Patricia Van Arnum, DCAT Editorial Director
As we reach the mid-point of 2018, how are approvals of new molecular entities faring? As of the end of June, the FDA had approved 20 NMEs, a similar number as approved this time last year when the FDA had approved 23 NMEs by mid-year with an eventual total of 46 NMEs approved for 2017. Although the numbers are on par, how about the drugs themselves?
Small molecules are dominating thus far, with 15 small-molecule NME approvals and five biologic-based NME approvals. Only one third (35%) of the approvals are from the pharmaceutical majors with small to mid-sized companies showing the NME muscle thus far.
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