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.

With the success of the partnership between J&J and partner Legend, more Chinese cell therapy developers are now looking to enter the US market. But for a complex product like a CAR-T therapy, the journey to the West is not short of challenges. Nasdaq-listed Gracell Bio wants to give it a shot based on quicker delivery and cost-effectiveness advantages.

Private Company Edition: In the first week of April, Cure Ventures launched with a $350m fund, the Alzheimer’s Drug Discovery Fund received $200m for its venture philanthropy strategy and Canaan revealed $850m in new funds. Also, OnKure raised $53.7m and Phlow closed a $36m series B round.