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February 22, 2013
07:52 EDTSNYEMA gives positive recommendations for Sanofi's Hexacima, Hexyon
The Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Hexacima, 0.5 ml, suspension for injection intended for primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b. The Committee also adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Hexyon, 0.5 ml, suspension for injection intended for primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against the same diseases. The applicant for these medicinal products is Sanofi Pasteur.
News For SNY From The Last 14 Days
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August 1, 2014
13:40 EDTSNYFDA expands approval of Lumizyme
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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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