Notizia - Recent Pharma, Healthcare and Biotech Happenings

Pharma News for AskBio, Almirall, Bayer, Pfizer

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Key Updates on Phase 1 Trial of AB-1005 Gene Therapy for Multiple System Atrophy-Parkinsonian Type; European Commission Approves EBGLYSS; Bayer Stopped OCEANIC-AF Study; Pfizer and Astellas’ XTANDI Approved by FDA; FDA Orphan Drug Designation to Epic Bio’s EPI-321; FDA Fast Track Designation to Chemomab’s CM-101 for PSC

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Pharma News and Updates for AbbVie, Arrowhead Pharma, Novartis, FORE Biotherapeutics, Ellipses Pharma, Karuna Therapeutics

AbbVie Announces Results of Study Evaluating SKYRIZI; FDA Fast Track Designation to Arrowhead’s ARO-APOC3; FDA Approves Dabrafenib Plus Trametinib for BRAF V600E–Mutated Low-Grade Glioma; FDA Grants ODD to Novel BRAF Inhibitor for Brain/CNS Malignancies; EP0042 Wins FDA Orphan Drug Status; Karuna Therapeutics Announces Results from Phase 3 EMERGENT-3 Trial of KarXT in Schizophrenia

MedTech News and Update for Sight Sciences, HeartBeam, LIVMOR, Occlutech, PADM Medical, Kardium, LivaNova

Sight Sciences’s Ergo-Series of the OMNI® Surgical System; HeartBeam to Acquire LIVMOR’s Assets; Occlutech Atrial Flow Regulator (FROST-HF) Study Updates; US FDA 510(k) Clearance for PADM Medical’s PRECISION ECO; Kardium ‘s Pulsed-Field Ablation Study; US FDA 510(k) Clearance for LivaNova’s Essenz Heart-Lung Machine

Pharma news and updates for Roche, Acadia, Shorla Oncology, Calliditas, Mesoblast, Sanofi, Provention Bio

Sanofi to Acquire Provention Bio; USFDA Committee Votes in Favor Roche’s Polivy; FDA to Review Mesoblast’s GvHD Drug; FDA Approves Acadia’s Daybue ; FDA Approves Nelarabine Injection; Calliditas’s Nefecon Trial Reuslt in IgA Nephropathy

MedTech News for Artica Systems, Nevro, Stratus® Medical, Restore Medical, Respiree, Abbott

Artica Systems’s Electric Whole-Body Cryotherapy Machines; Nevro’s Revolutionary HFX iQ™ Spinal Cord Stimulation System; COBRA Study of Stratus® Medical for Nimbus® Radiofrequency Ablation Device; Restore Medical’s CONTRABAND™ System; US FDA 510(k) Clearance for RS001 Cardio-respiratory Wearable; FDA Approval to Abbott’s Traumatic Brain Injury (TBI) Blood Test

Pharma News and Updates for Incyte, Eisai, Biogen, Reata Pharmaceuticals, Genenta Science, Harbour BioMed, Ikena Oncology

Incyte’s Clinical Trial for Myelofibrosis; Eisai and Bioge’s Leqembi; FDA Approves Reata Pharmaceuticals’ SKYCLARYS; Temferon Lands FDA Orphan Drug Status for Glioblastoma; Harbour BioMed Announces Results from Phase III Trial of Batoclimab; FDA Fast Track Designation to Ikena’s AHR Antagonist IK-175

MedTech News and Updates for SOPHiA GENETICS, QIAGEN, Co-Diagnostics, Abbott, SpectraWAVE, Bioelectronic Medicine

Eko’s AI-powered Sensora Platform; SOPHiA GENETICS and QIAGEN Announced Partnership; Co-Diagnostics’s At-Home and Point-of-Care Co-Dx PCR Home™ Platform; Abbott’s Minimally Invasive Heart Devices Updates; SpectraWAVE’s HyperVue™ Intravascular Imaging System; FDA Approval to Bioelectronic Medicine’s Bioelectric Technology

Pharma News and Updates for SpringWorks Therapeutics, AskBio, Mitsubishi Tanabe Pharma America, Sage Therapeutics, Biohaven Pharma

SpringWorks’s Desmoid Tumors Therapeutic, Nirogacestat; Orphan Drug Designation to AskBio’s AB-1003; Mitsubishi Tanabe’s Phase 3 Trial of RADICAVA ORS in ALS; EU Orphan Drug Designation to Sage Therapeutics’s SAGE-718; FDA Fast Track Status to Biohaven’s Taldefgrobep Alfa

MedTech News and Updates for Medtronic, Stryker, Dexcom, Rhaeos, Synchrony

Medtronic’s Extravascular Defibrillator System; Stryker’s Q Guidance System for Cranial Applications; Synchrony Medical’s LibAirty™ Airway Clearance System Study; Cognito Therapeutics’s Pivotal Study HOPE Update; Dexcom’s G6 Continuous Glucose Monitoring System Launch in Singapore; Rhaeos Raised $10.5M in Series A Funding

Pharma News and Updates for Actinium, Apellis, Chiesi, IVERIC, Travere, Takeda

Actinium Announces Phase III SIERRA Trial Results; FDA Approves Apellis’s Geographic Atrophy Drug; FDA Gives Green Light to Chiesi’s Lamzede; FDA Accepts NDA and Grants Priority Review for Avacincaptad Pegol; FDA Approves Travere’s Kidney Disorder Drug; Takeda Presents Phase 3 GRAPHITE Study Results

MedTech News GI Dynamics, EndoStream Medical, Ibex, Sunrise

GI Dynamics’s I-STEP Clinical Study of EndoBarrier; EndoStream’s Clinical Trial for Nautilus™ Intrasaccular System; CE Mark for Ibex’s Galen™ Prostate; Sunrise’s At-home Sleep Apnea Test; Globus Medical Announced Merger with NuVasive; Boston Imaging’s HERA W10 Elite

Pharma News and Updates for Leo Pharma, GSK, Roche, Aldeyra, IASO Bio

Leo Pharma’s Hand Eczema Clinical Trial Updates; GSK’s PD-1 inhibitor Jemperli Approval; Roche Announces Phase III Result of Vabysmo; FDA Accepts NDA for Aldeyra’s reproxalap; RMAT and Fast Track Designations to IASO Bio’s CT103A; Orphan Drug Designation to Jubilant Therapeutics’s JBI-778

MedTech News Updates LivaNova, Candela, 3M, Aspivix, Ethicon

LivaNova Launched SenTiva DUO; Candela Launched Matrix System; 3M Launched Medical Adhesive; MONARCH Platform Performed First Kidney Stones Removal Procedure; Biosense Webster Presented Data of HELIOSTAR Balloon Ablation Catheter; FDA 510(k) Clearance to Aspivix’s Cervical Stabilizer Carevix

Pharma News Updates for Merck, Sanofi, GSK, Hinova, Endogena, Amylyx

Merck’s Keytruda Wins Another FDA Approval; Sanofi Pauses Trial of Myasthenia Gravis Drug, tolebrutinib; FDA Approves GlaxoSmithKline’s Jesduvroq; FDA IND Application Clearance for Hinova’s HP518; FDA Fast Track Designation to Endogena’s EA-2353; Amylyx Updates on Global Phase 3 PHOENIX Trial

Medtech News and Updates for Alma, Abbott, Axonics, AtriCure, MedAlliance

Alma Announced the Launch of Alma Duo; Phillips-Medisize Launched a Pen Injector Platform; FDA Approved Abbott’s Spinal Cord Stimulation; Axonics Received FDA Approval for Rechargeable Sacral Neuromodulation; SELUTION SLR Coronary Sirolimus DEB Study Enrolls First Patient; AtriCure LeAAPS Clinical Trial

latest-pharma-news-and-updates-for-eli-lilly-novartis-janssen-ipsen-kite

Eli Lilly’s Jaypirca Approval; Novartis’ Adakveo EMA Review; Janssen’s CARTITUDE-4 Study of CARVYKTI; Negative Review on Ipsen’s Palovarotene; Gilead Sciences and Kite’s Yescarta NICE Recommendations; Daiichi Sankyo and AstraZeneca’s Enhertu EU Approval

Latest MedTech News and Updates for Tandem, NeuroMetrix, Cytovale, icotec ag

Tandem Acquires AMF Medical; NeuroMetrix Launched DPNCheck 2.0 Device; FDA Approves Cytovale’s IntelliSep Sepsis Test; FDA Clearance for the Ø 4.5mm VADER Pedicle Screws; Pie Medical Imaging’s vFFR FASTIII Trial; Hip Innovation Technology Announced Initiation Investigational Device Exemption Study

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