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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
Madrigal Pharmaceuticals’ nonalcoholic steatohepatitis (NASH) drug resmetirom has posted strong topline study results showing clinical benefit for patients with liver fibrosis — paving the way for the company to seek accelerated approval early next year. Read More
Part two of Drug Industry Daily’s special report on the state of Alzheimer’s disease research looks ahead to some promising approaches likely to be developed in 2023 and beyond.Read More