Although U.S. President Joe Biden suggested in September that the pandemic is over, health officials insist there is still much to do in preparation for an endemic stage of the SARS-CoV-2 virus. The number of weekly COVID-19 confirmed cases both globally and in the U.S. is similar with each of the last two years, but deaths from the virus are at some of the lowest levels since the pandemic began. Still, the virus will continue to evolve and circulate, and the biopharma industry will need to develop new booster vaccines, antivirals and monoclonal antibodies, among other candidates, to prepare for upcoming battles.

Despite a sharp increase in mid-August, BioWorld’s Biopharmaceutical Index  ended that month up a mere 1.4% and rose only slightly in September to 1.5% as of the 26th. It has done significantly better than the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, which are down 23.2% and 19.5%, respectively.

The amount of clinical news in 2022 continues to lag last year, partly due to a decline in COVID-19-related data. Through the last week of September, there have been a total of 2,495 phase I, II and III clinical entries, compared with 3,027 during the first three quarters of 2021. This represents a drop in activity of 17.6%.

While U.S. FDA approvals are down by 27% in 2022, the agency was busy throughout the month of September, clearing seven new molecular entities (NMEs), the most for any month this year.