Search Results - "Cote, Timothy R."

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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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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CK20 and CK7 protein expression in colorectal cancer: demonstration of the utility of a population-based tissue microarray by Hernandez, Brenda Y., Frierson, Henry F., Moskaluk, Christopher A., Li, Yu Jim, Clegg, Limin, Cote, Timothy R., McCusker, Margaret E., Hankey, Benjamin F., Edwards, Brenda K., Goodman, Marc T.

“…The ability to use archival tissue to test externally valid hypotheses of carcinogenesis is dependent on the availability of population-based samples of cancer…”
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Tissues from population-based cancer registries: a novel approach to increasing research potential by Goodman, Marc T., Hernandez, Brenda Y., Hewitt, Stephen, Lynch, Charles F., Coté, Timothy R., Frierson, Henry F., Moskaluk, Christopher A., Killeen, Jeffrey L., Cozen, Wendy, Key, Charles R., Clegg, Limin, Reichman, Marsha, Hankey, Benjamin F., Edwards, Brenda

“…Population-based cancer registries, such as those included in the Surveillance, Epidemiology, and End-Results (SEER) Program, offer tremendous research…”
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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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Deaths among children less than two years of age receiving palivizumab: an analysis of comorbidities by MOHAN, APARNA K, BRAUN, M MILES, ELLENBERG, SUSAN, HEDJE, JUDITH, COTÉ, TIMOTHY R

“…BACKGROUND.Palivizumab (Synagis) is used for prophylaxis against respiratory syncytial virus infection among children at high risk for respiratory syncytial…”
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Survival among women with borderline ovarian tumors and ovarian carcinoma: A population-based analysis by SHERMAN, Mark E, MINK, Pamela J, CURTIS, Rochelle, COTE, Timothy R, BROOKS, Sandra, HARTGE, Patricia, DEVESA, Susan

“…Serous and mucinous ovarian tumors of low malignant potential (LMP-S and LMP-M, respectively) are noninvasive tumors that portend excellent survival when…”
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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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