Complexity Has Benefits: Data Show Biologics, Targeted Agents Have Better Approval Prospects
Biologics have 9.1% likelihood of making it through the clinic to approval, compared to 5.7% for new molecular entities, according to an analysis of 10 years of Biomedtracker drug development data by BIO, Informa Pharma Intelligence and QLS.
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BIO/Biomedtracker analysis strengthens the case for expanded use of drug development tools like biomarkers with finding that well-defined patient populations in clinical trials are associated with greater likelihood of approval.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Keeping Track: Breakthroughs Of Summer Break Ground In Psychiatry, Cancer (Especially Nasopharygeal Cancer) And Vaccines
US FDA’s marquee expedited review program added 15 new breakthrough therapy designations between June and August.