Merck Reports Acceptance of BLA to the US FDA for V920 Ebola Virus Vaccine

Merck To Acquire Tilos Therapeutics for ~ $773M

Shots:

  • The US FDA has accepted BLA and granted Priority Review to its V920, under review for the prevention of disease caused by the Ebola Zaire virus with its PDUFA date as Mar 14, 2020
  • Merck continues to expand investigational supply to support international Ebola outbreak response. The news investigational supply will be based on a combination of leveraging material from its ongoing production activities at a manufacturing site at Germany and new production at the clinical manufacturing site in the US
  • Merck’s V920 is an investigational Ebola Zaire vaccine and has received FDA’s BT designation in Jul’2016. The EMA has accepted its MAA in Mar’19 and submission have been made to WHO for prequalification status and to health authority representatives of the African Vaccine Regulatory Forum (AVAREF)

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