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takyon [soylentnews.org] writes:

New drug approvals hit 21-year high in 2017 [reuters.com]

U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light -- more than double the previous year -- while the figure also rose in the European Union.

The EU recommended 92 new drugs including generics, up from 81, and China laid out plans to speed up approvals in what is now the world's second biggest market behind the United States.

Yet the world's biggest drugmakers saw average returns on their research and development spending fall, reflecting more competitive pressures and the growing share of new products now coming from younger biotech companies. Consultancy Deloitte said last month that projected returns at 12 of the world's top drugmakers were at an eight-year low of only 3.2 percent.

Many of the drugs receiving a green light in 2017 were for rare diseases and sub-types of cancer, which often target very small populations, although they can cost hundreds of thousands of dollars. Significantly, the U.S. drug tally of 46 does not include the first of a new wave of cell and gene therapies from Novartis, Gilead Sciences and Spark Therapeutics that were approved in 2017 under a separate category.

Food and Drug Administration Commissioner Scott Gottlieb has indicated that it might be time to revise the Orphan Drug Act of 1983 [npr.org].

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