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…
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…
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…
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…
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. Source: Drug Industry Daily
The European Union appears to have reversed its previous stance on intellectual property (IP) waivers for COVID-19 vaccines and therapeutics. Instead of threatening to veto IP waivers in ongoing World…
Will more city and county governments now begin suing pharmacy companies over their role in the opioid crisis? Source: Drug Industry Daily
Due to the Biden Administration’s failure to furnish Congress with papers by the deadline, Robert Califf is unlikely to get a full Senate floor vote on his nomination for the…
GlaxoSmithKline (GSK) has forged an exclusive license agreement with Arrowhead Pharmaceuticals to develop and commercialize ARO-HSD, Arrowhead’s investigational RNA interference (RNAi) therapeutic currently in a phase 1/2 trial. The deal…