Tag Archives: familial hypercholesterolemia

April, 2017

26 April
The Medicines Company and Alnylam Announce Agreement with FDA on Phase 3 Program for Inclisiran

PARSIPPANY, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–The Medicines Company (NASDAQ:MDCO) and Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) today announced that The Medicines Company has agreed with the U.S. Food and Drug Administration (FDA) on plans for the Phase III clinical program for inclisiran, which is designed to support the submission of a New …
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15 March
Amgen’s PCSK9 Inhibitor Repatha Meets Primary Endpoint in Late-Stage Clinical Trial

THOUSAND OAKS, Calif., March 14, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that four-year follow-up results from the Repatha® (evolocumab) OSLER-1 study, the longest PCSK9 inhibitor clinical trial to date, were published in JAMA Cardiology. Repatha, when added to standard of care (SOC), achieved median low-density lipoprotein cholesterol (LDL-C) reductions …
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10 February
Appeals Court Grants Stay of Permanent Injunction for Praluent During Appeals Process

Paris, France and Tarrytown, New York – February 8, 2017 – Regeneron Pharmaceuticals, Inc (NASDAQ: REGN) and Sanofi announced today that the United States Court of Appeals for the Federal Circuit has stayed (suspended) the permanent injunction for Praluent® (alirocumab) Injection pending the companies’ appeal. This ruling (available here) means …
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28 August
FDA Approves Amgen’s PCSK9 Inhibitor Repatha

The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options. Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, is approved for use in addition to …
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