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The agency said the testimonials do not “adequately support the suggestion in the presentation that other patients switching to Livalo from other statins will experience a similar reduction in side effects.” Read More
Impax Laboratories has sued the Federal Trade Commission for improperly deciding that it’s 2010 settlement with Endo Pharmaceuticals over Opana ER (oxycodone extended release) was anticompetitive. Read More
The U.S. Sixth Circuit Court of Appeals threw out Ohio Attorney General Dave Yost’s attempt to stop the Oct. 21 opioid bellwether trial of two Ohio counties against drugmakers and distributors. Read More
The company was accused of paying kickbacks to patients by covering patient copayments regardless of financial need and paying telemedicine physicians to write prescriptions without a legitimate prescriber-patient relationship. Read More
The FDA issued a complete response letter to Tanvex BioPharma for its proposed biosimilar for Amgen’s Neupogen (filgrastim) for the creation of white blood cells following chemotherapy. Read More