Search Results - "Timothy, R. Coté"

The need for worldwide policy and action plans for rare diseases by Forman, John, Taruscio, Domenica, Llera, Virginia A., Barrera, Luis A., Coté, Timothy R., Edfjäll, Catarina, Gavhed, Désirée, Haffner, Marlene E., Nishimura, Yukiko, Posada, Manuel, Tambuyzer, Erik, Groft, Stephen C., Henter, Jan-Inge

“…There are more than 6000 rare diseases (defined as affecting <5/10 000 individuals in Europe, <200 000 people in the United States). The rarity can create…”
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Accelerating orphan drug development by Coté, Timothy R, Xu, Kui, Pariser, Anne R

“…Interest in developing drugs for rare diseases has increased substantially in recent years. This article from the US Food and Drug Administration highlights…”
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Tuberculosis following the Use of Etanercept, a Tumor Necrosis Factor Inhibitor by Mohan, Aparna K., Timothy, R. Coté, Block, Joel A., Manadan, Augustine M., Siegel, Jeffrey N., Braun, M. Miles

“…Infliximab, a tumor necrosis factor (TNF) antagonist, is associated with tuberculosis (TB), but it is unknown whether this phenomenon is true of all TNF…”
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Primary melanomas of the esophagus and anorectum: epidemiologic comparison with melanoma of the skin by Coté, Timothy R, Sobin, Leslie H

“…The objective of this study was to use recently available data to describe the epidemiology of melanomas of the esophagus and the anorectum in contrast to…”
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Emergence of orphan drugs in the United States: a quantitative assessment of the first 25 years by Coté, Timothy R, Braun, M. Miles, Farag-El-Massah, Sheiren, Xu, Kui

“…The development of drugs for rare diseases — often known as orphan drugs — is attracting increasing interest and investment, catalysed in part by incentives…”
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Regulatory considerations for developing drugs for rare diseases: orphan designations and early phase clinical trials by Pariser, Anne R, Xu, Kui, Milto, John, Coté, Timothy R

“…The development of drug and biological products intended to treat rare diseases (Orphan diseases) is one of the fastest growing areas of clinical research, and…”
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Infectious complications of biologic treatments of rheumatoid arthritis by Mohan, Aparna K, Coté, Timothy R, Siegel, Jeffrey N, Braun, Miles M

“…Agents that block the action of tumor necrosis factor-α and recombinant interleukin-1 have been shown to be effective biologic treatment modalities in patients…”
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Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseases by Xu, Kui, Coté, Timothy R.

“…Facing substantial obstacles to developing new therapies for rare diseases, some sponsors are looking to 'repurpose' drugs already approved for other…”
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Primary malignant neoplasms of the appendix: A population-based study from the Surveillance, Epidemiology and End-Results Program, 1973-1998 by MCCUSKER, Margaret E, COTE, Timothy R, CLEGG, Limin X, SOBIN, Leslie H

“…Cancer of the appendix is an uncommon disease that is rarely suspected rarely before surgery. Although several case series of these tumors have been published,…”
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Case reports of heart failure after therapy with a tumor necrosis factor antagonist by KWON, Hyon J, COTE, Timothy R, CUFFE, Michael S, KRAMER, Judith M, BRAUN, M. Miles

“…Etanercept and infliximab are U.S. Food and Drug Administration-approved tumor necrosis factor (TNF) antagonists. To describe adverse event reports of heart…”
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Pathology and classification of ovarian tumors by Chen, Vivien W., Ruiz, Bernardo, Killeen, Jeffrey L., Coté, Timothy R., Wu, Xiao Cheng, Correa, Catherine N., Howe, Holly L.

“…The authors present a summary of the developmental events and anatomic features that provide information regarding the natural history of ovarian cancers. In…”
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Clinical pharmacology as a cornerstone of orphan drug development by Bashaw, Edward D., Huang, Shiew-Mei, Coté, Timothy R., Pariser, Anne R., Garnett, Christine E., Burckart, Gilbert, Zhang, Lei, Men, Angela Y., Le, Christine D., Charlab, Rosane, Gobburu, Jogaro V., Lesko, Lawrence J.

“…A recent US Food and Drug Administration (FDA) advisory committee meeting highlighted the potential of clinical pharmacology to overcome challenges in orphan…”
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Autologous Cultured Chondrocytes: Adverse Events Reported to the United States Food and Drug Administration by Wood, Jennifer J, Malek, Mark A, Frassica, Frank J, Polder, Jacquelyn A, Mohan, Aparna K, Bloom, Eda T, Braun, M Miles, Coté, Timothy R

“…BackgroundCarticel is an autologous cultured chondrocyte product that has been approved by the United States Food and Drug Administration for the repair of…”
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Duchenne muscular dystrophy: Drug development and regulatory considerations by McNeil, D. Elizabeth, Davis, Carole, Jillapalli, Devanand, Targum, Shari, Durmowicz, Anthony, Coté, Timothy R.

“…Duchenne muscular dystrophy (DMD) is one of the most commonly recognized dystrophinopathies. There are no approved therapeutic options available for this…”
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Therapies for Inborn Errors of Metabolism: What Has the Orphan Drug Act Delivered? by TALELE, Sonali S, KUI XU, PARISER, Anne R, BRAUN, M. Miles, FARAG-EI-MASSAH, Sheiren, PHILLIPS, M. Ian, THOMPSON, Barry H, COTE, Timothy R

“…The 1983 US Orphan Drug Act established a process through which promising therapies are designated as orphan products and, later, with satisfactory safety and…”
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Spectrum of AIDS-associated malignant disorders by Goedert, James J, Coté, Timothy R, Virgo, Phillip, Scoppa, Steven M, Kingma, Douglas W, Gail, Mitchell H, Jaffe, Elaine S, Biggar, Robert J

“…To clarify which types of cancer result from AIDS, we compared the cancer experiences of people with AIDS with those of the general population by matching…”
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Endocrine tumors of the uterine cervix: incidence, demographics, and survival with comparison to squamous cell carcinoma by McCusker, Margaret E, Coté, Timothy R, Clegg, Limin X, Tavassoli, Fattaneh J

“…The aim was to describe the epidemiology of endocrine tumors of the cervix in comparison with invasive squamous cell carcinomas using population-based data…”
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The Orphan Drug Act and the Development of Stem Cell-Based Products for Rare Diseases by Freeman, Scott N., Burke, Kathryn A., Imoisili, Menfo A., Coté, Timothy R.

“…The Orphan Drug Act encourages the development of products for rare diseases and conditions. Many conditions that stand to benefit from stem cell-based…”
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Botulinum toxin type A injections: Adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases by Coté, Timothy R., Mohan, Aparna K., Polder, Jacquelyn A., Walton, Marc K., Braun, M. Miles

“…Botulinum toxin type A (BTA) (Botox) received Food and Drug Administration (FDA) approval for therapeutic treatment of strabismus and blepharospasm in 1989,…”
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Drug-induced systemic lupus erythematosus and TNF-α blockers by Mohan, Aparna K, Edwards, Evelyne T, Coté, Timothy R, Siegel, Jeffrey N, Braun, M Miles

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