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Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants.
Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Brooks D, Grenham A, Wählby Hamrén U, Mankad VS, Ren P, Takas T, Abram ME, Leach A, Griffin MP, Villafana T; MELODY Study Group. Hammitt LL, et al. N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275. N Engl J Med. 2022. PMID: 35235726 Clinical Trial.
Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity.
Domachowske J, Madhi SA, Simões EAF, Atanasova V, Cabañas F, Furuno K, Garcia-Garcia ML, Grantina I, Nguyen KA, Brooks D, Chang Y, Leach A, Takas T, Yuan Y, Griffin MP, Mankad VS, Villafana T; MEDLEY Study Group. Domachowske J, et al. N Engl J Med. 2022 Mar 3;386(9):892-894. doi: 10.1056/NEJMc2112186. N Engl J Med. 2022. PMID: 35235733 Clinical Trial. No abstract available.
Nirsevimab for Prevention of RSV in Term and Late-Preterm Infants.
Muller WJ, Madhi SA, Seoane Nuñez B, Baca Cots M, Bosheva M, Dagan R, Hammitt LL, Llapur CJ, Novoa JM, Saez Llorens X, Grenham A, Kelly EJ, Mankad VS, Shroff M, Takas T, Leach A, Villafana T; MELODY Study Group. Muller WJ, et al. N Engl J Med. 2023 Apr 20;388(16):1533-1534. doi: 10.1056/NEJMc2214773. Epub 2023 Apr 5. N Engl J Med. 2023. PMID: 37018470 No abstract available.
Safety of Re-dosing Nirsevimab Prior to RSV Season 2 in Children With Heart or Lung Disease.
Domachowske JB, Chang Y, Atanasova V, Cabañas F, Furuno K, Nguyen KA, Banu I, Kubiak RJ, Leach A, Mankad VS, Shroff M, Takas T, Villafana T, Wählby Hamrén U. Domachowske JB, et al. Among authors: kubiak rj. J Pediatric Infect Dis Soc. 2023 Aug 31;12(8):477-480. doi: 10.1093/jpids/piad052. J Pediatric Infect Dis Soc. 2023. PMID: 37466917 Free PMC 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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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: kubiak rj. Bioanalysis. 2023 Jul;15(14):773-814. doi: 10.4155/bio-2023-0135. Epub 2023 Aug 1. Bioanalysis. 2023. PMID: 37526071
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: kubiak rj. Bioanalysis. 2024 Apr;16(7):77-119. doi: 10.4155/bio-2024-0024. Epub 2024 Feb 22. Bioanalysis. 2024. PMID: 38389403
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).
Stevenson L, Richards S, Pillutla R, Torri A, Kamerud J, Mehta D, Keller S, Purushothama S, Gorovits B, Litwin V, Stebbins C, Marini J, Beaver C, Sperinde G, Siguenza P, Staack RF, Qiu Y, Amaravadi L, Amur S, Fleener CA, Baltrukonis D, Catlett I, Cherry E, Chung S, Cludts I, Donato LD, Fischer S, Fraser S, Garofolo F, Green C, Gunn G, Haidar S, Haulenbeek J, Henderson N, Hopper S, Ishii-Watabe A, Islam R, Janelsins B, Jawa V, Kakkanaiah V, Kamondi S, Kolaitis G, Kubiak RJ, Kumar S, Kurki P, Liang M, Liu P, Maxfield K, Myler H, Palackal N, Palmer R, Pedras-Vasconcelos J, Piccoli S, Rhyne P, Saito Y, Savoie N, Schick E, Schweighardt B, Shih J, Song A, Sriraman P, Staelens L, Sumner G, Sun Y, Ullmann M, Verthelyi D, Wadhwa M, Wang YM, Xu Y, Yan H, Yang TY, Zeng R. Stevenson L, et al. Among authors: kubiak rj. Bioanalysis. 2018 Dec;10(24):1973-2001. doi: 10.4155/bio-2018-0287. Epub 2018 Nov 29. Bioanalysis. 2018. PMID: 30488726 Review.
Multiplex Bioanalytical Methods for Comprehensive Characterization and Quantification of the Unique Complementarity-Determining-Region Deamidation of MEDI7247, an Anti-ASCT2 Pyrrolobenzodiazepine Antibody-Drug Conjugate.
Huang Y, Yuan J, Mu R, Kubiak RJ, Ball K, Cao M, Hussmann GP, de Mel N, Liu D, Roskos LK, Liang M, Rosenbaum AI. Huang Y, et al. Among authors: kubiak rj. Antibodies (Basel). 2023 Oct 17;12(4):66. doi: 10.3390/antib12040066. Antibodies (Basel). 2023. PMID: 37873863 Free PMC article.
Safety, Tolerability and Pharmacokinetics of Half-Life Extended Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Monoclonal Antibodies AZD7442 (Tixagevimab-Cilgavimab) in Healthy Adults.
Forte-Soto P, Albayaty M, Brooks D, Arends RH, Tillinghast J, Aksyuk AA, Bouquet J, Chen C, Gebre A, Kubiak RJ, Pilla Reddy V, Seegobin S, Streicher K, Templeton A, Esser MT. Forte-Soto P, et al. Among authors: kubiak rj. J Infect Dis. 2023 May 12;227(10):1153-1163. doi: 10.1093/infdis/jiad014. J Infect Dis. 2023. PMID: 36683419 Free PMC article. Clinical Trial.
29 results