Another Disappointing Year for Drug Approvals
This article was originally published in RPM Report
Executive Summary
New molecular entity approvals dipped in 2010 and Innovative Commercial Therapies dropped even more sharply. Add to that a significant drop in filings in 2010 and it is hard to be optimistic about a turnaround in approval numbers any time soon.
You may also be interested in...
FDA’s Banner Year for Drug Approvals: Time to Change the Focus
FDA is entering a big legislative year with a good story to tell based on 30 new molecular entity approvals. But the level of submissions remains constant—suggesting it may be time to shift the focus from what comes out of FDA to what makes it in.
FDA and the R&D Crisis: Time to Stop the Blame Game
Everyone knows R&D productivity has dipped to levels that threaten the private drug development model, and almost everyone says regulatory hurdles are part of the problem. That isn’t how FDA sees it. One thing is clear: blaming FDA won’t help anyone, so it may be time to pay more attention to FDA’s ideas for solutions rather than continue to point fingers.
Believing In Biosimilars: Industry Takes Long View on FDA Pathway
FDA is open for business on biosimilars as it works out the specifics of the new review pathway. But for companies considering an entry into the space, two big questions still remain: Does a profitable market exist, and how conservative will FDA be on those initial approvals? Executives from across the biopharmaceutical industry weigh in during The RPM Report’s FDA/CMS Summit.