cardiology

Jardiance gets parity with Farxiga in US as FDA clears use in heart failure

Eli Lilly and Boehringer Ingelheim have claimed FDA approval for their diabetes therapy Jardiance in heart failure with reduced ejection fraction (HFreF), setting up a market tussle with AstraZeneca’s Farxiga. The US regulator has cleared a 10mg daily dose of Jardiance (empagliflozin) to reduce the risk of cardiovascular death plus hospitalisation for heart failure in …

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Abbott bags FDA okay for AI-based heart imaging software

The FDA has approved an artificial intelligence-based imaging software developed by Abbott that is used to help physicians carry out procedures like implanting stents to open up narrowed blood vessels in the heart.  Abbott‘s Ultreon software is billed as a first-of-its-kind platform that is designed to be used with optical coherence tomography (OCT), an imaging …

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Look out BMS, Cytokinetics has its eye on mavacamten’s turf

Shares in Cytokinetics surged after it reported positive mid-stage results for CK-274, a drug for hypertrophic cardiomyopathy (HCM) that could tread on the toes of Bristol-Myers Squibb’s mavacamten – acquired as part of its $13.1 billion takeover of MyoKardia last October. In HCM, the heart muscle become thickened and in some patients can obstruct blood …

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First US patient gets total heart replacement with CARMAT device

An experimental artificial heart developed by French medical device specialist CARMAT has been implanted into the first of 10 subjects due to be enrolled in a US trial. The Aeson bioprosthetic device has already been implanted in a number of European patients with end-stage biventricular heart failure – affecting both sides of the heart – …

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Novartis tries to rescue stalled inclisiran filing with FDA

Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes the drug. The US regulator issued Novartis with a complete response letter (CRL) for inclisiran in December, citing “unresolved facility inspection-related conditions” at …

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Novo Nordisk crowns cell therapy pipeline with $598m Heartseed deal

Novo Nordisk is paying $55 million upfront to secure rights to a cell therapy for heart failure developed by Japanese startup Heartseed. The Danish drugmaker has acquired exclusive rights outside Japan to Heartseed’s HS-001 therapy based on heart muscle cells (cardiomyocytes) derived from human stem cells, and is due to start the phase 1/2 LAPiS …

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UK regulator backs Amarin’s cardiology drug Vazkepa

Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March.  The Medicines and Healthcare products Regulatory Agency (MHRA) granted a marketing authorisation for Vazkepa (icosapent ethyl) as a treatment to reduce risk of cardiovascular events in high-risk patients. These are defined as patients who …

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The Paradigm Shift That Wasn’t: The ISCHEMIA Trial

By ANISH KOKA A recent email that arrived in my in-box a few weeks ago from an academic hailed the latest “paradigm shift” in cardiology as it relates to the management of stable angina.  (Stable angina refers to chronic,non-accelerating chest pain with a moderate level of exertion).  The points made in the email were as …

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Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label

Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes. The US regulator is looking at data from the EMPEROR-Reduced trial of Jardiance (empagliflozin), which found that the drug achieved a 25% …

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Push for better patient outcomes drives new standard of care [Sponsored]

In this webinar on Feb. 10,healthcare experts from Desert Oasis Healthcare and iRhythm Technologies will discuss how Zio monitors, designed to be worn for longer duration than holter monitors, represent a new standard of care in remote cardiac monitoring.

FDA rejects Novartis’ cholesterol drug after factory inspection issue

Novartis’ cholesterol drug inclisiran has hit a speed bump with the FDA, which has rejected the potential blockbuster because a manufacturing facility has yet to be inspected. Matters appear to have been complicated by the pandemic and the travel disruption that it has caused, which is preventing an FDA team from visiting the plant in …

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Entresto set for big sales hike after FDA panel endorsement

Novartis’ Entresto is on course to become the first drug to be approved in the US for a form of heart failure that is notoriously hard to treat effectively, despite missing the mark in a phase 3 trial. An FDA advisory committee 12 to 1 in favour of approving Entresto (sacubitril/valsartan) for heart failure with …

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