Novartis will appeal to U.S. Court of Appeals to uphold validity of Entresto® combination patent; maintains 2023 guidance and mid-term outlook

Basel, July 07, 2023 — Novartis today announced that the U.S. District Court for the District of Delaware issued a negative decision regarding the validity of a patent covering Entresto and combinations of sacubitril and valsartan, which expires in 2025 with its pediatric exclusivity. Novartis strongly believes the combination patent is valid and will appeal to…

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US FDA approves expanded indication for Novartis Leqvio® (inclisiran) to include treatment of adults with high LDL-C and who are at increased risk of heart disease

EAST HANOVER, N.J., July 10, 2023 /PRNewswire/ — Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Leqvio® (inclisiran) to enable earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy1. This patient population includes those…

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ASPC and NLA publish joint clinical perspective on the importance of low-density lipoprotein cholesterol measurement and control as performance measures

Despite the established role of low-density lipoprotein cholesterol (LDL-C) as a major risk factor for cardiovascular disease (CVD), and the persistence of CVD as the leading cause of morbidity and mortality in the United States, national quality assurance metrics no longer include LDL-C measurement as a required performance metric. This clinical perspective reviews the history…

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Bayer’s KERENDIA® (finerenone) Receives Updated Label to Include Findings From Phase III FIGARO-DKD Cardiovascular Outcomes Study in Patients With Chronic Kidney Disease and Type 2 Diabetes

Bayer announced today that it received approval from the United States (U.S.) Food and Drug Administration (FDA) for an update to the label for KERENDIA® (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA), to include findings from the FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).1 FIGARO-DKD is…

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ACC Recognizes PA Title Change to Physician Associate 

We are thrilled to share the official writeup for Physician Associates in ACC’s Cardiology Magazine, with comment from our APAC President Viet Le, PA-C FACC FAHA. Following endorsement by the ACC’s Cardiovascular Team Section PA Work Group and Membership Committee, the ACC Board of Trustees recently approved use of the “Physician Associate” designation in future…

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ASPC Announces Official Program Covering the ABCs of Preventive Cardiology at Premier Annual Congress on CVD Prevention

JACKSONVILLE, Fla. – The American Society for Preventive Cardiology (ASPC) announces the official program for the ASPC 2022 Congress on CVD Prevention, scheduled July 29-31, 2022 in Louisville, KY. The program covers the “ABCs of Preventive Cardiology” over the 2.5 day live, in-person program, and can be found on aspconline.org/2022congress. Included in the 2022 program…

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Jardiance® phase III EMPA-KIDNEY trial will stop early due to clear positive efficacy in people with chronic kidney disease

OXFORD, United Kingdom and RIDGEFIELD, Conn. and INDIANAPOLIS, March 16, 2022 /PRNewswire/ — The EMPA-KIDNEY trial, evaluating the effect of Jardiance® (empagliflozin) in adults with chronic kidney disease (CKD), will stop early based on a recommendation from the trial’s Independent Data Monitoring Committee. This follows a formal interim assessment that met prespecified criteria for positive efficacy, announced the Medical Research Council (MRC) Population…

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REGENERON AND ULTRAGENYX COLLABORATE TO COMMERCIALIZE EVKEEZA® (EVINACUMAB) OUTSIDE THE UNITED STATES

Evkeeza is a first-in-class medicine approved by the U.S. Food and Drug Administration (FDA) and European Commission (EC) to treat an ultra-rare inherited form of high cholesterol TARRYTOWN, N.Y. and NOVATO, Calif., Jan. 7, 2022 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Ultragenyx Pharmaceutical Inc. today announced a license and collaboration agreement for Ultragenyx to clinically develop, commercialize and distribute Evkeeza® (evinacumab)…

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