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 https://pharmadevicenews.com/edison-scientific-signs-pfizer-agreement-to-deploy-kosmos-ai-scientist-across-pharmaceutical-rd/ PharmaDeviceNews en 2026-10-30T05:49:11+00:00 Edison Scientific signs Pfizer agreement to deploy Kosmos AI scientist across pharmaceutical R&D Edison Scientific, FutureHouse, Kosmos, Pfizer Inc., Sam Rodriques, San Francisco, Spark Capital, Springer Nature, Triatomic Capital https://pharmadevicenews.com/wp-content/uploads/2026/08/PDN-Generic-Image.webp https://pharmadevicenews.com/hsg-has-taken-control-of-peiertech-but-why-is-medical-grade-nitinol-attracting-private-equity-investment/ PharmaDeviceNews en 2026-10-30T05:45:13+00:00 HSG has taken control of PeierTech, but why is medical-grade nitinol attracting private equity investment? Amy Shen, China, HSG, Jiangsu, Jiangyin, PeierTech, Sequoia China, Steve Jia https://pharmadevicenews.com/wp-content/uploads/2026/08/PDN-Medical-Devices.webp https://pharmadevicenews.com/glooko-reports-no-severe-hypoglycaemia-in-267-patient-endotool-iv-labour-and-delivery-analysis/ PharmaDeviceNews en 2026-10-30T04:10:16+00:00 Glooko reports no severe hypoglycaemia in 267-patient EndoTool IV labour and delivery analysis Advocate Health, Diabetes Technology Society, EndoTool IV, EndoTool IV Cloud, GestationalCare, Glooko Inc., Joseph Aloi, Mark Clements, Mike Alvarez, United States Food and Drug Administration, Wake Forest University School of Medicine https://pharmadevicenews.com/wp-content/uploads/2025/12/pharmadevicenews-1.png https://pharmadevicenews.com/ono-pharmaceuticals-ono-1110-missed-three-pain-trial-endpoints-so-why-is-the-drug-still-moving-forward/ PharmaDeviceNews en 2026-10-30T04:01:32+00:00 Ono Pharmaceutical’s ONO-1110 missed three pain trial endpoints, so why is the drug still moving forward? Japan, Ltd., Ono Pharmaceutical Co., ONO-1110, ONO-1110-04, ONO-1110-05, ONO-1110-06, ONO-1110-07, ONO-1110-08, Osaka https://pharmadevicenews.com/wp-content/uploads/2026/08/PDN-Generic-Image.webp https://pharmadevicenews.com/pythia-labs-launches-ai-antibody-platform-after-generating-binders-against-15-of-22-therapeutic-targets/ PharmaDeviceNews en 2026-10-30T03:53:25+00:00 Pythia Labs launches AI antibody platform after generating binders against 15 of 22 therapeutic targets CCR8, CXCR4, IL11, Joshua Laniado, Los Angeles, MRGPRX2, Pythia Labs, Pythia-1, San Diego, Todd O. Yeates https://pharmadevicenews.com/wp-content/uploads/2025/12/pharmadevicenews-1.png