Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Pensar Medical’s Partnership with Centurion Therapeutics; BD’ Acquisition of Critical Care; Haleon’s Launch of Eroxon; embecta Receives FDA Clearance; INFINITY-SWEDEHEART Trial of Elixir Medical’s DynamX Bioadaptor; Median Technologies’ Pivotal REALITY Study

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Pharma News for Exelixis, AstraZeneca, Kyverna

BMS, and Exelixis’s Opdivo + CABOMETYX in First-Line Advanced Renal Cell Carcinoma; AIRSUPRA Now Available as the First and Only FDA-approved Anti-inflammatory Rescue Option for Asthma; AstraZeneca’s Voydeya Receives First-ever Regulatory Approval; EMA Grants ODD to GC Biopharma’s Sanfilippo Syndrome (Type A) Treatment; FDA Approves NRx Pharma’s IND Application of NRX-101; FDA Fast Track Designation to Kyverna’s KYV-101

Pharma News for AskBio, Merck, SELLAS, RemeGen

Bayer’s AskBio Initiates Phase II GenePHIT Trial; FDA Approves Merck’s KEYTRUDA Plus Chemoradiotherapy as Treatment for Stage III-IVA Cervical Cancer; FDA Fast Track Designation to SELLAS Life Sciences R/R AML; RemeGen’s RC88; Shorla Oncology Announces FDA Filing Acceptance of New Drug Application for Novel Formulation to Treat Breast and Ovarian Cancer; Tonix Pharma’s TNX-102 SL for Fibromyalgia

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

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