The US Food and Drug Administration and the European Medicines Agency approved six new molecular entities (NMEs) during the third quarter 2010, of which, six were developed or licensed by Fitch Ratings-rated pharmaceutical developers, according to the agency's new Global Pharmaceutical R&D Pipeline report. In addition, Japan's Ministry of Health, Labor and Welfare cleared six new medicines developed by Fitch-rated pharmaceutical companies for sale in the region.
To date, approximately one-half of the original 22 new therapeutics have been filed as planned in 2010, while there have been three drug project cancellations and six extensions to original filing goals. In the third quarter, the applications for four NMEs were filed to drug regulators in Europe or the USA, keeping a modest yet steady pace throughout the year of around three per quarter.
But 12 projects terminated
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