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When drugmakers change analytical validation methods during a drug’s lifecycle, the FDA says they should archive product samples to permit comparative studies of the old and new validation methods. Read More
Actavis plans to buy Forest Labs in a $25 billion deal that would expand the company’s reach into the primary care market and add to its pipeline in a wide range of diseases. Read More
New data collection methods show more trials than previously thought need to meet their postmarketing requirements (PMR) and postmarketing commitments (PMC), a new FDA report says. Read More
In another blow to Aveo’s oncology pipeline, Astellas announced it is ending a global partnership with the company to develop its troubled cancer drug tivozanib by August 11. Read More