Covid-19 claims an­oth­er PDU­FA vic­tim as Glax­o­SmithK­line push­es back planned PD-1 roll­out

Bris­tol My­ers Squibb isn’t the on­ly phar­ma gi­ant that’s been stand­ing in the FDA’s wait­ing line for site in­spec­tions.

Glax­o­SmithK­line is telling us to­day that their H2 2020 PDU­FA dead­line for the PD-1 drug dostar­limab — picked up in its Tesaro buy­out — was pushed back due to a de­lay in the man­u­fac­tur­ing site in­spec­tion need­ed for a reg­u­la­to­ry de­ci­sion. And that is forc­ing the com­pa­ny to re­vise its time­line.

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