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The FDA has warned an Indian active pharmaceutical ingredient (API) manufacturer for a laundry list of severe quality violations, such as failing to test batches and losing records. 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
Bayer and Onyx’s drug Nexavar joins a growing list of drug candidates targeting liver cancer that have failed in Phase III. The drugmakers revealed Tuesday the product did not meet its primary endpoint. 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
The congressional drumbeat of opposition to Zogenix’s painkiller Zohydro ER continues, with two Democratic senators ratcheting up the rhetoric by calling for HHS to revoke the controversial drug’s approval. Read More
The partnership will bring together researchers to discover and develop new drugs for autoimmune diseases currently treated with small-molecule biologics. Read More
Drugmakers seeking marketing authorization in Australia will soon be able to make complete submissions in electronic format, allowing for cost savings and potentially swifter reviews. Read More
Generic drugmakers in the EU must create a program to assess the effectiveness of their risk minimization efforts for each marketed drug, EU regulators say. Read More
Beginning on June 16, whenever a drugmaker receives approval for a generic drug by an EU member state, it will have 15 calendar days to report the approval to the EMA’s new centralized electronic registry. Read More
The FDA is telling drugmakers not to file supplemental applications for minor postapproval manufacturing changes such as swapping excipient suppliers, moving a manufacturing process within a plant or removing coloring or flavoring ingredients from a drug. Read More
Baxter and Sagent Pharmaceuticals are the latest generic drugmakers to recall products with leaky containers, notifying healthcare providers that affected product may be contaminated with particulates. Read More