A federal appeals court has struck down Moderna’s coronavirus vaccine-related challenge to patents held by Arbutus Biopharma. Read More

Novavax is throwing two punches at Omicron, the new COVID-19 variant that’s sparking fresh waves of travel restrictions: evaluating how well its lead COVID-19 vaccine candidate NVX-CoV2373 targets the new variant and creating a new vaccine made specifically to target the highly mutated virus. Read More

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. Read More

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. Read More

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. Read More

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. Read More

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. Read More

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. Read More

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. Read More

India-based Bharat Biotech’s COVID-19 vaccine, Covaxin (BBV152), was just 50 percent effective in preventing infections among hospital employees in India who received the recommended two doses. Read More

Did former FDA Commissioner Stephen Hahn cave to political pressure from the Trump Administration in authorizing hydroxychloroquine and convalescent plasma as treatments for COVID-19 even though there was scant evidence of their efficacy? Read More

The two-dose Pfizer-BioNTech COVID-19 vaccine regimen was 100 percent effective in preventing disease in children aged 12-15 years, the companies reported. Read More