Innovation is on a roll with the sector establishing a record of 59 new molecular entities (NMEs) gaining U.S. approval last year, a 22 percent increase over the 46 medicines approved in 2017, and six more than the previous industry high-water mark for the number of NMEs approved in one year in the U.S. established back in 1996. In addition, for the first time ever, the FDA approved more orphan drugs than non-orphans and the number of big pharma approvals fell.