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AstraZeneca scores Chinese approval for heart failure therapy Forxiga

AstraZeneca scores Chinese approval for heart failure therapy Forxiga

AstraZeneca said that Forxiga (dapagliflozin) has secured approval in China for its use in the reduction of the risk of cardiovascular (CV) death and hospitalization for heart failure (hHF) in adults having heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF). The approval for the sodium-glucose co-transporter 2 inhibitor (SGLT2 inhibitor) from the Chinese […]

Farxiga : AstraZeneca gets FDA fast track status for heart failure after MI

AstraZeneca has secured fast track designation for Farxiga (dapagliflozin) in the US for its use in reducing the risk of hospitalization for heart failure (hHF) or cardiovascular (CV) death in adults after an acute myocardial infarction (MI) or heart attack. The fast track designation for the oral once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor is based on […]

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VisCardia wraps up VisONE heart failure pilot study

VisONE heart failure pilot study : Oregon-based medical device developer VisCardia has wrapped up its first-in-human study of the implantable VisONE system for medically refractory heart failure patients who have reduced ejection fraction (HFrEF) and preserved ventricular synchrony. The VisONE Heart Failure pilot trial was a prospective, open-label, multi-center study held at certain European Heart […]

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Arena Pharmaceuticals’ APD418 gets FDA fast track status in decompensated heart failure

Arena Pharmaceuticals has secured that fast track designation for its drug candidate APD418 from the US Food and Drug Administration (FDA) for the treatment of decompensated heart failure (DHF). APD418 is a β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope. According to the San Diego-based biopharma company, APD418 is a selective antagonist that has been designed […]

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Impulse Dynamics raises $80m to commercialize Optimizer Smart System

Impulse Dynamics, a US medical device company, has secured $80.25 million in a Series D financing round led by medical technology investor Amzak Health Investors for the commercialization of its Optimizer Smart System for heart failure. Optimizer Smart System is an implantable device which has been approved by the US Food and Drug Administration (FDA) […]

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