https://pharmadevicenews.com/reflow-medical-reports-zero-major-cardiac-events-at-one-year-in-nine-patient-spur-elute-study/ PharmaDeviceNews en 2026-11-02T04:14:03+00:00 Reflow Medical reports zero major cardiac events at one year in nine-patient Spur Elute study Beth Israel Deaconess Medical Center, DEEPER CORONARY, Harvard Medical School, Kathleen Kearney, Reflow Medical Inc., Scott Harding, Spur Elute, Transcatheter Cardiovascular Therapeutics, Wellington Hospital https://pharmadevicenews.com/wp-content/uploads/2026/11/Reflow-Medical-Spur-Elute-Pilot-Data-e1793592603331.webp https://pharmadevicenews.com/ge-healthcare-unveils-allia-celeo-ai-guided-interventional-system-with-european-ce-marking/ PharmaDeviceNews en 2026-11-02T04:06:37+00:00 GE HealthCare unveils Allia Celeo AI-guided interventional system with European CE marking Allia Celeo, Allia Moveo, GE HealthCare Technologies Inc., Jyoti Gera, Kat Davis, OnWatch Predict, San Diego, Transcatheter Cardiovascular Therapeutics https://pharmadevicenews.com/wp-content/uploads/2026/11/Pharma-Device-News_-AI-Imaging-Revolution-e1793592326660.webp https://pharmadevicenews.com/altruist-biologics-secures-nmpa-priority-review-for-localised-production-of-multinational-clients-biologic/ PharmaDeviceNews en 2026-11-02T03:28:10+00:00 Altruist Biologics secures NMPA priority review for localised production of multinational client’s biologic Altruist Biologics, China, Hangzhou, Innovent Biologics, Kaisong Zhou, National Medical Products Administration, Suzhou https://pharmadevicenews.com/wp-content/uploads/2026/08/PDN-tablets-generic-e1788149113473.webp https://pharmadevicenews.com/neurosense-reported-a-7-92-point-als-function-gap-with-primec-but-will-its-phase-3-trial-confirm-a-real-treatment-benefit/ PharmaDeviceNews en 2026-11-01T17:40:55+00:00 NeuroSense reported a 7.92-point ALS function gap with PrimeC, but will its Phase 3 trial confirm a real treatment benefit? Alon Ben-Noon, Harvard Medical School, Health Canada, JAMA Neurology, Massachusetts General Hospital, Merit Cudkowicz, NEALS, NeuroSense Therapeutics, PARADIGM, PARAGON, PrimeC, Shiran Zimri https://pharmadevicenews.com/wp-content/uploads/2025/12/pharmadevicenews-1.png https://pharmadevicenews.com/laplace-interventional-is-taking-on-an-approved-tricuspid-valve-with-triumph-but-can-its-new-implant-deliver-better-outcomes/ PharmaDeviceNews en 2026-11-01T17:37:14+00:00 Laplace Interventional is taking on an approved tricuspid valve with TRIUMPH, but can its new implant deliver better outcomes? Ballad Health, Edwards Lifesciences, EVOQUE, Kingsport, Laplace Interventional, Mayo Clinic, Oklahoma Heart Institute, Transcatheter Cardiovascular Therapeutics, TRIUMPH, Tulsa, Vanderbilt University Medical Center https://pharmadevicenews.com/wp-content/uploads/2026/11/TRIUMPH-Tricuspid-Valve-Trial-News-Graphic-e1793554581270.webp https://pharmadevicenews.com/eisai-is-about-to-reveal-five-years-of-lecanemab-treatment-data-but-will-long-term-therapy-justify-its-benefits-and-risks/ PharmaDeviceNews en 2026-11-01T14:34:34+00:00 Eisai is about to reveal five years of lecanemab treatment data, but will long-term therapy justify its benefits and risks? Alzheimer’s disease, Biogen Inc., Boston, Clarity AD, CTAD 2026, Eisai Co., LEADER, lecanemab, LEQEMBI, Leqembi Iqlik, Ltd. https://pharmadevicenews.com/wp-content/uploads/2026/11/Alzheimers-Drug-Data-Infographic-e1793543623687.webp https://pharmadevicenews.com/glenmark-pharmaceuticals-opens-160000-sq-ft-us-distribution-hub-serving-321-locations-across-43-states/ PharmaDeviceNews en 2026-11-01T14:28:03+00:00 Glenmark Pharmaceuticals opens 160,000 sq ft US distribution hub serving 321 locations across 43 states Allentown, Elmwood Park, Glenmark Pharmaceuticals Inc. USA, Glenmark Pharmaceuticals Limited, Lehigh Valley, Monroe, North Carolina, Pennsylvania https://pharmadevicenews.com/wp-content/uploads/2026/11/Glenmarks-Allentown-Distribution-Hub-e1793543162694.webp https://pharmadevicenews.com/eli-lilly-just-lifted-its-2026-sales-outlook-by-5-5bn-but-can-surging-glp-1-demand-keep-outrunning-price-pressure/ PharmaDeviceNews en 2026-11-01T14:18:48+00:00 Eli Lilly just lifted its 2026 sales outlook by $5.5bn, but can surging GLP-1 demand keep outrunning price pressure? AtaiBeckley, Eli Lilly and Company, Foundayo, Jardiance, Merida Biosciences, Mounjaro, Onswik, retatrutide, Zepbound https://pharmadevicenews.com/wp-content/uploads/2026/11/Eli-Lilly-Raises-2026-Guidance-e1793542613985.webp https://pharmadevicenews.com/setara-biosciences-raises-90m-to-advance-star-0871-for-cmt2c-and-overactive-bladder-after-jazz-acquisition/ PharmaDeviceNews en 2026-11-01T04:46:33+00:00 Setara Biosciences raises $90m to advance STAR-0871 for CMT2C and overactive bladder after Jazz acquisition ABS-0871, ABS-1230, Actio Biosciences, Canaan, David Goldstein, Deerfield Management, Droia Ventures, EcoR1, Euclidean Capital, Jazz Pharmaceuticals, Regeneron Ventures, San Diego, Setara Biosciences, STAR-0871, THERON https://pharmadevicenews.com/wp-content/uploads/2026/11/Setaras-90m-Drug-Development-Drive-e1793508316802.webp https://pharmadevicenews.com/alkermes-launches-180-patient-phase-2-alks-7290-trial-testing-orexin-activation-in-major-depression/ PharmaDeviceNews en 2026-11-01T04:40:40+00:00 Alkermes launches 180-patient Phase 2 ALKS 7290 trial testing orexin activation in major depression Alkermes plc, ALKS 7290, ClinicalTrials.gov, Craig Hopkinson, Montgomery–Åsberg Depression Rating Scale, United States https://pharmadevicenews.com/wp-content/uploads/2026/11/Alkermes-Depression-Trial-Infographic-e1793507957133.webp https://pharmadevicenews.com/latus-bios-new-aav-capsids-reach-80-of-kidney-glomeruli-but-can-better-delivery-translate-into-safer-gene-therapies/ PharmaDeviceNews en 2026-11-01T04:35:34+00:00 Latus Bio’s new AAV capsids reach 80% of kidney glomeruli, but can better delivery translate into safer gene therapies? AAV-Kd-1, AAV-PN, AAV9, Children’s Hospital of Philadelphia, ESGCT, Hamburg, Huntington’s Disease, Latus Bio, LTS-101, LTS-201, Nature Communications https://pharmadevicenews.com/wp-content/uploads/2026/11/Latus-Bio-AAV-Delivery-Signals-e1793507654439.webp https://pharmadevicenews.com/pretzel-therapeutics-receives-uk-trial-authorisation-for-px578-ahead-of-phase-2-polg-disease-study/ PharmaDeviceNews en 2026-10-31T15:33:25+00:00 Pretzel Therapeutics receives UK trial authorisation for PX578 ahead of Phase 2 POLG disease study Ashish Dugar, Caitlin Abell, Doug Turnbull, Jay Parrish, Massachusetts, Medicines and Healthcare products Regulatory Agency, Newcastle University, POLARIS, Pretzel Therapeutics, PX578, United Mitochondrial Disease Foundation, United States Food and Drug Administration, Waltham https://pharmadevicenews.com/wp-content/uploads/2026/10/Pharma-Device-News_-PX578-UK-Trial-Authorization-e1793460685793.webp https://pharmadevicenews.com/immunomes-varegacestat-cut-progression-risk-by-84-but-can-it-challenge-an-already-approved-european-desmoid-tumour-treatment/ PharmaDeviceNews en 2026-10-31T15:25:26+00:00 Immunome’s varegacestat cut progression risk by 84%, but can it challenge an already approved European desmoid tumour treatment? Clay Siegall, European Commission, European Medicines Agency, Immunome Inc., Merck KGaA, Nirogacestat, Ogsiveo, RINGSIDE, United States Food and Drug Administration, varegacestat https://pharmadevicenews.com/wp-content/uploads/2026/10/Pharma-Device-News_-Varegacestat-EMA-Review-e1793460191859.webp https://pharmadevicenews.com/eurosets-unveils-trilly-baby-oxygenator-for-infant-heart-surgery-ahead-of-planned-european-rollout/ PharmaDeviceNews en 2026-10-31T15:14:48+00:00 Eurosets unveils Trilly Baby oxygenator for infant heart surgery ahead of planned European rollout Antonio Petralia, Belgrade, Europerfusion 2026, Eurosets, GVM Care & Research, Italy, Medolla, Serbia, Trilly Baby https://pharmadevicenews.com/wp-content/uploads/2026/10/Eurosets-introduces-Trilly-Baby-oxygenator-for-infant-cardiac-surgery-scaled-e1793459642256.webp