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AstraZeneca received good news Friday when a key European committee recommended approval of its new drug to treat opioid-induced constipation and a diagnostic test that can help identify patients for its cancer drug Iressa. Read More
Boehringer Ingelheim won FDA approval Thursday for its chronic obstructive pulmonary disease (COPD) drug Spiriva Respimat and plans to launch the drug by the new year. Read More
With patent expirations looming, AbbVie secured a new indication for its blockbuster biologic Humira to treat children suffering from moderate to severe Crohn’s disease. Read More
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