A Phase IIb trial testing Cartesian’s autologous mRNA-engineered CAR-T therapy for the treatment of generalized myasthenia gravis (MG) met the primary endpoint.

The notice of opportunity for hearing on the US FDA’s proposal not to approve an insomnia sNDA for Vanda’s Hetlioz opens another front in the company’s aggressive campaign against complete response letters and generic competition to the sleep disorder drug.

Astellas’ chief strategy officer, Adam Pearson, talks to Scrip about the company’s launch execution thrust for key therapies ahead of the loss of exclusivity for Xtandi and also deal-making appetite and choices, including the Iveric Bio buyout and walking away from the collaboration with Cartesian Therapeutics.

Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.