Notizia - Recent Pharma, Healthcare and Biotech Happenings

Pharma News For Astellas, AnaMar, Biosyngen

Notizia - Recent Pharma, Healthcare and Biotech Happenings

4DMT Presents Data From Phase II PRISM Clinical Trial; Adaptimmune Announces FDA Acceptance of Biologics License Application for Afami-cel; Astellas Submits Supplemental New Drug Application in Japan for PADCEV with KEYTRUDA; AnaMar Announces US and EU Orphan Drug Designation for AM1476; Biosyngen Announces FDA Fast Track Designation for BST02; Acepodia Announces FDA Clearance of IND Application for ACE2016

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Pharma News for Eli Lilly, Alnylam, Elevar

Lilly to Acquire Versanis; FDA Approves Beyfortus for RSV in Infants; Alnylam Presented Updates on Interim Phase 1 Results for ALN-APP; FDA Accepts NDA for Rivoceranib Plus Camrelizumab; FDA Fast Track Designation to Karyopharm’s Selinexor; Adcentrx’s IND Application for ADRX-0706

MedTech News for ResMed, Stryker, OncoBeta

ResMed Acquired Somnoware; Stryker Launched Q Guidance System; AlloSource’s AceConnex Pre-Sutured Fascia; Urotronic’s Optilume BPH Catheter System; Verve Medical’s Pivotal Trial of RPD Renal Pelvic Denervation System; OncoBeta Provided Update on Rhenium-SCT

Pharma News Astellas, Eisai, Iovance, Biophytis

FDA Grants Priority Review for Zolbetuximab BLA; FDA Traditional Approval for LEQEMBI for Alzheimer’s Disease; Iovance Announces Regulatory and Clinical Updates for TIL Therapy in Advanced NSCLC; Biophytis Seeks FDA Approval to Launch Phase 3 Study of Potential Treatment of Sarcopenia; Orphan Drug Designation to Marker Therapeutics’s MT-401 for AML Treatment; Axsome Therapeutics Initiates Phase 3 Trial of Solriamfetol for ADHD

MedTech News for Enovis, Dexcom, Abbott, Elios

Enovis Acquires Novastep; Rockwell Medical Announced Collaboration with B. Braun; Dexcom G7 Received Health Canada Approval for Next-Generation CGM; Abbott’s World’s First Dual Chamber Leadless Pacemaker; Elios Vision’s Pivotal Trial of ELIOS; Synergy Spine’s Synergy Disc 2-Level IDE Trial

Pharma News for BioMarin, CellTrans, Genenta, GSK

First Gene Therapy for Severe Hemophilia A; FDA Approves CellTrans’s Type 1 Diabetes Cellular Therapy; FDA Approve Amneal’s Parkinson’s Drug Over Safety Concerns; NLS Pharmaceutics’s Phase III Clinical Trials of Quilience; Genenta Science’s Temferon for the Treatment of Glioma; FDA Fast Track Designation to GSK’s Gonorrhea Drug

MedTech news for Eko. Haemonetics. Roche, Medtronic, Biodesix

GE HealthCare, DePuy Synthes Announced Collaboration; Eko Health Launched CORE 500 Digital Stethoscope; Haemonetics’s NexSys PCS Plasma Collection System; Roche’s Alzheimer’s Disease Cerebrospinal Fluid (CSF) Assays; Medtronic’s MiniMed 780G system; Biodesix’s VeriStrat Blood-Based Host Immune Classifier

Pharma News for Pfizer, Sarepta, FibroGen, Erasca

FDA Approves Jardiance for Type 2 Diabetes; FDA Approves Pfizer’s LITFULO for Alopecia Areata; Sarepta Therapeutics’s ELEVIDYS Approval; Tonix Pharmaceuticals to Acquire Two Migraine Products from Upsher-Smith; FibroGen’s Phase 3 ZEPHYRUS-1 Study of Pamrevlumab; FDA Orphan Drug Designation to ERAS-801 for Malignant Glioma

MedTech News for Surmodic, Galvanize, STERIS, Orthofix

Orthofix Launched WaveForm A; BD Entered into Agreement with STERIS; Surmodics’s SurVeil™ Drug-Coated Balloon; Cardio Flow Design’s 4D Flow MRI Blood Flow Analysis Software; Galvanize Therapeutics’s RheOx® System; AWAK and SGH’s Wearable Peritoneal Dialysis Device Trial

Pharma News for GSK, Roche, Avita, Ipsen

FDA Extended the Review Period for Momelotinib; FDA Approves Roche’s Columvi; Avita Medical Obtains FDA Approval of RECELL; FDA Approves Odevixibat for ALGS; TME Pharma Receives IND Approval for NOX-A12; Aldeyra’s Phase 3 INVIGORATE‑2 Trial of Reproxalap

MedTech News for Endologix, SunMed, BD

Centinel Spine’s Prodisc C Match-the-Disc Cervical TDR System; Reflow Medical’s DEEPER OUS Trial; FDA Approval to Endologix’s Detour System; FDA Clearance to Smith+Nephew’s Shoulder Replacement System; SunMed Acquired Avanos’s Respiratory Health Business; BD’s Automate Clinical Flow Cytometry

Pharma News for Kyverna, Annovis, Astellas, FibroGen

FDA Fast Track Status to Kyverna’s KYV-101; Annovis’s Phase III Study for Buntanetap; Gilteritinib Demonstrated Benefit in AML Patients; FDA Orphan Drug Designation to DTx Pharma’s DTx-1252; FibroGen’s LELANTOS-1 Phase 3 Clinical Study Result

MedTech News for Olympus, Artelon, Masimo, Gore

Olympus’s Next Generation Electrosurgical Generator; Biocomposites Acquires Artoss GmbH; Artelon’s FlexBand, FlexPatch, and FlexBand Plus; Masimo’s Radius VSM; Gore’s GORE VIAFORT Vascular Stent; Synergy Spine Solutions’s 1-Level IDE Trial

Pharma News for Pfizer, Daiichi Sankyo, Kyverna, Servier

Daiichi Sankyo’s Intravenous Iron Replacement Therapy; ANeuroTech’s Adjunctive Anti-depression Drug, ANT-01; Kyverna Therapeutics’s KYV-101 in Lupus Nephritis; Servier Presents Data from Phase 3 INDIGO Trial of Vorasidenib; FDA Approves Pfizer’s ABRYSVO

MedTech News for Cepheid, Anika, EMVision

THINK Surgical’s TMINI Miniature Robotic System; Cepheid’s Xpert NPM1 Mutation Test; Anika’s Hyalofast® US Pivotal Phase III Study; EMVision’s Portable Brain Scanner Trial; HeartBeam and Samsung’s Strategic Alliance Agreement; Eosolutions’s Dr. Banner Balloon Guide Catheter

Pharma News for Lexicon, Novartis, Takeda and HUTCHMED

FDA Approves Lexicon’s INPEFA (Sotagliflozin); PTC Therapeutics’s Vatiquinone MOVE-FA Registration-Directed Trial; EU Approval to Novartis’s Sickle Cell Disease Drug; EMA Approves Neoadjuvant Nivolumab/Chemotherapy in Resectable NSCLC; FDA Grants Priority Review to Fruquintinib for mCRC; FDA Orphan Drug Designation to Vega Therapeutics’s VGA039

MedTech News for Eosolutions, Grünenthal, Orlucent

Eosolutions Corp’s Dr. Banner Balloon Guide Catheter; US FDA Approves the Cyltezo® Pen; Orlucent’s Handheld Mole Imaging System; Grünenthal’s Resiniferatoxin for Pain Associated with Knee Osteoarthritis; Element Science’s Jewel Patch Wearable Cardioverter Defibrillator; A.Menarini Diagnostics’s PRIME MDx Platform

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