Tag Archives: heart failure

September, 2018

19 September
Pfizer Presents New Analyses from the Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy Study

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that additional sensitivity and post-hoc analyses from the Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) study provide further detail on the effect of tafamidis across wild-type, hereditary, and New York Heart Association (NYHA) class sub-groups of patients with transthyretin amyloid cardiomyopathy (ATTR-CM).1 Tafamidis is …
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24 May
Pfizer’s Tafamidis Receives Breakthrough Therapy Designation from the FDA for Treatment of Transthyretin Cardiomyopathy

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that tafamidis received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the treatment of patients with transthyretin cardiomyopathy, a rare, fatal, and underdiagnosed condition associated with progressive heart failure.1,2 This decision is supported by topline results from the tafamidis …
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6 June
Pfizer’s Tafamidis Receives Fast Track Designation for Treatment of Transthyretin Cardiomyopathy

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to tafamidis, the company’s investigational treatment for transthyretin cardiomyopathy (TTR-CM). This rare disease is associated with progressive heart failure and is universally fatal.1,2,3Currently in Phase 3 clinical development for TTR-CM, tafamidis …
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29 August
CHART-1: Largest Cardiac Regenerative Therapy Trial Brings New Insights

Rome, Italy – 28 August, 2016: A therapy that uses bone-marrow stem cells to promote heart repair did not significantly improve the primary outcome over a sham procedure among patients with congestive heart failure. However, it revealed critical new insights, according to investigators of the CHART-1 trial. Although findings of …
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11 December
Cardiorentis’ ADHF Drug Receives Fast Track Status from the FDA

ZUG, Switzerland, Dec. 11, 2015 /PRNewswire/ — Cardiorentis AG, a privately held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to Ularitide, an investigational therapy for the treatment of acute decompensated heart failure (ADHF). The FDA’s Fast Track process is intended …
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