Supporting ‘n of 1’ gene therapy development, the playbook from a Foundation for the National Institutes of Health-backed consortium aims to help investigators who are not traditional product sponsors prepare for meetings with US FDA and IND submissions.

With an ambitious growth plan for its CDMO operations, Ajinomoto is planning to complete the acquisition of Forge Biologics Holdings by December, adding the US-based firm’s capabilities in gene therapy services.

While the European Medicines Agency and industry speculate as to why 2022 saw far fewer applications for a place on the priority medicines scheme for drugs for unmet medical needs, they are enthusiastic about improvements to the initiative that are set to be trialed soon.

Private Company Edition: Acelyrin will use its latest funding for Phase III development of izokibep in inflammatory diseases. Also, ArsenalBio raised $220m to take its programmable cell therapies into the clinic and RayzeBio’s $160m series D round will fund clinical trials for its radiopharmaceuticals.