NME Candidates For 2012 Have Modest Ambitions; Standard Reviews And Small Molecules Dominate

With the same range of novel product submissions as in 2011, the year ahead could reach an equally healthy tally of new molecular and novel biological entity approvals. But a look at upcoming applications suggests that the makeup of those classes could be very different.

The biopharmaceutical industry starts 2012 with every chance of matching the high number of new molecular and novel biological entity approvals posted in 2011, but whereas 2011’s class of novel products was marked by a number of breakthroughs, the makeup of the class of 2012 is likely to be more conventional, slanted towards standard review products, small molecules and more experienced sponsors.

The number of NME and NBE submissions under review at FDA is likely to be in the same range in...

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