FDA lifts partial hold on cancer drug after Innate resolves manufacturing issue
Innate Pharma has smoothed over a bump on a Phase II for lacutamab, resuming enrollment in the US as the FDA lifts its partial hold.
The hold, which was issued in January, came after the French biotech stopped treating new patients following discussions with regulators in Europe. Its manufacturing subcontractor, Rentschler Fill Solutions, had abruptly filed for bankruptcy and withdrawn a certificate of conformity on the lacutamab batches they produced.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.