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As part of its ongoing efforts to make clinical trials more representative of the population, the FDA yesterday issued a final guidance on what sponsors should do to make trials more accessible and appealing to under-represented racial, ethnic, gender and age groups. Read More
The FDA has issued an Emergency Use Authorization (EUA) for Eli Lilly’s monoclonal antibody treatment bamlanivimab (LY-CoV555), clearing the drug for use in high-risk patients with mild-to-moderate COVID-19 who don’t need hospitalization or oxygen. Read More
Pfizer and BioNTech have pulled ahead to become the frontrunners in the race for a COVID-19 vaccine, announcing that the first interim analysis from their late-stage trial showed the candidate was more than 90 percent effective. Read More
One arm of the UK’s RECOVERY trial evaluating potential COVID-19 treatments is including aspirin in combination with the drugs being evaluated. Read More
Humanigen on Friday revealed positive interim data in a late-stage clinical trial of its monoclonal antibody lenzilumab for the treatment of COVID-19 patients, but a trial design expert contended that the disclosure was inappropriate and could put the trial’s integrity at risk. Read More
In an investor call yesterday, Regeneron CEO Leonard Schleifer said he hoped for an early decision by the FDA on an Emergency Use Authorization (EUA) of the company’s COVID-19 antibody cocktail treatment REGN-COV2. Read More
Researchers saw a beneficial reduction in hyperphagia, an overeating disorder, and significant reduction in fat mass following 13 weeks of treatment. Read More
Sponsors of randomized clinical trials (RCT) using real-world data (RWD) to support regulatory decisions in the UK should show they have applied the same data validity and integrity standards used for conventional trial sources, according to a draft guidance the Medicines and Healthcare products Regulatory Agency (MHRA) published in late October. Read More