HONG KONG – Eisai Co. Ltd. has received not one, but two approvals from Japan’s Ministry of Health, Labour and Welfare (MHLW), for its anticancer agent Remitoro (denileukin diftitox) and multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib mesylate).
China’s National Medical Products Administration granted conditional approval two Chinese-developed COVID-19 vaccines in less than 24 hours on Feb. 25. One of the vaccines approved was developed by Tianjin-based Cansino Biologics Inc., and the other by China National Pharmaceutical Group (Sinopharm) through its Wuhan Institute of Biological Products subsidiary.
Although FDA approvals in 2020 are falling just shy of records, the amount of regulatory news this year is more than twice the amount seen only four years ago and a 41% increase over that reported in 2019. The COVID-19 pandemic accounts for roughly 14% of the total, but regardless, by all accounts, 2020 has been an excessively busy year for both the biopharma industry and regulatory agencies.
While the number of FDA approvals in 2020 are lockstep in line with last year, despite disruptions from the COVID-19 pandemic, the amount of regulatory news this year tracked by BioWorld has risen by 43% over 2019. Compared with 2018, it is 52% higher.