Alk­er­mes is hand­ed a CRL for ‘3831, mark­ing an­oth­er set­back on the R&D front

Alk­er­mes $ALKS is go­ing to have to wait some more be­fore launch­ing its an­ti-psy­chot­ic com­bo drug ALKS-3831. The FDA has hand­ed the biotech a CRL, re­ject­ing the ap­pli­ca­tion in the com­pa­ny’s lat­est set­back in R&D.

Af­ter get­ting a ma­jor­i­ty of the out­side ex­perts that re­viewed the drug for the FDA to pro­vide a thumbs up on ap­proval, the biotech re­port­ed to­day that their man­u­fac­tur­ing op­er­a­tions didn’t pass muster dur­ing their re­mote in­spec­tion of records — an al­ter­na­tive to a for­mal sur­vey the agency adopt­ed last sum­mer as a re­sult of the pan­dem­ic.

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