The filing is backed by Phase III data from the lidERA Breast Cancer study
The companies say the drug has now demonstrated clinical benefit in three separate Phase 3 trials
The transaction includes an upfront payment of $1.55 billion, along with up to $1.1 billion in regulatory and commercial milestone payments
First-in-class treatment of life-threatening, drug-resistant Acinetobacter baumannii infections advancing toward Phase II clinical proof-of-concept
Accreditations for Bhayla manufacturing site strengthen the company’s global quality credentials and support expansion of its hormone portfolio into regulated international markets
Acquisition provides direct access to the Dutch healthcare market, enhancing Marksans’ sales, distribution and market-access capabilities across regulated European markets
An exploratory overall survival signal also leaned in favor of the combination, though the companies noted the result remains preliminary
The safety profile was described as manageable, though not without notable toxicities
CEPI will commit up to US $50 million to fund preclinical research and Phase 1 clinical trials of Moderna’s mRNA-based vaccine candidate
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