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News Breaks
December 14, 2012
07:31 EDTISIS, SNYGenzyme, Isis say CHMP adopts negative opinion on KYNAMRO MAA
Genzyme, a Sanofi company (SNY), and Isis Pharmaceuticals (ISIS), announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion for its marketing authorization application for KYNAMRO for the treatment of patients with Homozygous Familial Hypercholesterolaemia. Genzyme plans to request a re-examination of the CHMP Opinion. An application for KYNAMRO is currently under review by the U.S. Food and Drug Administration. In October, KYNAMRO received a positive vote by an FDA advisory panel that Genzyme had provided sufficient efficacy and safety data to support the marketing of KYNAMRO for the treatment of patients with Homozygous Familial Hypercholesterolaemia.
News For SNY;ISIS From The Last 14 Days
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July 6, 2015
07:05 EDTISISAkcea Therapeutica receives orphan drug designatoin from FDA for Volanesorsen
Akcea Therapeutics, a wholly-owned subsidiary of Isis Pharmaceuticals, announced that the FDA has granted Orphan Drug Designation to volanesorsen for the treatment of patients with Familial Chylomicronemia Syndrome. FCS is a rare genetic disease characterized by extremely high triglyceride levels and risk of pancreatitis. In a Phase 2 study published in the NEJM in December 2014, patients with FCS treated with volanesorsen achieved substantial reductions in apoC-III, triglycerides, chylomicrons and apoC-III-associated very low density lipoprotein-cholesterol particles.1 Akcea is currently conducting an international multi-center, randomized, double-blind, placebo-controlled Phase 3 study in patients with FCS.
June 25, 2015
14:03 EDTSNYSanofi initiated with a Buy at HSBC
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June 23, 2015
18:04 EDTISISIsis Pharma granted FDA orphan status for treatment of familial chylomicronemia
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08:58 EDTISISIsis Pharmaceuticals shares not reflecting SMA data, says Needham
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June 22, 2015
07:01 EDTISISIsis Pharmaceuticals reports data from ISIS-SMN Rx in Phase 2 study
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