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
HTL will build, validate and operate a botulinum manufacturing facility in the US
Trillium’s portfolio includes biologics that are designed to enhance the ability of patients’ innate immune system to detect and destroy cancer cells
Targeting KIT by frameshifting mRNA transcripts as a therapeutic strategy for aggressive mast cell neoplasm
SAB-185 is currently being evaluated in NIH-sponsored Phase 2/3 adaptive trial
OptumRx to make Pear’s three commercial Prescription Digital Therapeutics accessible to patients with Optum formulary access.
Founded in 2019, the start-up develops digital therapeutics, a therapeutic intervention from the convergence of biology and information technology
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