Drug Approval | February 23, 2023
Moderna and Merck announce investigational personalized cancer vaccine mRNA-4157/V940
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
The new Beyfortus data are consistent with all data accumulated to date and confirm its strong profile
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
The agreement between Eli Lilly and Janssen was established to allow the two companies to share resources for the goal of accelerating the evaluation of the respective companies’ assets, mirikizumab and Tremfya (guselkumab).
Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US
mRNA-1345 demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults
Moderna and Merck announced mRNA-4157/V940, in combination with KEYTRUDA, demonstrated a 44% reduction in the risk of disease recurrence or death in melanoma patients
If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine
Advent will also be making an open offer to acquire additional 26% of the outstanding equity shares of the company from the public shareholders.
First PARP inhibitor and new hormonal agent combination approved for these patients in Europe
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