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4,422 stories matching this filter · ← front page

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  • GSK pays $12 million to Wave for liver-focused siRNA program, expanding its RNA drug pipeline
    GSK is paying Wave Life Sciences $12 million upfront to take ownership of a hepatic program that emerged from their long‑running collaboration. The payment follows a 2022 agreement in which GSK pa…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Merck reports positive mid-stage results for Prometheus' tulisokibart in painful skin disease
    Merck presented new data from a mid-stage trial of tulisokibart, a drug acquired through its $10.8 billion purchase of Prometheus Biosciences. The trial evaluated multiple dose levels in patients…
    Endpoints · 1mo agoPositive readoutPositive↗ source
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  • Mid-dose petrelintide shows strongest weight loss in phase-2 trial, paving way for pivotal study
    Roche and Zealand Pharma released new phase-2 data for petrelintide, an amylin analog being developed for obesity treatment. In the Zupreme 1 trial, the 5 mg dose achieved the greatest mean weight…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Trump administration's final Medicare pricing rule limits savings, covering only four firms
    The Trump administration released a final rule intended to lower Medicare prices for drugs administered in physician offices. The rule is part of the Global Benchmark for Efficient Drug Pricing (GL…
    STAT · 1mo agoRegulatoryNegative↗ source
  • HHS launches SURPASS program to accelerate clinical trials using AI and adaptive designs
    HHS announced a new five-year initiative called SURPASS, aimed at speeding up and expanding clinical trials by leveraging artificial intelligence and computational modeling. The program, run throu…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Patient death raises safety concerns before Bristol Myers lung drug readout
    A patient died from a fatal liver injury while taking part in a trial of Bristol Myers Squibb's lung disease candidate. The company disclosed the incident in a May amendment to its trial documents…
    Endpoints · 1mo agoNegative↗ source
  • 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
  • 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
  • Varda Space Industries secures $251 million Series D to develop drug manufacturing in orbit
    California startup Varda Space Industries announced it has closed a $251 million Series D financing round. The capital will be directed toward building and launching manufacturing facilities in lo…
    Endpoints · 1mo agoDealPositive↗ 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
  • Lilly's amylin-Zepbound combo shows up to 23.3% weight loss in obesity-diabetes patients at EASD 2026
    Lilly presented new data on its amylin‑Zepbound combination at the European Association for the Study of Diabetes meeting in Milan. The trial focused on patients who have both obesity and type 2 di…
    Endpoints · 1mo agoPositive readoutPositive↗ 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
  • FDA launches nationwide recruitment to broaden scientific and consumer representation on advisory committees
    The U.S. Food and Drug Administration announced a new nationwide effort to recruit qualified experts and consumer representatives for its advisory committees. The agency issued two Federal Register…
    fda press · 1mo agoRegulatoryPositive↗ 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
  • 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 · 1mo 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 · 1mo agoPositive readoutNeutral↗ 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