Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Laborie’s Enhanced Gastrointestinal Diagnostics; Carestream’s Image Suite MR 10 Software Launch; Implicity’s Heart Failure Algorithm FDA 510(k) Approval; AngioDynamics’ AlphaVac F1885 System CE Mark Approval; HeartBeam’s Artificial Intelligence Algorithm for Arrhythmias; Onward ARC-EX Nerve Stim Hit Pivotal Trial

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MedTech News for Medtronic, Cala, Medline, Rivermark Medical

Medtronic Announced World’s First Approval for MiniMed 780G System; CE Mark for Medtronic’s Next Generation Micra Leadless Pacing Systems; Biosense Webster Received Approval for VARIPULSE PFA Platform; Rivermark Medical Updated on Flostent System; Cala Disclosed TAPS Therapy Data for Essential Tremor; Medline Introduced Transparent Wound Dressing

Pharma News for Merck, AbbVie, Abbisko

Merck to Acquire Harpoon Therapeutics; Novo Nordisk Enters Into Collaborations with Omega Therapeutics and Cellarity; AbbVie’s Lutikizumab’s Phase II Trial Result for Hidradenitis Suppurativa; Abbisko’s CSF-1R Inhibitor Pimicotinib (ABSK021); Cabaletta Bio’s CABA-201; FDA Grants Fast Track” Designation for Soligenix’s Dusquetide

MedTech News for Enovis, AnX Robotica, CGBio

HR Pharmaceuticals Announced Collaboration with Poiesis Medical; Enovis Acquired Lima Corporate; AnX Robotica Announced FDA Clearance for ProScan; FDA Breakthrough Device Designation for CGBio’s ‘NOVOSIS PUTTY’; EndoSound Received 510(k) Clearance for Breakthrough EVS Innovation; Boston Scientific Initiated AVANT GUARD Clinical Trial

Pharma News for Cytokinetics, Chiesi, AstraZeneca, Zevra

Cytokinetics Announces Results From SEQUOIA-HCM Clinical Trial of Aficamten; FDA Approves Chiesi’s FILSUVEZ Topical Gel; Bristol Myers Squibb Adds Premier Radiopharmaceutical Platform; AstraZeneca to Acquire Gracell; Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application; Innovent Dosed First Participant in Phase 3 Clinical Study (GLORY-2) of Mazdutide (IBI362)

MedTech News for Savara, CRVx, Gore, Masimo

Savara Introduced aPAP ClearPathTM; RaySearch Released RayStation 2024A; FDA Approved Expanded Label for CVRx Neuromod Tech; FDA Clearance to Masimo’s Baby Monitoring System; Kansas City Proton Institute’s Advanced MEVION S250i Proton Therapy System; Gore’s Arise II Pivotal Study of the Gore® Ascending Stent Graft

Pharma News for Amylyx, Sellas, Apnimed, Ocelot

ImPact Biotech’s IND Application for Padeliporfin VTP; Orphan Drug Designation to Ocelot Bio’s OCE-205 for Ascites; Amylyx’s Phase 3 ORION Study of AMX0035 for PSP; SELLAS Receives FDA Orphan Drug Designation for SLS009 for PTCL Treatment; Apnimed Updated on Second Phase 3 Clinical Study of AD109 for OSA

MedTech News for Integra, B. Braun, Medtronic, Perfuze

Integra to Buy J&J’s Acclarent; B. Braun Launches the CARESITE Micro Luer Access Devic; FDA Approves Medtronic’s Novel PulseSelect Pulsed Field Ablation System; FDA Clearances to Perfuze’s Novel Neurovascular Aspiration and Access Catheters for Stroke Treatment; ShiraTronics Successfully Implants First Migraine System; Sight Sciences Announced the Six-Month Results For Heat Therapy Device

Pharma News for Eisai, Biogen, Merck, BMS, Kyverna

Eisai Submits Marketing Authorization Application for Tasurgratinib; CHMP Issues Positive Opinion for Biogen’s SKYCLARYS; European Commission Approves Merck’s KEYTRUDA + Chemotherapy HER2-ve Gastric or GEJ Adenocarcinoma; BMS Provides Update on RELATIVITY-123 Trial; Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101; Verrica and Torii Pharma Announces Positive Top-line Results from a Confirmatory Phase 3 Trial of TO-208

MedTech News for AcelRx, Kaneka, ZimVie, NeuroOne

Micro Medical Solutions’s Pivotal STAND Clinical Trial; AcelRx’s Continuous Renal Replacement Therapy; Kaneka Acquired Japan Medical Device Technology; Tandem Diabetes Care Launched t:slim X2 Insulin Pump Software; ZimVie’s Vital Spinal Fixation System and Brainlab Spine & Trauma Navigation; NeuroOne’s OneRF Ablation System

Pharma News for Merck, Ipsen, bluebird bio

Merck and Moderna Initiate Study to Evaluate V940; FDA Approves Vertex and CRISPR Therapeutics’ CASGEVY for SCD; Novartis Updated on its Investigational Iptacopan Phase III Study; FDA Grants Priority Review for New Drug Application for Elafibranor; FDA Approves bluebird bio’s LYFGENIA for Patients SCD; FDA Fast Track Designation for DMD Gene Therapy

Pharma News for Merck, Roche, AbbVie, Abbisko Pfizer

FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev; Roche and Carmot Therapeutics’s Definitive Merger Agreement; AbbVie to Acquire ImmunoGen; FDA Grants Orphan Drug Designation to LP-284; Merck Announces Commercialization Agreement With Abbisko; Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial

MedTech News for BrainSpec, Revvity, FormaPath, Pramand

Baird Medical’s Microwave Ablation System; BrainSpec’s AI-Backed Solution for Non-Invasive Brain Chemistry Measurement; AWAK’s AI-Enabled Kidney Disease Prediction Tool; Revvity’s EONIS Q System; FormaPath Announced Advancement in Cancer Pathology; Pramand Launched CraniSeal Dural Sealant

Pharma News for Sanofi, Sosei, AstraZeneca, Arcturus

Dupixent Significantly Reduced COPD Exacerbations; Sosei Heptares to Regain Ownership of GSK4381406; AstraZeneca Gains Rights to Usynova’s KRAS Inhibitor; FDA Approvs OGSIVEO for Desmoid Tumors; Orphan Drug Designation for ARCT-032 for the Cystic Fibrosis; FDA Fast Track Designation for ADP101 for Food Allergies

MedTech News for Ethicon, Medtronic, Surmodics, GSK

Ethicon’s ETHIZIA Hemostatic Sealing Patch; FDA Approves Medtronic’s Minimally Invasive Device to Treat Hypertension; Boston Scientific Acquires Relievant Medsystems; AstraZeneca Launched Evinova; Surmodics Announced Data of the SWING Trial; GSK Advancing the Low Carbon Ventolin Program to Phase III Trials

Pharma News for AskBio, Almirall, Bayer, Pfizer

Key Updates on Phase 1 Trial of AB-1005 Gene Therapy for Multiple System Atrophy-Parkinsonian Type; European Commission Approves EBGLYSS; Bayer Stopped OCEANIC-AF Study; Pfizer and Astellas’ XTANDI Approved by FDA; FDA Orphan Drug Designation to Epic Bio’s EPI-321; FDA Fast Track Designation to Chemomab’s CM-101 for PSC

MedTech News for Samsung, Lunit, Vivasure

GE Healthcare and Masimo Announced Collaboration; Samsung Launched New Ultrasound System ‘V6’; MONARCH Platform Approved for Bronchoscopy in China; Lunit Received FDA Nod for Lunit INSIGHT DBT; Route 92 Medical Releases Tenzing Technology Clinical Findings; Vivasure Medical Enrolled 100th Patient for its Vivasure PerQseal Closure Device System Study

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