Coronary/Structural Heart

Orsini Specialty Pharmacy Selected To Be The Exclusive Specialty Pharmacy Partner For Evkeeza™ (evinacumab-dgnb)

ELK GROVE VILLAGE, Ill., Feb. 16, 2021 /PRNewswire/ — Orsini Specialty Pharmacy, a leader in rare diseases and gene therapies, announced today that it has been selected by Regeneron Pharmaceuticals, Inc. as the exclusive specialty pharmacy partner for EvkeezaTM (evinacumab-dgnb). Evkeeza is approved by the U.S. Food and Drug Administration (FDA) as an adjunct […]

WeHealth™ Digital Medicine and BioSerenity Initiate a New Phase to Accelerate Cardioskin™ Commercialization

BioSerenity acquires Cardioskin™ global distribution rights PARIS and ATLANTA, Feb. 16, 2021 /PRNewswire/ — WeHealth™ Digital Medicine (e-health division of the Servier Group) and BioSerenity announced today that BioSerenity gains global distribution rights for Cardioskin™, the first WeHealth™ digital Solution co-developped with a start-up, to accelerate the commercialization of Cardioskin™. After successfully collaborating to develop the Cardioskin™, the […]

Novartis Entresto® granted expanded indication in chronic heart failure by FDA

Entresto is the first and only therapy approved in the US to treat patients diagnosed with guideline-defined heart failure to include both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF)1-3 Expanded indication enables potential treatment of more adults with […]

VALBIOTIS Authorized to Launch HEART, the Phase II Multi-center Clinical Study With TOTUM-070, for the Reduction of Blood LDL-cholesterol Levels

The favorable opinion of the CPP (French ethic committee) and authorization from the ANSM (French National Agency for the Safety of Medicines and Health Products) allow the operational launch of the HEART study. The HEART study will be conducted under the scientific expertise of Jean-Marie Bard, Professor and Hospital Practitioner […]

Thrombolytic Science Reinforces Its IP Portfolio with Patents in Europe, the Commonwealth of Independent States and Japan

New Patents to Support Global Partnering of Novel Bio-inspired Clot-dissolving Therapy CAMBRIDGE, MA, February 10, 2021 / B3C newswire / — Thrombolytic Science, LLC (TSI) today announced the granting of three new patents during the last 12 months.  The invention relates to methods and compositions for safe and effective thrombolysis for ischemic […]

Aziyo Biologics Announces Product Design Completion for its Next Generation CanGaroo® Envelope for Implantable Electronic Devices

SILVER SPRING, Md., Feb. 11, 2021 (GLOBE NEWSWIRE) — Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes in patients undergoing surgery, announced today product design completion for CanGaroo® with antibiotics, the next generation of the Company’s CanGaroo […]

Olatec Therapeutics LLC Announces a Scientific Publication on the Positive Results in the First Known Clinical Trial with a Selective Oral NLRP3 Inhibitor, Dapansutrile, in Patients with Heart Failure

The Phase 1b, randomized, double-blinded, dose escalation, single-center, repeat dose study design assessed the safety and pharmacodynamics with dapansutrile in subjects with stable heart failure with reduced ejection fraction (HFrEF) Antonio Abbate MD PhD, the Principal Investigator, is Professor of Medicine and Medical Director of the Clinical Research Unit at […]

FDA Approves First-in-class Evkeeza™ (evinacumab-dgnb) for Patients with Ultra-rare Inherited Form of High Cholesterol

TARRYTOWN, N.Y., Feb. 11, 2021 /PRNewswire/ — Homozygous familial hypercholesterolemia (HoFH) is an ultra-rare inherited condition that affects approximately 1,300 patients in the U.S. and is characterized by extremely high low-density lipoprotein cholesterol (LDL-C) In pivotal Phase 3 HoFH trial, adding Evkeeza to standard lipid-lowering therapies reduced LDL-C by nearly half at 24 […]

CARMAT Receives FDA Approval to Use the New Version of Its Artificial Heart in the US Early Feasibility Study (EFS)

First enrollment in the study expected in Q1 2021 PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today provides […]

First Patient in Europe Treated With Cardiovascular Systems, Inc. Diamondback 360® Coronary Orbital Atherectomy System

ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that the first patient in Europe has been treated with its Diamondback 360® Coronary Orbital Atherectomy System (OAS). Professor Nicolas Van […]