PCR137 Within-Trial Interviews to Contextualize the Patient Experience and Supplement Clinical Outcomes Assessments in a Pivotal Trial of a Newly Described, Fatal and Ultra-Rare Pediatric Disease

Autor: Litcher-Kelly, L, Ozen, A, Ollis, S, Feldman H, Baris, Yaworsky, A, Medrano, P, Chongsrisawat, V, Brackin, T, Perlee, L, Walker, M, Pradeep, S, Lenardo, MJ, Harari, O, Jalbert, JJ

Publikováno v: In Value in Health June 2024 27(6) Supplement:S321-S321

Antipsychotic use and the risk of hip fracture among older adults afflicted with dementia.

Autor: Jalbert JJ (AUTHOR), Eaton CB (AUTHOR), Miller SC (AUTHOR), Lapane KL (AUTHOR)

Publikováno v: Journal of the American Medical Directors Association. Feb2010, Vol. 11 Issue 2, p120-127. 8p.

Association between allergic conditions and COVID-19 susceptibility and outcomes.

Autor: Chen C; Regeneron Pharmaceuticals, Inc., Tarrytown, New York., Song X; Regeneron Pharmaceuticals, Inc., Tarrytown, New York., Murdock DJ; Regeneron Pharmaceuticals, Inc., Tarrytown, New York., Marcus A; Regeneron Pharmaceuticals, Inc., Tarrytown, New York., Hussein M; Regeneron Pharmaceuticals, Inc., Tarrytown, New York., Jalbert JJ; Regeneron Pharmaceuticals, Inc., Tarrytown, New York., Geba GP; Regeneron Pharmaceuticals, Inc., Tarrytown, New York. Electronic address: gregory.geba@regeneron.com.

Publikováno v: Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology [Ann Allergy Asthma Immunol] 2024 May; Vol. 132 (5), pp. 637-645.e7. Date of Electronic Publication: 2024 Jan 17.

Evaluating the efficacy and safety of pozelimab in patients with CD55 deficiency with hyperactivation of complement, angiopathic thrombosis, and protein-losing enteropathy disease: an open-label phase 2 and 3 study.

Autor: Ozen A; Department of Pediatrics, Division of Allergy and Immunology, Marmara University, School of Medicine, Istanbul, Türkiye; The Istanbul Jeffrey Modell Diagnostic Center for Primary Immunodeficiency Diseases, Istanbul, Türkiye; The Isil Berat Barlan Center for Translational Medicine, Istanbul, Türkiye., Chongsrisawat V; Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Patumwan, Bangkok, Thailand; King Chulalongkorn Memorial Hospital, Thai Red Cross Society Patumwan, Bangkok, Thailand., Sefer AP; Department of Pediatrics, Division of Allergy and Immunology, Marmara University, School of Medicine, Istanbul, Türkiye; The Istanbul Jeffrey Modell Diagnostic Center for Primary Immunodeficiency Diseases, Istanbul, Türkiye; The Isil Berat Barlan Center for Translational Medicine, Istanbul, Türkiye., Kolukisa B; Department of Pediatrics, Division of Allergy and Immunology, Marmara University, School of Medicine, Istanbul, Türkiye; The Istanbul Jeffrey Modell Diagnostic Center for Primary Immunodeficiency Diseases, Istanbul, Türkiye; The Isil Berat Barlan Center for Translational Medicine, Istanbul, Türkiye., Jalbert JJ; Regeneron Pharmaceuticals, Sleepy Hollow, NY, USA., Meagher KA; Regeneron Pharmaceuticals, Tarrytown, NY, USA., Brackin T; Regeneron Pharmaceuticals, Tarrytown, NY, USA., Feldman HB; The Genetics Institute, Tel Aviv Sourasky Medical Center, Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel., Baris S; Department of Pediatrics, Division of Allergy and Immunology, Marmara University, School of Medicine, Istanbul, Türkiye; The Istanbul Jeffrey Modell Diagnostic Center for Primary Immunodeficiency Diseases, Istanbul, Türkiye; The Isil Berat Barlan Center for Translational Medicine, Istanbul, Türkiye., Karakoc-Aydiner E; Department of Pediatrics, Division of Allergy and Immunology, Marmara University, School of Medicine, Istanbul, Türkiye; The Istanbul Jeffrey Modell Diagnostic Center for Primary Immunodeficiency Diseases, Istanbul, Türkiye; The Isil Berat Barlan Center for Translational Medicine, Istanbul, Türkiye., Ergelen R; Department of Radiology, Marmara University, School of Medicine, Istanbul, Türkiye., Fuss IJ; Mucosal Immunity Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., Moorman H; Molecular Development of the Immune System Section, Laboratory of Immune System Biology, Laboratory of Clinical Immunology and Microbiology, and Clinical Genomics Program, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., Suratannon N; Center of Excellence for Allergy and Clinical Immunology, Division of Allergy, Immunology and Rheumatology, Chulalongkorn University, Patumwan, Bangkok, Thailand; King Chulalongkorn Memorial Hospital, Thai Red Cross Society Patumwan, Bangkok, Thailand., Suphapeetiporn K; Center of Excellence for Medical Genomics, Medical Genomics Cluster, Chulalongkorn University, Patumwan, Bangkok, Thailand; Excellence Center for Genomics and Precision Medicine, Thai Red Cross Society Patumwan, Bangkok, Thailand., Perlee L; Regeneron Pharmaceuticals, Tarrytown, NY, USA., Harari OA; Regeneron Pharmaceuticals, Tarrytown, NY, USA. Electronic address: olivier.harari@regeneron.com., Yancopoulos GD; Regeneron Pharmaceuticals, Tarrytown, NY, USA., Lenardo MJ; Molecular Development of the Immune System Section, Laboratory of Immune System Biology, Laboratory of Clinical Immunology and Microbiology, and Clinical Genomics Program, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Publikováno v: Lancet (London, England) [Lancet] 2024 Feb 17; Vol. 403 (10427), pp. 645-656. Date of Electronic Publication: 2024 Jan 23.

Regulatory and HTA Considerations for Development of Real-World Data Derived External Controls.

Autor: Curtis LH; Duke Department of Population Health Sciences and Duke Clinical Research Institute, Durham, North Carolina, USA., Sola-Morales O; Fundació HiTT and Universitat Internacional de Catalunya (UIC), Barcelona, Spain., Heidt J; IQVIA, Regulatory Science and Strategy, Falls Church, Virginia, USA., Saunders-Hastings P; Epi Excellence LLC, Garnet Valley, Pennsylvania, USA., Walsh L; IQVIA, Epidemiology and Drug Safety Practice, Boston, Massachusetts, USA., Casso D; IQVIA, Epidemiology and Drug Safety Practice, Seattle, Washington, USA., Oliveria S; IQVIA, Epidemiology and Drug Safety Practice, New York, New York, USA., Mercado T; IQVIA, Regulatory Science and Strategy, Falls Church, Virginia, USA., Zusterzeel R; IQVIA, Regulatory Science and Strategy, Falls Church, Virginia, USA., Sobel RE; Regeneron Pharmaceuticals Inc., Pharmacoepidemiology, Tarrytown, New York, USA., Jalbert JJ; Regeneron Pharmaceuticals Inc., Health Economics & Outcomes Research, Tarrytown, New York, USA., Mastey V; Regeneron Pharmaceuticals Inc., Health Economics & Outcomes Research, Tarrytown, New York, USA., Harnett J; Regeneron Pharmaceuticals Inc., Health Economics & Outcomes Research, Tarrytown, New York, USA., Quek RGW; Regeneron Pharmaceuticals Inc., Health Economics & Outcomes Research, Tarrytown, New York, USA.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2023 Aug; Vol. 114 (2), pp. 303-315. Date of Electronic Publication: 2023 Jun 09.