| The birth pangs of monoclonal antibody therapeutics: the failure and legacy of Centoxin. | |
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MedLine Citation:
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PMID: 22531443 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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This paper examines the development and termination of nebacumab (Centoxin®), a human IgM monoclonal antibody (mAb) drug frequently cited as one of the notable failures of the early biopharmaceutical industry. The non-approval of Centoxin in the United States in 1992 generated major concerns at the time about the future viability of any mAb therapeutics. For Centocor, the biotechnology company that developed Centoxin, the drug posed formidable challenges in terms of safety, clinical efficacy, patient selection, the overall economic costs of health care, as well as financial backing. Indeed, Centocor's development of the drug brought it to the brink of bankruptcy. This article shows how many of the experiences learned with Centoxin paved the way for the current successes in therapeutic mAb development. |
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Authors:
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Lara Marks |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't; Review Date: 2012-04-26 |
Journal Detail:
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Title: mAbs Volume: 4 ISSN: 1942-0870 ISO Abbreviation: MAbs Publication Date: 2012 May-Jun |
Date Detail:
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Created Date: 2012-09-10 Completed Date: 2013-02-06 Revised Date: 2013-05-02 |
Medline Journal Info:
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Nlm Unique ID: 101479829 Medline TA: MAbs Country: United States |
Other Details:
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Languages: eng Pagination: 403-12 Citation Subset: IM |
Affiliation:
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Department of Primary Care and Public Health, King's College London, London, UK. Lara.Marks@kcl.ac.uk |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Antibodies, Monoclonal
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therapeutic use* Biopharmaceutics / trends Costs and Cost Analysis Drug Approval Drug Discovery* Humans Immunotherapy* Product Recalls and Withdrawals Sepsis / immunology, therapy* United States |
| Chemical | |
Reg. No./Substance:
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0/Antibodies, Monoclonal; 138330-99-1/nebacumab |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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