News Breaks |
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| January 29, 2013 |
| 18:11 EDT |  | SNY | FDA 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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News For SNY From The Last 14 Days Check below for free stories on SNY the last two weeks. |
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| May 23, 2013 |
| 08:18 EDT | | SNY | Merrimack completes enrollement in a Phase 2 study of MM-121 with Sanofi
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| May 21, 2013 |
| 07:44 EDT |  | SNY | Sachs Associates to host a forum
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| May 20, 2013 |
| 17:26 EDT | | SNY | Regeneron, Genentech, Sanofi enter into 'Zaltrap agreement'
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| 11:27 EDT | | SNY | Appeals court reverses, remands patent ruling in Sanofi suit against Mylan, Teva
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| May 17, 2013 |
| 08:03 EDT | | SNY | Sanofi reports positive topline results from pivotal Phase III Jakarta study
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| 05:18 EDT | | SNY | Sanofi says JAK2 inhibitor for myelofibrosis met primary endpoint
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| May 15, 2013 |
| 15:16 EDT | | SNY | Sanofi systemic sclerosis treatment designated for orphan drug status
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| 05:39 EDT | | SNY | Sanofi, Regeneron announce patient enrollment in two Phase 3 trials
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| May 13, 2013 |
| 09:44 EDT |  | SNY | Several companies reportedly interested in buying Adcock Ingram, Globes says
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| 07:30 EDT | | SNY | TechConnect to host a summit
2013 National Innovation Summit is being held in Washington, D.C. on May 12-16. |
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