Notizia - Recent Pharma, Healthcare and Biotech Happenings

Pharma News for GSK, Roche, Eli Lilly, Coherus

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Phase III RUBY Trial of Jemperli Plus Chemotherapy Updates; FDA Approves Roche’s Vabysmo for RVO; FDA Grants Priority Review to Tovorafenib Low-Grade Glioma; FDA Approves Lilly’s Omvoh; FDA Approves Toripalimab for Nasopharyngeal Carcinoma; FDA Fast Track Designation to ONCT-534 R/R mCRPC

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Pharma News for Sangamo, Santen, and Eli Lilly

Daiichi Sankyo’s Ezharmia; Pfizer & Sangamo Hemophilia A Gene Therapy Trial; Approval for Fennec’s Pedmark; FDA Approves UBE and Santen’s OMLONTI; EC Approves AstraZeneca’s Tezspire; FDA Approves Selpercatinib; FDA Grants Accelerated Approval to Eli Lilly’s Retevmo; GSK & Spero Announce Exclusive License Agreement

MedTech News Updates for Medtronic, Edwards, Otsuka

Smith+Nephew’s OR3O Dual Mobility System; Medtronic Launches the Evolut FX Next-Gen TAVR System; FDA Approves Edwards’s Pascal Precision Transcatheter Valve Repair System; FDA Clearance to Zimmer Biomet’s Identity Shoulder System; Otsuka Announces Results of RADIANCE II Trial; Smith+Nephew Announces Data for its REGENETEN™ Bioinductive Implant

Pharma News and Updates for Akero Chiesi Pfizer

AstraZeneca’s Danicopan Trial; CHMP Recommends Sanofi/AstraZeneca’s nirsevimab; Akero’s NASH Drug Trial; FDA Grants Orphan Drug Status to SY-5609; BMS’s Opdivo Trial Results; Pfizer to File for FDA Approval for Meningitis Vaccine; EMA Orphan Drug Designation to CAN-2409; FDA Starts Priority Review of Chiesi ‘s velmanase alfa

Latest MedTech News for Olympus and Aerin

Aerin Medical’s RhinAer Stylus; CE Mark for Haemonetics’s VASCADE Vascular Closure Device; J&J Vision Launches ACUVUE OASYS MAX 1-Day; Olympus Launches VISERA ELITE III Surgical Visualization Platform; GlucoRx’s Non-Invasive Glucose Monitoring Platform; Medtronic-BioIntelliSense’s Partnership; Corindus’s CorPath GRX Neurovascular System Trial; GE & Lantheus [18F]flurpiridaz PET Radiotracer Trial; Pulmonx’s AeriSeal System Trial; AtriAN’s Second Study on Cardioneuroablation

Pharma News for Amgen BioNTech and Gilead

Amgen Announced the Result of its CodeBreak-200 Trial; FDA Clears Bristol-Myers Squibb’s Deucravacitinib; BioNTech’s Amplified CAR-T Therapy; TIL Therapy Improves on Yervoy in Melanoma; GSK’s Daprodustat will have to face FDA Advisory Committee; Breakthrough Therapy Status to Pfizer’s Group B Strep Vaccine; EU Approves Gilead’ Tecartus; Gilead’ Trodelvy Results in TROPiCs-02 Trial

Medtech News for eCential Baxter Magnus

eCential Robotics’s Surgical Robotic Platform for Spine Surgery; Baxter Gets 510(k) Clearance for Syringe Pump; Medical Microinstruments’s NanoWrist Instruments; Magnus’ SAINT Neuromodulation System; Henry Schein Acquires Midway Dental Supply

Pharma News for Azurity, Sobi, and Sanofi

AstraZeneca’s Imfinzi for Biliary Tract Cancer; FDA Clears Boehringer’s Spesolimab; Novo Nordisk to Acquire Forma Therapeutics; Sanofi’s Xenpozyme Approved for ASMD; Another FDA Approval to Azurity’s Konvomep; Amgen’s Lumakras Trial Results; FDA Grants Priority Review to Sanofi & Sobi’s efanesoctocog alfa; Neurocrine Bio to Takeover UK Biotech Diurnal

MedTech News for Miracor, Oticon, and Medtronic

Miracor Medical’s Picso Pivotal Study; Medtronic’s Extravascular ICD; Galaxy Medical’s CENTAURI Pulsed Electric Field System; UltraSight’s Novel Cardiac AI Technology; Oticon Launched the World’s Smallest Hearing Aid; Medtronic Completes Acquisition of Affera

Pharma News for Aktis, Alcon and Takeda

Aktis’s Novel Targeted Alpha Radiopharmaceuticals; Koye Partners with Sonde Health; Novartis to Spin Off Sandoz Business; Alcon to Buy Aerie Pharma; Fast Track Designation to Merck’s MK-2060; FDA Approves Ibrutinib for Chronic GvHD; French Authorities Clears BrainVectis’s Clinical Trial; Takeda’s Dengue Vaccine TAK-003 Gets Approval in Indonesia

MedTech Updates for Edwards and Abbott

Edwards’s Pascal Precision System; Abbott’s New Spinal Cord Stimulation Device; Imagin to Acquire enCAGE Coil Precision Ablation System; Boston Heart Diagnostics Launches LipidSeqTM; Rocket VR Health Partners with Penn Medicine’s Abramson Cancer Center; Thermedical’s Clinical Trial to Treat Ventricular Tachycardia

Pharma News for Cidara, Merck, Gilead

EMA to review Cidara Therapeutics’ Rezafungin; EU Approves Gilead Sciences’ Sunlenca; FDA Approves Axsome’s Auvelity; EU Marketing Authorisation to Oncopeptides’s Pepaxti; Merck Signs $ 3.5 B Deal with Orna; FDA to review AstraZeneca and Merck’s Lynparza; FDA Approval to Bluebird’s Zynteglo; FDA Decision Date for GSK’s Momelotinib

Latest MedTech News for CereVasc and Nanopath

CereVasc’s eShunt System Study; FDA Approves NGS-Based CDx for Trastuzumab Deruxtecan; Nanopath Secures $10 Million Funding; BD, Accelerate Diagnostics Announce Collaboration; Avails Medical’s Clinical Trials for eQUANT; Movano Ring Exceeds Accuracy Targets for SpO2 & Heart Rate Monitoring

Pharma News for Novartis and Gilead

Novartis’ Canakinumab for NSCLC; Novartis’s Zolgensma Updates; Trodelvy Prospects in New Breast Cancer Use; Novartis Secures European Approval For Pluvicto; Bristol-Myers Squibb’s Abecma Phase III Trials; Trastuzumab Approved for Deruxtecan for HER2-Mutant NSCLC

Medtech news for Glaukos, GE, and Bluejay

Rapid Medical’s TIGERTRIEVER 13; Glaukos’s Istent Infinite System; GE Healthcare’s Definium 656 HD; NeuroOne’s Signed Exclusive Development & Distribution Agreement with Zimmer; Kaia Health’s Rise-uP Randomized Controlled Trial; Bluejay’s Symphony IL-6 Test

Latest Pharma News for AstraZeneca and Bayer

FDA Approves AstraZeneca’s Enhertu; Bayer Wins FDA Approval for Prostate Cancer Therapy, Nubeqa; Gilead Sciences to Acquire MiroBio; AstraZeneca & Merck’s Lynparza Gets EU Approval; Pfizer to Acquire Global Blood Therapeutics; Sironax Raises USD 200 Million

MedTech News for iRhythm and Respiri

FDA Clearance to iRhythm’s ZEUS System; Respiri Introduces the Wheezo Device & App; CONMED to Acquire Biorez for $ 85 Million; FDA Clearance to Ambu’s Single-Use Bronchoscope; FDA 510(k) Clearance to Glaukos’s iStent infinite

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