The US approval of HLB and Hengrui’s liver cancer combination therapy looks set to be delayed after the FDA issues a CRL related mainly to CMC data, but the two companies appear positive on a quick resolution to the setback given a lack of other efficacy or safety concerns.

Public Company Edition: Verona Pharma arranged up to $400m in new debt and up to $250m in revenue-related financing ahead of its COPD drug launch. Also, Organon, Sobi and Pacira priced $1bn, $275.1m and $250m note sales, respectively. Marinus, Emergent and Ginkgo cut jobs.

Five novel agents are among the user fee goal dates coming up in May 2024.

More than 100 biopharma executives and experts told Scrip their predictions for therapeutic area advances in the coming year. The recent commercial success of GLP-1s in diabetes and obesity and their potential in further disease areas fuelled excitement around the metabolic space. Expectations were also positive in neurology following the launch of Leqembi for Alzheimer’s disease in 2023, while the multiple opportunities to improve cancer treatment kept oncology top of the pile overall.