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The latest clinical trial results for Amgen’s talimogene laherparepvec immunotherapy may not be as strong as the company hoped, say FDA advisory committee briefing documents. Read More
Drugmakers in Europe must record and report suspected adverse events that are brought to their attention concerning drugs they donate outside the EU to treat neglected tropical diseases. Read More
Eli Lilly’s targeted antitumor drug Cyramza has snagged its fourth cancer indication from the FDA, this time as a second-line treatment for patients with metastatic colorectal cancer. Read More
Drugmakers in Europe will need to submit proposed educational materials in a specific format and with specified content as part of their risk-mitigation strategy, under a draft addendum to the European Medicines Agency’s good pharmacovigilance practices guidelines. Read More
Nearly three years after generics giant Mylan accused Warner Chilcott and Mayne Pharmaceuticals of “product hopping” with their acne medication Doryx, a federal judge has dismissed the case, ruling in favor of the brandmakers. Read More
The European Medicines Agency is seeking feedback on the chemical structure and properties it considers in evaluating new active substance status. Read More
Particulates continue to be a major cause of recalled injectables, with Mylan on Thursday recalling eight lots of four drugs after foreign matter was found during quality control tests. Read More