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The European Medicines Agency (EMA) has launched a new pilot program that gives some study leeway to drugmakers working on pediatric investigation plans (PIP) for innovative children’s medicines. Read More
The European Medicines Agency (EMA) is requesting public comment on its new multi-stakeholder platform, Accelerating Clinical Trials (ACT) EU, for improving clinical trials within the trade bloc. Read More
Nearly four dozen pediatric clinical trials involving more than 3,600 children failed to publish their findings on ClinicalTrials.gov or in scientific literature, according to a new analysis by U.K.-based trial transparency advocacy group TranspariMED and other non-U.S. researchers. Read More
The FDA has launched a pilot program to increase the efficiency and predictability of biosimilar development, and decrease the cost and time of development — and has released a “research roadmap” to help researchers reach those goals. Read More
Merck’s KEYNOTE trials of its mega-blockbuster cancer drug Keytruda (pembrolizumab) had mixed results this week, failing in another bid for prostate cancer but hitting the mark with biliary tract cancer. Read More
Moderna is claiming a phase 3 win based on interim trial data for its investigational mRNA-1345 vaccine targeting respiratory syncytial virus (RSV). Read More
With a decision from the FDA on Eisai’s Alzheimer’s drug candidate lecanemab expected as soon as today, an autopsy report published in the New England Journal of Medicine highlighted the potential for devastating consequences associated with concomitant treatment with the antiamyloid antibody and thrombolytic therapy for ischemic stroke. Read More
Pfizer has posted positive topline phase 3 numbers for its fidanacogene elaparvovec infusion, setting the stage for an escalation in the race with CSL Behring to cure hemophilia B via gene therapy. Read More