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As the countdown begins toward an eagerly anticipated FDA authorization for Pfizer’s COVID-19 vaccine candidate, an advisory committee of the Centers for Disease Control and Prevention (CDC) is meeting today to discuss the phased distribution of coronavirus vaccines. Read More
The FDA has granted a priority review to Sanofi’s biologics license application (BLA) for an experimental enzyme replacement therapy for patients suffering from Pompe disease, a rare illness that causes muscle deterioration and reduced lung capacity. Read More
Better communications between the FDA and sponsors, and more clarity from the agency on the issue of interchangeability, were among the suggestions from industry yesterday at a public meeting on the next iteration of the user fee program under the Biosimilar User Fee Act of 2017, dubbed BSUFA III. Read More
The FDA released a draft guidance yesterday with proposed recommendations for making changes to the labeling of a previously approved oncology drug that describes how to use the drug in a combination drug regimen. Read More
Russia’s Gamaleya Research Institute has reportedly resumed dosing in a phase 3 trial evaluating its COVID-19 vaccine, Sputnik V., but a Russian government spokesperson denies that the study was ever paused. Read More
The Roche Group’s rheumatoid arthritis drug Actemra (tocilizumab) was found to reduce mortality and improve outcomes for high-risk COVID-19 patients, according to researchers from the UK’s Imperial College London. Read More
As some of the world’s largest drugmakers gear up to manufacture and distribute COVID-19 vaccines, a relatively tiny competitor, Massachusetts-based Moderna, faces some unique challenges. Read More
Researchers at the University of Oxford expect to report results from their phase 3 trials of AstraZeneca’s (AZ) COVID-19 vaccine candidate, AZD1222, before Christmas, the study’s leader said. Read More