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March 7, 2014
13:10 EDTREGN, SNYRegeneron, Sanofi advised by FDA of adverse events in PCSK9 inhibitor class
In a filing with the SEC earlier today, Sanofi (SNY) disclosed that the company and Regeneron (REGN) have been advised by the FDA that it has become aware of neurocognitive adverse events in the PCSK9 inhibitor class. Neither company knows the circumstances under which the FDA became aware of these adverse events or whether these adverse events were observed with a drug candidate tested as monotherapy or in combination with a statin or other cholesterol-lowering agent. The FDA has requested that Sanofi and Regeneron make an assessment of potential neurocognitive adverse events across the global development program for alirocumab, especially in the longer-term studies. While neither company is aware of any neurocognitive adverse event signal relating to alirocumab, if this or another adverse event signal is detected, the further development of alirocumab may be delayed or fail, or its commercial value diminished, which could severely harm future prospects.
News For REGN;SNY From The Last 14 Days
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November 30, 2015
08:28 EDTSNYSanofi has a conference call hosted by JPMorgan
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08:16 EDTSNYPieris Pharmaceuticals achieves payment milestone in Sanofi collaboration
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November 29, 2015
19:37 EDTSNYSanofi working with Lazard to explore sale of animal health unit, Reuters says
Lazard (LAZ) is working with Sanofi (SNY) to prepare a sale or listing of the company's Merial animal health division, which could value the unit at up to $12.7B, reports Reuters, citing sources. The investment bank is expected to land the lead advisory role for the potential deal, sources told Reuters, which added that the sale would play a "pivotal role" in getting Sanofi "back on track." Reference Link
November 24, 2015
05:23 EDTREGN, SNYSanofi, Regeneron announce Praluent ODYSSEY OUTCOMES trial enrollment complete
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November 20, 2015
06:09 EDTSNYSanofi, AstraZeneca to exchange more than 210,000 compounds
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November 18, 2015
08:11 EDTSNYIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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