The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

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.

Appeals court finds that Juno/BMS patent is invalid, overturning $1.2bn jury verdict against Kite/Gilead. Ruling illustrates court does not like functionally-defined patent claims, attorneys say. Decision could impact future CAR-T patents and disputes.

Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.