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Pfizer was dealt a heavy blow Wednesday after a judge cleared the way for five generic drugmakers to begin making generic versions of Pfizer’s blockbuster osteoarthritis drug Celebrex. 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
Purdue Pharma is reporting positive results for an investigational once-daily analgesic that could compete with Zogenix’s controversial painkiller Zohydro ER, which, unlike Purdue’s candidate, lacks abuse-deterrent properties. 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 FDA has slapped Institut Biochimique SA (IBSA) and Akirmax Pharmaceuticals with an untitled letter for omitting risk information and important contraindications on a Facebook page promoting the hyperthyroid drug Tirosint. Read More
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