The latest global regulatory news, changes and updates affecting biopharma, including: Researcher gets prison time for trade secret theft; USPTO responds to COVID-19 challenge.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, BMS, Cerecor, Chinook, Durect, Kintor, Mustang, Neurmedix, Paxmedica, Russian Direct Investment Fund, Sesen, SQZ, VBI Vaccines.
New hires and promotions in the biopharma industry, including: Actimed, Allena, Biofrontera, Destiny, Elicio, Gain, Imago, Lipum, Oncosec, Quralis, Sangamo, Scenic, Tryp, Windtree.
While the FDA’s Center for Drug Evaluation and Research met all action dates for the 53 new molecular entities approved in 2020, despite the COVID-19 pandemic, developers of at least 8 drugs continue to wait for a decision beyond their expected timelines.