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Telescoped Process to Manufacture 6,6,6-Trifluorofucose via Diastereoselective Transfer Hydrogenation: Scalable Access to an Inhibitor of Fucosylation Utilized in Monoclonal Antibody Production.
Achmatowicz MM, Allen JG, Bio MM, Bartberger MD, Borths CJ, Colyer JT, Crockett RD, Hwang TL, Koek JN, Osgood SA, Roberts SW, Swietlow A, Thiel OR, Caille S. Achmatowicz MM, et al. Among authors: roberts sw. J Org Chem. 2016 Jun 3;81(11):4736-43. doi: 10.1021/acs.joc.6b00646. Epub 2016 May 20. J Org Chem. 2016. PMID: 27152753
Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid.
Algorri M, Acharya A, Bernstein J, Cauchon NS, Chen XH, Huynh-Ba K, Krantz C, Li T, Li Y, McLamore S, Roberts SW, Schwinke D, Shah R, Schirmer A, Strickland H, Tang K, Watson T. Algorri M, et al. Among authors: roberts sw. AAPS Open. 2022;8(1):19. doi: 10.1186/s41120-022-00066-1. Epub 2022 Dec 5. AAPS Open. 2022. PMID: 36530577 Free PMC article.
Correction: Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies.
Roberts SW, Elvang TLB, Syed L, Samuelsen MB, Arp-Hansen EL, Nielsen HK, Lund IK, Dünweber DL, Listov-Saabye N, Bjørn-Larsen D, Hjelmsmark A, Mikkelsen TA. Roberts SW, et al. Ther Innov Regul Sci. 2023 Mar;57(2):396-398. doi: 10.1007/s43441-022-00487-w. Ther Innov Regul Sci. 2023. PMID: 36472778 No abstract available.
Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies.
Roberts SW, Elvang TLB, Syed L, Samuelsen MB, Arp-Hansen EL, Nielsen HK, Lund IK, Dünweber DL, Listov-Saabye N, Bjørn-Larsen D, Hjelmsmark A, Mikkelsen TA. Roberts SW, et al. Ther Innov Regul Sci. 2023 Mar;57(2):386-395. doi: 10.1007/s43441-022-00477-y. Epub 2022 Nov 18. Ther Innov Regul Sci. 2023. PMID: 36401076
77 results