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A nonprofit coalition is calling for congressional action that would allow the FDA to offer formal scientific opinions on the use of medical products outside the U.S. to streamline and strengthen regulatory pathways for drugs and vaccines in less developed countries. Read More
The European Medicines Agency is recommending that sponsors use clinical trial information from adults to support the development of therapies for children. Read More
After a Phase 1 trial designed by Portuguese drugmaker Bial Laboratories left one patient dead and the hospitalization of others, a committee appointed by France’s Agency for Medicines and Health Products Safety determined that an “off-target effect” of the compound is a probable explanation for the tragedy. Read More
The European Medicines Agency and the FDA are launching investigations into Gilead Sciences’ cancer drug Zydelig following an increased rate of serious adverse events, including deaths. Read More
How much training do clinical investigators and clinical study staff need to stay up to date on good clinical practices, particularly to ensure compliance for multiregional clinical trials? In a recent study, the Clinical Trials Transformation Initiative evaluated the content, frequency, format and enrollment evidence of GCP training and provided recommendations to improve the efficiency of GCP training. Jonathan Seltzer, the director of clinical research at the Lankenau Heart Institute and a co-author of the study, “Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency,” talks with CTA about the findings.Read More
Sanofi and Regeneron Pharmaceuticals said their rheumatoid arthritis treatment sarilumab demonstrated superiority over AbbVie’s blockbuster Humira in a Phase 3 Study. Read More
The average cost of developing a new drug continues to rise, even as approval rates decline, according to a report that pegs the cost of ushering a candidate through FDA approval at $2.6 billion. Read More
The FDA’s plans to create a pilot database of clinical outcome assessments lacks the depth and breadth of data needed to make it worthwhile, according to comments from industry and advocacy groups. Read More
The European Medicines Agency and the FDA are launching investigations into Gilead Sciences’ cancer drug Zydelig following an increased rate of serious adverse events, including deaths. Read More