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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
Claims that Allergan repeatedly tried to delay Restasis generics from entering the U.S. market are plausible, a U.S. District Judge ruled on Tuesday, shooting down the pharmaceutical giant’s attempts to have the multi-district litigation dismissed. Read More
An FDA advisory panel voted unanimously Thursday to recommend that the agency establish patient-focused dissolution standards for extended-release solid oral dosage forms. Read More
Failure to submit trial data to ClinicalTrials.gov on time could cost drugmakers up to $10,000 per violation, the FDA said in draft guidance issued Thursday. Read More
“With science evolving at such a fast pace, our challenge will be to achieve a balance between being agile to find solutions to emerging scientific or regulatory issues and being consistent with previous decisions,” Enzmann said. Read More
The drugmaker claimed that 60 percent of patients receiving its 500 mg dose saw targeted tumors shrink even though the efficacy rate was actually much lower. Read More