Merck has shared these additional analyses with the FDA and they will be presented to the FDA’s Antimicrobial Drugs Advisory Committee on Nov. 30th
The multi-target agreement covers five programmes focused on off-the-shelf vaccines for cancer and infectious disease
Bioanalytical approach to accelerate development efforts in the identification of compounds that can treat chlorine or sulfur mustard injuries
Biocon Biologics and Viatris co-developed the products
The collaboration will combine Metagenomi’s next-generation CRISPR-based and other novel gene editing systems with Moderna’s mRNA and LNP technologies
The acquisition expands Takeda’s immuno-oncology and innate immune cell therapy portfolio with novel platforms leveraging T cells for the potential treatment of solid tumours and haematological malignancies
Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
The rolling submission to the U.S. FDA will begin in the fourth quarter of this year
Advancement to Phase 3 is a major milestone for SAB’s unique DiversitAb immunotherapy platform that produces fully human polyclonal antibodies without human donors
Everest gains access to a clinically validated mRNA platform and a potentially “best-in-class” mRNA COVID-19 vaccine with full technology transfer
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