Pfizer: meningitis vaccine gets FDA's breakthrough status

(CercleFinance.com) - US pharmaceutical giant Pfizer said on Monday that US regulators have given breakthrough therapy status to an active immunization to prevent meningitis B in children aged between 1 and 9.


Pfizer's Trumenba previously received a breakthrough therapy designation in 2014 for the prevention of meningitis B in adolescents and young adults, and later the same year received FDA approval as the first meningitis B vaccine approved in the US.

The health group also announced today that the European Commission has approved Mylotarg for the treatment of acute myeloid leukaemia.

Finally, Pfizer today announced that it has received a complete response letter from the FDA saying that it cannot approve the new drug application for the company's proposed biosimilar of Roche cancer drug Herceptin.

Copyright (c) 2018 CercleFinance.com. All rights reserved.