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March 21, 2014
08:06 EDTSNYGenzymeís Lemtrada approved in Brazil for MS treatment
Genzyme, a Sanofi company, announced that Brazilís national health surveillance agency, ANVISA, has approved Lemtrada for the treatment of patients with relapsing forms of multiple sclerosis. The approval in Brazil follows the recent approvals of Lemtrada in Mexico, Canada, Australia and the European Union. Lemtrada is currently not approved in the U.S. The Lemtrada clinical development program included two randomized Phase III studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a in patients with RRMS who had active disease and were either new to treatment or who had relapsed while on prior therapy. In CARE-MS I, Lemtrada was more effective than interferon beta-1a at reducing annualized relapse rates. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The most common side effects of Lemtrada are infusion associated reactions, infections, lymphopenia and leukopenia. Autoimmune conditions and serious infections can occur in patients receiving Lemtrada.
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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