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A UK cost-effectiveness watchdog doesn’t plan to recommend national reimbursement of three treatments that treat severe ulcerative colitis because of unclear effectiveness data. Read More
Celgene’s psoriasis drug Otezla will soon be available to a new group of patients following the FDA’s approval this week of an extended indication. Read More
Connecticut’s attorney general has joined a growing chorus of voices urging the FDA to immediately approve a generic version of AstraZeneca’s acid-reflux drug Nexium, either by clearing first-filer Ranbaxy’s version or by finding that the Indian firm forfeited its exclusivity because of rampant delays. Read More
A federal judge earlier this month affirmed the FDA’s decision to approve generic versions of Hospira’s sedative Precedex under a pathway that allows manufacturers Mylan and Par to proceed with products that “carve out” the brand firm’s method-of-use patent in the drug’s labeling. Read More
Generic drugmakers submitting ANDAs indicating impurities in proposed products that exceed established thresholds must provide detailed justification to avoid having the application rejected, the FDA said. Read More
While European regulators approve new drugs at a faster clip than their Canadian counterparts, both jurisdictions pull drugs from the market for safety reasons at the same rate, a new study finds. Read More