COVID-19 UPDATE

COVID-19 UPDATE

Two days ago, EMA notified the start of a rolling review of data on the monoclonal antibody regdanvimab (Celltrion) for the treatment of COVID-19. These are great news, as now there are a total of 5 products being evaluated by EMA (3 vaccines and 2 treatments) which could be placed on the market during the following months, depending on the results of the evaluation.

The development of new tools to treat COVID-19 brings renewed hopes to fight against the pandemic. At Asphalion we are actively aiding in the development of vaccines and treatments for COVID-19, bringing our best to help all developers get their products ready to be authorized.

For further information you can contact us at: info@asphalion.com

Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2
IDMP version 2.0 has been published