Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year. 

JAMA reports on the COVID-19 Prevention Network’s efforts. Also, Inhibikase said the US FDA lifted a hold on its drug for Parkinson’s disease, while Astellas Pharma said the agency lifted a clinical hold on its gene therapy for Pompe disease. And Trefoil, Theriva Biologics and Nektar initiated new trials.

Leading the group were Trinomab Biotech, which develops antibodies for infectious diseases, and cell and gene developers BRL Medicine and XellSmart.

Dr Toichi Takenaka, the first winner of the Lifetime Achievement Award in the inaugural Pharma Intelligence Awards Japan earlier this year, talks to Scrip about his journey from researcher to CEO and today as a mentor for Japanese bioventures. Starting his career in an “empty lab” in the 1960s motivated him to pursue a string of collaborations with universities in Japan and on to the discovery of four successful drugs.