News | February 25, 2023
EMA recommends refusal of the marketing authorization for Lagevrio
Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
The safety profile of LAGEVRIO in this trial was generally consistent with that observed in previously reported clinical studies
FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US
This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting
Results are the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial
Presentations include new data on investigational medicines – favezelimab (MK-4280), zilovertamab vedotin (MK-2140) and nemtabrutinib – as well as KEYTRUDA (pembrolizumab) in multiple blood cancers
Acquisition expands Merck’s growing hematology portfolio
Separate Phase 3 study evaluating 200 days of therapy with PREVYMIS in HSCT recipients at high risk of late clinically significant CMV infection recently completed, meeting its primary endpoint
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