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Endo Pharmaceuticals and Impax Laboratories are facing a lawsuit alleging that the two drugmakers conspired to keep a generic version of Endo’s pain medication Opana ER off the market. Read More
Clinical investigators looking to develop new therapies for children with Gaucher disease may use multi-company, multi-arm trials or data extrapolation techniques, according to a joint strategic plan released by the FDA and European Medicines Agency. Read More
Drugmakers conducting animal trials to support the development of biological and chemical weapon countermeasures should control for animal age, health, weight and physical environment when designing study protocols, the FDA says in draft guidance implementing the Animal Efficacy Rule. Read More
Eight African nations have signed up to participate in the second European & Developing Countries Clinical Trials Partnership, with a ninth expected to follow suit soon. Read More
Bayer HealthCare, Boehringer Ingelheim and Eli Lilly are the latest drugmakers to make more clinical trial data available — in line with a recent push for transparency on the part of European regulators. Read More
Manufacturers of biosimilars should take extra care in designing clinical trials and executing other steps needed to demonstrate that their products line up with reference drugs, according to key FDA draft guidance on creating versions of the complex therapies. Read More
Drug companies that redact commercially confidential information from clinical study reports in Europe will have to justify their actions, a spokesman for the European Medicines Agency says. Read More
Drugmakers may distribute new risk information to physicians on approved products if they meet a set of standards around the validity of the information, the FDA said in its latest effort to relax limits on the distribution of journal articles and other texts to prescribers. Read More
With a deadline looming, the pharmaceutical industry still needs to decide which data systems are most efficient and cost-effective for implementing the federal track-and-trace law, experts say. Read More
Generic firm Glenmark Pharmaceuticals wants a federal appeals court to rehear its case over rights to the combination hypertension drug Tarka, arguing that an April decision was invalid because it incorrectly attributed exclusive patent rights. Read More