A sparsely populated user fee calendar for the remainder of 2011 likely precludes a repeat of FDA’s stunning approval performance in the first half of this year. Still, with 20 approvals of new molecular entities and novel biologics during those first six months, the agency is all but assured of one of its best years in a decade – at the least.

South Korea has formulated new detailed policy measures to support the formation of major bioclusters, which will offer tax and other incentives in a bid to lure foreign firms and talent.