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
The FDA released a draft guidance yesterday with proposed recommendations for making changes to the labeling of a previously approved oncology drug that describes how to use the drug in…
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:…
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…
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…
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…
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…
The United Kingdom will launch a new Medical Device Information System (MDIS) in January that aims to improve device monitoring and performance and link them to patient outcomes. Source: The…