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The Washington Legal Foundation is asking the Supreme Court to revisit its stance on drugmakers’ liability in state tort suits over FDA-approved labeling. Read More
Good data integrity practices are drawing attention on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices. Read More
Horizon Pharma CEO Timothy Walbert says the company will re-evaluate its relationship with Express Scripts after the pharmacy benefits manager filed suit against the drugmaker and terminated one of its drug dispensers, Linden Care. Read More
The Office of Pharmaceutical Quality is in the midst of its third pilot of integrated quality assessments, a team-based review process that will be the central tenet of OPQ’s review of drug applications. Read More
Two British pharmaceutical giants saw positive results in studies of their respective lupus candidates, a rare show of progress for the underfunded condition with few care options and even fewer innovations. Read More
The U.S. Supreme Court has refused to hear patent infringement cases brought by two drugmakers against Apotex, paving the way for the Canadian company to produce a generic version of Benicar. Read More