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Bio China 2012

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A Big Year for Novel Drug 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 drug 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.

The top three therapeutic areas (cancer, cardiovascular, and metabolic) accounted for 60% of novel drug approvals. Most of these approvals were small molecule NDAs approved through FDA’s CDER (Center for Drug Evaluation and Research). On the biologics front, it was not antibodies that stole the show last year, but rather therapeutic enzymes and synthetic peptides. [Read more here]

Looking to hear more about the launch of these new products? CEOs from public companies with 2012 FDA approvals, such as Gilead (GILD), Onyx (ONXX), Affymax (AFFY), Exelexis (EXEL), Arena (ARNA), and Protalix (PLX), will be presenting at the upcoming BIO CEO Conference February 11-12th in New York. As the world’s largest independent conference focused on publicly traded biotech’s, it is the essential event for scouting 2013’s Phase III catalysts and NDA/BLA filers.