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  • Big pharma Q3 earnings roll out as FDA launches rare-disease initiative and uniQure's Huntington's gene therapy enters review
    Over the past week, a dozen major pharmaceutical companies reported third‑quarter results, including AstraZeneca, Biogen, GSK, Bristol Myers Squibb, Merck, Sanofi, AbbVie and Regeneron. Pfizer pos…
    BioSpace · 6d agoEarningsNeutral↗ source
  • Madrigal ex-clinical head sues, alleging liver-injury data cover-up for Rezdiffra
    Madrigal Pharmaceuticals is being sued by its former senior vice president and head of clinical development, Michael Charlton, who claims senior leaders suppressed serious liver‑injury data for the…
    Fierce Biotech · 6d agoRegulatoryNegative↗ source
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  • Minghui licenses sub-q TED drug to Japan's ASKA in up to $440 million deal
    Minghui Pharmaceutical of China has signed a licensing agreement with Japan's ASKA Pharmaceutical, granting exclusive rights to develop and sell its late‑stage thyroid eye disease (TED) candidate i…
    Fierce Biotech · 6d agoDealPositive↗ source
  • Blackstone Life Sciences and Boston Scientific launch $455 million partnership to develop next-generation heart pump
    Blackstone Life Sciences has entered a collaboration with Boston Scientific, committing $455 million to co‑fund development of a next‑generation miniature heart pump system. The device, called the…
    Fierce Biotech · 6d agoDealPositive↗ source
  • AbbVie pays $100M upfront in $1.4B deal for Nxera's phase-1 IBD candidate
    AbbVie has agreed to pay $100 million upfront for the worldwide rights to Nxera's oral EP4 receptor agonist, designated NXE0033744, with the total deal value potentially reaching $1.4 billion throu…
    Fierce Biotech · 6d agoDealPositive↗ source
  • Ultragenyx to cut 20% of staff and halve R&D budget as it pivots to commercial sales
    Ultragenyx announced it will reduce its workforce by about 20%, bringing headcount down to roughly 1,000 employees. The cuts follow an earlier 10% reduction announced in February and are part of a…
    Fierce Biotech · 6d agoLayoffsNegative↗ source
  • Charles River partners with Ipsen to employ virtual control groups in toxicology studies
    Charles River Laboratories and French biopharma Ipsen announced a collaboration to use Charles River’s virtual control group (VCG) database in an upcoming toxicology study. The VCG approach aims t…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Novo claims 80% share of oral GLP-1 market as rivalry with Lilly intensifies
    Novo's CEO Mike Maziar Doustdar said the company leads the oral GLP-1 market, stating the Wegovy pill holds about 80% of prescriptions since its launch in January. Eli Lilly, however, reported tha…
    BioSpace · 6d agoEarningsNeutral↗ source
  • Pfizer targets Europe first for upcoming Lyme disease vaccine amid rising US cases
    Pfizer is planning to launch its Lyme disease vaccine in Europe first, leveraging its existing tick-borne encephalitis franchise in the region. The vaccine, developed with French partner Valneva,…
    BioSpace · 6d agoRegulatoryPositive↗ source
  • China targets five $1 billion blockbuster drugs by 2030, two already achieved
    China's latest five-year plan aims to develop five domestically created drugs that each generate over $1 billion in global sales by 2030. According to industry analysts, two drugs have already sur…
    BioSpace · 6d agoPositive↗ source
  • FDA urges biosimilar sponsors to use alternative efficacy studies while AI reshapes regulatory work
    AI is becoming common in regulatory work. Experts say it will not replace regulatory professionals but will help them work more efficiently and free up time for human interaction. They stress that…
    raps · 6d agoRegulatoryNeutral↗ source
  • Boehringer bets big on China, offering $7B biobucks for Sino cancer programs
    Boehringer Ingelheim is building up its China strategy, inking a deal to develop new cancer treatments with Sino Biopharmaceutical just weeks after opening an R&D facility in Shanghai.
    BioSpace · 5d agoDealNeutral↗ source
  • Amgen launches autoinjector study for GLP-1 candidate MariTide as Phase 3 readouts loom
    Amgen has begun a study of an autoinjector formulation of its GLP-1 drug candidate MariTide, as the company prepares for pivotal Phase 3 data expected next year. The candidate is marketed as havin…
    BioSpace · 5d agoNeutral↗ source
  • Novo and Pfizer say MFN pricing agreements remain unchanged despite Democratic gains in Congress
    On their third‑quarter earnings calls, the CEOs of Novo Nordisk and Pfizer said the Most Favored Nation drug‑pricing contracts they signed under the previous administration are still in effect and…
    BioSpace · 6d agoRegulatoryNeutral↗ source
  • nPhase secures $30M Series D to grow AI-driven clinical data platform
    CRO nPhase announced it has closed a $30 million Series D financing round. The capital will be directed toward expanding its AI-native clinical data platform that debuted in September, which aims t…
    Fierce Biotech · 6d agoDealPositive↗ source
  • Smith+Nephew ends talks with J&J on orthopedics merger as growth stalls
    Smith+Nephew announced that discussions with Johnson & Johnson’s DePuy Synthes about a possible orthopedics combination have ended. The talks were disclosed in the company’s third‑quarter release;…
    Fierce Biotech · 6d agoDealNegative↗ source
  • FDA urges biosimilar makers to adopt alternatives to clinical efficacy trials
    FDA's Office of Therapeutic Biologics and Biosimilars, led by director Sarah Yim, announced that the agency is working to help sponsors rely less on clinical efficacy studies when developing biosim…
    raps · 6d agoRegulatoryPositive↗ source
  • Sanofi drops Nurix STAT6 degrader program amid molecule-specific concerns
    Sanofi has halted development of an early‑stage STAT6 degrader program that it licensed from Nurix Therapeutics. The decision was announced after the asset entered Phase 1 trials for type 2 inflamm…
    BioSpace · 5d agoNeutral↗ source
  • BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026
    BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…
    BioSpace · 6d agoNeutral↗ source
  • Flagship partner Louisa Helms credits high-school librarian for sparking biotech career
    Louisa Helms, a BioSpace 40 Under 40 honoree and partner at Flagship Pioneering, reflects on a unique path into biotech. In high school she was mentored by librarian Tammy Carabello, who turned th…
    BioSpace · 6d agoPositive↗ source
  • Sanofi halts Nurix STAT6 degrader program two months after phase-1 start
    Sanofi announced it is ending its collaboration with Nurix on a STAT6 degrader, just two months after the drug entered a phase-1 study. The two companies have worked together since 2019, with Sano…
    Fierce Biotech · 6d agoDealNegative↗ source
  • MiniMed appoints diabetes and digital health veteran David Segal as chief medical officer
    MiniMed, the insulin pump maker that spun off from Medtronic, announced the appointment of Dr. David Segal as its new chief medical officer. Segal replaces Dr. Robert Vigersky, who has served as C…
    Fierce Biotech · 6d agoPositive↗ source
  • AbbVie bets up to $1.47B for Nxera’s discarded IBD program
    AbbVie’s $100 million upfront cash payment will purchase global rights to Nxera’s deprioritized oral small molecule, which has already completed Phase 1 testing.
    BioSpace · 5d ago↗ source
  • T-Therapeutics secures $133M Series B to advance TCR-CD3 bispecifics with major pharma investors
    T-Therapeutics announced a $133 million Series B financing round backed by several of the world’s largest drug developers, including Eli Lilly, Johnson & Johnson, Merck KGaA and Sanofi, along with…
    Fierce Biotech · 6d agoDealPositive↗ source
  • Neurocrine launches new safety study after another death linked to Prader-Willi drug Vykat
    Neurocrine Biosciences announced it will start a new study to evaluate dosing and safety of its rare disease drug Vykat in patients with Prader-Willi syndrome who have complex health issues. The m…
    BioSpace · 6d agoRegulatoryNegative↗ source