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The UK’s Drug Safety Research Unit (DSRU) is gearing up to start an active surveillance study of COVID-19 vaccines following the country’s emergency clearance of Pfizer’s highly effective coronavirus vaccine, the group announced. Read More
Moderna is preparing to launch a new phase 2/3 trial in the U.S. to assess its promising coronavirus vaccine in adolescent participants aged 12 to 17, though it’s not yet clear when it will start enrolling volunteers. Read More
The U.S. government is exercising its option for an additional 650,000 doses of Eli Lilly’s neutralizing antibody bamlanivimab (LY-CoV555) for $812.5 million, following the drug’s Emergency Use Authorization (EUA) in November for mild-to-moderately ill COVID-19 patients at high risk. Read More
AstraZeneca’s (AZ) late-stage U.S. coronavirus vaccine trial is likely to have efficacy data in January that could be enough for the company to request Emergency Use Authorization (EUA), Operation Warp Speed’s chief adviser Moncef Slaoui said this week. Read More
The Commerce Department is requesting comments on the U.S. supply chain for essential medicines and on the wider public health “industrial base” and is providing an unusually short window for responses. Read More
Teva Pharmaceuticals subsidiary Actavis Laboratories infringed upon five patents belonging to Tris Pharma by producing and marketing generic versions of Tris’s Quillivant XR, an extended-release liquid formulation of methylphenidate to treat attention deficit hyperactive disorder (ADHD), a federal court has ruled. Read More
Regeneron has partnered with the University of Pennsylvania (UPenn) to develop a gene therapy nasal delivery system for its COVID-19 antibody cocktail, casirivimab and imdevimab, which received an Emergency Use Authorization from the FDA last month for mild-to-moderately ill coronavirus patients at high risk. Read More
The global police organization Interpol issued a warning yesterday to countries to prepare for a new wave of organized criminal activity, including cyber hacking of drugmakers as governments prepare to ship their vaccines. Read More