GSK takes equity stake in Spero, and global rights to tebipenem except for certain Asian markets. Merck KGaA gets rights to Nerviano’s next-generation PARP inhibitor for cancer.

Leaders of FDA’s oncology center say sponsors could initiate a single randomized trial prior to receiving accelerated approval or conduct a single-group AA study concurrently with a randomized trial. FDA and sponsor could agree in advance on criteria for approval and withdrawal.

Private Company Edition: Acelyrin will use its latest funding for Phase III development of izokibep in inflammatory diseases. Also, ArsenalBio raised $220m to take its programmable cell therapies into the clinic and RayzeBio’s $160m series D round will fund clinical trials for its radiopharmaceuticals. 

Office of Neuroscience Director Billy Dunn touted FDA’s ability to withdraw approval for AMX0035 if subsequent data indicate a lack of substantial evidence of effectiveness. However, this provision appears to have been infrequently used and involves a potentially time-consuming hearing.