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Business

New Drug Approvals Soar

by Lisa M. Jarvis
January 12, 2015 | APPEARED IN VOLUME 93, ISSUE 2

In an encouraging sign of the health of the pharmaceutical industry, new drug approvals soared to an 18-year high in 2014. The Food & Drug Administration gave the green light to 41 new molecular entities last year, up from 27 in 2013. In years past, a surge in new approvals often meant a flood of “me-too” drugs had made it onto the market. But the 2014 class of new drugs is ripe with innovation: The list includes 16 first-in-class treatments, compared with just nine drugs with a novel mechanism of action approved in 2013. Last year was the best year ever for rare disease drug approvals, FDA said, with orphan drugs accounting for roughly 40% of the new drugs approved. Other highlights were 12 new treatments for infectious diseases, including four much-needed new antibiotics. And eight new cancer drugs hit the market, a crop that included several immunotherapies that represent major advances for patients. FDA crammed seven of those new drug approvals into the last month of the year.

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