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With an eye toward rare-disease research, the Biotechnology Industry Organization and a Duchenne patient advocacy group are joining forces to help drugmakers design clinical studies with patient input. Read More
A drug wholesaler has been indicted for allegedly defrauding pharmacies to the tune of $100 million by selling them second-hand prescription medications obtained through the black market. Read More
The FDA’s Office of Regulatory Affairs is making progress on its new program alignment and released information on what the new structure will look like. Read More
With such a strong unmet need in severe asthma patients and convincing evidence of improvement in this population, Teva Pharmaceuticals’ candidate reslizumab warrants approval, FDA advisors said Wednesday. Read More
Participants in a Senate hearing Wednesday on drug price manipulation said the best way to stem the practice is to speed competitors to market and consider using compounders. Read More
Indian regulators have approved a generic version of Gilead’s hepatitis C drug Harvoni (ledipasvir-sofosbuvir) in a country with the highest infection rate on the planet. Read More