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  • Siemens Healthineers teams with Paradromics to develop multimodal imaging platform for brain-computer interfaces
    Siemens Healthineers and Paradromics announced a collaboration to build an advanced multimodal imaging system designed to support implantable brain‑computer interfaces (BCIs). The partnership combi…
    Fierce Biotech · 24d agoDealPositive↗ 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
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  • 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
  • As AbbVie’s Crohn’s combo beats Skyrizi in mid-stage test, analysts laud autoimmune vision
    AbbVie’s next-gen dual-targeting therapy elicited higher rates of remission than its IL-23 inhibitor Skyrizi in a Phase 2a trial of Crohn’s disease, leading analysts to wonder if the blockbuster ca…
    BioSpace · 24d ago↗ 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
  • Disc’s rebuffed rare disease drug sets up FDA redo after ‘clean’ Phase 3 sweep
    Disc Medicine’s bitopertin—rejected by the FDA in February—significantly reduced levels of a key disease biomarker and significantly increased the time patients with erythropoietic protoporphyria w…
    BioSpace · 24d ago↗ source
  • Labcorp to acquire BioReference Health assets for $722M cash
    Labcorp and OPKO Health announced an agreement in which Labcorp will purchase select assets of BioReference Health, a subsidiary of OPKO. The assets include laboratory testing businesses focused o…
    Fierce Biotech · 25d agoDealPositive↗ 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
  • China drafts policy to block foreign buyouts of key cell-gene therapy and siRNA platforms
    China’s government has released a draft amendment to its export blacklist that would prohibit or tightly control foreign purchases of certain biopharmaceutical platforms. The rule targets propriet…
    Fierce Biotech · 27d agoRegulatoryNegative↗ 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
  • 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 · 27d agoPositive↗ 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
  • Nouscom secures €120M to advance off-the-shelf cancer vaccine for Lynch syndrome
    Swiss biotech Nouscom announced a €120 million (about $135 million) Series D financing round. The capital will fund a registration-enabling pivotal trial of its cancer-preventing vaccine candidate.…
    Fierce Biotech · 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
  • 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 · 27d agoRegulatoryNegative↗ source