The changes will result in one company focused exclusively on cancer cell therapies and another on strategic transactions to build a pipeline of innovative medicines.
The agency affirmed the use of biopsies for biomarker-driven trials but cautioned against optional biopsies that offer little value to the patient or trial.
Vertex aims to further bolster its gene-editing therapy pipeline by using Orna's lipid nanoparticle delivery technologies during the three-year collaboration.