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…
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…
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…
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:…
The FDA released a draft guidance yesterday with proposed recommendations for making changes to the labeling of a previously approved oncology drug that describes how to use the drug in…
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 International Medical Device Regulators Forum (IMDRF) made some progress toward global harmonization of device standards at its most recent meeting — held for the first time as a virtual…
The FDA has raised concerns about the risk of infections associated with CardioQuip’s modular heater-cooler device. Source: The GMP Letter
Health Canada is fast-tracking the review of submissions related to rapid antigen detection tests (RADTs) and nucleic acid tests and has released new guidance on antigen testing. Source: The GMP…