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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking industry feedback on a potential no-deal Brexit scenario in which the agency would function as a medicine and medical device regulator on its own. Read More
Westminster Pharmaceuticals and CVS committed fraud in knowingly selling adulterated thyroid drugs, according to a class-action federal lawsuit. Read More
“Cutting list prices and rolling back proposed increases in particular are an unprecedented recognition of the fundamental changes going on in drug markets,” said Dan Best, senior advisor to the HHS Secretary for drug pricing reform. Read More
“Bringing transparency to drug pricing and educating the public about the cost of their prescriptions is common sense,” said Sen. Chuck Grassley (R-Iowa). Read More
A judge threw out the state of New Jersey’s claims that Purdue Pharma created a public nuisance, but allowed several of its charges that the company violated the False Claims Act and the CFA, the state’s consumer fraud law. Read More
PhRMA has filed an updated version of its lawsuit against California’s drug pricing transparency law, providing specifics the court said its initial complaint lacked. Read More
The FDA has invited applicants for certain products containing bendamustine to share how broad of a scope they believe Eagle Pharmaceuticals’ seven-year orphan drug exclusivity for Bendeka (bendamustine) should be, and if it should apply to Treanda. Read More
“At this point, we don’t see a clinical need for outsourcing facilities to compound from these bulk substances,” said FDA Commissioner Scott Gottlieb. Read More
The petition cites materials from Janssen that say consumers “may be asked to switch to a biosimilar that works in a similar way” to its drug Remicade, phrasing that wrongly implies a biosimilar would have a different mechanism of action. Read More