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Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies.
Sun B, Sengupta N, Rao A, Donnelly C, Waichale V, Roy AS, Ramaswamy S, Pathak D, Bowsher RR, Raiter Y, Aubonnet P, Barve A. Sun B, et al. Among authors: donnelly c. BMC Endocr Disord. 2021 Jun 26;21(1):129. doi: 10.1186/s12902-021-00797-4. BMC Endocr Disord. 2021. PMID: 34174848 Free PMC article. Clinical Trial.
A pharmacokinetics phase 1 bioequivalence study of the trastuzumab biosimilar MYL-1401O vs. EU-trastuzumab and US-trastuzumab.
Waller CF, Vutikullird A, Lawrence TE, Shaw A, Liu MS, Baczkowski M, Sharma R, Barve A, Goyal P, Donnelly C, Sengupta N, Pennella EJ. Waller CF, et al. Among authors: donnelly c. Br J Clin Pharmacol. 2018 Oct;84(10):2336-2343. doi: 10.1111/bcp.13689. Epub 2018 Jul 31. Br J Clin Pharmacol. 2018. PMID: 29926514 Free PMC article. Clinical Trial.
Pharmacokinetic and pharmacodynamic bioequivalence of biosimilar MYL-1601D with US and European insulin aspart in healthy volunteers: A randomized, double-blind, crossover, euglycaemic glucose clamp study.
Hövelmann U, Raiter Y, Chullikana A, Liu M, Donnelly C, Lawrence T, Sengupta N, Cl G, Ranganna G, Barve A. Hövelmann U, et al. Among authors: donnelly c. Diabetes Obes Metab. 2021 Dec;23(12):2670-2678. doi: 10.1111/dom.14519. Epub 2021 Aug 25. Diabetes Obes Metab. 2021. PMID: 34378861 Free PMC article. Clinical Trial.
Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog®) in Patients with Type 1 Diabetes After 24 Weeks: A Randomized Open-Label Study.
Blevins TC, Raiter Y, Sun B, Donnelly C, Shapiro R, Chullikana A, Rao A, Vashishta L, Ranganna G, Barve A. Blevins TC, et al. Among authors: donnelly c. BioDrugs. 2022 Nov;36(6):761-772. doi: 10.1007/s40259-022-00554-6. Epub 2022 Sep 17. BioDrugs. 2022. PMID: 36114990 Free PMC article. Clinical Trial.
Phase III double-blind study comparing the efficacy and safety of proposed biosimilar MYL-1402O and reference bevacizumab in stage IV non-small-cell lung cancer.
Socinski MA, Waller CF, Idris T, Bondarenko I, Luft A, Beckmann K, Vishweswaramurthy A, Loganathan S, Donnelly C, Hummel MA, Shapiro R, Woods M, Rao A, Nayak VG, Ranganna G, Barve A. Socinski MA, et al. Among authors: donnelly c. Ther Adv Med Oncol. 2021 Nov 18;13:17588359211045845. doi: 10.1177/17588359211045845. eCollection 2021. Ther Adv Med Oncol. 2021. PMID: 34819997 Free PMC article.
Case-control study of environmental toxins and risk of amyotrophic lateral sclerosis involving the national ALS registry.
Talbott EO, Malek AM, Arena VC, Wu F, Steffes K, Sharma RK, Buchanich J, Rager JR, Bear T, Hoffman CA, Lacomis D, Donnelly C, Mauna J, Vena JE. Talbott EO, et al. Among authors: donnelly c. Amyotroph Lateral Scler Frontotemporal Degener. 2024 Apr 9:1-10. doi: 10.1080/21678421.2024.2336108. Online ahead of print. Amyotroph Lateral Scler Frontotemporal Degener. 2024. PMID: 38591179
1,002 results