For months, it had been clear that 2018 would be a banner year for pharmaceutical innovation. The question was, by how much would it shatter the previous (1996) record of 50 approvals (excluding diagnostics and imaging agents)? We now know. It exceeded it by over 20 percent. Last year, U.S. regulators approved a total of 61 drugs – 59 by FDA’s Center for Drug Evaluation and Research (CDER), plus two recombinant therapies (Andexxa and Jivi) by its Center for Biologics Evaluation and Research (CBER). Yet, 2018 stands out not only for the sheer volume of new drug approvals, but also for their quality, and the affirmation of several important trends that make it a watershed. It is also another signal that the innovation crisis that caused so much pain in the first decade of this millennium is now solidly behind us. In 2015, I wrote about the dawn of a hyper-innovation age. It has become more tangible ever since, but perhaps in a different way than might have been expected back then.
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