Amgen detailed plans for increasing sales of drugs acquired in its Horizon transaction and outlined growth opportunities in its R&D pipeline during a rare disease showcase. 

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.

Tecartus label still will not state that secondary malignancy cases have been reported in patients who received the product. CBER officials also address causality questions in a NEJM paper.

Sponsors still say they have no evidence the CAR-Ts cause secondary malignancy even though US FDA ordered their labels updated with a boxed warning of the adverse event. Tecartus label will not state that postmarketing secondary malignancies have been found in patients using the product.