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Sponsors that use surrogate endpoints, such as biomarkers, in confirmatory cancer trials may need to provide postmarketing data to verify that the information used to gain marketing authorization in the EU remains valid in practice. Read More
EU member states will be able to purchase pandemic vaccines and other medical countermeasures as a group, under a new procurement scheme adopted Thursday. Read More
Impax said Friday it has refiled an NDA for its Parkinson’s disease drug Rytary after implementing quality systems improvements at the plant where the drug was slated to be made. Read More
The European Medicines Agency is looking into potential heart risks linked to testosterone-containing drugs after an EU member state regulator raised safety concerns. Read More
The FDA has banned Canadian generics maker Apotex from importing drugs to the U.S. made at its Bangalore, India, site, pending quality upgrades. Read More
The FDA has closed out a warning letter issued to West-Ward Pharmaceuticals after the generic drugmaker completed a two-year overhaul of parts of its quality system. Read More
Merck is reporting strong mid-stage trial results for a drug combo to treat hepatitis C, which may position it to be the strongest alternative to Gilead’s Sovaldi. Read More