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A New York federal judge has tossed out a lawsuit alleging Eli Lilly misled the public over withdrawal symptoms linked to its antidepressant Cymbalta. 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.
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Drug sponsors need to find more thoughtful, comprehensive ways of recording and integrating patient outcomes data into their efficacy analyses, but long questionnaires may not be the solution, a top FDA official says.
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Sponsors of clinical trials for new migraine therapies should focus on enrolling more women of childbearing age, as more women than men suffer from migraines, according to FDA draft guidance on trial design expectations for the pain drugs. Read More
A new Society for Clinical Research Sites white paper outlines a set of best practices that members of industry group TransCelerate hope will eventually help clinical trial sites improve their compliance. Read More
Clinical trial sites need to brush up on their good clinical practice training specs and shouldn’t expect sponsors to compensate them for doing so, says Christine Pierre, president of the Society for Clinical Research Sites. Read More
The FDA is strengthening its bioresearch monitoring program as part of a sweeping plan to overhaul its approach to inspections and regulatory monitoring. Read More
Researchers approaching the FDA with new drug development tools, such as potential biomarkers or innovative trial designs, will now have a centralized place to bring their ideas for advice as the agency replaces its fragmented approach to considering such concepts with a new streamlined system. Read More
Belgian pharma giant UCB is divesting its U.S.-based specialty generics subsidiary Kremers Urban Pharmaceuticals in a $1.525 billion sale to a pair of private equity firms. Read More
India’s final guideline on drug patent applications drops a proposed clause that would have required manufacturers to list names of similar generic products in their filings. Read More