Notizia - Recent Pharma, Healthcare and Biotech Happenings

Medtech news for Mindray, Alveofit, Limaca

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Mindray’s 2-in-1 Handheld Ultrasound Device; NuVasive’s Precice Bone Transport System; FDA for alveofit’s alveoair; FDA 510(k) Clearance Limaca’s Precision GI™ Endoscopic Biopsy Device; Evolution Optiks’s Neuro-Optical Testing Device; Moderna Expanded Field of mRNA Medicine

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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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Genentech’s gantenerumab Fails in Phase III Trial; CHMP Recommends’ Dupixent; FDA Clears Imfinzi and Imjudo with chemotherapy; NICE Recommends Ipsen’s Cabometyx (cabozantinib); NICE Backs KEYTRUDA; NRG Announces £16 Million Series A Funding; FDA Backs AstraZeneca’s PT027

MedTech News for QuantuMDx, Medtronic, Exactech, and ProciseDx

QuantuMDx & Menarini’s Agreement; TruClear System Launched by Medtronic in India; FDA 510(k) Clearance for TriVerse Primary Knee Replacement System; FDA Clearance to ProciseDx’s Reactive Protein (CRP) Assay and ProciseDx Instrument; Evolution Optiks’s Enrollment of LFR-260 Phoropter in US; Kardium First-in-Human Clinical Study of the New Globe Pulsed Field System

Pharma News for Amgen, AstraZeneca, Sanofi, Anavex, Sensorion, GSK

Amgen’s Olpasiran Candidate; GSK’s Novel Antibiotic for Urinary Tract Infections; AstraZeneca and Sanofi’s Beyfortus Approval; FDA Orphan Designation to Anavex’s Anavex2-73; FDA Rare Pediatric Disease Designation to Sensorion’s OTOF-GT; GSK’s Blenrep Fails in Phase III Trial in R/R Multiple Myeloma

MedTech News for AngioDynamics, Ameda, Pfizer, Cochlear

AngioDynamics’s AlphaVac F18 PE System; Pfizer’s RSVpreF/PF-06928316 Trial; Intelligent Ultrasound’s ScanNav Anatomy PNB; FDA Approves the Cochlear Nucleus 8 Sound Processor; Ameda’s Pearl Breast Pump; J&J to Buy Abiomed; Thermo Fisher Scientific to Acquire The Binding Site Group

Pharma News for Actinium, Santhera, Gilead, Seres, BMS, Boehringer

Actinium Announces SIERRA Trial Results; Santhera Seeks FDA Review for Vamorolone; Seres Announces BLA Submission for SER-109; BMS Announces Results of COMMANDS Trial; Boehringer’s PDE4B Moves Late-stage Clinical Testing; FDA Rejects Gilead’s Hepcludex; Approval to J&J’s BCMAxCD3 Bispecific Antibody for Multiple Myeloma; Syncona to Acquire AGTC

MedTech News for Enspectra, Mentice, and EndoStim

FDA Approval to DePuy TELIGEN System; FDA Breakthrough Device Designation for the EndoStim System; GE and Accuray Announces Collaboration; Mentice and Acandis Announces a Three-Year Agreement; Indigo Diabetes Enrolled First Participant in the Shine Clinical Trial; FDA IDE Approval to MedAlliance’s SELUTION SLR

Pharma News Updates for Sumitomo, AstraZeneca, and AbbVie

Sumitomo to Purchase Myovant; AstraZeneca’s Tremelimumab Plus Imfinzi Approved in the US; AbbVie Acquires DJS Antibodies; Roche and Hookipa Pharma Signs USD 25 Million Deal; FDA Accepts BMS’s New Drug Application for CAMZYOS; Jazz and Zymeworks Sign Exclusive Licencing Agreement

MedTech News for NeuroLogica, Medtronic, and Pfizer

Biosense Webster’s HELIOSTAR Radiofrequency Balloon Ablation Catheter; Philips’s ClarifEye Augmented Reality Surgical Navigation Solution; NeuroLogica’s Elite Mobile Computed Tomography Devices; Medtronic’s Natural Conduction System for Heart; Pfizer & BioNTech’s Omicron BA.4/BA.5-Adapted Bivalent Booster Trial; Castle Biosciences’s TissueCypher® Barrett’s Esophagus Test

Pharma News and Updates for Takeda, Gilead, and Odyssey

CHMP Reviews Takeda’s Qdenga; FDA Sets Date for Gilead’ Trodelvy Review; Odyssey’s Announces $ 168 Million Series B Financing; Tavros and Vividion Signs Agreement; Pharming Submits Leniolisib for Approval in the EU; FDA Fast Track Designation to Mereo’s Alvelestat

MedTech Updates for Neuspera, Abbott, and ZEISS,

Neuspera Medical’s Nuvella System; Abbott Presented the Data for FreeStyle Libre 2 System; ZEISS Receives FDA 510(k) Clearance for MTLawton; FDA 510(k) Clearance for the GHOST 3D-Printed Titanium Spacer System; Thermo Fisher Scientific Launched CE-IVD Marked TaqPath Enteric Bacterial Select Panel; BIOCORP and Merck Announced New Partnership

Pharma News Merck, AstraZeneca, and GSK

Merck’s Sotatercept Trial Result; PARP Rivals Closing in on AstraZeneca and Merck’s Lynparza; FDA Clears GSK’s Boostrix for Pertussis; Fast Track Designation to Nanoscope Therapeutics’s MCO-010; FDA Awards Fast Track Designation to Eftilagimod Alpha Plus Pembrolizumab; Solid Biosciences to Acquire AavantiBio

MedTech News for Olympus and Fujifilm

Olympus’s THUNDERBEAT Open Fine Jaw Type X Surgical Energy Device; Merit Medical’s TEMNO Elite; Thermo Fisher Scientific’s Oncomine Dx Target Test; Fujifilm Latest Generation Endoscopic Ultrasound; Indigo Diabetes’s Shine Clinical Trial; Cala Health Published Data for its TAPS Therapy

Pharma News for Zealand Pharma, Amylyx, Sarepta

Zealand Pharma’s Phase III Results of Glepaglutide; FDA Approves Amylyx’s ALS Drug Relyvrio; Novo Nordisk and Ventus Therapeutics Signs Licencing Deal; FDA Approves Futibatinib; Sarepta Files Duchenne Muscular Dystrophy for FDA Approval; Biogen and Eisai’s Lcanemab Phase III Study

MedTech News for Asahi, Prosoma, and Zynex

Asahi Intecc Partners with Penumbra; Prosoma and EVERSANA Announce Commercialisation Partnership; Zynex Starts Enrollment in the Blood Loss Detection Clinical Trial; Reva Initiates Enrollment in the MOTIV IDE Clinical Trial; FDA Clearance to QT Imaging to Calculate Fibroglandular Volume of the Breast; FDA 510k Clearance to iMediSync’s EEG scanner ‘iSyncWave’

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

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