Covid-19 roundup: Re­gen­eron nabs pri­or­i­ty re­view for mAb; Preprint sug­gests mix­ing boost­ers is safe ahead of ad­comms

Near­ly a year af­ter be­ing grant­ed an EUA, Re­gen­eron and Roche’s Covid-19 an­ti­body cock­tail will now go be­fore the FDA for a chance at full ap­proval.

The big biotech an­nounced Thurs­day it has sub­mit­ted a BLA for the drug, shoot­ing for an OK to treat Covid-19 in non-hos­pi­tal­ized pa­tients and as pro­phy­lax­is in cer­tain in­di­vid­u­als. Reg­u­la­tors grant­ed pri­or­i­ty re­view, set­ting April 13, 2022 as the PDU­FA date, and Re­gen­eron said the agency is prepar­ing an ad­comm be­fore then.

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