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News Breaks
January 29, 2013
18:11 EDTSNYFDA approves new orphan drug Kynamro to treat inherited cholesterol disorder
The U.S. Food and Drug Administration today approved Kynamro injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia. The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol, apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol. The safety and effectiveness of Kynamro were evaluated in a clinical trial of 51 patients with HoFH. On average, levels of LDL-C fell by about 25% during the first 26 weeks in those receiving the drug. The FDA approved Kynamro with a risk evaluation and mitigation strategy with elements to assure safe use, including prescriber and pharmacy certification, and documentation of safe-use conditions, which requires a prescription authorization form for each new prescription. Kynamro is manufactured by Cambridge, Mass.-based Genzyme Corp, which is owned by Sanofi (SNY). Reference Link
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September 17, 2014
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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