Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.

As vaccines near availability, Moncef Slaoui says his full-time role at OWS may be ending. He has not met with the Biden Transition team, but notes that other Warp Speed officials have.

Strong top-line efficacy in pyruvate kinase deficiency patients who don’t receive regular transfusions looks approvable, analysts say, but Agios will await data in regularly transfused patients.