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3,148 stories matching this filter · ← front page

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  • Biogen's anti-tau Alzheimer drug BIIB080 fails primary endpoint in Phase 2, but shows slower decline
    Biogen reported results of its Phase 2 trial of BIIB080, a tau-targeting therapy for Alzheimer’s disease. The study’s primary endpoint was not met, meaning the drug did not achieve the pre-specifi…
    Endpoints · 3mo agoNegative readoutNeutral↗ source
  • Regenxbio reports positive Duchenne gene therapy trial results, targets FDA approval by 2027
    Regenxbio announced that its gene therapy for Duchenne muscular dystrophy achieved the required endpoints in a pivotal clinical trial. The data met the study's predefined criteria, which the compa…
    Endpoints · 3mo agoPositive readoutPositive↗ source
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  • CREATE Medicines raises $122 million to advance CAR-T candidates into human trials
    CREATE Medicines, formerly Myeloid Therapeutics, announced a $122 million financing round. The funding came from Newpath Partners, ARCH Venture Partners, Hatteras Venture Partners and other invest…
    STAT · 3mo agoDealPositive↗ source
  • Acting FDA Commissioner Kyle Diamantas Seen as Drama-Free Stabilizer for Biotech
    Kyle Diamantas has been named the acting commissioner of the Food and Drug Administration, stepping into the role after Marty Makary’s resignation. He previously led the FDA’s food safety division,…
    STAT · 3mo agoRegulatoryPositive↗ source
  • FDA searches for new commissioner as Marty Makary departs, Trump administration outlines priorities
    Marty Makary is leaving his role at the FDA, as reported in STAT’s D.C. Diagnosis newsletter. The Trump administration has released a lengthy wish list for the next FDA commissioner, indicating th…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • MacroGenics sells manufacturing operations to Bora for $122.5M; West Pharma reports cybersecurity breach
    MacroGenics announced it is selling its clinical and commercial drug substance manufacturing portfolio to CDMO Bora. The deal includes an upfront payment of $122.5 million. The transaction transfe…
    Endpoints · 3mo agoDealNeutral↗ source
  • STAT launches investigative series on alcohol epidemic killing 178,000 Americans annually
    STAT has begun a new investigative series that examines the United States’ ongoing alcohol crisis, which the outlet says results in roughly 178,000 deaths each year. The reporting team traveled na…
    STAT · 3mo agoNegative↗ source
  • STAT+: CDC plans to transfer monkeys to nonprofit’s sanctuary as it seeks to reduce animal testing
    The CDC intends to transfer more than 160 macaques to Born Free USA, a nonprofit that runs a large primate sanctuary in Texas, as the agency seeks to phase out…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Biogen pushing tau drug forward despite Alzheimer’s study failure
    One of the company’s more closely watched research assets, BIIB080 is now heading to late-stage testing based on “the strength of the biomarker and efficacy data” seen in a Phase 2 trial.
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ source
  • Major digital health firms stay out of Medicare's chronic care ACCESS pilot
    The latest STAT Health Tech newsletter reports that the biggest players in digital health are not participating in Medicare's ACCESS pilot, a program designed to test chronic-care solutions for Med…
    STAT · 3mo agoNeutral↗ source
  • Alcohol treatment sees growing shift toward alternatives beyond Alcoholics Anonymous
    The article highlights a growing movement away from traditional Alcoholics Anonymous programs toward newer, more flexible approaches for treating alcohol use disorder. It notes that many patients a…
    STAT · 3mo agoNeutral↗ source
  • In vivo CAR-T therapies dominate talks at ASGCT 2026 conference
    The reporter is on the ground in Boston covering the American Society of Gene & Cell Therapy's annual meeting. Sessions across the conference are highlighting in vivo CAR-T approaches, showing tha…
    Endpoints · 3mo agoNeutral↗ source
  • Pharma firms must complete extensive paperwork and undergo monitoring to qualify for a 20% tariff reduction
    The Department of Commerce announced that pharmaceutical manufacturers must complete a detailed application to qualify for a reduced 20% tariff rate. The requirement follows an executive order sig…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Three years of falling overdose deaths spark cautious optimism amid lingering concerns
    Over the past three years, the United States has seen a steady decline in overdose deaths, a trend that has generated cautious optimism among public‑health observers. While the numbers are encourag…
    STAT · 3mo agoPositive↗ source
  • Physician warns AI could undermine authentic care in addiction treatment
    Physician Steve D. Klein, an addiction medicine specialist, argues that recent AI tools marketed for addiction care miss the core of patient treatment. He describes seeing a prototype that, while t…
    STAT · 3mo agoNegative↗ source
  • Penn Medicine to Leverage $1.1 Million AI Grant for Doctor Training Program
    Penn Medicine announced plans to incorporate artificial intelligence into its physician education efforts after receiving a $1.1 million grant from an education grant program in January. The grant…
    Endpoints · 3mo agoNeutral↗ source
  • MIT reports 10% drop in research output and 20% fall in graduate admissions amid funding and immigration challenges
    MIT President Sally Kornbluth announced that the institute's research enterprise is 10% smaller than a year ago. The university also said graduate admissions for the 2026-2027 year are down 20%, c…
    STAT · 3mo agoNegative↗ source
  • MetALD emerges as a growing U.S. liver crisis linked to obesity, diabetes and heavy drinking, hitting young adults and women
    U.S. doctors are naming a new liver condition, MetALD, that combines metabolic dysfunction with alcohol related damage. The syndrome reflects the overlap of obesity, diabetes and heavy drinking tha…
    STAT · 3mo agoNegative↗ source
  • iECURE’s early gene-therapy success in a baby fails to replicate in larger trial
    Early last year iECURE reported that its experimental gene therapy appeared to cure an infant suffering from a severe genetic disorder. The company has now released data from a follow-up study tha…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • FDA leadership gap deepens uncertainty for biotech as acting officials take charge
    Marty Makary's resignation as FDA commissioner has left the agency without a permanent head. Kyle Diamantas is serving as the temporary leader, while three senior drug-review positions are filled b…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Lilly data show lower-dose GLP-1 injections and oral pill help sustain weight loss
    Eli Lilly presented new research on how patients who have lost weight with GLP‑1 medicines can maintain that loss over time. The studies followed people who had achieved significant reductions usin…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Assertio rejects Garda bid, accepts Zydus offer valuing company at $23.50 per share
    Assertio Holdings announced it has terminated its pending acquisition by Garda Therapeutics after the board approved a higher offer from another suitor. The new proposal from Zydus Worldwide value…
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • Takeda plans to cut 4,500 jobs, about 9% of workforce, under new CEO's restructuring plan
    Takeda announced it will eliminate roughly 9% of its global workforce, affecting about 4,500 positions, over the coming fiscal year. The cuts are part of a restructuring effort that began under th…
    Endpoints · 3mo agoLayoffsNegative↗ source
  • Valneva to cut up to 15% of workforce as travel slowdown lowers vaccine demand
    Valneva, a French vaccine developer, announced it will lay off between 10% and 15% of its employees. The cuts are linked to a decline in demand for travel vaccines, which the company says is drive…
    Endpoints · 3mo agoLayoffsNegative↗ source
  • Trump administration seeks new FDA commissioner to restore trust, prioritize food policy and accelerate drug approvals
    The Trump administration is moving quickly to name a successor to FDA commissioner Marty Makary, who resigned. Officials say the search will take several weeks and they are looking for a leader wh…
    STAT · 3mo agoRegulatoryNeutral↗ source