Frederick, Maryland, October 2, 2023: BioFactura, Inc. today announced a contract option activation of over $16 million by the Biomedical Advanced Research and Development Authority (BARDA) part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, as part of its prime contract valued at over $77 million … Continue reading
Frederick, Maryland, September 11, 2023: BioFactura, Inc. announced the publication of the phase 1 study for BFI-751, a biosimilar candidate to Stelara (ustekinumab) (Jeffrey N. Hausfeld, Rodeina Challand, Kristi McLendon et al; Pharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI-751): Results From a Randomized Phase 1Trial. Clinical Pharmacology, in Drug Development, 2023, 0(0) 1–12). Pairwise comparisons … Continue reading
Frederick, Maryland, July 10, 2023: BioFactura, Inc. today announced that CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has entered into an exclusive license to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara (Ustekinumab). Ustekinumab is a recombinant monoclonal antibody that works by blocking both interleukins IL-12 and IL-23 and is used … Continue reading
Frederick, Maryland, July 14, 2022: BioFactura Inc. (“BioFactura”) today announced its second contract option activation of $15.9 million from the Biomedical Advanced Research and Development Authority (BARDA) to advance development of an antibody cocktail therapeutic for the treatment of smallpox. This funding is part of BioFactura’s prime contract valued at up to $68.2 million for the … Continue reading
Frederick, Maryland, September 9, 2021: BioFactura Inc. (“BioFactura”), a leading developer of high-value biosimilar and biodefense drugs using its patented StableFast™ platform, announces an agreement with Rani Therapeutics (“Rani”) to assess its Ustekinumab Biosimilar (BFI-751) in combination with Rani’s RaniPill™ platform. BFI-751 is being developed by BioFactura Australia Pty Ltd, a subsidiary of BioFactura, as a biosimilar … Continue reading
Frederick, Maryland, May 25, 2021: BioFactura, a leading developer of high-value biosimilar and biodefense drugs using its patented StableFastTM platform, announces today the initiation of a pivotal PK (pharmacokinetics) Phase 1 Clinical Trial for its Ustekinumab Biosimilar (BFI-751), to assess the effects on healthy human volunteers compared to the biologic medicine, Stelera®. This is the first … Continue reading
Frederick, Maryland, February 19, 2021: BioFactura, Inc. today announced a contract option activation of over $13 million by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, as part of BioFactura’s prime contract valued at … Continue reading
Frederick, Maryland, September 24, 2020: BioFactura, Inc. was issued a new patent in the U.S. and also granted patent coverage in the EU for novel technologies that improve the productivity of its proprietary StableFastTM Biomanufacturing Platform. The new Multiplex Selection components of the platform allow for concurrent selection strategies to be applied during stable cell … Continue reading
Frederick, Maryland, July 27, 2020: BioFactura, Inc. today announced a $1 million Small Business Innovation Research (SBIR) Phase II contract awarded by the Joint Science & Technology Office—Chemical and Biological Defense (JSTO-CBD) of the Department of Defense (DoD). The goal of this project is to develop, optimize, and scale-up a highly efficient mammalian cell culture-based … Continue reading
Frederick, Maryland, September 26, 2019: BioFactura, Inc. today announced a contract awarded by the Biomedical Advanced Research and Development Authority (BARDA) valued at up to $67.4 million for the advanced development of its Smallpox Biodefense Therapeutic as a potential medical countermeasure (MCM) for the treatment of smallpox. This product has the potential to fulfill an … Continue reading