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March 22, 2013
08:32 EDTSNYGenzyme receives positive CHMP opinion for once-daily, oral AUBAGIO
Genzyme, a Sanofi Company, announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion regarding the approval of once-daily, oral AUBAGIO for the treatment of adult patients with relapsing-remitting multiple sclerosis. The CHMP did not recommend that AUBAGIO receive a new active substance designation. Additional marketing applications for AUBAGIO are under review by regulatory authorities around the world.
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July 30, 2014
16:31 EDTSNYRegeneron, 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.
12:33 EDTSNYRegeneron, Sanofi likely to file alirocumab BLA this year, says Piper Jaffray
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08:08 EDTSNYSanofi and Regeneron report positive Phase 2 results of alirocumab
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July 28, 2014
09:02 EDTSNYSanofi, InnerWorkings sign global marketing partnership
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July 21, 2014
07:11 EDTSNYInternational Society of DNA Vaccines to hold a conference
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