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A federal judge validated Shire’s patent on its delayed-release Lialda, ruling that Mylan infringed two of the patent’s claims when seeking to launch a generic of the bowel disease drug. Read More
Eight Democratic senators have sent a letter to the FDA, airing their concerns over the effects of the government-wide hiring freeze on the agency’s mission. Read More
The FDA and other government agencies are being ordered to identify two regulations to be eliminated for each new one they propose and to reconsider the industry’s costs of compliance, according to an executive order issued by President Donald Trump. Read More
Teva’s subsidiary Barr Laboratories agreed to pay $225 million to settle a class action lawsuit alleging it reached pay-for-delay settlements that postponed the launch of generic versions of Bayer’s antibiotic Cipro. Read More
The U.S. Court of Appeals for the Federal Circuit affirmed Cumberland Pharmaceuticals’ patent for its second-generation version of Acetadote, barring Mylan from marketing a generic of the overdose therapy. Read More