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Drugmakers designing trials for alcoholism treatments can use a primary endpoint of no heavy drinking rather than total abstinence, the FDA says, in an acknowledgement that abstinence as a goal in these studies is often unattainable. Read More
Clinical trial sites using software to obtain patients’ informed consent remotely should make sure the data is stored securely, the FDA says. Read More
The FDA has approved United Therapeutics’ Unituxin in combination with three other drugs for children with neuroblastoma who have seen at least some response to prior combination therapies. Read More
A federal judge has ordered Reckitt Benckiser to release documents the company wanted to suppress in an ongoing FTC probe into allegations the company illegally delayed generic competition to its opioid-dependence treatment Suboxone. Read More
The FDA has won a consent decree against a Texas compounder barring the company, Specialty Compounding, from producing and selling sterile drugs until it fixes manufacturing quality deficiencies that led to past reports of bacterial contamination of its products. Read More
With the FDA beginning to approve biosimilars, the next major hurdle for the emerging sector will be in the courts, where brandmakers and would-be competitors are arguing over how they will approach patent infringement lawsuits, especially when it comes to sensitive manufacturing data. Read More