Novartis is in the process of "exiting" the "small number" of scientists involved in the fraud, CEO Narasimhan says.
Novartis AG tried to squash any thoughts that it had a nefarious intent in not disclosing the data fraud it knew about before approval of its gene therapy Zolgensma, saying the company wanted a full understanding of the issue first before bringing it to the attention of regulators.
CEO Vasant Narasimhan said during a 7 August conference call with analysts that the company determined safety, efficacy, and quality...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.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.
