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Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

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

Artivion Amended Agreements With Endospan On June 01, 2024, Artivion, Inc. a prominent company in cardiac and vascular surgery specializing in aortic disease, announced that it revised its credit facility and option purchase agreements with Endospan Ltd. ("Endospan"), an Israeli-based, privately-held developer of the NEXUS® Stent Graft System ("NEXUS"). In 2019, Artivion provided a credit facility to Endospan and entered into an option agreement to acquire Endospan upon the U.S. Food and Drug Administration ("FDA") approval of NEXUS. Endospan created NEXUS, the first and only approved branched endovascular system for treating aortic arch disease, including aorti...

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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

Pharma News for Takeda, AskBio, Bayer, Lipella

Takeda’s ADZYNMA Approved by FDA; AskBio Presents Preliminary Data from Phase I Trial of Gene Therapy for CHF; Bayer’s Aflibercept 8 mg Recommended for Approval in EU; FDA Orphan Drug Designation to MAIA Biotechnology’s THIO; First Patient Dosed in Phase III ProstACT GLOBAL Study; FDA Grants Orphan Designation for Lipella’s LP-310 Drug Candidate

Pharma News Sibionics, Abbott, CleanNA, Orthofix

SIBIONICS’s Ground-breaking GS1 Continuous Glucose Monitoring System; Abbott’s HPV Test to Run on Alinity m; CleanNA’s CE-IVD Molecular Diagnostics Product; Orthofix’s WaveForm L Interbody System; Alucent Biomedical’s AlucentNVS Technology; Surmodics’s TRANSCEND Trial Data

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