Global pharma R&D hit some bumps in 2nd-qtr but approval trends remain positive for 2010, say Fitch

The US Food and Drug Administration approved seven new molecular entities (NMEs) and biological pharmaceuticals during the second quarter of 2010, according to Fitch Ratings' new Global Pharmaceutical R&D Pipeline report, in a virtual repeat of the first quarter. In the European Union, the European Medicines Agency (EMEA) cleared three NMEs, including Amgen/GlaxoSmithKline’s injectable osteoporosis drug Prolia (denosumab), which was also approved in the USA.

Six of these NMEs were developed by pharmaceuticals companies rated by Fitch. So far in 2010, FDA approvals of new small-molecule and biological therapies have paced ahead of those in the same period last year, when 27 new treatments, including two vaccines were authorized.