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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 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 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

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