A Big Year for Novel Drugs Approvals

What was your top Biopharma highlight for 2012? If it wasn’t the stellar move in the AMEX Biotech Index (up 42%), or the reauthorization of PDUFA, then perhaps it was the decade high for innovative drugs approvals. We would need to go back to the 1990s to find a year with as many FDA approvals for novel drugs as we had in 2012. Adding to the positive trend in numbers, up 29% from the robust 31 approvals in 2011, a number of last year’s approvals came earlier than expected. Vertex’s Kalydeco and Ariad’s Iclusig, for example, both came three months ahead of their respective PDUFA dates. Over 50% of the approvals had FDA Priority review or Orphan designations.



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