Search Results - "Goyal, Jaya"

Neurofilament light levels are associated with long-term outcomes in multiple sclerosis by Kuhle, Jens, Plavina, Tatiana, Barro, Christian, Disanto, Giulio, Sangurdekar, Dipen, Singh, Carol M, de Moor, Carl, Engle, Bob, Kieseier, Bernd C, Fisher, Elizabeth, Kappos, Ludwig, Rudick, Richard A, Goyal, Jaya

“…Background: Neurofilament light chain (NfL) is a promising marker of disease activity/treatment response in multiple sclerosis (MS), although its predictive…”
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Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A by Mahlangu, Johnny, Powell, Jerry S., Ragni, Margaret V., Chowdary, Pratima, Josephson, Neil C., Pabinger, Ingrid, Hanabusa, Hideji, Gupta, Naresh, Kulkarni, Roshni, Fogarty, Patrick, Perry, David, Shapiro, Amy, Pasi, K. John, Apte, Shashikant, Nestorov, Ivan, Jiang, Haiyan, Li, Shuanglian, Neelakantan, Srividya, Cristiano, Lynda M., Goyal, Jaya, Sommer, Jurg M., Dumont, Jennifer A., Dodd, Nigel, Nugent, Karen, Vigliani, Gloria, Luk, Alvin, Brennan, Aoife, Pierce, Glenn F.

“…This phase 3 pivotal study evaluated the safety, efficacy, and pharmacokinetics of a recombinant FVIII Fc fusion protein (rFVIIIFc) for prophylaxis, treatment…”
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Phase 3 Study of Recombinant Factor IX Fc Fusion Protein in Hemophilia B by Powell, Jerry S, Pasi, K. John, Ragni, Margaret V, Ozelo, Margareth C, Valentino, Leonard A, Mahlangu, Johnny N, Josephson, Neil C, Perry, David, Manco-Johnson, Marilyn J, Apte, Shashikant, Baker, Ross I, Chan, Godfrey C, Novitzky, Nicolas, Wong, Raymond S, Krassova, Snejana, Allen, Geoffrey, Jiang, Haiyan, Innes, Alison, Li, Shuanglian, Cristiano, Lynda M, Goyal, Jaya, Sommer, Jurg M, Dumont, Jennifer A, Nugent, Karen, Vigliani, Gloria, Brennan, Aoife, Luk, Alvin, Pierce, Glenn F

“…A fusion protein comprising factor IX and the dimeric Fc domain of IgG1 has a half-life that is five times as long as that of native factor IX, allowing…”
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Temporal profile of serum neurofilament light in multiple sclerosis: Implications for patient monitoring by Calabresi, Peter A, Arnold, Douglas L, Sangurdekar, Dipen, Singh, Carol M, Altincatal, Arman, de Moor, Carl, Engle, Bob, Goyal, Jaya, Deykin, Aaron, Szak, Suzanne, Kieseier, Bernd C, Rudick, Richard A, Plavina, Tatiana

“…Objective: To understand how longitudinal serum neurofilament light chain (sNfL) patterns can inform its use as a prognostic biomarker in multiple sclerosis…”
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Safety and prolonged activity of recombinant factor VIII Fc fusion protein in hemophilia A patients by Powell, Jerry S., Josephson, Neil C., Quon, Doris, Ragni, Margaret V., Cheng, Gregory, Li, Ella, Jiang, Haiyan, Li, Lian, Dumont, Jennifer A., Goyal, Jaya, Zhang, Xin, Sommer, Jurg, McCue, Justin, Barbetti, Margaret, Luk, Alvin, Pierce, Glenn F.

“…Current factor VIII (FVIII) products display a half-life (t1/2) of ∼ 8-12 hours, requiring frequent intravenous injections for prophylaxis and treatment of…”
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Recombinant factor IX-Fc fusion protein (rFIXFc) demonstrates safety and prolonged activity in a phase 1/2a study in hemophilia B patients by Shapiro, Amy D., Ragni, Margaret V., Valentino, Leonard A., Key, Nigel S., Josephson, Neil C., Powell, Jerry S., Cheng, Gregory, Thompson, Arthur R., Goyal, Jaya, Tubridy, Karen L., Peters, Robert T., Dumont, Jennifer A., Euwart, Donald, Li, Lian, Hallén, Bengt, Gozzi, Peter, Bitonti, Alan J., Jiang, Haiyan, Luk, Alvin, Pierce, Glenn F.

“…Current factor IX (FIX) products display a half-life (t1/2) of ∼ 18 hours, requiring frequent intravenous infusions for prophylaxis and treatment in patients…”
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Lymphotoxin-LIGHT pathway regulates the interferon signature in rheumatoid arthritis by Bienkowska, Jadwiga, Allaire, Norm, Thai, Alice, Goyal, Jaya, Plavina, Tatiana, Nirula, Ajay, Weaver, Megan, Newman, Charlotte, Petri, Michelle, Beckman, Evan, Browning, Jeffrey L

“…A subset of patients with autoimmune diseases including rheumatoid arthritis (RA) and lupus appear to be exposed continually to interferon (IFN) as evidenced…”
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Feasibility of the use of combinatorial chemokine arrays to study blood and CSF in multiple sclerosis by Edwards, Keith R, Goyal, Jaya, Plavina, Tatiana, Czerkowicz, Julie, Goelz, Susan, Ranger, Ann, Cadavid, Diego, Browning, Jeffrey L

“…Meningeal inflammation, including the presence of semi-organized tertiary lymphoid tissue, has been associated with cortical pathology at autopsy in secondary…”
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Investigational Assay for Haplotype Phasing of the Huntingtin Gene by Svrzikapa, Nenad, Longo, Kenneth A., Prasad, Nripesh, Boyanapalli, Ramakrishna, Brown, Jeffrey M., Dorset, Daniel, Yourstone, Scott, Powers, Jason, Levy, Shawn E., Morris, Aaron J., Vargeese, Chandra, Goyal, Jaya

“…Novel treatments for Huntington’s disease (HD), a progressive neurodegenerative disorder, include selective targeting of the mutant allele of the huntingtin…”
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Analysis of Normal Epithelial Cell Specific-1 (NES1)/Kallikrein 10 mRNA Expression by in Situ Hybridization, a Novel Marker for Breast Cancer by DHAR, Sanjay, BHARGAVA, Rohit, YUNES, Michael, BIAO LI, GOYAL, Jaya, NABER, Stephen P, WAZER, David E, BAND, Vimla

“…Purpose: Normal epithelial cell specific-1 ( NES1 )/ kallikrein 10 gene is expressed in normal mammary and prostate epithelial cells, but the expression of…”
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Assay Formats: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team by Dudal, Sherri, Baltrukonis, Daniel, Crisino, Rebecca, Goyal, M. Jaya, Joyce, Alison, Österlund, Karolina, Smeraglia, John, Taniguchi, Yoshitaka, Yang, Jihong

“…As part of the GBC (Global Bioanalysis Consortium), the L3 assay format team has focused on reviewing common platforms used to support ligand binding assays in…”
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Translational biomarkers: from discovery and development to clinical practice by Subramanyam, Meena, Goyal, Jaya

“…The refinement of disease taxonomy utilizing molecular phenotypes has led to significant improvements in the precision of disease diagnosis and customization…”
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PGN-EDODM1: Preclinical Data Supporting the Development of an Enhanced Delivery Oligonucleotide (EDO) for the Treatment of Myotonic Dystrophy Type 1 (DM1) (S48.001) by Holland, Ashling, Klein, Arnaud, Godfrey, Caroline, Svenstrup, Niels, Larkindale, Jane, Bracegirdle, Sonia, Furling, Denis, Goyal, Jaya

“…Abstract only…”
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PGN-EDO51: Preclinical Data Supporting the Development of an Enhanced Delivery Oligonucleotide (EDO) for the Treatment of Duchenne Muscular Dystrophy (DMD) (P3-8.002) by Holland, Ashling, Godfrey, Caroline, Lonkar, Pallavi, Svenstrup, Niels, Larkindale, Jane, McArthur, James, Bracegirdle, Sonia, Goyal, Jaya

“…Abstract only…”
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Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics by Gorovits, Boris, Wakshull, Eric, Pillutla, Renuka, Xu, Yuanxin, Manning, Marta Starcevic, Goyal, Jaya

“…Many biotherapeutics currently in development have complex mechanisms of action and contain more than one domain, each with a specific role or function…”
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PGN-EDO51, an Enhanced Delivery Oligonucleotide (EDO) for the Treatment of Duchenne Muscular Dystrophy (DMD): Results of a Phase 1 Study in Healthy Volunteers (P3-8.004) by Mellion, Michelle, Larkindale, Jane, Lonkar, Pallavi, Goyal, Jaya, Holland, Ashling, Foy, Jeff, Garg, Brijesh, Yu, Shaoxia, Frank, Anthony, Abbott, Chris, Svenstrup, Niels, Cormier, Jennifer, Vacca, Sarah, McArthur, James

“…Abstract only…”
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Centrally sponsored schemes in Andaman and Nicobar Islands: a governance paradox by Goyal, Jaya

“…Purpose – The purpose of this paper is to present the Andaman and Nicobar Islands (ANI) as a case to delineate contextual and often paradoxical challenges in…”
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Positive results from a first-in-human study supporting continued development of PGN-EDO51 for the treatment of duchenne muscular dystrophy (DMD) by Larkindale, Jane, Mellion, Michelle, Lonkar, Pallavi, Goyal, Jaya, Holland, Ashling, Foy, Jeff, Garg, Brijesh, Yu, Shaoxia, Shoskes, Jennifer, Frank, Anthony, Abbott, Chris, Svendstrup, Niels, Cormier, Jennifer, Vacca, Sarah, Mcarthur, James

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Accountability, Nutrition and Local Institutions in India by Goyal, Jaya, Sekher, Madhushree

“…In contemporary governance discourse, accountability is found linked to almost every conceivable aspect of ‘good governance’ – from developmental effectiveness…”
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Pre-Existing Biotherapeutic-Reactive Antibodies: Survey Results Within the American Association of Pharmaceutical Scientists by Xue, Li, Fiscella, Michele, Rajadhyaksha, Manoj, Goyal, Jaya, Holland, Claire, Gorovits, Boris, Morimoto, Alyssa

“…The immunogenicity profile of a biotherapeutic is determined by a multitude of product and patient-related risk factors that can influence the observed…”
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