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FDA Commissioner Scott Gottlieb Wednesday said the agency plans to scrap its existing guidance on developing new pain drugs and replace it with guidances designed to promote development of new opioid alternatives and improve benefit and risk assessments of new opioid drugs in the works. Read More
Drug sponsors wishing to take part in the FDA’s pilot meeting program to discuss complex innovative trial designs (CIDs) with agency staff may now file meeting requests. Read More
Gilead said it is in “ongoing discussions with NICE to identify appropriate treatment comparators which can clarify how cell therapy may be made available to patients in the UK.” Read More
In a citizen petition filed Monday, Pfizer asked the FDA to issue draft guidance to prevent misleading communications by reference drug sponsors on the effectiveness of biosimilars. Read More
A New York couple filed a class-action lawsuit against a distributor and two dispensers of valsartan products, claiming they were exposed to carcinogenic materials. Read More
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