Roche and Regeneron Pharmaceuticals have received approval from Japan’s Ministry of Health, Labour and Welfare for Ronapreve to treat mild to moderate Covid-19. The drug is a combination of two monoclonal antibodies, casirivimab and imdevimab. Japan is the first country to provide full approval for the treatment, which is authorised for emergency or temporary use in several other countries, including the US and EU.
The European Medicines Agency’s human medicines committee has begun a rolling review of Sanofi’s Covid-19 vaccine, Vidprevtyn. The review is based on initial data from non-clinical and early clinical studies in adults. Upon the availability of data, the regulator will assess whether the benefits of the vaccine outweigh its risks. The review will be ongoing until the data required for a marketing authorisation filing is available.
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Takeda Pharmaceutical has entered a new agreement with Moderna and the Japanese government to import and supply 50 million additional doses of Moderna’s Covid-19 vaccine in 2022, including the option for booster vaccines, if authorised. The partners previously agreed on the supply of 50 million doses of the vaccine this year, taking the total of both agreements to 100 million doses.
