We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The European Medicines Agency (EMA) says it is no longer acceptable for sponsors to conduct placebo-controlled clinical trials when developing monotherapy drugs for lipid disorders. Read More
The FDA’s proposal to establish tighter controls on hydrocodone combination drug products such as Vicodin should only apply to doses 5 mg or higher, drugmakers say. Read More
Janssen’s third try to expand the indication for its anticoagulant Xarelto floundered Thursday when FDA advisors voted to recommend against its approval, citing concerns about the drug’s risks and missing clinical data. Read More
Health Canada issued guidance last month clarifying how the agency’s several centers will collect and manage information and material submitted by sponsors of prescription drugs. Read More
Merck’s blood thinner vorapaxar appears headed for the regulatory finish line after years of clinical hiccups, securing a 10-1 vote in favor of approval from an FDA advisory panel Wednesday. Read More
Chelsea Therapeutics’ second encounter with an FDA advisory panel over its blood pressure drug Northera has garnered an even stronger positive nod than a 2012 vote that resulted in a surprise complete response letter. Read More
Highlighting a growing dispute in the pharmaceutical industry, Johnson & Johnson is arguing that biosimilars should have international non-proprietary names (INN) that are similar to, but distinguishable from, reference products. Read More
Generic and brand drugmakers are urging the FDA to drop plans to require them to report manufacturing stoppages expected to result in shortages within five days of the stoppage occurring. Read More