Coronary/Structural Heart

Bayer Partners with Huma on Bayer® Aspirin Heart Risk Assessment Online Educational Tool to Raise Awareness of Heart Health and its Risk Factors

Huma’s predictive algorithm will power a new global online patient engagement tool* that provides an accessible solution for heart health education NEW YORK, Feb. 1, 2023 /PRNewswire/ — Huma Therapeutics Limited (“Huma”), a leading global digital health company, and Bayer, a leading global life sciences company, have partnered to develop the Bayer Aspirin […]

Occlutech Continues its Progress in US FDA Study OCCLUFLEX – Enrolls First Patient in Europe

SCHAFFHAUSEN, CH / ACCESSWIRE / January 31, 2023 / Occlutech Holding AG Occlutech Holding AG (“Occlutech”), one of the world’s leading providers of minimally invasive structural heart disease devices, continues its progress in the US market. The first patient has now been enrolled in the global US study OCCLUFLEX in […]

Idorsia submits European marketing authorisation application for aprocitentan for the treatment of patients with resistant hypertension

The application includes data from the Phase 3 registration study of patients with resistant hypertension, where aprocitentan demonstrated a sustained blood pressure reduction over 48 weeks and was well-tolerated Allschwil, Switzerland – January 31, 2023 Idorsia Ltd (SIX: IDIA) today announced that it has submitted a marketing authorisation application (MAA) to the European […]

Valbiotis Announces Positive Results in the Bioavailability and Mode of Action TOTUM•854 Clinical Study, Against High Blood Pressure

TOTUM•854 protects human cells of the vascular wall, particularly against inflammation and oxidative stress, which is key to preventing worsening of high blood pressure. TOTUM•854 also reduces angiotensin I-converting enzyme (ACE1) activity, one of the main modes of action known to reduce blood pressure. The bioavailability study also confirms the […]

Help Therapeutics Announces IND Approval of First Universal iPSC-derived Cardiomyocyte Therapy for End-stage Heart Failure in China

BEIJING, Jan. 30, 2023 /PRNewswire/ — Help Therapeutics Co., Ltd. (hereinafter Help Therapeutics) has revealed that the China Center for Drug Evaluation (CDE) has approved the investigational new drug (IND) application of HiCM-188, a human (allogeneic) iPS cell-derived cardiomyocyte therapy in patients with worsening ischemic heart failure. China CDE has approved Help […]

scPharmaceuticals Provides FUROSCIX® (furosemide injection) Commercial Update

Commercial launch planned for February 20, 2023 BURLINGTON, Mass., Jan. 30, 2023 (GLOBE NEWSWIRE) — scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize therapies, advance patient care, and reduce healthcare costs, today announced that the company is targeting February […]

Amarin Announces VAZKEPA® (Icosapent Ethyl) Approved By Medsafe In New Zealand

Marks 7th Regulatory Approval for VASCEPA®/VAZKEPA® Franchise in Key International Markets Since 2022 DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 27, 2023 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that Medsafe in New Zealand has granted approval to VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular (CV) events […]

JACC Publication Guides Use of CareDx’s HeartCare Transplant Rejection Surveillance in Clinical Practice

Guide Helps Transplant Centers Continue the Evolution from Endomyocardial Biopsies to Noninvasive Surveillance Using AlloMap GEP and AlloSure dd-cfDNA BRISBANE, Calif.–(BUSINESS WIRE)–CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced […]

XyloCor Therapeutics Reports Positive Topline Safety and Efficacy Results from Phase 2 EXACT Clinical Trial of XC001 Novel Gene Therapy for Refractory Angina

-No serious adverse events related to drug product were reported -Patients demonstrated improvements in exercise capacity and reductions in episodes of chest pain -Cardiac imaging results provide mechanistic evidence supporting the therapeutic potential of XC001 in cardiovascular disease WAYNE, Pa.–(BUSINESS WIRE)–XyloCor Therapeutics, a clinical-stage biopharmaceutical company developing novel gene therapies […]

MedAlliance leads US Sirolimus DEB race: First US Patient enrolled into SELUTION SLR Coronary Sirolimus DEB Study

GENEVA, Jan. 25, 2023 /PRNewswire/ — The first US patient has been enrolled at MedStar Washington Hospital Center in the SELUTION4ISR study evaluating SELUTION SLR™ to support FDA approval. This milestone follows Investigational Device Exemption (IDE) approval in the US in October 2022. SELUTION SLR is the first sustained limus release coronary drug-eluting balloon […]