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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