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  • Amgen's daxdilimab shows 6-point CLASI-A reduction in phase 2 lupus trial
    Amgen reported data from its phase 2 study of the ILT7-targeting monoclonal antibody daxdilimab in patients with discoid lupus. The trial enrolled 72 patients and tested two dose levels. The lower…
    Fierce Biotech · 24d agoPositive readoutPositive↗ source
  • FDA seeks new advisory committee members, signaling renewed focus on external expertise
    The FDA announced it is inviting subject‑matter experts and consumer representatives to serve on its advisory committees. The call follows a period when the advisory committees had a reduced role…
    raps · 24d agoRegulatoryNeutral↗ source
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  • CMS finalizes GLOBE Medicare drug price demo, projected savings cut to $440 million
    The Centers for Medicare & Medicaid Services (CMS) announced it has completed the GLOBE demonstration program, which is intended to lower the cost of prescription drugs covered by Medicare. Earlie…
    Endpoints · 23d agoRegulatoryNeutral↗ source
  • AbbVie’s eczema antibody shows statistically significant benefit in Phase 2 trial
    AbbVie presented Phase 2 results for its experimental eczema treatment, an anti‑IL‑13 antibody named Zumilokibart. The study met its primary endpoints, demonstrating statistically significant impr…
    Endpoints · 23d agoPositive readoutNeutral↗ source
  • Massachusetts offers $40M in tax incentives to spur 1,600+ life-science jobs
    Massachusetts announced $40 million in tax incentives for 38 life‑science companies, targeting the creation of about 1,644 new jobs. Most of the companies-31 of them-will expand outside Boston and…
    BioSpace · 23d agoRegulatoryPositive↗ source
  • Beam Therapeutics files lawsuit accusing former scientist of stealing IP to launch Chinese biotech venture
    Beam Therapeutics has initiated legal action alleging that a former employee misappropriated proprietary gene-editing technology. The company claims the scientist used the stolen information to co…
    STAT · 24d agoCRLNegative↗ source
  • BioNTech to shut three German manufacturing sites after failing to secure buyers, risking 1,860 jobs
    BioNTech announced it will close three manufacturing facilities in Germany after an unsuccessful search for buyers. The sites in Idar-Oberstein, Marburg and Tübingen were slated for possible sale,…
    BioSpace · 24d agoNegative↗ source
  • Merck reports positive phase 2b results for anti-TL1A antibody in hidradenitis suppurativa
    Merck announced that its experimental anti-TL1A antibody achieved a positive outcome in a phase 2b study. The trial enrolled patients with moderate to severe hidradenitis suppurativa, a chronic in…
    Fierce Biotech · 24d agoPositive readoutPositive↗ source
  • Connect Biopharma's IL-4/IL-13 blocker cuts COPD exacerbations by 85% in Phase 2 trial
    Connect Biopharma reported phase 2 results for its IL-4/IL-13 inhibitor rademikibart in COPD patients. In the Seabreeze STAT study of 159 participants who had recent exacerbations, adding rademiki…
    Fierce Biotech · 24d agoPositive readoutNeutral↗ source
  • VertigoDx receives FDA 510(k) clearance for its portable SmartVertigo diagnostic system
    The U.S. Food and Drug Administration has issued a 510(k) clearance for VertigoDx's portable vertigo assessment tool, allowing it to be marketed in the United States. The system, called SmartVerti…
    Fierce Biotech · 24d agoRegulatoryPositive↗ source
  • American Biotech Innovation Alliance urges Congress to prioritize US leadership in biopharma
    The American Biotech Innovation Alliance, formed in May, appeared on Capitol Hill on September 30, 2026 to address lawmakers. The group argued that maintaining U.S. dominance in biopharma requires…
    Endpoints · 23d agoNeutral↗ source
  • Ned Sharpless joins Hatteras Venture Partners as managing director, Andrew Witty returns as chairman
    Hatteras Venture Partners, a North Carolina venture capital firm focused on life‑science startups, announced that former National Cancer Institute director Norman “Ned” Sharpless has joined the fir…
    Endpoints · 24d agoDealPositive↗ source
  • Bicara CEO Claire Mazumdar to step down, COO Ryan Cohlhepp to assume leadership in 2027
    Claire Mazumdar, who co‑founded Bicara and has served as its chief executive for almost seven years, announced she will step down at the end of the year. She will take parental leave and then move…
    BioSpace · 24d agoPositive↗ source
  • Industry groups back FDA draft guidance on single‑trial approvals but seek clearer flexibility rules
    Industry associations and other stakeholders have expressed overall support for the FDA's draft guidance that outlines when a single pivotal trial, supplemented by confirmatory evidence, can be suf…
    raps · 24d agoRegulatoryNeutral↗ source
  • Researchers create mouse with human-derived brain cortex, sparking ethical and scientific debate
    A research team led by Stanford professor Sergiu Pașca has reported in Nature the creation of a laboratory mouse whose cerebral cortex is built from human brain cells derived from stem cells. The s…
    STAT · 24d agoNeutral↗ source
  • Experts call for regulation of kratom and potent 7-OH products, debate over specific rules
    Kratom leaf products have been sold in the United States for many years without formal regulatory oversight. Users often turn to them for chronic pain, anxiety, or to ease opioid withdrawal, despit…
    STAT · 24d agoRegulatoryNeutral↗ source
  • Women-led biotech M&A drops sharply in 2026, only two major deals recorded so far
    Last year saw an unprecedented wave of women-led biotech transactions, with eleven high‑value deals out of 72 total biopharma mergers in 2025. In 2026 the pace has slowed dramatically, with just…
    BioSpace · 24d agoDealNegative↗ source
  • Biopharma must incentivize scientists to make early go-no-go decisions
    The article argues that simply urging scientists to think like entrepreneurs is not enough; biopharma firms need to align rewards with that mindset. Because only about one in ten drug candidates t…
    BioSpace · 24d agoNeutral↗ source
  • Pennsylvania reports four measles deaths this year, CDC records only two
    Pennsylvania health officials say four people have died from measles so far in 2026. The Centers for Disease Control and Prevention, however, lists only two measles deaths in its national count. T…
    STAT · 24d agoNeutral↗ source
  • STAT releases AI Prognosis newsletter on health tech leaders' policy discussions in Washington
    STAT's AI Prognosis newsletter issued a new edition that looks at what health technology executives are saying about policy issues in Washington. The piece was authored by Brittany Trang, a Ph.D.…
    STAT · 23d agoNeutral↗ source
  • Biopharma needs to reward scientists' judgment
    It’s not enough for organizations to want scientists to think like entrepreneurs. They have to incentivize and reward for that behavior.
    BioSpace · 24d ago↗ source
  • AstraZeneca invests $2 billion in Summit Therapeutics to advance PD-1xVEGF bispecific ivonescimab with ADC combos
    AstraZeneca is committing $2 billion to Summit Therapeutics, acquiring a 12% equity stake at a premium to the biotech's closing price. The funding is aimed at accelerating development of the PD‑1xV…
    Fierce Biotech · 25d agoDealPositive↗ source
  • FDA approves Egetis’ Emcitate for rare genetic disease as Novo secures Chinese weight-loss pill in $2.6 billion deal
    The U.S. Food and Drug Administration has granted approval to Egetis' Emcitate, a therapy targeting a rare genetic disorder. This marks a regulatory milestone for the company and patients awaiting…
    raps · 25d agoDealPositive↗ source
  • AstraZeneca invests $2 billion in Summit Therapeutics to fund Phase 3 trials of ivonescimab
    AstraZeneca has agreed to a $2 billion all‑stock investment in Summit Therapeutics. The deal involves the purchase of preferred shares that can be converted into common stock, but it does not inclu…
    BioSpace · 25d agoDealPositive↗ source
  • Novo Nordisk signs $2.6 billion deal with China's Hengrui for oral GLP-1/GIP candidate
    Novo Nordisk announced a licensing agreement with Chinese drugmaker Hengrui Pharmaceuticals, paying $300 million upfront for rights to a preclinical GLP-1/GIP dual-receptor agonist. The candidate,…
    Fierce Biotech · 25d agoDealPositive↗ source