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  • Massachusetts jury awards former MIT professor David Sabatini $6 million in defamation case
    A Massachusetts jury has ordered a $6 million damages award to David Sabatini, a former professor at MIT and noted biologist. The verdict stems from a defamation lawsuit that Sabatini filed after…
    Endpoints · 24d agoNeutral↗ source
  • Arbitrators profit heavily from No Surprises Act disputes, raising concerns over health-care billing practices
    The STAT Health Care Inc. newsletter reports that the arbitration mechanism created by the No Surprises Act, intended to resolve out-of-network billing conflicts, has become a lucrative business fo…
    STAT · 24d agoNegative↗ source
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Former GOP lawmakers warn that confusing vaccine messaging could hurt party's midterm prospects
Two former Republican congressmen say the party's mixed messaging on vaccines has become a political liability. They argue that the lack of a clear stance could alienate voters and damage Republic…
STAT · 24d agoNegative↗ source
  • Early CDMO engagement: balancing speed with flexibility in CMC planning
    Bringing a new therapy to the clinic requires clinical, non‑clinical, regulatory and CMC activities to move forward together. In early development, having drug material available is often on the cr…
    BioPharma Dive · 24d agoNeutral↗ source
  • Measles resurgence threatens Republican midterm prospects, physicians warn
    Physicians and former Republican congressmen Larry Bucshon and Michael C. Burgess wrote an opinion piece warning that the recent measles surge is turning into a political liability for the GOP. Va…
    STAT · 24d agoNegative↗ source
  • Japan’s PMDA releases guidance on evaluating generative AI-enabled medical devices
    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a set of review points aimed at medical devices that incorporate generative artificial intelligence. The guidance outlines th…
    raps · 24d agoRegulatoryNeutral↗ source
  • MedTech firms grow more comfortable with FDA's Quality Management System Regulation amid inspection concerns
    At The MedTech Conference in Boston, a senior industry executive reported that the medtech sector is gradually accepting the new Quality Management System Regulation (QMSR) despite early worries.…
    raps · 24d agoRegulatoryNeutral↗ source
  • Study shows low extractables in single-use components support ADC manufacturing
    Cytiva conducted extractables testing on disposable chromatography column housings and flow kits used in antibody-drug conjugate production. The tests used dimethylacetamide (DMA) and dimethyl sul…
    BioPharma Dive · 24d agoNeutral↗ source
  • Editor shares personal loss and calls for assisted suicide options for severe mental illness
    Torie Bosch, an editor at STAT, recounts the repeated suicide attempts of her mother, culminating in her death in 2016. She describes the ongoing cycle of crises, hospitalizations and the emotional…
    STAT · 24d agoNegative↗ source
  • Theranos whistleblower says new film ‘You Can See Everything’ is art, not a documentary
    Tyler Shultz, a former Theranos scientist who became a whistleblower, wrote an opinion piece criticizing Nathan Fielder’s recent film about Elizabeth Holmes. He argues the movie, titled “You Can S…
    STAT · 24d agoNegative↗ source
  • Cambridge biologist David Sabatini awarded $6 million after jury rejects harassment claims
    David Sabatini, a former MIT and Whitehead Institute researcher, faced allegations of inappropriate conduct from a younger colleague, leading to his removal from the institute. A Suffolk County ju…
    STAT · 24d agoPositive↗ source
  • AbbVie’s Skyrizi combo beats Skyrizi alone in mid-stage Crohn’s trial
    AbbVie’s Skyrizi-based combination therapy for inflammatory bowel disease worked better than Skyrizi alone in a mid-stage trial in Crohn’s disease, the company said Monday. The new product is coden…
    Endpoints · 24d ago↗ source
  • Endpoints Weekly highlights search for Alzheimer’s ‘statin’, Arrowhead’s tau-lowering injectable and AI Day recap
    Endpoints Weekly released its latest edition, previewing several biotech stories including a quest for a “statin of Alzheimer’s” and new data on Arrowhead’s injectable therapy that reduces tau prot…
    Endpoints · 26d agoNeutral↗ source
  • 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 · 26d 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 · 27d agoApprovalPositive↗ source
  • Moderna’s stock soars after Phase 3 success of melanoma vaccine with Merck
    BioPharma Dive’s latest data-visualization series charts Moderna’s dramatic stock rebound in 2026 after a period of decline. The company had struggled when demand for its COVID-19 vaccine fell, pr…
    BioPharma Dive · 27d agoPositive readoutPositive↗ source
  • 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 · 27d agoNeutral↗ source
  • City Therapeutics raises $200 million in IPO, becoming 26th biotech listing of 2026
    City Therapeutics announced that it has completed a $200 million initial public offering, making it the 26th biotech to go public in 2026. The company, based in Kendall Square, will begin trading…
    Endpoints · 27d agoDealPositive↗ 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 · 27d agoRegulatoryNegative↗ source
  • Iambic Therapeutics CEO discusses $150 million IPO and AI's evolving role in drug development
    Iambic Therapeutics completed a $150 million initial public offering, raising fresh capital and seeing its share price climb to about $24.50, roughly a 50% increase from earlier in the week. CEO T…
    BioPharma Dive · 27d agoDealPositive↗ source
  • Novartis ends mid-stage Fabhalta trial in lupus nephritis citing strategic considerations
    Novartis has terminated its mid-stage trial of Fabhalta (iptacopan) in patients with lupus nephritis, according to a federal clinical trials registry. The company said the decision was driven by s…
    Endpoints · 27d agoCRLNegative↗ source
  • EU regulators endorse Eli Lilly’s oral GLP-1 pill orforglipron
    The European Medicines Agency’s human medicines committee (CHMP) has given a positive opinion on Eli Lilly’s oral GLP-1 medication, orforglipron, providing the drug with EU regulatory backing. The…
    Endpoints · 27d agoRegulatoryNeutral↗ source
  • City Therapeutics raises $200 million in IPO to fund next-gen RNAi programs
    City Therapeutics, a biotech focused on RNA interference, completed a $200 million initial public offering, selling about 11.1 million shares at $18 each. The proceeds will back three drug candida…
    BioPharma Dive · 27d agoDealPositive↗ source
  • Estuary Biotherapeutics raises $93 million Series A to develop gene therapies for ADPKD
    Estuary Biotherapeutics, a California gene‑therapy startup backed by Biogen, announced a $93 million Series A financing led by RA Capital. The capital will support development of two genetic medic…
    BioPharma Dive · 27d agoDealPositive↗ 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 · 27d agoRegulatoryNegative↗ source