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Genentech and Boehringer Ingelheim want the FDA to amend or clarify parts of its draft guidance on the use of liquids or soft foods as drug administration vehicles. Read More
In the latest development in the ongoing saga over Allergan’s transfer of Restasis patents to a Native American tribe, the partners sued Amneal for infringing upon two patents for the dry-eye drug. Read More
The Congressional Budget Office (CBO) estimates bipartisan legislation designed to speed generic drugs to market could save the federal government as much as $3.3 billion. Read More
FDA guidance on submitting field alert reports contradicts federal regulations on the time frame for when reports must be submitted, Perrigo and GlaxoSmithKline said in public comments. Read More
The EMA expanded its investigation of valsartan impurities after a new contaminant was discovered in an Indian manufacturer’s active substance, losartan. Read More
“I believe it’s something that’s going to have wide support,” said temporary voting member Paul J. Smith, director of the University of Maryland’s statistics program. Read More
“The inferences plaintiffs draw — namely, that Allergan's efforts bore fruit in causing delay — are logical and amply support the plausibility requirement,” the judge said. Read More