New drug approvals slide in 2013


After the feeling that the life science sector had perhaps turned an important corner in 2012, based upon what was seen as a meaningful uptick in the rate of new drug approvals, 2013 actually turned out to be something of a dud - a return to the bleak "business as usual" scenario of poor returns from hefty investments that has beset the industry for some years now. You can see the full report here online at the Fierce Biotech website, but for those of you in a hurry, the gist of the news is summarized in the FB report's introductory paragraphs.

"The wave of new drug approvals that had been building at the FDA has broken. According to the official tally of new drug and biologics approvals at the agency, the biopharma industry registered only 27 OKs for new entities in 2013--a sharp plunge from 2012's high of 39 that once again raises big questions about the productivity and sustainability of the world's multibillion-dollar R&D business.

After 2012 some experts boasted that the industry had turned a corner, with the agency boasting that it was outstripping the Europeans in the speed and number of new drug approvals. But for 2013 the numbers look a lot closer to the bleak average of 24 new approvals per year seen in the first decade of the millennium than the 35 per year projected by McKinsey through 2016.

The agency says it was hampered by a sharp drop in the number of new drug applications, forcing a sudden plunge in the annual total--even after starting the year with a new breakthrough therapy designation (BTD) designed to speed the arrival of major therapeutic advancements."

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