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The FDA wants drugmakers to use clinical remission as their primary endpoint when conducting trials for short-term ulcerative colitis therapies. Read More
The FDA is simplifying the process of developing written procedures for an IRB, providing industry with a comprehensive checklist that satisfies both FDA and HHS requirements. 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
When planning an international clinical trial, setting endpoints that are clinically meaningful across regions and planning ahead for local factors are recommended in draft FDA guidance. Read More
The EMA is mapping out trial designs for the development of therapies to treat Crohn’s disease, ulcerative colitis and mycobacterium tuberculosis. Read More
The fallout continues from a series of deaths in Juno Therapeutics’ leukemia trial, as the company disclosed that it experienced four patient deaths, not three as it had previously reported. Read More
The EMA is advising drugmakers to rely on two types of analyses — metabolic and mechanism of action — to determine the minimum effective dosage for antimicrobial drugs. Read More