In February, the U.S. FDA greenlit 11 new drugs, a slight decrease from the 14 approvals seen in the same month the previous year but an increase from January’s tally of eight FDA approvals.
Precision psychiatry got some love at two quite different meetings this week, the European Congress of Neuropsychopharmacology’s New Frontiers meeting and BioEurope Spring. The New Frontiers Meeting, an annual two-day meeting dedicated to cutting-edge issues in brain disease research, focused on big-picture and scientific – at times almost philosophical – questions of how to get to a classification scheme for brain disorders that aligns with the underlying biology.
In February, deals formed by biopharma firms reached $7.76 billion, down from January, which marked the sixth-highest month in BioWorld’s records going back to 2016. Meanwhile, biopharma M&As amounted to $18.22 billion for the month, positioning it among the top 10 highest-value months in the past four years.
Med-tech deal value in February jumped to $255.61 million, an increase of 137.23% from the $107.75 million in deals from January, yet below the 2023 monthly average of $886.13 million. On the M&A front, med-tech transactions hit their lowest point since May 2019, totaling only $16 million.
At first glance, the number of drugs that received accelerated approval from the U.S. FDA’s Center for Drug Evaluation and Research (CDER) in 2023 was nothing to write home about. Yes, CDER granted nine accelerated approvals last year, up from six in 2022. But the proportion of novel drugs with accelerated approval was 16% both years. And when compared with the 12 drugs in 2020 and the 14 that received accelerated approval in 2021, last year’s crop was a little lackluster. However, a deeper look at the 2023 class of accelerated approvals shows a historic milestone. For the first time since the path was created in 1992, the number of novel biologics getting accelerated approval at CDER outpaced the number of small-molecule drugs.
The med-tech financing landscape in 2024 has shown remarkable improvement over last year, with $4.62 billion raised in the initial two months, an increase of 176.62% from the $1.67 billion raised during the same period in 2023.