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Sponsors should include clear assessments of necessary future actions in their periodic safety update reports, not simply provide a list of adverse events, according to new guidance from the European Medicines Agency. Read More
In another attempt to quell the opioid abuse epidemic, two FDA advisory committees voted Wednesday to recommend approval of an NDA for an immediate-release opioid painkiller. Read More
FDA commissioner nominee Scott Gottlieb was grilled by a Senate panel Wednesday over his financial ties to the industry he would be charged with regulating. Read More
A federal judge ruled that three generics manufacturers infringed on Novartis’ patents related to its Zortress treatment, used during kidney and liver transplants. Read More
Three drugmakers have filed amicus briefs in support of Regeneron and Sanofi’s efforts to reverse a district court ruling that validated Amgen patents on Repatha and barred the companies from selling their cholesterol drug Praluent. Read More