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 https://pharmadevicenews.com/darwin-biotech-reports-early-als-functional-and-nfl-signals-from-randomised-phase-1-alt001-study/ PharmaDeviceNews en 2026-10-31T05:19:30+00:00 Darwin Biotech reports early ALS functional and NfL signals from randomised Phase 1 ALT001 study ALT001, Beijing, Beijing Tiantan Hospital, Capital Medical University, Clearwater, Darwin Biotech, NEALS, Network of Excellence for ALS, Wang Yu, Weiqi Chen, Yilong Wang https://pharmadevicenews.com/wp-content/uploads/2026/10/ALT001-Shows-Early-Promise-in-ALS-e1793423901343.webp https://pharmadevicenews.com/gemelli-biotech-highlights-85-patient-study-linking-intestinal-sulfide-overproduction-to-distinct-gene-expression-changes/ PharmaDeviceNews en 2026-10-31T05:15:25+00:00 Gemelli Biotech highlights 85-patient study linking intestinal sulfide overproduction to distinct gene-expression changes American Society for Microbiology, Cedars-Sinai, Gemelli Biotech, IBS-Smart, Juliana de Freitas Germano, Mark Pimentel, mSystems, REIMAGINE, Ritesh Agarwal, Trio-Smart https://pharmadevicenews.com/wp-content/uploads/2026/10/Gemelli-Biotech-Gut-Gene-Infographic-e1793423679772.webp https://pharmadevicenews.com/avenzo-therapeutics-to-present-first-orion-1-phase-1-data-for-selective-cdk4-inhibitor-avzo-023/ PharmaDeviceNews en 2026-10-31T05:09:42+00:00 Avenzo Therapeutics to present first ORION-1 Phase 1 data for selective CDK4 inhibitor AVZO-023 Allorion Therapeutics, Avenzo Therapeutics, AVZO-021, AVZO-023, ORION-1, San Antonio, San Antonio Breast Cancer Symposium https://pharmadevicenews.com/wp-content/uploads/2026/10/Avenzo-ORION-1-Data-Spotlight-e1793423320691.webp https://pharmadevicenews.com/setpoint-medical-completes-first-boston-implant-of-fda-approved-rheumatoid-arthritis-neurostimulation-system/ PharmaDeviceNews en 2026-10-31T04:14:12+00:00 SetPoint Medical completes first Boston implant of FDA-approved rheumatoid arthritis neurostimulation system Beth Israel Deaconess Medical Center, Boston, Brian J. Stout, Joshua P. Aronson, Massachusetts, Murthy V. Simhambhatla, RESET-RA, SetPoint Medical, SetPoint System, United States Food and Drug Administration https://pharmadevicenews.com/wp-content/uploads/2026/10/Vagus-Nerve-Implant-Medical-News-Infographic-e1793419988207.webp https://pharmadevicenews.com/transcode-therapeutics-has-advanced-ttx-mc138-into-phase-2a-so-why-is-it-exploring-a-sale-or-strategic-partnership/ PharmaDeviceNews en 2026-10-31T04:08:40+00:00 TransCode Therapeutics has advanced TTX-MC138 into Phase 2a, so why is it exploring a sale or strategic partnership? Natera Inc., Philippe P. Calais, PRE-I-SPY, Quantum Leap Healthcare Collaborative, Signatera, TransCode Therapeutics Inc., TTX-MC138, Tungsten Advisors, Zdravka Medarova https://pharmadevicenews.com/wp-content/uploads/2026/10/TransCode-Biotech-Licensing-News-Banner-e1793419657739.webp https://pharmadevicenews.com/can-ascletis-asc30-compete-with-established-oral-glp-1-treatments/ PharmaDeviceNews en 2026-10-31T04:02:42+00:00 Can Ascletis ASC30 compete with established oral GLP-1 treatments? ASC30, Ascletis Pharma Inc., AURORA-1, AURORA-2, European Medicines Agency, Jinzi Jason Wu, United States Food and Drug Administration https://pharmadevicenews.com/wp-content/uploads/2026/10/Pharma-Device-News_-ASC30-Clinical-Update-e1793419314996.webp https://pharmadevicenews.com/preservative-free-ketamine-gets-fda-approval-as-nrx-pharmaceuticals-targets-us-hospital-supply/ PharmaDeviceNews en 2026-10-30T19:29:59+00:00 Preservative-free ketamine gets FDA approval as NRx Pharmaceuticals targets US hospital supply Nephron Pharmaceuticals, NRx Pharmaceuticals, NRX-100, U.S. Food and Drug Administration https://pharmadevicenews.com/wp-content/uploads/2026/10/Preservative-free-ketamine-injection-vials-e1793388266679.webp https://pharmadevicenews.com/sabirnetug-trial-failure-forces-acumen-pharmaceuticals-to-reassess-alzheimers-drug-development-strategy/ PharmaDeviceNews en 2026-10-30T19:19:41+00:00 Sabirnetug trial failure forces Acumen Pharmaceuticals to reassess Alzheimer’s drug development strategy ACU193, Acumen Pharmaceuticals, ALTITUDE-AD, Halozyme Therapeutics, JCR Pharmaceuticals, Sabirnetug, U.S. Food and Drug Administration https://pharmadevicenews.com/wp-content/uploads/2026/10/Brain-Scans-e1793387890333.webp