The director of the agency’s patient-focused drug development program talks to the Pink Sheet about how the program has improved the development and evaluation of new drugs, initiatives underway, and plans to standardize and harmonize the process.

Troubles are mounting for Clovis and its PARP inhibitor Rubraca, and now the company looks to be just months from bankruptcy.

Public Company Edition: PTC will get $350m up front as part of an initial $500m commitment. Also, while Biohaven and Vaxcyte launched traditional follow-on offerings, Recursion and Agios took the private placement and royalty sale routes, while others revealed job cuts and other strategic updates. 

Mereo will reduce its headcount by 40% to focus on its lead programs while NeuBase revealed a 60% workforce reduction to extend its cash runway. Also, Invivyd (formerly Adagio), Greenlight and BioMarin announced job cuts, while Otonomy and others planned strategic shifts.