FDA’s curb on overseas cell processing to hit smaller cell and gene therapy companies: GlobalData
Regulators haven’t specified how many trials are affected, though therapies like CAR-T, which sometimes use overseas manufacturing steps, could fall under the policy
The FDA now bars new clinical trials that send US patients’ live cells overseas, including to China, for gene editing and return infusion, a move tied to two executive orders. While the scope and impact are unclear, smaller cell and gene therapy companies that rely on foreign manufacturing may be hardest hit. Regulators haven’t specified how many trials are affected, though therapies like chimeric antigen receptor T-cell (CAR-T), which sometimes use overseas manufacturing steps, could fall under the policy, says GlobalData.
Abigail Beany, Editor, Clinical Trials Arena at GlobalData, comments, “As the FDA’s recent stance continues to evolve, the full impact remains to be seen. However, the decisions cell and gene therapy (CGT) companies make under the Trump administration may indicate a trend toward more cost-effective development strategies.”
Additionally, GlobalData’s Bio/Pharmaceutical Outsourcing Report, August 2025 reveals Eli Lilly has informed UK wholesalers that it will temporarily stop taking new orders for the weight-loss drug Mounjaro (tirzepatide) to manage surging consumer demand and reported stockpiling ahead of a planned 170 per cent list-price increase in September. Existing allocations for pharmacies and providers remain in place, regular ordering is expected to resume after September 1, 2025, and there are currently no reports of supply disruptions despite widespread panic buying.
The Bio/Pharmaceutical Outsourcing Report is a monthly analysis of news and trends affecting pharmaceutical contract manufacturing organisations. The report lists the latest contract manufacturing agreements, opportunities and threats for CDMOs, M&A and financing of CDMOs, and emerging regulatory news.