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News Breaks
January 29, 2013
18:33 EDTSNY, ISISSanofi, Isis announced FDA approval of Kynamro injection
Genzyme, a Sanofi (SNY) company, and Isis Pharmaceuticals (ISIS) announced that the U.S. Food and Drug Administration has approved its New Drug Application for Kynamrotm injection. Kynamro, given as a 200 mg weekly subcutaneous injection, has been approved as an adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol, apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol in patients with homozygous familial hypercholesterolemia. Kynamro contains a Boxed Warning citing the risk of hepatic toxicity. Patients taking Kynamro should have liver enzyme testing before starting the drug and periodically thereafter. The safety and effectiveness of Kynamro have not been established in patients with hypercholesterolemia who do not have HoFH. The effect of Kynamro on cardiovascular morbidity and mortality has not been determined.
News For SNY;ISIS From The Last 14 Days
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July 6, 2015
16:34 EDTSNYRetrophin closes sale of Priority Review Voucher to Sanofi
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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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