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A federal court in Delaware Monday refused to undo a 2017 decision awarding $70 million to Amgen in its patent infringement battle with Hospira. Read More
Illinois consumers covered under the Affordable Care Act will have access to expanded coverage for opioid addiction in 2020. The move comes after the Centers for Medicare and Medicaid Services Monday approved the state’s request to add the new benefits. Read More
DOJ officials “may have agreed to an inappropriately lenient treatment of Purdue Pharma simply because it was represented by Mr. Giuliani,” the senators said. Read More
The U.S. Court of Appeals for the Federal Circuit Friday denied a request by generic drugmakers for a rehearing to challenge an epilepsy drug patent’s validity. Read More
FDA draft guidance on assessing a new drug’s impact on blood pressure does not adequately explain the agency’s thinking on the use of smaller clinical trials and should incorporate a more risk-based approach, according to comments from three leading drug sponsors. Read More
The FDA is proposing to exclude three substances from its 503B Bulks List of substances for outsourcing facilities to use in compounding drugs — including one that’s the subject of an Endo lawsuit against the agency. Read More
For products that have a short shelf life and cannot be stockpiled, suppliers should have plans for products to be transported via air freight. Read More
The Senate passed an amendment Thursday to require drugmakers to list prescription drug prices in direct-to-consumer ads in an effort to promote lower prices through increased transparency. Read More