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April 20, 2023
SAB Biotherapeutics has received both breakthrough and fast track designations from FDA for its lead antibody drug candidate for treating influenza.
April 18, 2023
Jaeger notes that the program is focused on addressing specific scientific questions that will produce immediate impacts on how CDER and FDA make drug approval decisions.
Merck will acquire Prometheus Biosciences, a clinical-stage biotechnology company specializing in immune-mediated diseases, at a total equity valuation of $10.8 billion.
Moderna and Merck reported that a combination therapy involving pembrolizumab and an mRNA demonstrated a 44% reduction in recurrence or death in cancer patients compared to non-combination treatments.
AbbVie’s RINVOQ has received European Commission approval for the treatment of moderately to severely active Crohn’s disease.
Gamida Cell’s therapy is meant to reduce the risk of infection following stem cell transplantation.
Integrated systems combine functions.
April 14, 2023
Avid Bioservices has launched new CGMP mammalian cell manufacturing suites at its Myford, Calif., facility.
FDA has granted fast track designation to Caribou Biosciences for its allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma.
Under this partnership, the two companies will develop bioprinted tissue therapeutics for diabetes and obesity.