Iovance Biotherapeutics' Amtagvi (lifileucel) received approval from the US FDA in February, marking a truly pivotal milestone in the field of solid tumor therapy for certain adult patients with unresectable or metastatic melanoma. As the first approved tumor infiltrating lymphocyte (TIL) therapy, it is set to expedite the regulatory pathway for next-generation products.

The Federal Trade Commission broke new ground last year in its opposition to M&A transactions and challenge of Orange Book patent listings. The biopharma community is waiting to see if deals will face similar hurdles in 2024 and whether there will be legal battles if manufacturers of drug-device combination products decline to delist their patents. Researchers advocate that the FTC extend its inquiry to device patents on GLP-1 receptor agonists, including Wegovy and Ozempic.

Private Company Edition: Publicly held Ascendis outsourced its preclinical AMD program to private Eyconis. Also, Innovation Endeavors revealed a new $630m VC fund and Mirae raised $50m for its first life science fund, while Accent, Comanche and Tr1X each brought in $75m rounds.

Biotech entrepreneurs tend to be an optimistic group, and there were many pockets of hope for 2024. However, the consensus remains that depressed valuations and paucity of fresh funds will continue to pose a challenge for the sector, and companies will need to prioritize carefully and work even harder to demonstrate and create value.