Archive for November 2020
Sanofi Gets Priority Review for Investigational Enzyme Therapy
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
Read MoreAstraZeneca Vaccine Results Likely By Christmas, With Early Efficacy Findings in Weeks
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
Read MoreRussia Denies Pause in COVID-19 Vaccine Trial
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
Read MoreRoche’s Actemra Improves COVID-19 Survival, Study Claims
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
Read MoreFDA Issues Advice on Cross Labeling for Oncology Drugs
The FDA released a draft guidance yesterday with proposed recommendations for making changes to the labeling of a previously approved oncology drug that describes how to use the drug in a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
Read MoreHow Moderna is Taking on the Pharma Giants With its COVID-19 Vaccine
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
Read MoreMeet Sooner With Us, Biosimilars Industry Asks FDA
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
Read MoreIMDRF Advances Device Conformity Assessment Documents
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 conference due to the COVID-19 pandemic. Source: The GMP Letter
Read MoreFDA Warns of Infection Risk From Heater-Coolers
The FDA has raised concerns about the risk of infections associated with CardioQuip’s modular heater-cooler device. Source: The GMP Letter
Read MoreHealth Canada Updates Guidelines on COVID-19 Testing
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 Letter
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