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Tennessee has joined a growing list of 11 states to pass legislation enabling pharmacists to substitute a biosimilar for a branded biological product, in a move applauded by industry. Read More
Dublin, Ireland-based Amarin Pharmaceuticals is asking a New York federal court to declare its off-label promotion of a cholesterol-lowering drug constitutionally protected free speech, after several FDA rejections of its desire to promote the drug for a wider patient population. 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 FDA slapped warning letters on two more drug outsourcing facilities for sloppy sterile processing, bringing to seven the number of compounders cited for sterile manufacturing deviations in the past six months. Read More
The FDA’s Office of Pharmaceutical Quality is developing a new inspection protocol that will focus on expert investigator-developed questions and assessment practices. Read More
Canadian biotech company Tekmira is set to restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, after the FDA downgraded a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day. Read More
Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. Read More