Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Masimo W1® Medical Watch Secured FDA 510(K) Clearance; Stereotaxis Received the CE Mark in Europe and Submitted a 510(K) Application in the US; Replimune Dosed First Patient in the IGNYTE-3 Clinical Trial; Daré Bioscience Announced the Publication of Positive Findings From the Phase IIb RESPOND Clinical Study; Baxter’s Definitive Agreement to Carlyle For USD 3.8 Billion; Moximed Successfully Closed a USD 91 Million Series D Financing Round

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MedTech News for Neoss, Tasso, Neuralink, Zepp

Zepp Health Launched OTC Hearing Aids; Neoss Launched NeoScan 2000; FDA Clearance for AI-Assisted Sleep Monitoring Device Dreem 3S; Tasso Received CE Mark Certification for Tasso+; Neuralink’s First-in-human BCI trial; Creative Medical to Initiate a Phase I/II Clinical Trial of StemSpine

Pharma News for Almirall, GSK, Cellectar

FDA Approves Ojjaara for Myelofibrosis; EMA Grants PRIME Designation to Iopofosine I-131; EBGLYSS Receives Positive CHMP Opinion; FDA Accepts Resmetirom NDA; FDA Fast Track Designation to KT-333 for PTCL; RedHill Announces FDA sNDA Approval for Talicia®

Medtech news for Mindray, Alveofit, Limaca

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

Pharma News for BMS, Alnylam, MaaT Pharma

BMS’s LPA1 Antagonist; Alnylam’s KARDIA-1 Phase 2 Study; Day One Biopharma Sought FDA Approval for Tovorafenib; EMA Orphan Drug Designation to MaaT Pharma’s MaaT033; Lundbeck and Otsuka Announce Topline Results from Two Phase III Trials of Brexpiprazole + Sertraline; Phase III CheckMate – 227 Trial Show Durable, Long-Term Survival with Opdivo Plus Yervoy

MedTech News for Vitestro, Signia, Synchron

Boston Scientific’s WATCHMAN FLX™ Pro; Quest Diagnostics’s AAV Test; Vitestro Started A.D.O.P.T. Clinical Trial; Signia Introduces Hearing Aids; Laborie Medical to Acquire Urotronic; Synchron’s Brain-Computer Interface Trial

Pharma News for Faron, Roche, Ergomed, Menarini

Daiichi Sankyo’s Trastuzumab Deruxtecan; ODD to Bexmarilimab for AML; Roche’ Alecensa; Ergomed Aims To Go Private; Tagraxofusp Receives ODD in Japan for BPCDN; FDA Fast Track Designation to Abliva’s KL1333

MedTech News for GE, Medtronic; Epineuron

GE HealthCare Launched CardioVisio; J&J’s Elita Laser Correction Platform; ICU Medical’s Plum Duo Infusion Pump and LifeShield Infusion Safety Software Update; Medtronic’s Inceptiv SCS with Closed-Loop Sensing to Treat Chronic Pain; Boston Scientific’s FARAPULSE Pulsed Field Ablation System; Epineuron’s REGAIN Trial

Pharma News for Nexcella, Janssen, Alentis

FDA Approves BMS’s Reblozyl for MDS; FDA Awards Orphan Drug Designation to NXC-201; Janssen Submits Supplemental NDA for Full Approval of BALVERSA; FDA Grants Fast Track Status to ALE.C04; FDA Orphan Drug Designation to Faron’s Bexmarilimab; FDA Clears IND Application for AHB-137

MedTech News for Mammotome, Geneseeq, BaroPace

Smith+Nephew’s Hip Arthroplasty System; Mammotome Launched the HydroMARK Plus Breast Biopsy Site Marker; FDA Clearance for Pioneering MARS System; CE Marks for NGS-based Test Kits; BaroPace Updated on Non-Pharmacologic Hypertension and Heart Failure Treatment Trial; Quanta Completed Enrollment in Home Run Study

Pharma News for Gilead, Incannex, Avidity

Eylea HD Injection 8 Mg Approved By FDA; Veopoz Receives FDA Approval for CHAPLE Disease Treatment; FDA Places Second Partial Clinical Hold on AML Enrollment for Magrolimab Trials; FDA Approval to Incannex’s Sleep Apnoea Clinical Trial; FDA Orphan Drug Designation to Avidity’s AOC 1044; Orphan Drug Designation to CanariaBio’s MAb-AR20.5

MedTech News for Viseon, ZimVie, Acorai

4WEB Medical’s Cervical Spine Plating Solution; Viseon Launched Visualization System for Minimally Invasive Spine Surgery; ZimVie’s New Mobi-C Implant; GE HealthCare’s Wireless Monitoring Solution; Acorai’s Non-Invasive Intracardiac Pressure Monitor; CytoSorbents’s STAR-T Pivotal Trial

Pharma News for Janssen, Galera, Genprex

J&J’s 2-in-1 Tablet for Prostate Cancer; FDA Approves TALVEY for Heavily Pretreated Multiple Myeloma; PDS Biotech Updated on VERSATILE-003 Trial; FDA Issues CRL to NDA for Avasopasem in Radiotherapy-Induced Severe Oral Mucositis in HNC; FDA Orphan Drug Designation to Genprex’s REQORSA; FDA Orphan Drug Designation to Bloomsbury’s BGT-OTCD

MedTech News for Quest, DuPont, BD

Quest Introduced Consumer-Initiated Blood Test for Alzheimer’s Disease Risk Assessment; DuPont Acquires Spectrum Plastics; BD Received 510(k) Clearance for Molecular Combination Test; Natera Updates on Phase III ALTAIR Trial of Signatera; Anteris’ DurAVR transcatheter heart valve Trial

Pharma News for Biogen, Astellas, Ascentage

FDA Approves ZURZUVAE for Postpartum Depression; Astellas Drug Acquired in $5.9B Deal Wins FDA Approval; FDA Clearance to Phase III Study of Lisaftoclax; FDA Issues CRL to BLA Resubmission for Remestemcel-L; Bavarian Nordic Updated on its Chikungunya Virus Vaccine; FDA Orphan Drug Designation to ABM-1310

MedTech News for icotec, Terumo, Genesis

Icotec’s VADER Pedicle System; Terumo BCT’ Reveos Automated Whole Blood Processing System; Genesis MedTech’s J-Valve Transfemoral System; STARmed Launched STARmed America in the USA

Pharma News for GSK, Biogen, Citius

FDA Expands GSK’s Jemperli Approval; Biogen to Acquire Reata Pharma; Enhertu Shows Survival Boost in HER2+ Solid Tumors; FDA Rejects Citius’ Revived IL-2 Therapy; FDA Fast Track designation to IVS-3001 for RCC; EU Orphan Drug Designation to Biohaven’s Taldefgrobep Alfa

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