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1,535 stories matching this filter · ← front page

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  • 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 · 4h 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 · 4h agoNegative readoutNegative↗ source
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  • 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 · 5h 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 · 5h 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 · 6h 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 · 7h 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 · 7h 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 · 11h 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 · 11h agoRegulatoryNegative↗ 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 · 12h agoPositive↗ 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 · 7h 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 · 11h agoPositive↗ 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 · 15h 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 · 7h agoRegulatoryNegative↗ source
  • RFK Jr. contrasts vaccine push in D.C. with addiction-treatment focus in California
    In Washington, the health secretary stood beside the president as an executive order was signed to overhaul childhood vaccination policy. The scene highlighted his push for broader vaccine adoption…
    STAT · 11h agoNeutral↗ source
  • How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine
    As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, s…
    BioSpace · 14h agoRegulatoryNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 5h agoLayoffsNegative↗ source
  • Paid paternity leave framed as preventive pediatric care in new opinion piece
    Pediatrician Nishant Pandya shares a recent clinic scene where a new father had to return to work the day after his daughter’s birth, highlighting the tension many families face. He notes that whi…
    STAT · 11h agoPositive↗ source
  • Experts propose safety framework for improving predictability, interpretation of CNS toxicity
    The use and implementation of new approach methodologies (NAMs) and digital technologies such as artificial intelligence (AI) may help improve the predictability and interpretation of central nervo…
    raps · 19h ago↗ source
  • FDA approves Bristol Myers' first oral therapy for advanced multiple myeloma, a new drug class
    The U.S. Food and Drug Administration gave its nod to an oral medication from Bristol Myers Squibb for patients with advanced multiple myeloma. The drug represents the first member of a novel clas…
    STAT · 3d agoApprovalPositive↗ source
  • FDA clears Bristol Myers' Zenbexus, first drug of a new class for advanced multiple myeloma
    The FDA announced approval of an oral therapy from Bristol Myers Squibb for patients with advanced multiple myeloma. The drug, iberdomide, will be marketed as Zenbexus and is intended to be used t…
    STAT · 3d agoApprovalPositive↗ source
  • EU regulator withdraws Amgen's Tavneos authorization over serious trial breaches
    European regulators have withdrawn the marketing authorization for Amgen's rare disease drug Tavneos, citing serious breaches in the pivotal clinical trial. The EMA said study staff from ChemoCent…
    BioSpace · 3d agoRegulatoryNegative↗ source
  • FDA grants accelerated approval to BMS’s iberdomide, branded Zenbexus, as generic competition hits Revlimid and Pomalyst sales
    The FDA has granted accelerated approval to iberdomide, now marketed as Zenbexus, for patients with multiple myeloma who have received at least one prior line of therapy. The drug is to be used in…
    BioSpace · 3d agoApprovalNeutral↗ source
  • FDA grants accelerated approval to Bristol's Zenbexus for multiple myeloma; PBMs adopt TrumpRx pricing; Novartis wins UK Entresto patent
    The U.S. Food and Drug Administration granted accelerated approval to Bristol Myers Squibb's oral therapy Zenbexus for patients with advanced multiple myeloma. The drug represents a new class of tr…
    STAT · 3d agoApprovalPositive↗ source
  • Capricor Therapeutics sees stock surge as FDA signals openness to extend review of DMD cell therapy
    Capricor Therapeutics' CEO Linda Marbán told investors that the FDA is receptive to adding open label extension data to its Biologics License Application for deramiocel, its Duchenne muscular dystr…
    BioSpace · 3d agoRegulatoryPositive↗ source