FDA action is expected on a handful of novel agents, including Daiichi Sankyo’s quizartinib, and conversion to full approval for Eisai/Biogen’s Leqembi.

In something of a surprise, Eagle Pharmaceuticals has announced its exit from the generic vasopressin market – one year after a hard-fought and hard-won launch.

Ongoing debate emanates from industry players around the most efficient design of the manufacturing process for cell and gene therapies. The arguments surrounding outsourcing, centralizing, and standardizing processes will no doubt continue through into the near future.

US FDA will continue to tie orphan exclusivity to uses or indications for which the drug was approved. Attorneys say this buys agency time to sort out complex policy and legal questions and continue to seek legislative fix. Additional litigation is also possible, as happened in Depomed case.