John Crowley will take the reins at BIO in March, about a year and a half after the departure of former CEO Michelle McMurry-Heath was announced.

In 17 suits against FDA in the last two years, firm seeks to block generics of its sleep-wake disorder drug and gain a jet lag indication. CEO Mihael Polymeropoulos tells the Pink Sheet that FDA has retaliated against Vanda for its first suit challenging a partial clinical hold on another drug.

Emerging Company Profile: The US biotech is advancing a pipeline of precision medicines targeting menin and farnesyltransferase for liquid and solid tumors, respectively, building on the work of two pioneering companies in the KRAS space.

More sponsors are submitting applications around the same time requiring the agency to make complicated decisions about exclusivity and whether approval of subsequent applications is barred, FDA attorney says.