Gilead aims to launch its key oncology product Trodelvy by 2024 in Japan while building a dedicated business unit for oncology in the firm’s Japanese office. The firm has expanded its exclusive rights for oncology products in APAC.

Private Company Edition: Two companies raised multiple hundreds of millions of dollars each helping to keep the number of $100m-plus venture capital mega-rounds on the rise in May. Also, Ascend raised $132.5m to make gene and cell therapies, and Nido emerged with $109m for neurological diseases.

Three of the accelerated approvals were for CAR-T products, a class that the agency considers to be gene therapies. The FDA’s September approval of bluebird bio’s Skysona for cerebral adrenoleukodystrophy was the lone non-cancer product in the group. Pink Sheet infographic tracks the required confirmatory studies and timelines for all four products.

A framework for sponsors and the FDA to discuss ways to extrapolate existing data to support a new cell therapy could cut the time to approval.