In tandem with Roivant, Cincinnati Children’s launches spinout Aruvant focused on hematologic disorders and separately teams with BridgeBio on genetic disease therapies. Roivant spinout Axovant licenses gene therapy candidates from University of Massachusetts.

FDA’s Center for Biologics Evaluation and Research approved six original BLAs in 2012, a solid if unspectacular showing. But some of the center’s most interesting approvals are products that do not appear on the original BLA count: quadrivalent flu vaccines (supplements to predecessor trivalent products) and hemapoietic cord blood cells (not included under the PDUFA umbrella).

FDA’s Center for Biologics Evaluation and Research approved six original BLAs in 2012, a solid if unspectacular showing. But some of the center’s most interesting approvals are products that do not appear on the original BLA count: quadrivalent flu vaccines (supplements to predecessor trivalent products) and hemapoietic cord blood cells (not included under the PDUFA umbrella).

FDA is entering a big legislative year with a good story to tell based on 30 new molecular entity approvals. But the level of submissions remains constant—suggesting it may be time to shift the focus from what comes out of FDA to what makes it in.