The FDA issued Targeted Medical Pharma a warning letter for failing to submit an IND application prior to beginning clinical investigations for a product the agency deemed to be a…

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. Source: Drug Industry…

Glatt Air Techniques did not properly clean manufacturing equipment and failed to quarantine drug products before release, according to the FDA. Source: Drug Industry Daily

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. Source:…

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. Source: Drug Industry Daily

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,…

The FDA cited Cook Pharmica over the drug manufacturer’s testing procedures, contamination safeguards and computer systems validations. Source: Drug Industry Daily

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. Source: Drug Industry Daily

Congress Friday unveiled its first draft of FDA user fee reauthorizations, with total dollar amounts in line with those previously negotiated by regulated industry. Source: Drug Industry Daily

Shire ViroPharma has asked a Delaware federal court to dismiss an FTC complaint accusing the drug company of abusing the citizen petition process. Source: Drug Industry Daily