CHMP recommends conditional approval of Pfizer-BioNTech COVID-19 vaccineEMA’s CHMP recommended granting a conditional MAA for Comirnaty (BNT162b2) from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) to prevent COVID-19 in individuals 16 years of age and...

EMA’s CHMP has backed autologous cells therapies Tecartus, from Gilead, and Lebmeldy, from Orchard, in its October set of opinions. The agency recommended conditional marketing approval for Tecartus brexucabtagene autoleucel from the Kite Pharma Inc....

Emory, UNC to test nucleoside analog against COVID-19 The Emory Institute for Drug Development and University of North Carolina at Chapel Hill are conducting preclinical studies of nucleoside analog to treat COVID-19, an Emory University...

Less than a year after emerging from stealth mode, gene therapy company Passage Bio revealed new details about its pipeline and clinical timelines through the filing of a prospectus for its planned IPO. Founded in...

Orchard plans to submit an MAA to EMA in 2020 for OTL-200 to treat metachromatic leukodystrophy after reporting that the therapy met a co-primary endpoint of improving motor function at two years following treatment in...

Takeda Pharmaceutical Co. Ltd.’s proposed acquisition of Shire plc is an acceleration of -- not a departure from -- CEO Christophe Weber’s stated strategy to build a top-tier global pharma, according to management. On May...