This week, Abbott, Click and Otsuka, Prenosis won the FDA nod respectively for an in vitro diagnostic to evaluate patients for concussion, the first prescription digital therapeutic to treat major depressive disorder and a software to predict sepsis. Also on the regulatory front, the FDA will now take 513(g)s forms via its eSTAR framework. In Europe, the debate of what personal information can be shared continues. 

Emerging Company Profile: CinFina is advancing two novel mechanisms of action in obesity as monotherapies and in combination with GLP-1s.

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.

Some 50 experts and executives in the biopharma sector shared their views on the major trends they expect to see driving change in the clinical trials arena in 2024. Artificial intelligence applied to clinical development, greater use of remote monitoring and increased patient diversity in trials were key themes.