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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