Anant Murthy, general manager of Argenx Europe, tells Scrip that the commercial infrastructure is in place for Vyvgart to enjoy a strong launch for the rare neuromuscular disorder which will mirror those seen in the US and Japan.

Biosimilar licensing agreement also includes option on Yervoy-based product. Oxford BioTherapeutics, ImmunoGen pair their technologies for development of novel cancer ADCs.

Current accelerated approval provisions are the ‘sweet spot’ for balancing access and efficacy, but more attention needs to be paid by sponsors and the agency to working out regulatory pain points earlier in the development process, CBER director tells gene/cell therapy conference.

In exploratory FDA analyses, PRO data appeared more sensitive at detecting an exposure-toxicity relationship for an oral small molecule cancer drug than clinician-reported data; Project Optimus representative dispels industry concerns that FDA wants firms to find the 'mythical' optimal dose.