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News Breaks
April 7, 2014
05:28 EDTSNYGenzyme to resubmit Lemtrada application for FDA review
Genzyme, a Sanofi company, announced that following constructive discussions with the FDA the company plans to resubmit in the second quarter its supplemental Biologics License Application, or sBLA, seeking approval of Lemtrada for the treatment of relapsing forms of multiple sclerosis. The resubmission will provide information to specifically address issues previously noted by the FDA in its December 27, 2013 Complete Response Letter. Genzyme had previously announced its intention to appeal the FDAs Complete Response Letter. In light of the planned resubmission, the company does not expect to pursue an appeal at this time.
News For SNY From The Last 14 Days
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July 21, 2014
07:11 EDTSNYInternational Society of DNA Vaccines to hold a conference
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July 16, 2014
09:03 EDTSNYSanofi held talks on mature drugs with Abbott, Mylan, PE firms, Reuters says
Sanofi (SNY) has shopped an $8.5B portfolio of mature drugs to Abbott (ABT), Mylan (MYL) and private equity firms, according to Reuters, citing an internal company document circulated by the CGT union. Sanofi is considering whether to sell, carve out or create a joint venture for the portfolio of about 200 drugs, but a Sanofi spokesman said no decision has yet been made, the report noted. Reference Link
July 9, 2014
17:02 EDTSNYRegeneron, Sanofi announce positive results from Phase 2b study of Dupilumab
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July 8, 2014
13:46 EDTSNYSanofi files patent infringement suit against Eli Lilly, Reuters says
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08:05 EDTSNYSanofi announces FDA accepted Toujeo NDA
Sanofi announced that the FDA has accepted for review the company's New Drug Application for Toujeo, an investigational basal insulin. The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency for EU countries on May 27. The NDA for Toujeo is based on results from the EDITION clinical trial program, which is a worldwide and extensive series of Phase III studies evaluating the efficacy and safety of Toujeo in over 3,500 people.

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