Archive for November 2021
FDA Panel Narrowly Backs EUA for Merck’s COVID-19 Antiviral
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
Read MoreFDA Signals Willingness to Quickly Collaborate with Industry to Tackle Omicron
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:…
Read MoreGSK Hires Vaccine Star Away from Pfizer to Boost its Vaccine Operations
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
Read MoreHouse to Vote on Budget Continuing Resolution as Early as Wednesday
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
Read MoreImmunoGen Will File BLA For Mirvetuximab In Hard-to-Treat Ovarian Cancer
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
Read MoreFDA Offers Advice on Using Real-World Evidence From Registries
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
Read MoreFDA Panel Reviews Data Showing Merck’s COVID-19 Antiviral Reduces Hospitalization by 30 Percent
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
Read MoreU.S. Trade Rep Will Press WTO for IP Framework for COVID-19 Vaccines Despite Meeting Postponement
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:…
Read MoreOcugen Hits A Stumbling Block for Its COVID-19 Vaccine Candidate
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
Read MoreU.S.-Based COVID-19 Vaccine Makers are Gearing up to Face Omicron with Biden Administration’s Help
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:…
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