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July 30, 2014
16:31 EDTREGN, SNYRegeneron, Sanofi announce plan to use priority review voucher for alirocumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the companies intend to use a FDA rare pediatric disease priority review voucher in connection with the Biologics License Application, or BLA, submission for alirocumab. The priority review voucher entitles the holder to designate a BLA for priority review, which provides for an expedited 6-month review from the filing date instead of the standard 10-month review. Regeneron Ireland, an indirect, wholly-owned subsidiary of Regeneron Pharmaceuticals, purchased the voucher from BioMarin GALNS, a direct, wholly-owned subsidiary of BioMarin Pharmaceutical (BMRN), which had received it through the FDA's rare pediatric disease priority review voucher program. Sanofi and Regeneron will equally share the purchase price of $67.5M. Sanofi and Regeneron expect to submit U.S. and EU regulatory submissions for alirocumab before year end.
News For REGN;SNY From The Last 14 Days
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April 15, 2015
11:56 EDTSNYSanofi initiated with a Buy at Societe Generale
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07:41 EDTSNYEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
April 10, 2015
07:17 EDTREGNExpert very bullish on outlook for Regeneron Eylea, says RBC Capital
RBC Capital reports that a retina expert with whom it spoke was "very bullish" on the outlook for Regeneron's Eylea, not just in DME but also in wet AMD. The firm says the expert's positive outlook was sparked by recently presented Protocol T data. RBC continues to believe that Eylea could beat guidance this year, while Phase III programs could boost the stock. RBC keeps a $490 price target and Outperform rating on the shares.
April 7, 2015
07:14 EDTSNYEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.

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