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Regeneron says manufacturing deficiencies at Sanofi site could potentially delay pending FDA OK of sarilumab

Published 10/28/2016, 07:53 AM
Regeneron says manufacturing deficiencies at Sanofi site could potentially delay pending FDA OK of sarilumab
SASY
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  • In a regulatory filing, Regeneron Pharmaceuticals "fill and finish" manufacturing facility could potentially delay the expected October 30 U.S. approval of sarilumab, an IL-6 inhibitor currently under review for the treatment of rheumatoid arthritis co-developed by the two companies. The site will be responsible for producing the finished product.
  • Sanofi (PA:SASY) has submitted comprehensive responses to the FDA and has been in discussions with the agency on the matter. No Form 483 was issued in connection with the inspection.
  • Since the October 30 PDUFA date is Sunday, the actual FDA notification date could be today.

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