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The biotech announced three major regulatory updates for its COVID-19 vaccine this morning.

Health Canada filing marks first protein-based COVID-19 vaccine submitted for authorization to regulatory authorities in Canada Submission of all modules...

Sanofi to help manufacture Janssen COVID-19 vaccine Sanofi’s vaccine manufacturing plant in Marcy l’Etoile, France, will formulate and fill vials of Janssen’s COVID-19 vaccine: producing around 12 million doses a month to help address global supply demands. Situated outside of Lyon, Sanofi's facility covers vaccine research, development and production. It produces vaccines against diseases such as diphtheria, typhoid, tetanus, polio and whooping cough.  Sanofi's Marcy l'Etoile facility will join other Moderna's vaccine will be produced from Recipharm's Mont...

CureVac has initiated a rolling review with the European Medicines Agency (EMA), working towards authorization for its mRNA COVID-19 vaccine in the European Union. The candidate is currently in Phase 3 trials in Europe and Latin America, and the rolling review with the EMA is its first submission for authorization globally. Phase 1 interim data, announced in November, showed that CVnCoV was generally well tolerated across all tested doses and induced strong antibody responses in addition to first indication of T cell activation. The quality of immune response was ...

Celltrion’s COVID-19 treatment candidate receives Korean MFDS Conditional Marketing Authorisation     Regdanvimab (CT-P59) receives conditional marketing authorisation from the Korean Ministry of Food and Drug Safety (MFDS); first anti-COVID-19 monoclonal antibody treatment to be approved in Korea  CT-P59 is authorised for the treatment of adult patients aged 60 and over, or with at least one underlying medical condition, with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19  Celltrion is under discussion with the European Medicines Ag...