Coronavirus Notebook: Veru’s Sabizabulin Prioritized By European & US Regulators, Kinarus’s KIN001 Offers ‘Synergistic Efficacy’
Sabizabulin is the first product to be assessed under the European Medicines Agency’s expanded mandate, and has also been filed for a US emergency use authorization. At global level, the World Health Organization has issued new guidance on the use of second booster doses of COVID-19 vaccines.
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The European Medicines Agency has identified the need for a number of changes to its 16-year-old guideline on the clinical evaluation of medicinal products for the prevention and treatment of ARDS.
UK First To Approve Moderna’s Bivalent COVID-19 Vaccine
The mRNA-1273.214 vaccine will add to the UK’s armory for protecting people against coronavirus over the coming winter season.
EMA Publishes List Of ‘Critical’ COVID-19 Products
A steering group set up by the EU regulator has produced a list of five vaccines and nine therapeutics that it deems essential for use in preventing and treating COVID-19. It will also draw up a list of critical medicines for use in emergency and intensive care during health crises.