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of 29
pro vyhledávání: '"Marjorie A. Shapiro"'
Autor:
Marjorie A. Shapiro
Publikováno v:
Frontiers in Oncology, Vol 14 (2024)
Over 160 therapeutic and in vivo diagnostic monoclonal antibodies have been approved by the US FDA since the first monoclonal antibody, muromonab, was approved in 1986. Approximately 42% of these approvals were for the treatment or in vivo diagnosis
Externí odkaz:
https://doaj.org/article/c71c0f56cdc342cf9beb8fea1321b849
Publikováno v:
Pharmaceutics, Vol 15, Iss 5, p 1538 (2023)
Viral diseases represent a major public health concerns and ever-present risks for developing into future pandemics. Antiviral antibody therapeutics, either alone or in combination with other therapies, emerged as valuable preventative and treatment
Externí odkaz:
https://doaj.org/article/ac65fe98a31d4dfb937e9e7ec43bf689
Publikováno v:
PLoS ONE, Vol 9, Iss 9, p e106699 (2014)
Monoclonal antibodies are important tools in research and since the 1990s have been an important therapeutic class targeting a wide variety of diseases. Earlier methods of mAb production relied exclusively on the lengthy process of making hybridomas.
Externí odkaz:
https://doaj.org/article/81542b1db53c4071bc00d813cad542b5
Autor:
Joel Welch, Jee Chung, Marjorie A. Shapiro, Chantal Depatie, Richard K. Burdick, Barbara Rellahan, Bev Ingram, Thomas Stangler, Alla Polozova, Catherine Srebalus-Barnes, Christopher Downey, Emanuela Lacana, Martijn Van Der Plas, Stephan Krause, Daeseok Choi, Qing Zhou, Emily Shacter
Publikováno v:
PDA journal of pharmaceutical science and technology. 73(4)
This workshop report summarizes the presentations, the breakout session outcomes, and the speaker panel discussions from the PDA Biosimilars Workshop held September 27-28, 2018, in Washington, DC. This format was deliberately selected for the worksho
Autor:
Emily Y. Jen, Jiang Liu, Lei Nie, Jee Eun Lee, Kelly J. Norsworthy, Ann T. Farrell, Donna Przepiorka, Pedro L. Del Valle, Charles Jewell, Antonina G. Aydanian, Chia-Wen Ko, Richard Pazdur, Christopher M. Sheth, Marjorie A. Shapiro
Publikováno v:
Clinical cancer research : an official journal of the American Association for Cancer Research. 24(14)
On September 1, 2017, the FDA granted approval for gemtuzumab ozogamicin (Mylotarg; Pfizer Inc.) in combination with daunorubicin and cytarabine and as a monotherapy for the treatment of adult patients with newly diagnosed CD33-positive acute myeloid
Publikováno v:
Nature reviews. Rheumatology. 13(2)
The goal of a development programme for a biosimilar product is to prove its biosimilarity to the reference product, rather than independently establish its safety and efficacy. In this Perspectives article, the authors describe the US FDA's rigorous
Autor:
Hyon-Zu Lee, Edvardas Kaminskas, Barry W. Miller, Richard Pazdur, Robert C. Kane, Robert Justice, Lei Nie, Pedro DelValle, Chia-Wen Ko, Stacey Ricci, Virginia E. Kwitkowski, Nitin Mehrotra, Joseph A. Grillo, Marjorie A. Shapiro, Haleh Saber, Julie Bullock, Ann T. Farrell, Jeffry Florian, Mate Tolnay
Publikováno v:
Clinical Cancer Research. 20:3902-3907
On November 1, 2013, the U.S. Food and Drug Administration (FDA) approved obinutuzumab (GAZYVA; Genentech, Inc.), a CD20-directed cytolytic antibody, for use in combination with chlorambucil for the treatment of patients with previously untreated chr
Autor:
Xiao Hong Chen, Yanli Ouyang, Janice Brown, Kyung Y. Lee, Haleh Saber, Karen M. McGinn, Kallappa Koti, Julie Bullock, Lara Akinsanya, Kathleen A. Clouse, Virginia E. Kwitkowski, Franciso Borrego, Edvardas Kaminskas, Ann T. Farrell, Marjorie A. Shapiro, Mark D. Rothmann, Richard Pazdur, Aakanksha Khandelwal, Bahru A. Habtemariam, R. Angelo de Claro, Robert C. Kane
Publikováno v:
Clinical Cancer Research. 18:5845-5849
The U.S. Food and Drug Administration (FDA) describes the accelerated approval of brentuximab vedotin for patients with relapsed Hodgkin lymphoma and relapsed systemic anaplastic large-cell lymphoma (sALCL). FDA analyzed the results of two single-arm
Autor:
Marjorie A. Shapiro, Patrick G Swann
Publikováno v:
Bioanalysis. 3:597-603
Ligand-binding assays are the predominant method used for determination of concentrations of biotechnology products in serum or other matrices, as well as for the determination of antidrug antibodies in nonclinical and clinical studies. The challenge
Autor:
Marjorie A. Shapiro, Mate Tolnay, Kathleen A Clouse, Barbara L Rellahan, Subramanian Muthukkumar, Patrick G Swann
Publikováno v:
Current Opinion in Immunology. 20:493-499
An increasing number of Investigational New Drug (IND) applications for therapeutic monoclonal antibodies (mAbs) have been submitted to US FDA over the past several years. Monoclonal antibodies and related products are under development for a wide ra