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The new guidance distinguishes between trials involving DMARD-naïve patients, those who have had an inadequate response to one prior DMARD treatment and those who have had an inadequate response to multiple treatments. Read More
The European Medicines Agency updated guidance on clinical investigations of rheumatoid arthritis drugs to add new endpoints and distinguish between patient subgroups in trials. Read More
Massive amounts of clinical trial data are lengthening drug development timelines as technical challenges create costly bottlenecks, according to a new industry survey from the Tufts Center for the Study of Drug Development. Read More
ClinicalTrials.gov received a new set of usability updates last month, including additional local search functions, a new glossary feature and redesigned study record pages. Read More
FDA released two guidance documents focusing on communications between the agency and drug developers to make drug development more efficient and to help sponsors avoid costly delays. Read More
Spending on prescription drugs sold through retail pharmacies in 2015 were estimated to comprise nearly 12 percent of total personal health care services spending in the United States. Read More
Closing what it calls an “unintended loophole,” the FDA will no longer issue orphan drug designations for smaller pediatric subpopulations of more common diseases, unless certain criteria are met. Read More
Makers of biopharmaceuticals will need to become more modular and agile to adjust for trends in personalized medicine and oncology, according to the Tufts Center for the Study of Drug Development. Read More