May 13, 2020 / 11:29 AM / 17 days ago

BRIEF-Bristol Myers Squibb, Bluebird Bio Provide Regulatory Update On Ide-Cel, Bb2121 For Treatment Of Patients With Multiple Myeloma

May 13 (Reuters) - bluebird bio Inc:

* BRISTOL MYERS SQUIBB AND BLUEBIRD BIO PROVIDE REGULATORY UPDATE ON IDECABTAGENE VICLEUCEL (IDE-CEL, BB2121) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA

* BRISTOL-MYERS - UPON PRELIMINARY REVIEW, FDA DETERMINED CHEMISTRY, MANUFACTURING & CONTROL MODULE OF BLA REQUIRES FURTHER DETAIL TO COMPLETE REVIEW

* BRISTOL-MYERS - RECEIVED REFUSAL TO FILE LETTER FROM FDA REGARDING BLA FOR IDECABTAGENE VICLEUCEL FOR PATIENTS WITH MULTIPLE MYELOMA

* BRISTOL-MYERS SQUIBB CO - NO ADDITIONAL CLINICAL OR NON-CLINICAL DATA HAVE BEEN REQUESTED OR ARE REQUIRED

* BRISTOL-MYERS SQUIBB CO - BRISTOL MYERS SQUIBB IS PLANNING TO RESUBMIT BLA NO LATER THAN END OF JULY 2020 Source text for Eikon: Further company coverage:

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