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News Breaks
December 14, 2012
07:31 EDTISIS, SNYGenzyme, Isis say CHMP adopts negative opinion on KYNAMRO MAA
Genzyme, a Sanofi company (SNY), and Isis Pharmaceuticals (ISIS), announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion for its marketing authorization application for KYNAMRO for the treatment of patients with Homozygous Familial Hypercholesterolaemia. Genzyme plans to request a re-examination of the CHMP Opinion. An application for KYNAMRO is currently under review by the U.S. Food and Drug Administration. In October, KYNAMRO received a positive vote by an FDA advisory panel that Genzyme had provided sufficient efficacy and safety data to support the marketing of KYNAMRO for the treatment of patients with Homozygous Familial Hypercholesterolaemia.
News For SNY;ISIS From The Last 14 Days
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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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