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
Jeffrey N. Hausfeld, Rodeina Challand, Kristi McLendon, Nathaniel Macapagal, Pam Bruce-Staskal, Christina Fiaschetti and Darryl B. Sampey. Clinical Pharmacology in Drug Development. July 2023. BioFactura has developed a proposed biosimilar candidate (BFI-751) to ustekinumab reference product. Results are reported for the first-in-human trial designed to compare the pharmacokinetic profiles, safety, and immunogenicity of BFI-751 and … Continue reading
From Mike Lee U.S. Senator of Utah July 13, 2023, WASHINGTON – Sens. Mike Lee (R-UT), Ben Ray Luján (D-NM), Mike Braun (R-IN), and J.D. Vance (R-OH) introduced the Biosimilar Red Tape Elimination Act to increase competition within the biological drug market and increase access to low-cost prescription drugs. <Read Full Article>… 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
From BioBuzz by Workforce Genetics By Steven Surdez 12AUG2022 A key recent hire for BioFactura was biosimilars and scientific affairs expert Rodeina Challand, who joined the team as its new VP of Scientific Affairs in late 2021. We caught up with Challand to discuss her background, the biosimilars market landscape, and why she’s excited about what’s next … 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
From Generics Bulletin/Informa Pharma Intelligence By Dean Rudge 14SEP2021 BioFactura, which is already using its ‘StableFast’ technology platform to develop its biosimilar ustekinumab candidate, has allied with fellow US-based biotech Rani Therapeutics to see if the biologic can be formulated into Rani’s proprietary ‘robotic’ pill. <Read Full Article>… 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