Breakthrough Therapy Designations
Executive Summary
Listing of all ‘breakthrough’ drugs, including status and basis of designation. Updated weekly.
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Cell/Gene Therapy Manufacturing Readiness Urged As A Condition For US Expedited Designation
Requiring that certain chemistry, manufacturing and controls conditions be satisfied before awarding breakthrough or regenerative medicine advanced therapy status would help ensure that the quality side of product development keeps pace with the clinical side, says Parexel's Mo Heidaran, a former CMC reviewer in the FDA’s biologics center.
Breakthrough Denial Doesn't Mean US FDA Won't Bring Full Resources To Application
Agency staff discuss how they offer early development advice to sponsors before a breakthrough decision is made and reassure them if the status is denied.
Oncopeptides Rescinds Pepaxto Voluntary Withdrawal, Which Could Set Up Battle With US FDA
After more review of clinical trial data, the myeloma drug’s sponsor wants to talk to the FDA again, but Oncopeptides execs said they cannot disclose the scientific details that led to the decision.