Man­u­fac­tur­ing woes de­rail a block­buster con­tender from Sanofi/Re­gen­eron. Who's next?

Sanofi wasn’t fret­ting need­less­ly over the up­com­ing FDA de­ci­sion re­gard­ing sar­ilum­ab.

The phar­ma gi­ant and its biotech part­ner Re­gen­eron $REGN an­nounced Fri­day af­ter­noon that the agency has turned thumbs down on the drug, is­su­ing a com­plete re­sponse let­ter for a drug that was wide­ly ex­pect­ed to be on a short path to a block­buster ap­proval.

As Sanofi $SNY flagged ear­li­er in its Q3 re­view, the prob­lem has more to do with the phar­ma gi­ant’s man­u­fac­tur­ing woes than Re­gen­eron’s da­ta on a drug ex­pect­ed to earn more than a bil­lion dol­lars a year.

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