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Analyzing the Potential of AAV2-GDNF Gene Therapy in Parkinson’s Disease Treatment: Insights from Phase Ib Trial Data

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Norlase, HAPPE Spine, Soterix Medical, Akura Medical, Intelivation Technologies, Signifier Medical Technologies

Norlase’s ECHO™ Green Pattern Laser; HAPPE Spine’sINTEGRATE-C™ Interbody Fusion System; Soterix Medical’s Parcel-Guided rTMS Depression Trial; Akura Medical’s High-Performance Mechanical Thrombectomy Platform; Intelivation Technologies’s Golden Isles™ Minimally Invasive Pedicle Screw System; Signifier Medical Technologies Announced Partnership with Sunrise

Pharma News and Updates for GSK, Gilead, ProMIS, Nucleix, PharmaTher, Vedanta Biosciences

FDA Approves GSK’s Arexvy for RSV; CHMP’s Opinion on Gilead’s Hepcludex® for HDV; FDA Clearance to ProMIS’s IND Application for PMN310; FDA Grants 501K Clearance to Bladder EpiCheck; PharmaTher Submits Fast Track Application for Ketarx to US FDA; Fast Track Designation to Vedanta Biosciences’ VE303

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FDA Grants Priority Review to BMS’ Luspatercept; Teva and MedinCell’s Risperidone FDA Approval; Biogens’s QALSODY FDA Accelerated Approval; FDA IND Authorization to Kiromic’s Deltacel; Atsena’s ATSN-201 FDA IND Clearance

MedTech News for Bausch + Lomb, Heidelberg Engineering, Oxford Nanopore, bioMérieux, Senseonics, Boomerang Medical, RapidAI, Neuspera Medical

Bausch + Lomb and Heidelberg Engineering Introduced SeeLuma; Oxford Nanopore and bioMérieux Signs Partnership Agreement; Boomerang Medical’s Bioelectronic Device for Inflammatory Bowel Disease; Senseonics’s ENHANCE Clinical Trial Updates; RapidAI’s Non-Contrast CT Imaging Product; FDA Clearance for Neuspera Medical’s Peripheral Nerve Stimulation System

Pharma News and Updates for RegeneRx, Aldeyra, Oncolyze, Soligenix, Aviceda

RegeneRx’s Phase 3 Neurotrophic Keratitis Clinical Trial of RGN-259; Aldeyra’s Phase 3 INVIGORATE-2 Clinical Trial Update; FDA Orphan Drug Designation to Oncolyze’s OM-301 for Multiple Myeloma; Soligenix Provides Regulatory Update on HyBryte; FDA Fast Track Designation to SAB Biotherapeutics’s SAB-176 Influenza Immunotherapy; Aviceda IND Application for AVD-104

Pharma News and Updates for Cingulate, Merck, Transcenta, Ipsen, Nuance

Ipsen’s Cabometyx Rejected by NICE; Vertex and CRISPR Therapeutics’s Submit BLA to the FDA for exa-cel; Orphan Drug Designation to Osemitamab for Pancreatic Cancer; FDA Clears Keytruda/Padcev for Bladder and Urothelial Cancer; Cingulate Completes Trial of CTx-1301 for ADHD; Nuance Pharma Announces Dosing of First Patient in ENHANCE Trial

MedTech News and Updates for Mindray, Getinge, Gore, CoreLink

Mindray’s TE Air Handheld Ultrasound System; Getinge’s iCast™ Covered Stent System; Clinical Trial Update for the FLASH Proton Therapy for Cancers in the Bones; Gore’s Gore® Viafort Vascular Stent IVC Study; CoreLink’s Siber® Ti—3D Printed SI Joint Fusion System; USound and Partners’s Next-Generation Over-the-Counter Hearing Aids

Pharma News and Updates for AbbVie, Arrowhead Pharma, Novartis, FORE Biotherapeutics, Ellipses Pharma, Karuna Therapeutics

AbbVie Announces Results of Study Evaluating SKYRIZI; FDA Fast Track Designation to Arrowhead’s ARO-APOC3; FDA Approves Dabrafenib Plus Trametinib for BRAF V600E–Mutated Low-Grade Glioma; FDA Grants ODD to Novel BRAF Inhibitor for Brain/CNS Malignancies; EP0042 Wins FDA Orphan Drug Status; Karuna Therapeutics Announces Results from Phase 3 EMERGENT-3 Trial of KarXT in Schizophrenia

MedTech News for Artica Systems, Nevro, Stratus® Medical, Restore Medical, Respiree, Abbott

Artica Systems’s Electric Whole-Body Cryotherapy Machines; Nevro’s Revolutionary HFX iQ™ Spinal Cord Stimulation System; COBRA Study of Stratus® Medical for Nimbus® Radiofrequency Ablation Device; Restore Medical’s CONTRABAND™ System; US FDA 510(k) Clearance for RS001 Cardio-respiratory Wearable; FDA Approval to Abbott’s Traumatic Brain Injury (TBI) Blood Test

Pharma News and Updates for Incyte, Eisai, Biogen, Reata Pharmaceuticals, Genenta Science, Harbour BioMed, Ikena Oncology

Incyte’s Clinical Trial for Myelofibrosis; Eisai and Bioge’s Leqembi; FDA Approves Reata Pharmaceuticals’ SKYCLARYS; Temferon Lands FDA Orphan Drug Status for Glioblastoma; Harbour BioMed Announces Results from Phase III Trial of Batoclimab; FDA Fast Track Designation to Ikena’s AHR Antagonist IK-175

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Wider Administration Window – Need of the Moment for Acute Ischemic Stroke Patients

MedTech News and Updates for Medtronic, Stryker, Dexcom, Rhaeos, Synchrony

Medtronic’s Extravascular Defibrillator System; Stryker’s Q Guidance System for Cranial Applications; Synchrony Medical’s LibAirty™ Airway Clearance System Study; Cognito Therapeutics’s Pivotal Study HOPE Update; Dexcom’s G6 Continuous Glucose Monitoring System Launch in Singapore; Rhaeos Raised $10.5M in Series A Funding

MedTech News GI Dynamics, EndoStream Medical, Ibex, Sunrise

GI Dynamics’s I-STEP Clinical Study of EndoBarrier; EndoStream’s Clinical Trial for Nautilus™ Intrasaccular System; CE Mark for Ibex’s Galen™ Prostate; Sunrise’s At-home Sleep Apnea Test; Globus Medical Announced Merger with NuVasive; Boston Imaging’s HERA W10 Elite

Pharma News and Updates for Leo Pharma, GSK, Roche, Aldeyra, IASO Bio

Leo Pharma’s Hand Eczema Clinical Trial Updates; GSK’s PD-1 inhibitor Jemperli Approval; Roche Announces Phase III Result of Vabysmo; FDA Accepts NDA for Aldeyra’s reproxalap; RMAT and Fast Track Designations to IASO Bio’s CT103A; Orphan Drug Designation to Jubilant Therapeutics’s JBI-778

MedTech News Updates LivaNova, Candela, 3M, Aspivix, Ethicon

LivaNova Launched SenTiva DUO; Candela Launched Matrix System; 3M Launched Medical Adhesive; MONARCH Platform Performed First Kidney Stones Removal Procedure; Biosense Webster Presented Data of HELIOSTAR Balloon Ablation Catheter; FDA 510(k) Clearance to Aspivix’s Cervical Stabilizer Carevix

Pharma News Updates for Merck, Sanofi, GSK, Hinova, Endogena, Amylyx

Merck’s Keytruda Wins Another FDA Approval; Sanofi Pauses Trial of Myasthenia Gravis Drug, tolebrutinib; FDA Approves GlaxoSmithKline’s Jesduvroq; FDA IND Application Clearance for Hinova’s HP518; FDA Fast Track Designation to Endogena’s EA-2353; Amylyx Updates on Global Phase 3 PHOENIX Trial

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