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Your First Drug's Approved and Launched...Now What?

 
• By Alex Lash

FDA new drug approvals are making a comeback, and a group of biopharma first-timers are leading the way. To understand the challenges they face in the transition from discovery to commercialization, IN VIVO looked at 50 companies spanning the past 10 years. Finally reaching the US market might be a biotech's defining moment, but for those who build to last, there could be more rewards beyond that first approval.

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 for biopharma firms that have for many years immersed themselves...

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