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Stock Market & Financial Investment News

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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August 28, 2015
08:01 EDTSNYAmgen pricing for Repatha competitive with Praluent, says Piper Jaffray
After the FDA announced last night that it has approved Amgen's (AMGN) Repatha injection, Piper Jaffray analyst Joshua Schimmer said that the drug's indications seem "generally in line" with those for Praluent from Regeneron (REGN) and Sanofi (SNY). Amgen disclosed an annual WAC of $14,100 for Repatha, which the analyst notes is about $500 per year below Praluent, but Schimmer said that the actual recognized price for each will ultimately be determined by discounting. Schimmer also noted that Amgen said it is working with payers and other purchasers on "innovative pricing programs," though he is uncertain if that means the company is working on a kind of "pay per performance" scheme. The analyst, who believes the market will prove large enough for both treatments, keeps a $200 price target and Overweight rating on Amgen shares.
August 27, 2015
19:14 EDTSNYExpress Scripts to cover both Repatha, Praluent for now, Bloomberg says
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August 20, 2015
11:33 EDTSNYLeerink major pharmaceuticals analyst holds an analyst/industry conference call
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