The G-BA has explained in more detail the procedures for mandating post-launch evidence generation under new legislation introduced in 2019.
Germany’s G-BA, the body in charge of drug pricing and reimbursement, has for the first time used new powers to oblige companies to generate post-launch evidence on their products.
Novartis AG/AveXis, Inc.will have to gather data on how different spinal muscular atrophy (SMA) treatments work, including their...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
