The US FDA's alert about liver failure and death in patients taking AbbVie Inc.'s hepatitis C fixed-dose combination therapies Viekira Pak and Technivie is a significant setback for a company that already is a distant second in the market behind Gilead Sciences Inc., and the agency's move clears the way for HCV newcomer Merck & Co. Inc.

An experimental gout drug from AstraZeneca plc unit Ardea Biosciences Inc., known as lesinurad, demonstrated only modest efficacy in clinical trials and has some concerning adverse cardiovascular (CV) and renal-related effects, FDA drug reviewers said on Oct. 21.

With the FDA set to make a decision any day on whether it will approve Apotex Corp.'s pegfilgrastim biosimilar, Amgen Inc. is seeking to block the product from entering the US market for at least six months after the medicine gains the agency's blessing.