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A federal judge threw out a case against GlaxoSmithKline that was part of multidistrict litigation over the labeling of its diabetes drug Avandia. Read More
Parts of the FDA’s recently updated draft guidance on the content and formatting of REMS documents are overly prescriptive, stakeholders said in public comments to the agency. Read More
The FDA’s lawyers and investigators are considering whether a breach of a duty to act or to correct violations must occur before criminal charges are brought. Read More
The FDA warned sterile drug manufacturer PharmScript for adulterated products and insanitary conditions at its Somerset, New Jersey facility. Read More
The Federal Circuit upheld the Patent Trial and Appeal Board’s invalidation of Daiichi Sankyo’s patents for the anti-clotting drug Effient (prasugrel). Read More
PhRMA announced it is partnering with the Addiction Policy Forum as part of a “multi-year, multi-million dollar” initiative to address opioid addiction. Read More
Lawmakers once again waded into the reasons for rising drug prices, as a House panel invited a diverse group of industry representatives to weigh in on the main causes and to propose solutions. Read More