The import, sale and marketing of a competitor to AbbVie’s Botox wrinkle treatment must be stopped for nearly two years, the U.S. International Trade Commission (ITC) ruled this week. Source:…
COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could…
GlaxoSmithKline has received FDA approval for Benlysta (belimumab) to treat active lupus nephritis, a serious inflammation of the kidneys that appears in about four in 10 patients with the most…
Before proceeding with trials that use complex innovative designs (CID), sponsors should meet with the FDA to discuss their plans, according to a final guidance released Wednesday that provides details…
The FDA released a draft guidance yesterday with proposed recommendations for making changes to the labeling of a previously approved oncology drug that describes how to use the drug in…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…
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…