Af­ter a painful stum­ble, As­traZeneca gets top check­point can­cer pro­gram back on track

The FDA has lift­ed the par­tial hold it dropped on As­traZeneca’s top pipeline drug dur­val­um­ab a month ago, al­low­ing in­ves­ti­ga­tors to re­sume re­cruit­ing pa­tients with head and neck can­cer for two key late-stage tri­als.

Play­ing catch-up with Mer­ck, Bris­tol-My­ers Squibb and Roche, the par­tial hold in Oc­to­ber rat­tled in­vestors, rais­ing a red flag that dragged the phar­ma gi­ant a bit fur­ther be­hind in one of the most com­pet­i­tive R&D fields in bio­phar­ma. But reg­u­la­tors agreed to get the stud­ies back on track with no change in pro­to­cols, ev­i­dent­ly sat­is­fied that the bleed­ing episodes that trig­gered the hold posed no spe­cial threat to oth­ers.

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