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To achieve the national cancer moonshot’s goal of accelerating cancer research, the FDA is planning to encourage more seamless, adaptive clinical trial designs for oncologic drugs. Read More
Drug sponsors that have falsified data will face three years of probation before being allowed to refile marketing applications, the Chinese FDA says. Read More
Juno Therapeutics has been sued in a class-action lawsuit alleging that the company violated federal securities law by failing to disclose a death during a clinical trial. Read More
Plasma fibrinogen can be used as a biomarker in interventional clinical trials examining patients at high risk for exacerbations or all-cause mortality in chronic obstructive pulmonary disease, according to final guidance to industry issued by FDA. Read More
The number of cardiovascular drugs entering the clinical development pipeline has been declining since 1990, according to a study evaluating public data from over 4,000 trials. The decline was seen across Phase I, II, and III clinical trials. Read More
The cancer moonshot’s blue ribbon panel made 10 recommendations to the National Cancer Advisory Board to guide scientific direction for the national research initiative, specifically organizing an immunotherapy clinical trials network. Read More