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News Breaks
February 11, 2013
10:30 EDTSNY, NVOSanofi advances after FDA delays rival insulin product
Sanofi (SNY) is climbing after the FDA decided that rival Novo Nordisk (NVO) would have to carry out a new study on its insulin product, Tresiba, before the product could be approved in the U.S. Sanofi's Lantus insulin competes with Tresiba, which has already been approved in Europe and Japan. Both Lantus and Tresiba are long acting insulin products, but Tresiba is effective for a longer time period and can be dosed more effectively, Novo has stated. The FDA required a new study to assess the effects of Tresiba on the heart before the product could be approved in the U.S. The study results probably won’t be reported before 2015, Novo said. In mid-morning trading, Sanofi advanced 90c, or 2%, to $47.40, while Novo Nordisk tumbled $26, or 13.50%, to $166.50.
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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 25, 2014
07:30 EDTNVONovo Nordisk receives positive opinion from CHMP
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07:23 EDTNVOEMA recommends approval for Novo Nordisk diabetes treatment
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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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