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Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Establishment Labs Gains FDA Approval for Motiva Implants; Surmodics Receives 510(k) Clearance for Pounce™ XL Thrombectomy System; Synergy Spine Solutions Completes Patient Enrollment in Synergy Disc® 2-Level IDE Clinical Trial; Medtronic Reports Strong Lesion Durability Data for PulseSelect™ Ablation System and Expands AiBLE™ Spine Surgery Ecosystem with Siemens Healthineers Partnership; Globus Medical Launches New Orthopedic Trauma Solutions

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pharma-news-for-ascendis pharma-novartis-servier

FDA Approves Ascendis Pharma’s YORVIPATH; ARS Pharma Gets FDA Green Light for First Nasal Spray; FDA Rejects Lykos’ MDMA-Assisted PTSD Therapy; Novartis’ FABHALTA Receives FDA Accelerated Approval; Servier Snags FDA Approval for Voranigo

medtech-news-for-mimedx-docgo-labcrop

MIMEDX Launches HELIOGENTM Fibrillar Collagen Matrix; DocGo Launches Mobile X-ray Program; Labcrop’s FDA De Novo Marketing Authorization; Inspire Medical Systems Receives FDA Approval; Alcyone Therapeutics Announces Continued Enrollment Approval from the FDA; Lunit’s AI for Tuberculosis Detection

pharma-news-for-Adaptimmune-GSK-Otsuka

Tecelra by Adaptimmune: First FDA-Approved Engineered Cell Therapy for Solid Tumors; GSK’s JEMPERLI Approved for Endometrial Cancer; MBX Biosciences Secures $63.5M in Series C for PEP™ Platform; FDA Stops Actinium’s Radiotherapy Blood Cancer Plans, Pushing Partnering Shift; Otsuka Acquires Jnana for Up to $1.1B, Enhancing Drug Discovery

medtech-news-for-stryker-vialase-diamyd-medical

Stryker’s Spine Guidance 5 Software FDA Approval; VIALASE Received CE Mark; The Texas Heart Institute Implanted the BiVACOR® Total Artificial Heart; Diamyd Medical’s Phase 3 Trial Positive Results; Cardio Diagnostics Holdings Inc.’s CDIO.AI; GE Healthcare and AWS Strategic Collaboration

pharma-news-for-astrazeneca-ipsen-pfizer

IMFINZI’s AEGEAN Phase III Trial Data for Treating Resectable NSCLC; Ipsen and Day One’s Exclusive Agreement to License and Market Tovorafenib Outside the US; Alzheimer’s Drug LEQUEMBI Rejected by EU; EU Apporves Pfizer’s Gene Therapy DURVEQTIX; CHMP Approves SPEVIGO’s New Indications 

medtech-news-for-ecential-robotics-microvention-ge-healthcare

STRATA Skin Sciences’ XTRAC Momentum™ 1.0 Device Approved in Japan; eCential Robotics Received FDA 510(k) Clearance for Spine Navigation and Robotic-Assistance Device; MicroVention Announced the Results of the Clinical Evaluation of WEB™ 17 Device; Neuspera Medical, Inc.’s SANS-UUI Pivotal Clinical Trial; GE HealthCare Announced an Agreement to Acquire the Clinical Artificial Intelligence Business; Sutter Health Implemented World’s First Wearable Doppler Ultrasound Patch

pharma-news-for-valneva-innovent-gsk-bayer

CEPI Grants $41.3 Million to Valneva; Innovent Achieves Phase III Success for Mazdutide; GSK’s BLENREP Combination Therapies EMA Review Application; Darolutamide Phase III ARANOTE Trial; Roche’s SUSVIMO Shows Long-Term Efficacy 

medtech-news-for-inspira-oticon-medical-spineguard

Inspira™ Approval of INSPIRA™ ART100 System; Oticon Medical’s Sentio™ System Received Regulatory Clearance; SpineGuard Filed its “510K” Dossier in the US; Vectorious Medical Technologies’ V-LAP Left Atrial Pressure Sensor Successful Implantation; Bedal International Raised $11 Million; Mytonomy Inc. Agreement With Vizient, Inc.

pharma-news-immutep-pfizer-novo-nordisk-arcutis

Immutep’ First-Line Treatment Positive Outcomes; Pfizer’s Once-Daily Oral GLP-1 Agonist Danuglipron; FDA Issues Complete Response Letter to Novo Nordisk; Arcutis’ ZORYVE® Cream 0.15% FDA Approval; NICE Recommends Ebglyss For Moderate To Severe Atopic Dermatitis

medtech-news-for-cordis-forma-medical-virpax

Cordis FDA Approval for MYNX CONTROL VENOUS Vascular Closure Device;  Forma Medical’s Optimal Plating System FDA Approval; Virpax’s Swine Model Pilot Study Positive Results; SetPoint Medical Positive Topline Results from Pioneering RESET-RA Study; Signature Orthopaedics Partnered with THINK Surgical; Nusano and PharmaLogic Formed Strategic Supply Agreement

pharma-news-for-eli-lilly-ideaya-roche-sanofi

Lilly’s Morphic Acquisition; IDEAYA’s IDE397 Positive Phase II Trial Result; XPOVIO (selinexor) Approval in China; Roche to Reintroduce Susvimo in the US; Dupixent EU Approval

medtech-news-for-artivion-masimo-icecure

Artivion and Endospan Agreement; Masimo and Cleveland Clinic Collaboration; Academic Medical Center’s Sedation-Free TNE With the EvoEndo Endoscopy System; IceCure’s Next-Gen XSenseTM Cryoablation System FDA Approval; KORU Medical Systems’ Clearance for FreedomEdge® Infusion System; Reflow Medical’s First Patient in Coronary Sirolimus-Eluting Retrievable Scaffold System

pharma-news-for-eisai-merck-verona-astrazeneca

Eisai Announces Solo Development of Farletuzumab Ecteribulin (FZEC); Johnson & Johnson’s Nipocalimab Phase III Trial; Merck’s WINREVAIR  EU CHMP Recommendation;  Verona Pharma’s  Ohtuvayre FDA Approval; AstraZeneca’s Lynparza and Imfinzi EU Approval

medtech-news-for-alcon-globus-medical-ricoh-esaote

Alcon’s 510(k) Clearance From the FDA; Globus Medical Received FDA Clearance; UK Pioneers First Skull-Mounted Epilepsy Device for Child; The Initiation of a Significant Clinical Trial of 3d Printed Models; Esaote Unveiled the Cutting-Edge Mylab™E80 @Sirm Ultrasound Device For 2024; Medasense Unveiled a Transformative Partnership With Nihon Kohden Corporation

pharma-news-for-alnylam-bms-daichii-sankyo-vertex

Alnylam’s HELIOS-B Phase III Study of Vutrisiran; Bristol Myers Squibb Secures FDA Nod for KRAZATI and Cetuximab; Daichii Sankyo’s EZHARMIA® Receives Japan Approval; Vertex’s Phase I/II VX-880 Trial; argenx’s VYVGART Hytrulo FDA Approval

medtech-news-for-boston-scientific-corporation-philips-akili-roche

Boston Scientific Corporation Agreement to Acquire Silk Road Medical; Philips Introduced Duo Venous Stent System; Akili’s EndeavorOTC Received FDA Clearance; Roche Achieved FDA Clearance; atHeart Medical Reported Long and Short-term Clinical Data; Bioretec Announced Successful Clinical Outcomes

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