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News Breaks
February 28, 2014
08:03 EDTSNY, ACTActavis confirms generic Multaq patent challenge
Actavis (ACT) confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Dronedarone Hydrochloride Tablets 400 mg. Actavis' ANDA product is a generic version of Sanofi's (SNY) Multaq, which is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent AF. Sanofi and Sanofi-Aventis U.S. filed suit against Actavis on February 26 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA until Jan. 1, 2017, or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
News For ACT;SNY 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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