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The FDA wants to improve the way it communicates with sponsors of investigational new drug applications and is seeking industry and academia’s advice on how to accomplish that goal. Read More
Sponsors seeking to enroll patients in studies of treatments for invasive aspergillosis may use the presence of the molecule galactomannan as a probable indicator of the infection, under an FDA program to qualify biomarkers used in drug development. Read More
Johnson & Johnson has spent $200 million on production of an Ebola vaccine that is set to begin human testing in the U.S., Europe and Africa in January, but talk of potential collaboration with GlaxoSmithKline remains only theoretical at this point. Read More
Sponsors of clinical trials for new migraine therapies should focus on enrolling more women of childbearing age early in the drug development process, as more women than men have the condition, according to a new FDA draft guidance. Read More
A coalition of drugmakers wants to boost performance at clinical trial sites by establishing common standards for good clinical practices and skill requirements for investigators. Read More
A question-and-answer document released by the European Medicines Agency in September clarifies terms of engagement and expected outcomes for applicants to the agency’s adaptive licensing pilot program. Read More