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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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September 22, 2014
07:21 EDTSNYEBD Group to hold a conference
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September 17, 2014
07:29 EDTISISIsis Pharmaceuticals earns $4M from Achaogen for Phase 3 study of plazomicin
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06:18 EDTSNYSanofi, MyoKardia announce collaboration
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September 16, 2014
07:33 EDTSNYMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
September 12, 2014
10:04 EDTSNYSanofi unit granted orphan status for treatment of Gaucher disease
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September 11, 2014
05:27 EDTSNYGenzyme announces positive interim results from Lemtrada extension study
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September 10, 2014
07:09 EDTSNYAmericas Committee for Treatment & Research in MS to hold a meeting
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September 8, 2014
14:16 EDTSNYSanofi announces FDA approval of Menactra vaccine
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