COVID does not appear to be a driving factor, and letters are split almost equally between clinical and quality concerns.

Public Company Edition: As their stock prices plummet, Adagio reshuffles its research plan and names a new CEO, while Yumanity restructures and seeks strategic alternatives. Also, Bristol sells $6bn worth of notes, Amgen issues $750m green bond, and Inhibrx and Amryt amend and refinance debt.

Approval total is one of FDA’s highest, but the large number of complete response letters obscures the staggering total of almost 80 new molecular entities and novel biologics that the agency acted on over the year.

Chinese firm RareStone licenses Rhythm’s Imcivree in greater China and will help enroll label-expansion studies for the drug. Omeros sells ophthalmic surgery drug Omidria and its commercial team to Rayner Surgical Group.