The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
The agreement has an initial term until March 31, 2029 and no further details on the financial terms of the deal are being disclosed
Aim of the collaboration is to develop mRNA platform technology, scale up and troubleshoot challenges in mRNA process optimization
Higher efficacy was observed in mRNA-1283 compared to Spikevax in adults 18 years of age and older
The companies have initiated Phase 3 studies in patients with high-risk melanoma and non-small cell lung cancer
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
Annapurna will lead the company in India ensuring patient access to its highly innovative medicines and vaccines
U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024
GAAP net loss of $1.2 billion and GAAP diluted EPS of $(3.07)
Keimed is a leading wholesale pharma distribution with industry leading operating metrics
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