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  • Jury awards $6 million to former MIT professor David Sabatini in defamation case
    A Suffolk County jury awarded $6 million in damages to former MIT professor David Sabatini after finding the plaintiff's claims were defamatory. The case stemmed from accusations by a younger coll…
    STAT · 3d agoPositive↗ source
  • Revolution Medicines' pancreatic cancer therapy Rasonque moves closer to European approval after FDA clearance
    Revolution Medicines' experimental drug Rasonque, aimed at treating pancreatic cancer, has received a recommendation for approval from European regulators. The recommendation follows an earlier po…
    STAT · 4d agoApprovalPositive↗ source
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  • Hospitals Turn to Longevity Clinics as New Revenue Stream
    STAT's biotech podcast "The Readout LOUD" featured a discussion about the rapid growth of longevity clinics that are being opened by hospitals. Reporters noted that the longevity medicine market i…
    STAT · 4d agoNeutral↗ source
  • Induced pluripotent stem cells gain momentum as new methods and clinical successes drive drug development
    Induced pluripotent stem cells (iPSCs) are moving from a research curiosity to a practical tool in drug development. After years of steady progress, recent advances are bringing iPSCs into the spot…
    BioSpace · 4d agoPositive↗ source
  • FDA issues warning letters to drug makers over CGMP lapses and highlights patient rep ties to industry-backed groups
    The FDA has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practice requirements, citing problems with ensuring product sterility and meeting sp…
    raps · 4d agoRegulatoryNegative↗ source
  • FDA issues warning to Eurofins over selective microbiology data recording at Pennsylvania lab
    FDA sent a warning letter to Eurofins after inspectors found issues at its Horsham, Pennsylvania laboratory. The inspection revealed that analysts had been selectively recording results of pour-pl…
    BioSpace · 4d agoRegulatoryNegative↗ source
  • FDA issues warning letters to drug makers and a lab over CGMP and GLP violations
    FDA sent warning letters to several drug manufacturers for not meeting current good manufacturing practice (CGMP) requirements. The letters point to issues such as ensuring final product sterility…
    raps · 4d agoRegulatoryNegative↗ source
  • City Therapeutics raises $200M in IPO to fund thromboembolic disease pipeline
    City Therapeutics, an RNA interference biotech focused on thromboembolic diseases, completed an initial public offering that raised $200 million. The company sold about 11 million shares at $18 ea…
    BioSpace · 4d agoDealPositive↗ source
  • HHS moves to let compounding pharmacies make select peptides as China tightens biotech exports but permits foreign licensing
    The HHS announced a policy that would allow compounding pharmacies to produce certain peptide drugs, expanding access and potentially lowering costs. The move is part of the Trump administration's…
    STAT · 4d agoRegulatoryNeutral↗ source
  • Patients stop meds for deeper reasons than forgetfulness, pharmacist says
    Marcela Gottschald, a pharmacist and journalist, reflects on her early assumption that patients missed doses mainly because they forgot, were frustrated by side effects, or lacked understanding of…
    STAT · 4d agoNeutral↗ source
  • Xilio Therapeutics appoints Yariv Houvras as chief medical officer
    Xilio Therapeutics announced the hiring of Yariv Houvras as its new chief medical officer. Houvras joins from Tubulis, where he served as senior vice president of clinical and translational develo…
    STAT · 4d agoNeutral↗ source
  • HHS staff push back on new performance review rules amid post-DOGE layoffs
    Federal employees at the Department of Health and Human Services are being asked to submit lengthy self-assessments as part of a revised annual performance review system. The change follows guidan…
    STAT · 4d agoNegative↗ source
  • Health policy experts debate Milton Friedman's role in U.S. health care challenges
    In a new STAT First Opinion series called Friendly Argument, two long‑time health policy scholars discuss the roots of America’s health‑care problems. The conversation features John E. McDonough, a…
    STAT · 4d agoNeutral↗ source
  • Key reads to catch up on Elizabeth Holmes before the new documentary releases
    STAT’s Morning Rounds newsletter offers a curated list of articles to review before watching the documentary "You Can See Everything" about Elizabeth Holmes. The piece reminds readers of the major…
    STAT · 4d agoNeutral↗ source
  • Jury deliberates conflicting accounts in David Sabatini misconduct trial at Whitehead Institute
    A Boston jury is hearing a civil case that pits two very different narratives about the conduct of renowned molecular biologist David Sabatini. The three‑week trial has focused on accusations that…
    STAT · 4d agoNegative↗ source
  • Estuary sails into kidney disease space with $103M for gene therapies
    Estuary Biotherapeutics is seeking to address the root cause of autosomal dominant polycystic kidney disease with two gene therapy programs based on science from Yale.
    BioSpace · 4d ago↗ source
  • OrbiMed raises two new life sciences funds worth $3B with one aiming for Asia
    The sixth cycle of OrbiMed’s Asia Partners fund included one with more than $1 billion earmarked for life science companies based on the Eastern continent.
    BioSpace · 4d ago↗ source
  • Merck and Moderna plan to seek approval for personalized mRNA melanoma vaccine after Phase 3 shows delayed recurrence
    At the 2026 STAT Summit, Merck and Moderna outlined their partnership to combine Keytruda with a personalized mRNA cancer vaccine aimed at melanoma patients. In a large Phase 3 trial, the vaccine…
    STAT · 4d agoRegulatoryPositive↗ source
  • AstraZeneca teams with insitro in up to $1.5 billion AI partnership to target MASH and cardiomyopathies
    AstraZeneca announced a partnership with AI-driven biotech insitro, committing up to $1.5 billion to discover new drug targets for metabolic dysfunction-associated steatohepatitis (MASH) and cardio…
    BioSpace · 5d agoDealPositive↗ source
  • Paul Stoffels launches Armed Cell Therapeutics, acquires Galapagos CAR-T assets for ~ $240 million
    Paul Stoffels, former J&J executive and ex‑CEO of Galapagos, has co‑founded a new Belgian biotech called Armed Cell Therapeutics. The company announced a licensing deal to acquire the CAR‑T cell t…
    BioSpace · 5d agoDealNeutral↗ source
  • Arrowhead’s siRNA shows strong tau reduction in early human study, outpacing other BBB platforms
    Arrowhead Pharmaceuticals reported that its investigational siRNA candidate ARO-MAPT produced notable reductions in cerebrospinal fluid tau in a Phase 1/2a trial of healthy volunteers. Doses of 2.…
    BioSpace · 5d agoPositive readoutPositive↗ source
  • Former FDA chiefs slam Trump administration, label DOGE a disaster and warn of staff loss, while AstraZeneca announces AI partnership
    Three former FDA commissioners publicly rebuked the Trump administration, saying its actions have harmed the agency. They said the administration’s handling of a large staff departure stripped the…
    STAT · 5d agoRegulatoryNegative↗ source
  • Biotech investors grow uneasy as XBI stalls despite overall gains
    Adam Feuerstein notes that while biotech stocks have performed well overall this year, investor sentiment has turned sour after the summer. The SPDR S&P Biotech ETF (XBI) remains up about 24% year…
    STAT · 5d agoNegative↗ source
  • Experts call for dedicated regulatory framework for clinical AI models, UK MHRA unveils AI-focused strategy
    Former FDA commissioner Scott Gottlieb, now at the American Enterprise Institute, wrote an opinion piece urging Congress to create a specific regulatory framework for artificial intelligence models…
    raps · 5d agoRegulatoryPositive↗ source
  • EMA to cement ACT EU pilot; MHRA unveils AI-era regulatory strategy
    The European Medicines Agency announced that in January 2027 it will make permanent a pilot project that assists sponsors in preparing clinical trial applications, turning a temporary scheme into a…
    raps · 5d agoRegulatoryNeutral↗ source