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Jazz Pharmaceuticals settled a seven-year long patent infringement suit over generic copies of its Xyrem solution for narcolepsy, just weeks before the case was scheduled to go to trial. Read More
Manufacturers and industry groups urged the FDA to develop guidance on its processes for assigning a lead center for the review of a combination product. Read More
Following an FDA import alert placed on a Chinese API manufacturer early last month, the World Health Organization was left without a prequalified source for the birth control drug levonorgestrel, also known as Plan B. Read More
A federal appeals court upheld that a Novartis patent for its multibillion-dollar MS drug Gilenya is invalid, opening the door for generics as early as 2019. Read More
Congress Friday unveiled its first draft of FDA user fee reauthorizations, with total dollar amounts in line with those previously negotiated by regulated industry. Read More