The U.S. Food and Drug Administration published a “Statement on Leronlimab,” CytoDyn’s monoclonal antibody that was initially being developed for HIV and cancer before the company began testing for Covid-19. In an unusual public scolding, the regulatory agency accused CytoDyn of misrepresenting clinical trial results for the drug in Covid-19.
The U.S. Food and Drug Administration issued final guidance on May 17 on master protocols for evaluating prevention and treatment options for Covid-19. The guidance took effect immediately and will remain in effect throughout the pandemic.
Gilead Sciences Inc. cut the company’s 2020 revenue forecast, citing lower-than-expected demand and difficulty in predicting sales of remdesivir, the only treatment approved in the United States for patients hospitalized with Covid-19.
Vir Biotechnology Inc. plans to start a mid-to-late stage trial of the company’s Covid-19 drug candidate in August, as drugmakers across the globe rush to find treatments for the highly infectious virus.
