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FDA lifts hold on trials of gene therapies for sickle cell disease, beta-thalassemia

healio.com
 2021-06-11

The FDA lifted the clinical holds on four studies designed to evaluate two gene therapies for hematologic conditions. The decision allows for resumption of the phase 1/phase 2 HGB-206 and phase 3 HGB-210 studies of bb1111 (LentiGlobin, bluebird bio) for adults and children with sickle cell disease, as well as the phase 3 Northstar-2 and Northstar-3 studies of betibeglogene autotemcel (bluebird bio) for treatment of adults, adolescents or children with transfusion-dependent beta-thalassemia.

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