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Nearly three years after generics giant Mylan accused Warner Chilcott and Mayne Pharmaceuticals of “product hopping” with their acne medication Doryx, a federal judge has dismissed the case, ruling in favor of the brandmakers. Read More
The European Medicines Agency is seeking feedback on the chemical structure and properties it considers in evaluating new active substance status. Read More
Particulates continue to be a major cause of recalled injectables, with Mylan on Thursday recalling eight lots of four drugs after foreign matter was found during quality control tests. Read More
HHS has promised to protect the maker of the experimental Ebola virus drug ZMapp from legal liability, meaning the company can’t be sued for claims of injury or loss related to use of the monoclonal antibody cocktail. Read More
The HHS Office of Inspector is urging Congress to rewrite the Medicare Part D in the Social Security Act to allow for collection of additional rebates from drug companies. Read More
European regulators are warning that combining certain hepatitis C drugs with the antiarrhythmic drug amiodarone could cause slow heart rate or heart block. Read More
GPhA Wednesday threw its weight behind Sandoz in closely watched litigation between Amgen and the French drugmaker, saying the U.S. district court in northern California was correct in denying Amgen’s request for a preliminary injunction to keep Sandoz’ biosimilar of Neupogen off the market. Read More
Reckitt Benckiser is voluntarily recalling 1.5 million units of four varieties of its Mucinex liquid cold medicines nationwide because the back labels may not show they contain acetaminophen and other active ingredients. Read More
The World Health Organization has launched VigiAccess, a database that allows users to view information on suspected adverse drug reactions collected by national drug authorities in more than 110 countries and spanning more than 100,000 products. Read More
In response to overwhelming requests from industry, the FDA is extending to June 8 the comment period on its draft rule overhauling the ANDA and 505(b)(2) approval processes. Read More