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GPhA is putting forward a compromise naming scheme for biosimilars that it hopes will quell the dispute over how to assign international nonproprietary names (INN) to follow-on biologics. Read More
The FDA on Wednesday banned imports to the U.S. from two more Indian manufacturers, ratcheting up the pressure on the country’s domestic drugmakers to improve product quality. Read More
The FDA is asking sponsors of BLAs, NDAs, and ANDAs to justify the amount of excess medication for injectable drug products they plan to pack in vials and ampules. Read More
The studies evaluated the humanized monoclonal antibody in patients with severe eosinophilic asthma who continued to have exacerbations on current medication. Read More
The EU Parliament Wednesday advanced major data privacy legislation, but made revisions to the proposal that removed two provisions that pharma companies had said would cripple clinical research efforts. Read More
The FDA has placed clinical trials for California-based biotech Geron’s blood cancer candidate, imetelstat, on hold after liver abnormalities were found in study subjects. Read More
The drugmaker says this is the first randomized trial of an angiogenic agent in combination with a vascular disrupting agent, but no chemotherapy. Read More
The European Medicines Agency (EMA) on Tuesday launched its latest transparency effort, publishing the first of many summaries of drugmakers’ risk management plans (RMP) that it plans to make available throughout 2014. Read More
The Centers for Medicare & Medicaid Services (CMS) has backed away from its controversial plan that would have removed protected status for antidepressants and immunosuppressants in formularies under Medicare Part D. Read More