Regulatory Roundup: FDA Posts PDUFA Meeting Minutes

The company has expanded its early and late phase analytical capabilities by including GMP cell-based potency assays at its sites in Cambridge, UK, and San Diego, Calif.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

The companies will collaborate to create and test circVec DNA–LNP formulations for use in potential therapeutic applications.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

SEKISUI has used a £15.7 million (US$20.7 million) investment to expand its clinical-grade drug substance manufacturing at its UK site.

Financing from OrbiMed, Novo Holdings, Jeito Capital, and others will enable Alentis Therapeutics to advance its pipeline of Claudin-1-targeted ADCs for treating solid tumors.