Feb. 23 Quick Takes: Hold for bluebird; plus priority review for Pfizer’s TicoVac and updates from Taiho and NeuroRx  

bluebird revealed late Wednesday in its 4Q20 earnings that FDA placed a clinical hold on its trials of LentiGlobin due to suspected unexpected serious adverse reactions in the Phase I/II HGB-206 trial. EMA also paused its renewal procedure for Zynteglo’s conditional marketing authorization based on the acute myelogenous leukemia and myelodysplastic syndrome SUSARs. On Feb. 16, the gene therapy company said it was temporarily suspending two clinical trials of its sickle cell candidate while it sorts out the causes of two new hematologic malignancies, and pausing marketing of its approved therapy as a matter of caution.

August decision date for Pfizer’s TicoVac
FDA accepted for priority review a BLA from Pfizer Inc. (NYSE:PFE) for TicoVac, a tick-borne encephalitis vaccine to prevent TBE in individuals aged 1 year and older. If approved, TicoVac would be the first vaccine in the U.S. to help protect those visiting or living in TBE endemic areas, according to the company. The PDUFA date is in August...