The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations
Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time
Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma
mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone in stage III/IV melanoma patients
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial and unmet need for additional therapeutic options for certain types of melanoma
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma
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