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.

Five companies have applied for marketing authorizations in Brazil to deliver rapid test kits to diagnose monkeypox cases in real time.

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%.

While there are significantly fewer initial public offerings in 2022 than in 2021 and 2020, the caution expressed by biopharma companies and investors seems to be paying off, with this year showing the best average performance of the three years.

As amounts raised through financings are significantly shy of last year, med-tech deals and M&As appear strong, with digital health dominating the landscape.