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The International Committee of Medical Journal Editors is seeking feedback on proposed requirements involving transparency for clinical trials authors as a condition for publication in member journals. Read More
The FDA plans to establish a system that would allow for the use of “real-world evidence” to help the agency more quickly identify safety signals and address concerns, according to its list of strategic priorities for 2016-2017. Read More
CBER’s Allergenic Products Advisory Committee gave a less than stellar assessment on the outlook of clinical trials for immunotherapies to treat food allergies. Read More
Telesta Therapeutics has received a complete response letter from the FDA, informing the company that its BLA for Mycobacterium phlei cell wall-nucleic acid complex would need an additional Phase 3 clinical trial to adequately establish the candidate’s efficacy and safety. Read More
The European Medicines Agency is asking for feedback on a revised guideline for the treatment of Alzheimer’s disease and other types of dementia. Read More
With the clinical trials industry facing its lowest rates of recruitment and retention, drug developers must incorporate big data and patient voices to improve trial efficiency and hasten innovation, says a new report by the Tufts Center for the Study of Drug Development. Read More
In an effort to stay ahead of the threat of evolving superbugs, the National Institutes of Health announced it will fund novel antibiotic research to either complement or replace existing drugs. Read More
Prizing collaboration and reduced burdens on drugmakers, the European Medicines Agency hopes to bolster a stronger drug development process in the coming years. Read More
The Biotechnology Innovation Organization and a Duchenne patient advocacy group are joining forces to help drugmakers design clinical studies with patient input and drive rare-disease research. Read More