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Development of a long-acting relaxin analogue, LY3540378, for treatment of chronic heart failure.
Verdino P, Lee SL, Cooper FN, Cottle SR, Grealish PF, Hu CC, Meyer CM, Lin J, Copeland V, Porter G, Schroeder RL, Thompson TD, Porras LL, Dey A, Zhang HY, Beebe EC, Matkovich SJ, Coskun T, Balciunas AM, Ferrante A, Siegel R, Malherbe L, Bivi N, Paavola CD, Hansen RJ, Abernathy MM, Nwosu SO, Carr MC, Heuer JG, Wang X. Verdino P, et al. Among authors: bivi n. Br J Pharmacol. 2023 Aug;180(15):1965-1980. doi: 10.1111/bph.16055. Epub 2023 Mar 8. Br J Pharmacol. 2023. PMID: 36780899
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).
Mora J, Palmer R, Wagner L, Wu B, Partridge M, Meena, Sonderegger I, Smeraglia J, Bivi N, Dakappagari N, Diebold S, Garofolo F, Grimaldi C, Kalina W, Kamerud J, Kar S, Marshall JC, Mayer C, Melton A, Merdek K, Nolan K, Picard S, Shao W, Seitzer J, Tanaka Y, Tounekti O, Vigil A, Walravens K, Xu J, Xu W, Xu Y, Yang L, Zhu L, Verthelyi D, Kubiak RJ, Coble K, Gupta S, Abhari MR, Richards S, Song Y, Ullmann M, Calderon B, Cludts I, Gunn GR, Gupta S, Ishii-Watabe A, Manangeeswaran M, Maxfield K, McCush F, O'Day C, Peng K, Poetzl J, Rasamoelisolo M, Saad OM, Scheibner K, Shubow S, Song S, Thacker S. Mora J, et al. Among authors: bivi n. Bioanalysis. 2024 Apr;16(7):77-119. doi: 10.4155/bio-2024-0024. Epub 2024 Feb 22. Bioanalysis. 2024. PMID: 38389403 Free article.
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).
Pan L, Mora J, Walravens K, Wagner L, Hopper S, Loo L, Bettoun D, Bond S, Dessy F, Downing S, Garofolo F, Gupta S, Henderson N, Irwin C, Ishii-Watabe A, Kar S, Jawa V, Joseph J, Malvaux L, Marshall JC, McDevitt J, Mohapatra S, Seitzer J, Smith J, Solstad T, Sugimoto H, Tounekti O, Wu B, Wu Y, Xu Y, Xu J, Yamamoto T, Yang L, Torri A, Kirshner S, Maxfield K, Vasconcelos JP, Abhari MR, Verthelyi D, Brodsky E, Carrasco-Triguero M, Kamerud J, Andisik M, Baltrukonis D, Bivi N, Cludts I, Coble K, Gorovits B, Gunn GR, Gupta S, Millner AH, Joyce A, Kubiak RJ, Kumar S, Liao K, Manangeeswaran M, Partridge M, Pine S, Poetzl J, Rajadhyaksha M, Rasamoelisolo M, Richards S, Song Y, Swanson S, Thacker S, Wadhwa M, Wolf A, Zhang L, Zhou L. Pan L, et al. Among authors: bivi n. Bioanalysis. 2023 Jul;15(14):773-814. doi: 10.4155/bio-2023-0135. Epub 2023 Aug 1. Bioanalysis. 2023. PMID: 37526071 Free article.
Safety and Immunogenicity of LY3415244, a Bispecific Antibody Against TIM-3 and PD-L1, in Patients With Advanced Solid Tumors.
Hellmann MD, Bivi N, Calderon B, Shimizu T, Delafontaine B, Liu ZT, Szpurka AM, Copeland V, Hodi FS, Rottey S, Aftimos P, Piao Y, Gandhi L, Galvao VR, Leow CC, Doi T. Hellmann MD, et al. Among authors: bivi n. Clin Cancer Res. 2021 May 15;27(10):2773-2781. doi: 10.1158/1078-0432.CCR-20-3716. Epub 2021 Jan 13. Clin Cancer Res. 2021. PMID: 33441294 Clinical Trial.
Characterization of the cytokine storm reflects hyperinflammatory endothelial dysfunction in COVID-19.
Sims JT, Krishnan V, Chang CY, Engle SM, Casalini G, Rodgers GH, Bivi N, Nickoloff BJ, Konrad RJ, de Bono S, Higgs RE, Benschop RJ, Ottaviani S, Cardoso A, Nirula A, Corbellino M, Stebbing J. Sims JT, et al. Among authors: bivi n. J Allergy Clin Immunol. 2021 Jan;147(1):107-111. doi: 10.1016/j.jaci.2020.08.031. Epub 2020 Sep 10. J Allergy Clin Immunol. 2021. PMID: 32920092 Free PMC article.
37 results