As cases and deaths begin to level out, not showing the up-and-down spikes indicative of the first two COVID-19 pandemic years, the world may finally breathe a sigh of relief. But behind the scenes, the biopharma industry and global governments are not underestimating the evolving SARS-CoV-2 virus.

With financings, U.S. FDA approvals and mergers and acquisitions all tracking behind last year, why would clinical data be any different? According to BioWorld research, clinical trial reports are down by 16.2% this year. The number of efforts targeting the COVID-19 pandemic, as well as the proportion of data focused on infectious diseases, are also dropping.

U.S. FDA approvals in 2022 are down by more than 30%, while new molecular entity approvals have been cut in half. So far this year, the U.S. FDA has approved 93 drugs and biologics, including expansions into new indications. In comparison with each of the last three years, it is a significant drop. There were 136 approvals in 2021, 143 in 2020 and 134 in 2019 announced by the end of August.

With potential regulatory approvals and filings for lymphoproliferative disease and mastocytosis drugs on the horizon, as well as high-money antibody-drug conjugate deals, the BioWorld Cancer Index (BCI) has shown some signs of life this summer. BCI is still down by 23.4% in 2022, but that is significantly better than the end of May when the index was down by 41%.