Archive for November 2021

In a 13-10 vote yesterday, an FDA advisory committee recommended that the FDA should grant Emergency Use Authorization (EUA) for molnupiravir, the antiviral pill co-developed by Merck and Ridgeback Biotherapeutics. Source: Drug Industry Daily

Amid the increasing travel bans, cancelations and worry caused by the new Omicron variant of the SARS-CoV-2 virus, Acting FDA Commissioner Janet Woodcock said yesterday that the FDA is ready to quickly collaborate with industry in whatever way is needed. However, immunogenicity studies would be required if vaccine makers need to modify their vaccines. Source:…

GlaxoSmithKline (GSK), whose COVID-19 vaccine development efforts have lagged behind those of competitors, has hired away one of the top scientists behind the Pfizer COVID-19 jab, which has been the most ubiquitous of the three vaccines approved for use in the U.S. Source: Drug Industry Daily

With government funding set to expire on Friday, the House could vote as soon as today on a stopgap measure to avert a shutdown and keep federal agencies operating. Source: Drug Industry Daily

Armed with strong results from a late-stage clinical trial, ImmunoGen plans to submit a new Biologics License Application (BLA) for its drug/antibody conjugate Mirvetuximab (mirvetuximab soravtansine) as a treatment for women with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Roche’s Avastin (bevacizumab). Source: Drug Industry Daily

The FDA has issued recommendations for sponsors who are hoping to use real-world data from registries to support regulatory approval of a new drug or biologic. Source: Drug Industry Daily

Merck’s COVID-19 antiviral, molnupiravir, lowered the risk of hospitalization or death by just 30 percent, according to the results of a late-stage study that will be reviewed today by an FDA expert panel. Source: Drug Industry Daily

In a pair of tweets, U.S. Trade Representative Katherine Tai said the U.S. would persist in pressing for members of the World Trade Organization (WTO) to move ahead with an intellectual property framework for COVID-19 vaccines. This, after an important in-person WTO ministerial meeting this week was postponed due to the fast-spreading Omicron variant. Source:…

The FDA has placed a clinical hold on Ocugen’s Investigational New Drug (IND) application for BBV152, the company’s COVID-19 vaccine candidate known as Covaxin outside the U.S. Source: Drug Industry Daily

While new COVID-19 variant Omicron is now charging across Asia and Europe, causing cancellations and travel bans, vaccine makers Moderna, Pfizer/BioNTech and Johnson & Johnson (J&J) each say they are already working to tackle it. And President Biden said the U.S. government is in touch with each company, ready to help accelerate contingency plans. Source:…