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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. Read More
The FDA released a draft guidance yesterday with proposed recommendations for making changes to the labeling of a previously approved oncology drug that describes how to use the drug in a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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Three large European investors are teaming up to form a $750 million company to create biopharmaceuticals businesses in Africa aiming to broaden the range of therapeutics available in the underserved markets there. Read More
The FDA has not been fully transparent about its Emergency Use Authorizations (EUAs) for COVID-19 treatments as it “does not uniformly disclose” its scientific review of safety and effectiveness data for EUAs, as it does for approvals for new drugs and biologics,” the Government Accountability Office said in a new report to Congress. Read More