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In an investor call yesterday, Regeneron CEO Leonard Schleifer said he hoped for an early decision by the FDA on an Emergency Use Authorization (EUA) of the company’s COVID-19 antibody cocktail treatment REGN-COV2. Read More
Researchers saw a beneficial reduction in hyperphagia, an overeating disorder, and significant reduction in fat mass following 13 weeks of treatment. Read More
Sponsors of randomized clinical trials (RCT) using real-world data (RWD) to support regulatory decisions in the UK should show they have applied the same data validity and integrity standards used for conventional trial sources, according to a draft guidance the Medicines and Healthcare products Regulatory Agency (MHRA) published in late October. Read More
UK Vaccine Taskforce Chairwoman Kate Bingham revealed Wednesday that the country will have millions fewer doses of AstraZeneca’s vaccine candidate available by the end of the year than previously anticipated. Read More
The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to fund development of a potential COVID-19 vaccine from China’s Clover Biopharmaceuticals with a global phase 2/3 study and through licensing and distribution. Read More
German biopharma company CureVac announced yesterday that its COVID-19 vaccine hopeful generated immune responses and was generally well-tolerated in phase 1 trial participants, lending support for a pivotal trial before year’s end. Read More