Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

argenx’s ALKIVIA Phase 3 Study Demonstrates Rapid and Durable Clinical Improvement with Efgartigimod in Autoimmune Myositis; Johnson & Johnson Reports Phase 2 Nipocalimab Data in Sjögren’s Disease Highlighting Patient-Prioritized Symptom Improvements; Immunocore Unveils Promising Brenetafusp–KIMMTRAK Data in Metastatic Uveal Melanoma; Real-World Study Shows REPATHA Cuts Heart Attack Risk by 20% Compared with Ezetimibe; Health Canada Approves Moderna’s mRNA Flu Vaccine and Combined Influenza-COVID-19 Vaccine

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FX Shoulder Solutions Secures EU MDR Approval for Humelock Reversed; Beckman Coulter Diagnostics Wins FDA Clearance for 15-Minute Bacterial-Viral Assay; Laza Medical Secures Series B Funding of Up to $160 Million to Transform Interventional Imaging; Medtronic Partners with Michael J. Fox Foundation to Expand Parkinson’s DBS Awareness and Reports Significant Blood Pressure Reductions with Symplicity in SPYRAL AFFIRM Real-World Study; SetPoint Medical Marks New Mexico Milestone with First SetPoint® System Procedures

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INOVIO’s VOCERYQ Receives FDA Accelerated Approval for Adult RRP; AbbVie Submits Etentamig Biologics License Application to FDA for R/R Multiple Myeloma; Setara Biosciences Raises $90 Million Series A to Advance Rare Disease Precision Medicines; BioMarin Expands Fabry Disease Portfolio With Exclusive Global License for Next-Generation ERT; Pfizer’s ELREXFIO Advances Multiple Myeloma Treatment With Positive Phase 3 Results

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Roche’s Divarasib Showcases Best-in-class Efficacy in Previously Treated KRAS G12C-mutated Lung Cancer; CLARITY-Gastric01 Shows 42% Lower Death Risk with Sonesitatug Vedotin; Lilly’s Olomorasib Shows Durable First-line Activity in KRAS G12C-mutant NSCLC; Izalontamab Brengitecan Doubles Median PFS in Phase 3 EGFR-Mutated NSCLC Trial; Novartis’ Remibrutinib Delivers Broad Disease Control with Consistent Safety in RMS

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ProBio Announces Completion of NMPA Pre-Approval Inspection at Its China Manufacturing Facility; Providence Medical Secures FDA Approval for CORUS PCSS 3D-T Spinal Device; Sony Semiconductor Solutions Launches Compact Image Sensor for Single-Use Endoscopes; Ping An Launches China’s First Comprehensive Alzheimer’s Disease Brain Health Management Program; Geneos Therapeutics Advances Personalized DNA Immunotherapy for Liver Cancer into Phase 2; Medtronic Reports Positive Real-World Data for Sphere-9 and PulseSelect PFA

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Nouscom Announces €120 Million Series D Funding and Upcoming Presentation of Long-Term Lynch Syndrome Clinical Data at ESMO; Viatris Announces FDA Approval of RYZUMVI for Presbyopia; Lilly’s Omvoh Meets Clinical Remission Endpoint in Children with Ulcerative Colitis; Estuary Biotherapeutics Debuts with $103 Million in Funding to Tackle Kidney Disease; Roche’s Enspryng Receives FDA Approval as a First-in-Class IL-6R Inhibitor for Thyroid Eye Disease

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B. Braun Receives Medicare Payment Approval for Peripheral Nerve Block Devices; FDA Approves Providence Medical’s CORUS PCSS 3D-T Spinal Device; PurMinds Enters Clinical Validation Collaboration with SpectroChip and Taiwan-Based Hospital; MemorialCare Leads South Los Angeles County in Robotic-Assisted Shoulder Replacement Technology; Clinical Study Demonstrates the Potential of Home-Based Diuretic Delivery for Heart Failure; VIVA 2026 Highlights New Clinical Trial Results

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Efzimfotase Alfa Achieves 17.05-Metre Numerical Improvement Over Placebo in Six-Minute Walk Test; Asahi Kasei Therapeutics Announces First Patient Dosed in Phase 2a Study of AIC468 for BK Virus; Teva’s WELTRUZA Gains FDA Approval for Once-Monthly Treatment of Adult Schizophrenia; Innovent’s SYCUME Meets Primary Endpoint in Phase 3 Inactive Thyroid Eye Disease Trial; Zealand Pharma’s Petrelintide Delivers Positive Topline Results in Phase 2 ZUPREME-2 Trial

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Okami Medical Secures Expanded Indication for LOBO Vascular Occluder; CraniUS Therapeutics Secures Second FDA 510(k) Clearance in Six Weeks and U.S. Patent for NeuroPASS™ 3; Danaher Accelerates Life Sciences Research with New AI-Powered Autonomous Lab; Aesthetic Brokers Advises SDBotox on Strategic Partnership; BD Advances Peripheral Vascular Innovation with Positive AGILITY Trial Results; Sonorous Neurovascular Secures FDA IDE Approval for Pivotal U.S. Trial of Venous Sinus Stent in Pulsatile Tinnitus

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Vaxcyte Announces Positive Phase 3 Topline Data for VAX-31 from OPUS-1 Trial; CSL and Alentis Partner to Advance Lixudebart for Rare Renal and Hepatic Diseases; Pfizer Announces Positive Repigmentation Results for LITFULO in Nonsegmental Vitiligo; AstraZeneca Completes Equity Investment in Summit Therapeutics; Lilly’s Jaypirca Receives FDA Approval Expansion for Certain Patients with Untreated CLL/SLL; Merck’s Tulisokibart Delivers Positive Phase 2b Results in Moderate-to-Severe Hidradenitis Suppurativa

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UTR Therapeutics’ UTRxMYCN M1-14 Granted FDA Orphan Drug and Rare Pediatric Disease Designations; Medtronic Announces Regulatory Milestones for New Cardiac Mapping and Ablation Software; Abbott Adds SimpleScreen™ CRC Blood Test to Colorectal Cancer Screening Portfolio; VEMERIX Introduces Patented Single-Use Ultrasound Puncture Kit With Customized Probe Compatibility; Avisi Technologies to Showcase Two-Year VisiPlate® Results at AAO Annual Meeting; FIRE1 Implants First Patient in NORM-HF Pivotal Trial for Innovative Heart Failure Management

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Roche Announces Positive Interim Results for Sefaxersen in IgA Nephropathy; Lilly’s Olumiant Receives FDA Approval for Pediatric Patients With Severe Alopecia Areata; AbbVie’s JUVMO Receives U.S. FDA Approval for Parkinson’s Disease; Biologics License Application for Ifinatamab Deruxtecan Withdrawn in Extensive-Stage Small Cell Lung Cancer; Mirum Pharmaceuticals Reports Primary Endpoint Success in Phase 3 AZURE-1 Study of Brelovitug in Chronic Hepatitis Delta Virus

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Powerful Medical’s AI ECG Technology Earns FDA De Novo Authorization for Heart Attack Detection; Werfen Secures US FDA 510(k) Clearance and CE Mark for Aptiva® APS IgA Reagent; Ontario Introduces Fetal Blood Type Screening to Improve Pregnancy Care; Medvue Concorde Acquires Next-Generation AI-Powered MRI System; Cardiol Therapeutics Hits Phase III MAVERIC Enrollment Target Early and Expands Pivotal Trial for CardiolRx; Ferronova Reports Preliminary MAGMAP Results in 62-Patient Gastric and Oesophageal Cancer Trial

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Novo’s CagriSema Shows Greater Weight Loss Than Tirzepatide in REIMAGINE 5 Trial; Telix and ITM Partner to Build a Radiopharmaceutical Powerhouse; Beacon Therapeutics Reveals Positive Topline Findings from VISTA Trial of Laru-zova for XLRP; FDA Clears Inluriyo in Combination with Verzenio for Adults with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer; IntraBio Announces FDA Approval of AQNEURSA for Ataxia-Telangiectasia

medtech-news-for-emboline-powerful-medical-zeiss

Ferronova Announces Preliminary MAGMAP Results in 62-Patient Gastric and Oesophageal Cancer Trial; Powerful Medical Secures FDA De Novo Authorization for AI ECG Model; ZEISS Advances Cataract Surgery with Introduction of AT LUCIA toric 721P; Waters Launches BD FACSDiscover A7 Cell Analyzer for Standardized Spectral Flow Cytometry; Nicklaus Children’s Hospital Completes One of the Country’s First Transcatheter Fontan Procedures in a Two-Year-Old

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TAGRISSO Delivers Landmark Eight-Year Survival Outcomes in Early-Stage EGFR-Mutated Lung Cancer; Scholar Rock Receives FDA Approval for ISEMBYLD; Pharming’s Joenja Receives FDA Approval as First U.S. Treatment for Children With APDS; AbbVie Reports Positive Phase 3 Results for Atogepant in Menstrual Migraine; Rezera’s Ruvonoflast Delivers Positive Inflammation Results with Favorable Safety in RESOLVE-1

medtech-news-for-emboline-alcon-avo

Emboline Secures FDA 510(k) Clearance for Emboliner® Embolic Protection System; Alcon’s Clareon Monofocal IOL Secures EU MDR Certification from TÜV SÜD; Shoulder Innovations Enters Exclusive Partnership with ALM Ortho for Complex Shoulder Reconstruction Solutions; Avo Expands MEDITECH Alliance, Bringing Full Suite of AI Solutions to EHR; Nicklaus Children’s Hospital Performs Pioneering Transcatheter Fontan Completion in Two-Year-Old Child; AEYE Health Publishes AEYE-DS Clinical Trial Results Demonstrating High Diagnostic Accuracy and >99% Imageability

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