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Actavis said it will continue marketing the original formulation of its blockbuster Alzheimer’s drug Namenda for 60 days longer than originally planned, as the drugmaker faces antitrust allegations over its plans to withdraw the product in favor of a newer version. Read More
Gilead Sciences is on track to launch another hepatitis C drug in Europe after an advisory panel of the European Medicines Agency recommended approval of Harvoni. Read More
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
Patients will be invited to participate in scientific discussions on the benefits and risks of certain drugs in Europe, under a new European Medicines Agency pilot project. Read More
The FDA is honing in on roughly eight to 10 quality metrics that the agency plans to collect from drugmakers starting in 2015, and expects to publish a guidance that names them by the end of the year. Read More
Drugmakers are worried that FDA draft guidance on how to identify and report counterfeit or suspicious goods could lead to numerous false alarms and potential shortages unless the guidance is amended. Read More
Over the next five years the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
India’s Central Drugs Standard Control Organization has issued a uniform set of procedures that state drug authorities should follow when inspecting facilities for good manufacturing practices and issuing certificates of pharmaceutical product. COPPs are required for drugs intended for export. Read More