Janssen’s Mark Wildgust explained how the Johnson & Johnson subsidiary is pushing forward with novel therapeutics and combination regimens with the goal of eliminating myeloma in the first line.

The approval of China's second CAR-T therapy has come amid reimbursement challenges, despite the pricing of its direct competitor being much lower than in the US. Chinese developers are pinning their hopes on rapid domestic market expansion via commercial insurance tie-ups as other CAR-Ts move through local development.

In the first half of 2021, just six requests from companies seeking accelerated assessment of their planned EU marketing authorization applications were granted; 11 were rejected. The outcomes of five decided on in July and August are still unknown.

The EU marketing authorization application for Takeda's dengue vaccine candidate is no longer being fast-tracked. Also, four requests for accelerated assessment were decided on at the latest meeting of the European Medicines Agency's drug evaluation committee, the CHMP.