FDA flash­es red light on Sanofi man­u­fac­tur­ing in­frac­tion, threat­en­ing a loom­ing block­buster de­ci­sion

The French phar­ma gi­ant Sanofi has a lot rid­ing on the ap­proval of sar­ilum­ab. Part­nered with Re­gen­eron, peak sales es­ti­mates top $1 bil­lion for this drug, which beat megablock­buster Hu­mi­ra in a head-to-head study on rheuma­toid arthri­tis. On­ly now Sanofi may not be able to keep up its end of the deal.

In a note in­clud­ed in its Q3 up­date, Sanofi says that the FDA has cit­ed their man­u­fac­tur­ing op­er­a­tions for cer­tain un­spec­i­fied de­fi­cien­cies. And that may de­rail the loom­ing ap­proval they were look­ing for. Here’s the note:

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