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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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July 31, 2014
19:08 EDTSNYSanofi raises stake in Regeneron to 22.5% from 21.6%
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05:56 EDTSNYSanofi reports Q2 business net income up 13% to EUR 1.54B
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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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July 17, 2014
07:10 EDTISISIsis Pharmaceuticals begins Phase 2 study of candidate for high lipoprotein(a)
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