As product approvals at the Food and Drug Administration rebound from the ebb tide of late last decade, a striking number of first-timers have recently joined the ranks of approved drug sellers. Since the start of 2010 ten firms have gotten their first FDA approvals, including such high-profile names as Human Genome Sciences Inc. and Dendreon Corp., and several more are lined up. (See Exhibit 1.)
This "graduating class" represents a major shift in focus from research and development to commercialization, a crucial and difficult step...