REGULATED INFORMATION – INSIDE INFORMATION 1 July 2021, 07:00 am CEST Interim data from 26 patients in the Roll-In Cohort reconfirm positive outcomes against all primary endpointsi Over 90% reduction in mean frequency of therapeutic paracentesis versus baseline All patients experienced at least 50% reduction in mean frequency of therapeutic paracentesis per month versus baseline Clinically important improvement in quality of life maintained even up to 12 months post-implantation Safety profile remains in line […]
Coronary/Structural Heart
NGM Amends Collaboration with Merck to Focus Primarily on Advancing Novel Medicines for Retinal and Cardiovascular and Metabolic (CVM) Diseases
Merck and NGM will continue their research, discovery and development collaboration with a narrower scope, focused primarily on retinal and cardiovascular and metabolic (CVM) targets of interest to Merck Merck will continue to advance MK-3655, an FGFR1c/KLB agonistic antibody, currently in an ongoing global Phase 2b clinical trial in patients […]
Carta Healthcare Announces Status as a Certified NCDR Software Vendor for the American College of Cardiology’s (ACC) CathPCI Registry
Atlas, Carta’s AI-assisted data abstraction software, seamlessly automates submission to the ACC’s CathPCI clinical data registry, allowing healthcare organizations to maximize the benefits of registry contributions SAN FRANCISCO–(BUSINESS WIRE)–Carta Healthcare, a provider of artificial intelligence (AI)-powered clinical data abstraction technology and services, today announced that it is now a certified […]
Ginkgo Heart, LLC Joins Innovators’ Network at American Heart Association Center for Health Technology & Innovation
American Heart Association consortium advances development of evidence-based health tech solutions PORTLAND, Maine–(BUSINESS WIRE)–Ginkgo Heart, LLC, has joined the American Heart Association Center for Health Technology & Innovation’s (the Center) Innovators’ Network. The Center is focused on building and fostering health technology relationships to develop innovative and scalable solutions. The […]
ABBOTT’S XIENCE STENT RECEIVES FDA APPROVAL FOR SHORTEST BLOOD THINNER COURSE FOR HIGH BLEEDING RISK PATIENTS
– New labeling approval for Abbott’s XIENCE™ stent builds on a legacy of safety and allows for one-month (as short as 28 days) dual anti-platelet therapy (DAPT) for patients at high bleeding risk (HBR) – The new XIENCE Skypoint™ stent received FDA approval in the U.S. and CE Mark approval […]
Cytokinetics Announces Additional Results From GALACTIC-HF Presented at the European Society of Cardiology Heart Failure 2021
Further Analyses of GALACTIC-HF Supplement Previously Announced Data Regarding Increased Treatment Effect of Omecamtiv Mecarbil in Patients with More Severe Heart Failure SOUTH SAN FRANCISCO, Calif., June 30, 2021 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) were presented at […]
Arrowhead Pharmaceuticals Initiates Phase 2b Study of Investigational ARO-ANG3 for Treatment of Mixed Dyslipidemia
PASADENA, Calif.–(BUSINESS WIRE)–Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has dosed the first patient in AROANG3-2001, a Phase 2b clinical study of ARO-ANG3, the company’s investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with mixed dyslipidemia. Javier San Martin, M.D., chief medical officer at […]
FDA Grants Highest Level of Approval to the Next Generation of Impella RP to Treat Right Heart Failure
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed’s (NASDAQ: ABMD) newest right heart pump, the Impella RP with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) as safe and effective to treat acute right heart failure for up to 14 days. Impella RP with SmartAssist is the first single-access temporary percutaneous ventricular […]
Hanmi Pharmaceutical finds new innovative potential for “Efpeglenatide”
Large-scale phase 3 trial shows significant reduction in cardiovascular and kidney disease risk First public reveal of results from large-scale, Sanofi-led global phase 3 trial for efpeglenatide Hanmi aims to achieve new innovations with biologic SEOUL, South Korea, June 29, 2021 /PRNewswire/ — Hanmi Pharmaceutical (hereinafter Hanmi) recently announced that its new, […]
AngelMed Announces FDA Approval of the Enhanced Real-Time Cardiac Monitor for Acute Coronary Syndrome (ACS) Events
AngelMed Guardian® System prompts high-risk ACS patients to seek medical care EATONTOWN, N.J., June 28, 2021 /PRNewswire/ — Angel Medical Systems, Inc., (dba AngelMed) a proactive diagnostics company focused on the advancement of long-term management of high-risk coronary disease, announced today the FDA approval of the second-generation AngelMed Guardian® device. The AngelMed Guardian System […]



