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  • Argenx reports positive Phase 3 results for Vyvgart Hytrulo in myositis
    Argenx announced that its subcutaneous formulation of Vyvgart, named Vyvgart Hytrulo, met the primary endpoint in a late‑stage Phase 3 trial in patients with myositis. The trial combined participa…
    BioPharma Dive · 5h agoPositive readoutPositive↗ source
  • Eyepoint's wet AMD therapy misses primary goal in Phase 3, stock tumbles
    Eyepoint reported that its experimental drug Duravyu did not keep vision in patients with wet age-related macular degeneration when given less frequently than the standard of care, causing the Phas…
    STAT · 3h agoNegative readoutNegative↗ source
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Infectious Disease336
  • EyePoint shares tumble as Durayvu misses primary goal in wet AMD trial
    EyePoint, a Boston biotech, saw its market value drop by nearly $1 billion after its lead candidate Durayvu failed to demonstrate non-inferiority to aflibercept in a pivotal phase 3 trial for wet a…
    BioPharma Dive · 6h agoNegative readoutNegative↗ source
  • AstraZeneca halts Phase 3 lung cancer trial of bispecific antibody volrustomig after interim data miss survival goal
    AstraZeneca announced termination of the Phase 3 study of its experimental bispecific antibody volrustomig in non‑small cell lung cancer. An interim data review by trial monitors indicated the dru…
    BioPharma Dive · 6h agoNegative readoutNegative↗ source
  • Slate Medicines secures $245M financing and Nasdaq listing via reverse merger with Fulcrum Therapeutics
    Slate Medicines, a North Carolina biotech, is moving toward a Nasdaq listing through a reverse merger with Fulcrum Therapeutics, six months after emerging from stealth. The transaction includes a…
    Fierce Biotech · 12h agoDealPositive↗ source
  • Sanofi to cut 229 Massachusetts jobs a year after $9.1 billion Blueprint Medicines acquisition
    Sanofi announced it will lay off 229 employees in Massachusetts, according to a filing with the state's Executive Office of Labor and Workforce Development. The workers are from Blueprint Medicine…
    STAT · 2h agoLayoffsNegative↗ source
  • IRS probes UnitedHealth tax filings and private-equity deals for doctor groups slow down
    UnitedHealth disclosed that the IRS has opened an investigation into its tax filings for 2017-2020, seeking to increase the company’s taxable income and potentially raise its tax bill for those yea…
    STAT · 7h agoRegulatoryNegative↗ source
  • EyePoint’s Phase 3 trial of duravyu fails to outperform aflibercept, shares plunge 70%
    EyePoint announced that its Phase 3 Lugano trial of the investigational tyrosine kinase inhibitor duravyu did not meet the primary efficacy endpoint when compared with the standard‑of‑care anti‑VEG…
    BioSpace · 7h agoNegative readoutNegative↗ source
  • Summit Therapeutics and Akeso celebrate third China approval for ivonescimab as new data show waning survival benefit
    Summit Therapeutics and its partner Akeso received a third approval in China for ivonescimab, a PD-1/VEGF bispecific antibody, for first-line treatment of advanced squamous non-small cell lung canc…
    BioSpace · 7h agoRegulatoryNegative↗ source
  • Akeso and Summit’s lung cancer candidate shows worsening tumor progression, while Europe halts Tavneos over trial concerns
    Akeso Therapeutics and Summit Therapeutics reported that their combined lung cancer therapy failed to improve outcomes, with data indicating a worsening in tumor progression compared to control. T…
    STAT · 8h agoNegative readoutNegative↗ source
  • AstraZeneca halts late-stage trial of volrustomig in metastatic lung cancer
    AstraZeneca said it is stopping a late-stage study of its experimental drug volrustomig combined with chemotherapy in patients with metastatic non-small cell lung cancer. The company made the decis…
    STAT · 8h agoNegative↗ source
  • AstraZeneca halts late-stage lung cancer trial of volrustomig after disappointing interim results
    AstraZeneca said it is ending its Phase 3 eVOLVE-Lung02 trial that evaluated the bispecific antibody volrustomig combined with chemotherapy as a first-line option for metastatic non-small cell lung…
    BioSpace · 9h agoNegative readoutNegative↗ source
  • Vera Therapeutics receives FDA accelerated approval for Trutakna, an IgA nephropathy drug showing promising kidney function stabilization
    Vera Therapeutics announced that its IgA nephropathy therapy Trutakna has been granted accelerated approval by the U.S. Food and Drug Administration. The approval follows the agency's review of dat…
    BioSpace · 9h agoApprovalPositive↗ source
  • Epic faces antitrust lawsuits and internal AI strategy turmoil ahead of annual user meeting
    Epic Systems, founded by Judy Faulkner, dominates the U.S. hospital electronic health record market and convenes its annual User Group Meeting with more than 20,000 attendees. The upcoming gatheri…
    STAT · 13h agoRegulatoryNegative↗ source
  • IRS launches probe into UnitedHealth over alleged tax avoidance from 2017-2020
    UnitedHealth Group is under investigation by the Internal Revenue Service, which says the insurer underpaid taxes by moving money to a foreign subsidiary during 2017-2020. The IRS is seeking to in…
    STAT · 13h agoRegulatoryNegative↗ source
  • Eli Lilly signs up to $370M ion-channel collaboration with OmniAb
    Eli Lilly has entered a collaboration with antibody platform company OmniAb that could involve up to $370 million in research, development and commercial milestone payments. OmniAb, which was spun…
    Fierce Biotech · 14h agoDealPositive↗ source
  • Italian biotech sector gains traction as venture capital and tech transfer improvements boost startups
    Italy has long been recognized for its high‑quality scientific research, yet converting that output into successful biotech startups has been a persistent challenge. Recent years have seen a shift…
    BioSpace · 14h agoPositive↗ source
  • AstraZeneca halts phase 3 lung cancer trial of bispecific antibody volrustomig after it falls short of Keytruda
    AstraZeneca stopped its phase 3 trial of the bispecific antibody volrustomig in metastatic non‑small cell lung cancer after interim data suggested the regimen would not meet the study's primary goa…
    Fierce Biotech · 17h agoNegative readoutNegative↗ source
  • Regeneron halts Phase 1/2a uveitis trial of anti-CD3 antibody after safety event
    Regeneron announced it is voluntarily ending the Phase 1/2a TITAN study of its anti‑CD3 monoclonal antibody, REGN7041, which was being evaluated for non‑infectious posterior uveitis. The decision…
    Fierce Biotech · 8h agoCRLNegative↗ source
  • Merck KGaA's US research site to cut 20 jobs amid broader R&D downsizing
    Merck KGaA's North American division, EMD Serono, announced it will lay off 20 employees at its Billerica, Massachusetts research site. The cuts are slated to take effect in the second half of Oct…
    Fierce Biotech · 8h agoLayoffsNegative↗ source
  • J&J returns rights to lymphoma CAR‑T therapy prizlon‑cel to AbelZeta
    Johnson & Johnson secured exclusive rights to the bispecific CAR T candidate prizlon‑cel in 2023, paying an upfront $245 million. The therapy, designed for large B‑cell lymphoma, achieved a 100% r…
    BioSpace · 10h agoDealNeutral↗ source
  • North Carolina’s bipartisan Medicaid pilot shows social services can cut health costs
    The article, written by former state health secretaries Mandy Cohen and Kody Kinsley, says North Carolina’s health‑care affordability crisis was tackled through a bipartisan pilot. The Healthy Opp…
    STAT · 13h agoPositive↗ source
  • FDA clears Lantheus' Tauklarify PET imaging agent for Alzheimer’s tau detection
    Lantheus received FDA clearance for its PET imaging agent Tauklarify, also known as MK-6240, which is designed to help diagnose Alzheimer’s disease by visualizing tau protein deposits. The clearan…
    Fierce Biotech · 14h agoRegulatoryPositive↗ source
  • State Laws Cut Private-Equity Acquisitions of Physician Practice Management Firms in Half
    State regulators in more than a dozen states have enacted laws that tighten oversight of private‑equity deals in health care, according to a new report. The tighter rules are reported to be slowing…
    STAT · 17h agoRegulatoryNeutral↗ source
  • Trump administration issues executive order overhauling federal vaccine program, drawing WHO criticism
    President Trump signed an executive order on Monday that reshapes the federal vaccine agenda, proposing changes that officials say lack supporting evidence. The World Health Organization publicly…
    STAT · 9h agoRegulatoryNegative↗ source