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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
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
Sen. Charles Grassley (R-Iowa) put pressure on the Centers for Medicare and Medicaid Service to release records on Mylan’s classification of the epinephrine auto-injector the EpiPen for Medicaid. Read More
Mezzion filed a lawsuit accusing its former manufacturer Dr. Reddy of fraud for concealing significant GMP deficiencies that resulted in the FDA’s refusal to approve an NDA for udenafil, an erectile dysfunction therapy. Read More
Pfizer is standing firm on its allegations that Texas violated federal laws when it disclosed the company’s Medicaid rebate information to local lawmakers. The company is challenging the state’s argument that the disclosure was necessary and permissible. Read More