logo
Plus   Neg
Share
Email

CytoDyn Files CMC Of Interim Order Application To Health Canada For COVID-19 - Quick Facts

CytoDyn Inc. (CYDY.OB), a late-stage biotechnology company developing leronlimab, has submitted the manufacturing section of the application for an Interim Order to Health Canada for COVID-19 under a rolling review. This documents the company's manufacturing practices are in full compliance with GMP requirements.

CytoDyn also noted that, in Brazil, two clinical trial protocols for COVID-19 will be submitted to ANVISA, the Brazilian regulatory authority. In the U.S., the company will soon finalize a COVID-19 trial protocol to potentially include a dosage regimen utilizing IV as the first dose and three subcutaneous doses thereafter.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Walt Disney World, the Orlando, Florida-based entertainment complex, is easing the health safety guidelines that were rolled out to prevent the spread of the ongoing COVID-19 pandemic. The complex is ending temperature checks in a phased manner following the advice of the Centers for Disease Control and Prevention (CDC) and local health officials. Frito-Lay North America, the convenient foods division of food and beverages giant PepsiCo, Inc., is recalling select Ruffles All Dressed Potato Chips citing the possible presence of undeclared milk ingredients, a known allergen, the U.S. Food and Drug Administration said. According to the agency, the recalled products may have distributed regionally to Walmart's Sam's Club Warehouses. Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced Friday that they have initiated the Biologics License Application (BLA) process with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The companies initiated...
Follow RTT