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  • Bristol Myers revises Phase 3 fibrosis trial after liver safety events, including a death
    Bristol Myers Squibb announced a change to its late-stage Phase 3 "Aloft" trial of the experimental pulmonary fibrosis drug admilparant. The amendment adds closer monitoring for liver-related adve…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • FDA begins review of Roche’s experimental multiple sclerosis pill fenebrutinib
    The FDA has accepted Roche's application for fenebrutinib, an experimental oral therapy for multiple sclerosis, and has started a priority review. The review will evaluate the drug in both relapsi…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
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  • U.S. plan to cut Medicaid for legal immigrants, including refugees and trafficking victims, takes effect Oct. 1
    Hundreds of thousands of lawfully present immigrants could lose Medicaid coverage beginning Oct. 1, according to state data. The change is part of the One Big Beautiful Bill Act, a Republican effor…
    STAT · 1mo agoRegulatoryNegative↗ source
  • PhRMA appoints former congressman Eric Cantor as CEO as Pierre Fabre resubmits Ebvallo approval request
    PhRMA announced that former U.S. House member Eric Cantor will become its president and chief executive on Nov 9, taking over from longtime leader Steve Ubl. Cantor served Virginia from 2000 to 201…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Poll finds most rural MAHA supporters say Trump health policies have not improved community health
    A new Associated Press‑KFF poll of more than 2,000 rural registered voters shows that while about half of respondents identify with the Make America Healthy Again (MAHA) movement, roughly eight in…
    STAT · 1mo agoNegative↗ source
  • Beam sues over alleged IP theft as Moderna appoints new COO and Pierre Fabre/Atara refile drug for ultra-rare blood cancer
    Beam Therapeutics has filed a lawsuit claiming a former scientist took proprietary information and used it to start a Chinese firm, alleging theft of its intellectual property. PhRMA announced a n…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • AI chemistry agent gives wrong answer after handling malformed data, highlighting safety concerns in drug research
    An AI chemistry agent called ChemAgent was tasked with checking whether a molecule had a known hepatobiliary side effect. The agent supplied the molecular structure in an invalid format to a speci…
    BioPharma Dive · 1mo agoNegative↗ source
  • Beam Therapeutics sues rival YolTech over alleged theft of base-editing data for AATD therapy
    Beam Therapeutics, a base editing biotech, filed a lawsuit in U.S. District Court in Massachusetts against YolTech Therapeutics and former employee Zi Jun (Emma) Wang, alleging theft of proprietary…
    Fierce Biotech · 1mo agoNegative↗ source
  • US must strengthen its biotech sector to stay ahead of China, authors argue
    Gary Locke and Patrick McHenry, former U.S. officials and senior advisers to the American Biosecurity Initiative, argue that the United States must invest in its own biotech capabilities to preserv…
    STAT · 1mo agoPositive↗ source
  • 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 · 1mo agoPositive readoutPositive↗ 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 · 1mo agoCRLNegative↗ 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 · 1mo 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 · 1mo 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 · 1mo agoRegulatoryPositive↗ 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 · 1mo 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 · 1mo agoRegulatoryNeutral↗ 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 · 1mo 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 · 1mo agoNeutral↗ 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 · 1mo 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 · 1mo agoDealPositive↗ source
  • AstraZeneca puts $2 billion into Summit Therapeutics and partners to test ivonescimab with its oncology pipeline
    AstraZeneca announced a $2 billion equity investment in Summit Therapeutics, acquiring roughly 109,000 shares of convertible preferred stock. The deal will give AstraZeneca about a 12% stake in Sum…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • UniQure’s gene therapy still slows Huntington’s disease after four years, but benefit declines
    UniQure reported that its one‑time gene therapy, AMT‑130, continues to decelerate the progression of Huntington’s disease four years after being surgically delivered into patients' brains. A new a…
    STAT · 1mo agoNegative readoutNegative↗ source
  • Lawmakers ask Trump to reconsider rule that would tighten import of prescription drugs from Canada
    Congressional members are pressing the Trump administration to revisit a federal rule slated to take effect on Oct. 22 that would tighten how prescription medicines are imported from Canada and oth…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Beam Therapeutics sues YolTech and Serapha Bio over alleged theft of base editing trade secrets
    Beam Therapeutics has filed a lawsuit in U.S. District Court in Massachusetts accusing Chinese biotech YolTech Therapeutics and its U.S. partner Serapha Bio of using confidential information to dev…
    BioPharma Dive · 1mo agoNegative↗ source
  • Novo to pay Hengrui up to $2.6 billion for rights to weekly obesity pill HRS-1596
    Novo announced a deal with China-based Hengrui Pharma, paying $300 million up front for rights to HRS-1596, a once‑weekly obesity pill. The agreement could rise to $2.6 billion if the candidate me…
    BioPharma Dive · 1mo agoDealNeutral↗ source