Search Results - "Habtemariam, Bahru"

FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell‐Induced Severe or Life‐Threatening Cytokine Release Syndrome by Le, Robert Q., Li, Liang, Yuan, Weishi, Shord, Stacy S., Nie, Lei, Habtemariam, Bahru A., Przepiorka, Donna, Farrell, Ann T., Pazdur, Richard

“…On August 30, 2017, the U.S. Food and Drug Administration approved Actemra (tocilizumab, Genentech, Inc., South San Francisco, CA) for the treatment of severe…”
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Single‐Dose Pharmacokinetics and Pharmacodynamics of Transthyretin Targeting N‐acetylgalactosamine–Small Interfering Ribonucleic Acid Conjugate, Vutrisiran, in Healthy Subjects by Habtemariam, Bahru A., Karsten, Verena, Attarwala, Husain, Goel, Varun, Melch, Megan, Clausen, Valerie A., Garg, Pushkal, Vaishnaw, Akshay K., Sweetser, Marianne T., Robbie, Gabriel J., Vest, John

“…Vutrisiran (ALN‐TTRsc02) is a liver‐directed, investigational, small interfering ribonucleic acid drug for the treatment of transthyretin (TTR)‐mediated…”
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Pharmacokinetics and Pharmacodynamics of the Small Interfering Ribonucleic Acid, Givosiran, in Patients With Acute Hepatic Porphyria by Agarwal, Sagar, Simon, Amy R., Goel, Varun, Habtemariam, Bahru A., Clausen, Valerie A., Kim, Jae B., Robbie, Gabriel J.

“…Givosiran is a small interfering ribonucleic acid agent that was recently approved in the United States for the treatment of acute hepatic porphyria (AHP)…”
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FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma by Lee, Hyon-Zu, Kwitkowski, Virginia E, Del Valle, Pedro L, Ricci, M Stacey, Saber, Haleh, Habtemariam, Bahru A, Bullock, Julie, Bloomquist, Erik, Li Shen, Yuan, Chen, Xiao-Hong, Brown, Janice, Mehrotra, Nitin, Dorff, Sarah, Charlab, Rosane, Kane, Robert C, Kaminskas, Edvardas, Justice, Robert, Farrell, Ann T, Pazdur, Richard

“…On July 3, 2014, the FDA granted accelerated approval for belinostat (Beleodaq; Spectrum Pharmaceuticals, Inc.), a histone deacetylase inhibitor, for the…”
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Phase 1/2 Study of Lumasiran for Treatment of Primary Hyperoxaluria Type 1: A Placebo-Controlled Randomized Clinical Trial by Frishberg, Yaacov, Deschênes, Georges, Groothoff, Jaap W, Hulton, Sally-Anne, Magen, Daniella, Harambat, Jérôme, Van't Hoff, William G, Lorch, Ulrike, Milliner, Dawn S, Lieske, John C, Haslett, Patrick, Garg, Pushkal P, Vaishnaw, Akshay K, Talamudupula, Sandeep, Lu, Jiandong, Habtemariam, Bahru A, Erbe, David V, McGregor, Tracy L, Cochat, Pierre

“…In the rare disease primary hyperoxaluria type 1, overproduction of oxalate by the liver causes kidney stones, nephrocalcinosis, kidney failure, and systemic…”
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U.S. Food and Drug Administration Approval: Carfilzomib for the Treatment of Multiple Myeloma by HERNDON, Thomas M, DEISSEROTH, Albert, PALMBY, Todd R, JEE, Josephine, ADAMS, William, MAHAYNI, Houda, BROWN, Janice, DORANTES, Angelica, SRIDHARA, Rajeshwari, FARRELL, Ann T, PAZDUR, Richard, KAMINSKAS, Edvardas, KANE, Robert C, KOTI, Kallappa M, ROTHMANN, Mark D, HABTEMARIAM, Bahru, BULLOCK, Julie, BRAY, Jeffrey D, HAWES, Jessica

“…The U.S. Food and Drug Administration (FDA) review leading to accelerated approval of carfilzomib is described. A single-arm trial enrolled 266 patients with…”
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U.S. Food and Drug Administration Approval Summary: Brentuximab Vedotin for the Treatment of Relapsed Hodgkin Lymphoma or Relapsed Systemic Anaplastic Large-Cell Lymphoma by DE CLARO, R. Angelo, MCGINN, Karen, ROTHMANN, Mark, SHAPIRO, Marjorie, BORREGO, Francisco, CLOUSE, Kathleen, XIAO HONG CHEN, BROWN, Janice, AKINSANYA, Lara, KANE, Robert, KAMINSKAS, Edvardas, FARRELL, Ann, KWITKOWSKI, Virginia, PAZDUR, Richard, BULLOCK, Julie, KHANDELWAL, Aakanksha, HABTEMARIAM, Bahru, OUYANG, Yanli, SABER, Haleh, LEE, Kyung, KOTI, Kallappa

“…The U.S. Food and Drug Administration (FDA) describes the accelerated approval of brentuximab vedotin for patients with relapsed Hodgkin lymphoma and relapsed…”
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Randomized Clinical Trial on the Long-Term Efficacy and Safety of Lumasiran in Patients With Primary Hyperoxaluria Type 1 by Hulton, Sally A., Groothoff, Jaap W., Frishberg, Yaacov, Koren, Michael J., Overcash, J. Scott, Sellier-Leclerc, Anne-Laure, Shasha-Lavsky, Hadas, Saland, Jeffrey M., Hayes, Wesley, Magen, Daniella, Moochhala, Shabbir H., Coenen, Martin, Simkova, Eva, Garrelfs, Sander F., Sas, David J., Meliambro, Kristin A., Ngo, Taylor, Sweetser, Marianne T., Habtemariam, Bahru A., Gansner, John M., McGregor, Tracy L., Lieske, John C.

“…Primary hyperoxaluria type 1 (PH1) is a rare genetic disease caused by hepatic overproduction of oxalate, leading to kidney stones, nephrocalcinosis, kidney…”
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Population Pharmacokinetics of Valsartan in Pediatrics by Habtemariam, Bahru, Sallas, William, Sunkara, Gangadhar, Kern, Steven, Jarugula, Venkateswar, Pillai, Goonaseelan

“…The objective of this work was to develop a population pharmacokinetic model to assess the influence of subject covariates on the pharmacokinetics of valsartan…”
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FC069: Pharmacokinetics and Pharmacodynamics of Lumasiran: Analysis of Four Clinical Studies by Gansner, John, Robbie, Gabriel, Habtemariam, Bahru

“…Abstract BACKGROUND AND AIMS Primary hyperoxaluria type 1 (PH1) is a rare genetic disorder characterized by hepatic oxalate overproduction that leads to…”
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Pharmacokinetic and Pharmacodynamic Properties of Cemdisiran, an RNAi Therapeutic Targeting Complement Component 5, in Healthy Subjects and Patients with Paroxysmal Nocturnal Hemoglobinuria by Badri, Prajakta, Jiang, Xuemin, Borodovsky, Anna, Najafian, Nader, Kim, Jae, Clausen, Valerie A., Goel, Varun, Habtemariam, Bahru, Robbie, Gabriel J.

“…Background Cemdisiran, an N -acetylgalactosamine (GalNAc) conjugated RNA interference (RNAi) therapeutic, is currently under development for the treatment of…”
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Abstract 11276: Safety and Tolerability of ALN-AGT, an RNA Interference Therapeutic Targeting Hepatic Angiotensinogen Synthesis, in Hypertensive Patients During Sodium Depletion or Irbesartan Coadministration by Huang, Stephen, Taubel, Jorg, Desai, Akshay S, Cheng, Yansong, Habtemariam, Bahru

“…IntroductionWe have recently reported that ALN-AGT, a subcutaneous (SC) investigational RNA interference therapeutic targeting hepatic angiotensinogen (AGT)…”
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Lumasiran for Advanced Primary Hyperoxaluria Type 1: Phase 3 ILLUMINATE-C Trial by Michael, Mini, Groothoff, Jaap W., Shasha-Lavsky, Hadas, Lieske, John C., Frishberg, Yaacov, Simkova, Eva, Sellier-Leclerc, Anne-Laure, Devresse, Arnaud, Guebre-Egziabher, Fitsum, Bakkaloglu, Sevcan A., Mourani, Chebl, Saqan, Rola, Singer, Richard, Willey, Richard, Habtemariam, Bahru, Gansner, John M., Bhan, Ishir, McGregor, Tracy, Magen, Daniella

“…Lumasiran reduces urinary and plasma oxalate (POx) in patients with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function. ILLUMINATE-C…”
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Pharmacokinetics and Pharmacodynamics of Patisiran in Patients with hATTR Amyloidosis and with Polyneuropathy After Liver Transplantation by Badri, Prajakta, Habtemariam, Bahru, Melch, Megan, Clausen, Valerie A., Arum, Seth, Li, Xingyu, Jay, Patrick Y., Vest, John, Robbie, Gabriel J.

“…Background and Objective Variants of the transthyretin ( TTR ) gene cause hereditary transthyretin-mediated (hATTR) amyloidosis, or ATTRv amyloidosis (v for…”
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Correction to: Pharmacokinetic and Pharmacodynamic Properties of Cemdisiran, an RNAi Therapeutic Targeting Complement Component 5, in Healthy Subjects and Patients with Paroxysmal Nocturnal Hemoglobinuria by Badri, Prajakta, Jiang, Xuemin, Borodovsky, Anna, Najafan, Nader, Kim, Jae, Clausen, Valerie A., Goel, Varun, Habtemariam, Bahru, Robbie, Gabriel J.

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Abstract 10974: Durable Reductions in Circulating Angiotensinogen and Blood Pressure Six Months After Single Doses of ALN-AGT, an RNA Interference Therapeutic Targeting Hepatic Angiotensinogen Synthesis, in Hypertensive Patients by Huang, Stephen, Taubel, Jorg, Casey, Sarah, Leung, Pui Man, Webb, David J, Desai, Akshay S, Cheng, Yansong, Rhyee, Sean, Harrop, Jamie, Habtemariam, Bahru, Bakris, George L

“…IntroductionALN-AGT, a subcutaneous (SC) investigational RNA interference therapeutic targeting hepatic angiotensinogen (AGT) synthesis, is being evaluated as…”
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The Nonclinical Disposition and Pharmacokinetic/Pharmacodynamic Properties of N -Acetylgalactosamine-Conjugated Small Interfering RNA Are Highly Predictable and Build Confidence in Translation to Human by McDougall, Robin, Ramsden, Diane, Agarwal, Sagar, Agarwal, Saket, Aluri, Krishna, Arciprete, Michael, Brown, Christopher, Castellanos-Rizaldos, Elena, Charisse, Klaus, Chong, Saeho, Cichocki, Joseph, Fitzgerald, Kevin, Goel, Varun, Gu, Yongli, Guenther, Dale, Habtemariam, Bahru, Jadhav, Vasant, Janas, Maja, Jayaraman, Muthusamy, Kurz, Jeffrey, Li, Jing, Liu, Ju, Liu, Xiumin, Liou, Steven, Maclauchlin, Chris, Maier, Martin, Manoharan, Muthiah, Nair, Jayaprakash K, Robbie, Gabriel, Schmidt, Karyn, Smith, Peter, Theile, Christopher, Vaishnaw, Akshay, Waldron, Scott, Xu, Yuanxin, Zhang, Xuemei, Zlatev, Ivan, Wu, Jing-Tao

“…Conjugation of oligonucleotide therapeutics, including small interfering RNAs (siRNAs) or antisense oligonucleotides, to -acetylgalactosamine (GalNAc) ligands…”
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FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia by de Claro, R Angelo, McGinn, Karen M, Verdun, Nicole, Lee, Shwu-Luan, Chiu, Haw-Jyh, Saber, Haleh, Brower, Margaret E, Chang, C J George, Pfuma, Elimika, Habtemariam, Bahru, Bullock, Julie, Wang, Yun, Nie, Lei, Chen, Xiao-Hong, Lu, Donghao Robert, Al-Hakim, Ali, Kane, Robert C, Kaminskas, Edvardas, Justice, Robert, Farrell, Ann T, Pazdur, Richard

“…On November 13, 2013, the FDA granted accelerated approval to ibrutinib (IMBRUVICA capsules; Pharmacyclics, Inc.) for the treatment of patients with mantle…”
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Phase 3 trial of lumasiran for primary hyperoxaluria type 1: A new RNAi therapeutic in infants and young children by Sas, David J., Magen, Daniella, Hayes, Wesley, Shasha-Lavsky, Hadas, Michael, Mini, Schulte, Indra, Sellier-Leclerc, Anne-Laure, Lu, Jiandong, Seddighzadeh, Ali, Habtemariam, Bahru, McGregor, Tracy L., Fujita, Kenji P., Frishberg, Yaacov, Bacchetta, Justine, Baudouin, Véronique, Becker-Cohen, Rachel, Tzvi Behr, Shimrit, Ben-Shalom, Efrat, Berdaguer, Maria, Bockenhauer, Detlef, Cochat, Pierre, Coenen, Martin, Cramer, Carl H., Deschênes, Georges, Dossier, Claire, Doye, Emilie, Feldman, Liat Feraru, Hohenadel, Maximilian, Kaguelidou, Florentia, Zebegret, Irina Libinson, Lieske, John C., Maisin, Anne, Milliner, Dawn S., Plonsky Toder, Moran, Pollack, Shirley, Portefaix, Aurélie, Ranchin, Bruno, Rinat, Choni, Safdar, Adnan, Schalk, Gesa, Srivaths, Poyyapakkam R., Tran, Cheryl L., Van't Hoff, William, Weinbrand-Goichberg, Jenny, Weissman, Irith

“…Primary hyperoxaluria type 1 (PH1) is a rare, progressive, genetic disease with limited treatment options. We report the efficacy and safety of lumasiran, an…”
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FC070: Lumasiran for Patients with Primary Hyperoxaluria Type 1 with Impaired Kidney Function: Data from the 6-Month Analysis of the Phase 3 Illuminate-C Trial by Groothoff, Jaap, Michael, Mini, Shasha-Lavsky, Hadas, Lieske, John, Frishberg, Yaacov, Simkova, Eva, Sellier-Leclerc, Anne-Laure, Arnaud, Devresse, Guebre-Egziabher, Fitsum, Azime Bakkaloglu, Sevcan, Mourani, Chebl, Saqan, Rola, Singer, Richard, Willey, Richard, Habtemariam, Bahru, Bhan, Ishir, Gansner, John, Magen, Daniella

“…Abstract BACKGROUND AND AIMS Primary hyperoxaluria type 1 (PH1) is a rare genetic disorder characterised by hepatic oxalate overproduction that leads to…”
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