Cardiovascular Diseases

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Insulet Corporation’s Omnipod® 5 Automated Insulin Delivery System Receives FDA Approval; FDA Gives Green Light to Expand Vericel’s MACI Arthro Label; SkinCure Oncology Announces New Study of Non-melanoma Skin Cancer Through Image-guided Superficial Radiation Therapy; SDC’s BYOD ePRO Solution Clinical Trial; PaceMate® Acquires Paceart Optima™ System; KARL STORZ Acquires a US-headquartered Company

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C2Dx’s Shaw Scalpel System; Texas Original’s RSO Gummies; Abbott’s Whole Blood Rapid Test FDA Clearance; Medtronic’s TAVR Device FDA Clearance; Nexalin’s Device Improved Symptoms; CYduct Diagnostics’ Positive Study Results

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Regeneron’s Odronextamab BLA; Novo Nordisk’s Cardior Pharmaceuticals Acquisition; Novartis’ Fabhalta CHMP Approval; Idorsia’s TRYVIO FDA Approval; AbbVie’s Landos Biopharma Acquisition

Pharma News for BeiGene, GSK, Sandoz, Travere

BeiGene’s BRUKINSA Gets FDA Accelerated Approval; GSK’s Positive Results in DREAMM-8 Phase III; Sandoz’s Denosumab Biosimilars FDA Approved; Terns Pharma’s TERN-701 Receives Orphan Drug Designation; Wegovy® Approved in US for Overweight Cardiovascular Risk; Travere Therapeutics Submits sNDA for FILSPARI IgAN Full Approval

MedTech News for Philips, Boston Scientific, Varian

Philips Teamed with SyntheticMR; BioPhotas’s Celluma Light Therapy; Boston Scientific’s AGENTTM Drug-Coated Balloon; Varian’s TrueBeam and Edge Radiotherapy Systems; Carthera’s Brain-Blood Barrier Trial; Prototype Device Effectively Treated Multiorgan Failure

Pharma News for Bayer, AstraZeneca, AbbVie, A2 Bio

Bayer’s New Cardiology Drug Acoramidis; Two Datopotamab Deruxtecan Applications Validated in the EU; AbbVie and OSE Immunotherapeutics Announce Announces Partnership; vTv Therapeutics Makes Major Move With Cadisegliatin; A2 Bio Scores FDA Orphan Drug Designation for its Therapy, A2B530; FDA Fast Track Designation for AlloNK® in Lupus Nephritis

Pharma News for Novartis, Iovance, Certa, Innovent

FDA Approves Xolair for Food Allergies; FDA Accelerated Approval for Iovance’s AMTAGVI; Astellas and Kelonia Enter into Research and License Agreement; Fast Track Designation to Certa’s FT011; Innovent Announces Phase 3 Clinical Trial Updates for IBI311; Orphan Drug Designation to Cardiol’s Pericarditis Drug Candidate

MedTech News for ResMed, Masimo, Viz.Ai, UroMems

Tandem’s Automated Insulin Patch Pump; ResMed’s Bilevel Sleep Respiratory Devices; Masimo’s First Over-The-Counter Fingertip Pulse Oximeter; Viz.Ai Algorithm for Quantifying Intracerebral Hemorrhage; Canary Medical’s Heart Sound Monitor; UroMems’ Smart Urinary Sphincter System

Pharma News for GSK, Gilead, CSL, CymaBay

GSK Receives FDA Fast Track Designation for Bepirovirsen; Gilead to Acquire CymaBay Therapeutics; CSL Announces Top-line Results from the Phase III AEGIS-II Trial; Ruxoprubart Scores FDA Orphan Drug Designation for PNH Treatment; CymaBay Announces FDA Acceptance of NDA and Priority Review for Seladelpar; Biogen Received European Commission Approval for SKYCLARYS

MedTech News for Dexcom, Philips, Toku, Carthera

Cerenovus Launched Next-Gen Stroke Revascularization Catheter; Dexcom Launched New ONE+ CGM System; Philips Received the US FDA Nod for Latest Intellivue Patient Monitor Software; Toku Obtained CE and UKCA Marks for AI Cardiovascular Risk Assessments; Genesis MedTech Completed Enrollment in TAVR Trial; Carthera’s Ultrasound Drug Delivery Trial

Navigating the Healthcare Horizon: Odyssey of Mergers, Funding, and Acquisitions in 2024

MedTech News for Samsung, BIOCORP, CroiValve, FastWave Medical

Samsung Partnered with Lunit; Boston Scientific Launched VersaVue single-use Flexible Cystoscope; Element Science’s Patch-wearable Cardioverter Defibrillator; BIOCORP Received 510(k) FDA Clearance for SoloSmart; FDA IDE for CroiValve’s Tricuspid Heart Valve; FastWave Medical’s First-in-human Study of its IVL Tech

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Atherosclerotic Cardiovascular Disease (ASCVD) Treatment Approaches: Beyond Statins

MedTech News for AngioDynamics, Enhatch, AbSolutions

FDA Breakthrough Device Designation to Pi-Cardia’s ShortCut; AbSolutions Med’s REBUILD Bioabsorbable Abdominal Wall Closure Device; AngioDynamics Announces FDA 510(k) Clearance of Auryon XL Radial Access Catheter; Enhatch Announces FDA Clearance for a TKA Patient-Specific Instrumentation System

Pharma News for AskBio, Merck, SELLAS, RemeGen

Bayer’s AskBio Initiates Phase II GenePHIT Trial; FDA Approves Merck’s KEYTRUDA Plus Chemoradiotherapy as Treatment for Stage III-IVA Cervical Cancer; FDA Fast Track Designation to SELLAS Life Sciences R/R AML; RemeGen’s RC88; Shorla Oncology Announces FDA Filing Acceptance of New Drug Application for Novel Formulation to Treat Breast and Ovarian Cancer; Tonix Pharma’s TNX-102 SL for Fibromyalgia

MedTech News for Medtronic, Cala, Medline, Rivermark Medical

Medtronic Announced World’s First Approval for MiniMed 780G System; CE Mark for Medtronic’s Next Generation Micra Leadless Pacing Systems; Biosense Webster Received Approval for VARIPULSE PFA Platform; Rivermark Medical Updated on Flostent System; Cala Disclosed TAPS Therapy Data for Essential Tremor; Medline Introduced Transparent Wound Dressing

Pharma News for Merck, AbbVie, Abbisko

Merck to Acquire Harpoon Therapeutics; Novo Nordisk Enters Into Collaborations with Omega Therapeutics and Cellarity; AbbVie’s Lutikizumab’s Phase II Trial Result for Hidradenitis Suppurativa; Abbisko’s CSF-1R Inhibitor Pimicotinib (ABSK021); Cabaletta Bio’s CABA-201; FDA Grants Fast Track” Designation for Soligenix’s Dusquetide

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