30. March 2018

The year 2017 was a landmark year for pharmaceutical industries in the US and Europe, with a sharp increase in the number of new molecular entities (NMEs) being approved in both geographies. The US Food and Drug Administration (USFDA) approved 46 NMEs in 2017, the second highest since 1996 when 53 NMEs were approved. In Europe, the European Medicines Agency (EMA) approved 35 drugs with a new active substance, up from 27 in 2016. Sales for most major pharmaceutical companies continued to grow in...

04. January 2018

The year gone by saw the highest number of generic drug approvals by the US Food and Drug Administration (FDA), along with the most ever novel drugs (46); the most ever novel devices, and the first ever gene therapies. In 2017, 46 new molecular entities (NMEs) were approved by the FDA , and that excludes the pathbreaking CAR-T and gene therapies.