Notizia - Recent Pharma, Healthcare and Biotech Happenings

Pharma News for Sanofi, Sosei, AstraZeneca, Arcturus

Notizia - Recent Pharma, Healthcare and Biotech Happenings

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

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MedTech News and Updates for Vivos, Arthrex, Chindex, Glaukos, Zimmer Biomet

Vivos Therapeutics ‘s DNA Oral Appliance for the Treatment of OSA; Arthrex’s TightRope Implant for Pediatric ACL Surgery; Chindex Medical Acquired 10 ViewRay MRIdian Systems; Zimmer Biomet to Acquire Embody; GE HealthCare to buy IMACTIS; Glaukos Announced the iDose TR Exchange Trial

Latest Pharma News and Updates for Ipsen, Chiesi, Takeda, ACELYRIN, Lantern Pharma

Ipsen to Acquire Albireo; Chiesi Farmaceutici to Buy Amryt Pharma; Takeda Presents Phase III Results of TAK-755 for cTTP; ACELYRIN Acquires ValenzaBio; FDA Approves LEQEMBI for Alzheimer’s Disease; Orphan Drug Designation to Lantern Pharma’s LP-284 for MLL

MedTech News and Updates for Inspira, Burning Rock, Verana, liberDi, Innova

Inspira and Terumo Signed Strategic Agreement; Cook Medical’s New Bipolar Electrodes Portfolio; Verana Health and Sight Sciences Collaborated on Glaucoma Research; Burning Rock’s OverC Multi-Cancer Detection Blood Test; Innova Vascular’s Thrombectomy System; liberDi’s Digital Dialysis System

Pharma News and Updates for Gilead, Biogen, Pfizer, MediWound, UCB

Gilead Buys Out Rights to Cancer Therapy from Jounce; FDA Places Clinical Hold on Biogen’s Orelabrutinib; Pfizer Announces Phase 3 BENEGENE-2 Study Result; FDA Approves MediWound’s NexoBrid; UCB Announces FDA Acceptance of BLA Resubmission for Bimekizumab; FDA Approves TG Therapeutics’ Briumvi

MedtTech News

PAVmed-Novosound’s Partnership; J&J Acquires Abiomed; Approval to Sysmex’s Assay Kit to Identify Amyloid Beta (Aβ) Accumulation; SI-BONE Announced FDA Clearance for Expanded Rod Compatibility with the iFuse Bedrock Granite Implant System; EOFlow’s Wearable Insulin Pump ‘EOPatch’; Icecure’s ProSense System, a Cryoablation Therapy

Pharma News for Gilead, Roche, AstraZeneca, Genentech, Mirati, Pfizer

Gilead Sciences’ Sunlenca Approval; FDA Approves Roche’s CD20xCD3 Bispecific Antibody Lunsumio; EU Approves AstraZeneca’s Imfinzi Plus Chemo; Pfizer Files Blockbuster Hope Etrasimod for Ulcerative Colitis; FDA Approves Mosunetuzumab for R/F Follicular Lymphoma; FDA Breakthrough Therapy Designation to Adagrasib Plus Cetuximab for KRAS G12C–Mutated Advanced CRC

MedTech News for Abbott, Medtronic, Insightec, Life Spine, Thermo Fisher

Medtronic’s Hugo Robotic-Assisted Surgery System Trial; Insightec’s Pivotal LIBERATE Clinical Trial; FDA Granted EMA for Thermo Fisher Scientific’s Monkeypox Test; Life Spine’s Trulift Lateral Expandable Spacer System & Lateral Pate System; Fujifilm & Inspirata Announces Asset Purchase Agreement; Abbott Launched SCS System for Chronic Pain

Pharma News and Updates for AbbVie, Ferring, Merck, CSL, Amicus, Takeda

Fourth FDA Approval for AbbVie’s Vraylar; FDA Approves Ferring’s Adstiladrin for NMIBC; Merck and Moderna’s mRNA Cancer Vaccine Trial; EMA Recommends the CSL’s Gene Therapy for Hemophilia B; CHMP Backs Amicus’ Pompe Disease Therapy; Takeda Announces the Phase 3 AURORA Study Result

MedTech News for BioGX, Stryker, Boston Scientific, Agilent, DexCom

BioGX’s ‘pixl’ Portable qPCR Platform; Stryker’s Citrefix Suture Anchor System; Boston Scientific to Acquire Majority Stake of Acotec Scientific; FDA Approved the Dexcom G7 CGM System; Agilent’s NSCLC Liquid Biopsy Companion Diagnostic Test Approval; ClearPoint Neuro’s Prism™ Neuro Laser Therapy

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Amgen to Purchase Horizon Therapeutics; IND Clearance to Vertex’s VX-522; FDA Fast-Track Designation for Moleculin’s WP1122; Orphan Drug Designation to Brim’s WP1122; Eisai Presents Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study; UCB Announces Phase 3 Studies for Bimekizumab

MedTech News and Updates for Olympus, GE, Journey Biosciences, NeuroOne, Enovis

Olympus Launches New Gynecologic Power Morcellator; Journey Biosciences Launched NaviDKD; GE Board Approves Separation of GE HealthCare; FDA Approval to Enovis’s STAR Ankle; FDA Clearance to Deep Blue Medical’s T-Line Hernia Mesh; NeuroOne Completed Feasibility Study with its OneRF Ablation System

Pharma News for Nkarta, Eisai, EQRx, Rigel Pharma, AUM, X4 Pharma

Nkarta’s Anti-CD19 Allogeneic CAR-NK Cell Therapy, NKX019; Eisai Presents Results of lecanemab for Alzheimer’s Disease; EQRx’s Aumolertinib for EGFR-Mutated NSCLC; FDA Approves Olutasidenib for IDH1-Mutated R/R AML; FDA Orphan Drug Designation to AUM302 for Neuroblastoma; X4 Pharma Announces Results for WHIM Syndrome Drug

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C4X Discovery and AstraZeneca Signs Deal; FDA Rejects Spectrum’s Poziotinib; Orphan Drug Designation to Tenaya’s Gene Therapy; EC Approves Regeneron’s Libtayo; Response Letter to Poziotinib for Metastatic NSCLC Harboring HER2 Exon 20 Mutations; Japan Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer

MedTech News for Empatica, ClariPi, Sony, Mainstay Medical, Zimmer

Mainstay Medical’s ReActiv8-C Study; Swing Therapeutics Announced Results from Studies of Stanza; FDA Approves Empatica’s Health Monitoring Platform; FDA Clearance to Persona OsseoTi Keel Tibia System; ClariPi Joins Siemens Healthineers Digital Marketplace; Sony Launches Cloud-based Solution for Flow Cytometry Data Analysis

Pharma News Updates Merck, Regeneron, Provention, Ardelyx, AbbVie

FDA Approves Teplizumab to Delay the Onset of Type 1 Diabetes; FDA Backs Ardelyx’s CKD Therapy Xphozah; Merck to Acquire Imago BioSciences; Accelerated Approval to ImmunoGen’s ELAHERE; Regeneron and CytomX Announces Research Collaboration; FDA Grants Priority Review to Epcoritamab R/R LBCL

MedTech News for Medtronic, Penumbra, and Genesis

Medtronic Launches Infusion Set for Insulin Pumps; Penumbra’s Virtual Reality-Based Rehabilitation System; FDA Approval to Genesis’s Chocolate Touch® Drug-coated Balloon PTA Catheter; FDA Nod to AEYE’s AI-based Autonomous Screening; Alpheus Medical Treats First High-Grade Glioma Brain Cancer Patient with its Proprietary Platform; Karidum’s Next Generation Globe® Pulsed Field System

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