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A survey of the world’s largest pharmaceutical companies found that only four were prepared to commit to single-digit percentage increases of the prices of their products annually. Read More
Glatt Air Techniques did not properly clean manufacturing equipment and failed to quarantine drug products before release, according to the FDA. Read More
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