Tag Archive for: Department of Justice

The U.S. Department of Justice has slapped BioMarin Pharmaceutical with a subpoena in connection with its sponsored testing programs for the rare disease therapies Vivizim and Naglazyme.

“Would-be insider traders tempted by the prospect of easy money should know that the Southern District of New York is watching, we’ll catch you, and we’ll make sure you pay the price for violating the law,” stated Damian Williams, United States Attorney for the Southern District of New York.

The Chamber of Commerce has asked for a preliminary injunction to halt the program before Oct. 1, the deadline for pharma companies to agree to Medicare negotiations on pricing for the first 10 drugs.

The U.S. Department of Justice asked the U.S. Supreme Court to stop Purdue Pharma from proceeding with a bankruptcy settlement that protects its Sackler family owners from lawsuits.

The new guidelines mark a significant shift in the approach to examining mergers in the pharma industry. Previously, the federal government’s antitrust enforcers primarily focused on direct competition, but the updated guidelines now consider how companies leverage their negotiating power.

The federal indictment alleged the two executives engaged in “false and misleading representations and material omissions” regarding the development of experimental monoclonal antibody leronlimab.

BioTelemetry Inc. and its subsidiary CardioNet LLC have reached a settlement over allegations that they knowingly submitted claims to Medicare, TRICARE, the Veterans Health Administration and the Federal Employee Health Benefits Program for heart monitoring tests that were performed, in part, outside the United States.