Archive for November 2020

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

The FDA released a draft guidance yesterday with proposed recommendations for making changes to the labeling of a previously approved oncology drug that describes how to use the drug in a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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily