio adds to a growing rare disease business for Shionogi by handing the company a marketed treatment for two inherited conditions.

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    GE HealthCare to acquire Sofie Biosciences for $945M

    The purchase expands GE HealthCare’s radiopharmaceutical capabilities, helping manufacture and distribute time-sensitive drugs used in PET imaging.

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    Immune reset

    Novartis wagers almost $8B on a Chinese biotech’s RNA drugs

    In exchange for a $575 million payment up front, Abogen Biosciences will furnish Novartis with access to its RNA technology, including an option to license its lead program ABO-2203.

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    This week in charts: Kodiak’s big comeback and Hengrui’s dealmaking

    The latest installment in BioPharma Dive’s data visualization series features a closer look at Kodiak’s stock performance and Hengrui's ties with U.S. and European drugmakers.

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    An AI agent made a tiny drug R&D mistake. Then it kept going.

    The error points to a big question for pharma as AI gains autonomy and high-profile failures sharpen safety concerns: What happens when a wrong answer becomes the basis for the next decision?

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    Adeline Kon/BioPharma Dive
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    Deep Dive

    Biotech M&A is accelerating. Track the deals that are happening here.

    Including Shionogi’s planned buyout of IntraBio, the last five biopharmaceutical acquisitions have involved privately held companies, extending a run that began in early August.

    Updated Oct. 5, 2026
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    Obesity drugs

    3 takeaways from a European obesity scientific meeting

    Eli Lilly impressed with its amylin-Zepbound combination data. Elsewhere, Novo demonstrated continued weight loss following a switch to oral and AbbVie and Boehringer gave glimpses into their contenders.

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    Pfizer’s eczema drug clears skin in mid-stage trial

    Detailed results are competitive with Dupixent and Ebglyss, but the drug lacks differentiation amid an increasingly competitive landscape, one analyst argued.

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    News roundup

    Lilly, Foghorn part ways; Wave’s FDA-approved plans

    The pharma giant cut its partnership after a cancer drug disappointed in testing. Elsewhere, Teva and Samsung Bioepis expanded a partnership and space biotech Varda brought in $251 million.

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    China competition

    Drugs from China are reshaping biotech. Track the licensing deals here.

    Hengrui’s $2.6 billion deal with Novo is its sixth with a major U.S. or European drugmaker since the start of 2025, the most of any China-based biopharmaceutical company over that timeframe.

    Updated Sept. 29, 2026
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    Sanofi, Regeneron broaden alliance to find their next Dupixent

    The deal carries a $1 billion upfront payment and tasks the two companies to develop long-acting antibody drugs that go after the same targets as their blockbuster anti-inflammation agent.

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    HHS kicks off new programs to speed clinical trials as Chinese competition looms

    The department is offering funding to teams with innovative proposals as it considers ending the traditional phased clinical trial system.

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    Bristol Myers trial revisions shake confidence in new class of fibrosis drugs

    A spokesperson confirmed that a “limited number” of liver-related safety events, including a patient death, were observed in testing of Bristol Myers’ admilparant — though it’s unclear whether the drug was to blame. 

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    News roundup

    PhRMA names next CEO; Pierre Fabre takes third swing at Ebvallo approval

    A former congressman will take over for prominent lobbyist Steve Ubl. Elsewhere, recent buyout deals paid dividends for Mirum and AbbVie.

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    FDA starts review of Roche’s multiple sclerosis pill

    The FDA previously hadn’t ever accepted an application of a drug like fenebrutinib in two major forms of MS. But safety questions still hang over Roche’s program.

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    Gene editing

    Beam sues 2 biotechs, alleging theft of base editing trade secrets

    Beam claimed a former scientist stole confidential information and quietly spun up a rival rare disease treatment at YolTech Therapeutics. Serapha Bio, which licensed that therapy, denies the charges. 

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    UniQure tumbles with latest data for Huntington’s gene therapy

    Analysts guessed that investors wanted to see stronger durability results at a four-year check-in of the key trial supporting a potential approval of "AMT-130."

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    Obesity drugs

    Novo to pay Hengrui up to $2.6B for a once-weekly obesity pill

    The deal, which hands Novo a challenger to Lilly’s market-leading Zepbound, comes as the Danish drugmaker looks to calm investor fears about its future.

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    Adeline Kon/BioPharma Dive/BioPharma Dive
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    Deep Dive // Emerging biotech

    Biotech startups are built on venture capital. Track funding rounds here.

    Six biotechs raised over $700 million in combined venture funding this week, though two of those companies — Solstice Oncology and Encoded Therapeutics — accounted for the bulk of the total.

    Updated Sept. 11, 2026
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    AstraZeneca invests $2B in Summit, gaining ‘seat at the table’ for PD-1/VEGF drug push

    The equity investment comes alongside a deal to test Summit’s ivonescimab alongside potentially many AstraZeneca drugs — but doesn’t hand the pharmaceutical company any ownership rights.

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    Immune reset

    ai3Bio, built from two biotechs, pursues a different path to an ‘immune reset’

    Rather than deplete malfunctioning B cells as many other emerging autoimmune drugs do, Ai3Bio’s therapies are designed to eliminate a particular group of T helper cells.

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    Kodiak skyrockets on positive study data for 2 eye drugs

    The Phase 3 findings suggested Kodiak might have multiple threats to Regeneron’s Eylea and added more than $3 billion to the company’s market value.