Notizia - Recent Pharma, Healthcare and Biotech Happenings

Pharma News for Takeda, AskBio, Bayer, Lipella

Notizia - Recent Pharma, Healthcare and Biotech Happenings

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

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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

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

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