Cell Therapy Firms Advised To Complete Major CMC Changes Before Pivotal Trials
The sooner CAR-T therapy developers ask their regulatory questions and make their CMC changes, the better, industry official says.
You may also be interested in...
Bristol-Myers will have to divest Celgene's blockbuster psoriasis pill to address concerns raised by the US FTC related to the merger. The news raised questions about whether FTC is giving more scrutiny to pipeline overlap.
In "very top-line" Phase IIb data, the magnitude of the treatment effect for valbenazine in children with Tourette syndrome was weaker than expected, and its loss from active development means there will be only a handful of candidates under evaluation for the disorder.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”