Search Results - "Salmonson, T"

Incorporating patient preferences into drug development and regulatory decision making: Results from a quantitative pilot study with cancer patients, carers, and regulators by Postmus, D, Mavris, M, Hillege, HL, Salmonson, T, Ryll, B, Plate, A, Moulon, I, Eichler, H-G, Bere, N, Pignatti, F

“…Currently, patient preference studies are not required to be included in marketing authorization applications to regulatory authorities, and the role and…”
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Accelerated Access to Innovative Medicines for Patients in Need by Baird, L G, Banken, R, Eichler, H-G, Kristensen, F B, Lee, D K, Lim, J C W, Lim, R, Longson, C, Pezalla, E, Salmonson, T, Samaha, D, Tunis, S, Woodcock, J, Hirsch, G

“…There is broad agreement among health‐care stakeholders that more must be done to ensure that patients have timely access to new and innovative medicines…”
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Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions by Pignatti, F, Ashby, D, Brass, EP, Eichler, H-G, Frey, P, Hillege, HL, Hori, A, Levitan, B, Liberti, L, Löfstedt, RE, McAuslane, N, Micaleff, A, Noel, RA, Postmus, D, Renn, O, Sabourin, BJ, Salmonson, T, Walker, S

“…Structured frameworks for benefit‐risk analysis in drug licensing decisions are being implemented across a number of regulatory agencies worldwide. The aim of…”
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A coordinated cross‐disciplinary research initiative to address an increased incidence of narcolepsy following the 2009–2010 Pandemrix vaccination programme in Sweden by Feltelius, N., Persson, I., Ahlqvist‐Rastad, J., Andersson, M., Arnheim‐Dahlström, L., Bergman, P., Granath, F., Adori, C., Hökfelt, T., Kühlmann‐Berenzon, S., Liljeström, P., Maeurer, M., Olsson, T., Örtqvist, Å., Partinen, M., Salmonson, T., Zethelius, B.

“…In response to the 2009–2010 influenza A(H1N1)pdm09 pandemic, a mass vaccination programme with the AS03‐adjuvanted influenza A(H1N1) vaccine Pandemrix was…”
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The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop by Manolis, E, Rohou, S, Hemmings, R, Salmonson, T, Karlsson, M, Milligan, PA

“…The European Medicines Agency (EMA) and the Federation of Pharmaceutical Industries and Associations (EFPIA) hosted a workshop on modeling and simulation…”
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Gatekeepers and Enablers: How Drug Regulators Respond to a Challenging and Changing Environment by Moving Toward a Proactive Attitude by Ehmann, F, Papaluca Amati, M, Salmonson, T, Posch, M, Vamvakas, S, Hemmings, R, Eichler, H G, Schneider, C K

“…This article analyzes the role of regulatory authorities in facilitating innovation in the pharmaceutical sector. We describe how regulators are expanding…”
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A guide for reporting the results of population pharmacokinetic analyses: a Swedish perspective by Wade, Janet R, Edholm, Monica, Salmonson, Tomas

“…Population pharmacokinetic analyses are frequently part of regulatory submissions and are mainly used to provide information on special populations (effects of…”
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The effect of amiloride on the in vivo effective permeability of amoxicillin in human jejunum: experience from a regional perfusion technique by Lennernäs, H., Knutson, L., Knutson, T., Hussain, A., Lesko, L., Salmonson, T., Amidon, G.L.

“…The purpose of this human intestinal perfusion study (in vivo) was twofold. Firstly, we aimed to determine the effective in vivo jejunal permeability ( P eff)…”
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Dosing recommendations in liver disease by Bergquist, C, Lindegård, J, Salmonson, T

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The European Medicines Agency Review of Kymriah (Tisagenlecleucel) for the Treatment of Acute Lymphoblastic Leukemia and Diffuse Large B‐Cell Lymphoma by Ali, Sahra, Kjeken, Rune, Niederlaender, Christiane, Markey, Greg, Saunders, Therese S., Opsata, Mona, Moltu, Kristine, Bremnes, Bjørn, Grønevik, Eirik, Muusse, Martine, Håkonsen, Gro D., Skibeli, Venke, Kalland, Maria Elisabeth, Wang, Ingrid, Buajordet, Ingebjørg, Urbaniak, Ania, Johnston, John, Rantell, Khadija, Kerwash, Essam, Schuessler‐Lenz, Martina, Salmonson, Tomas, Bergh, Jonas, Gisselbrecht, Christian, Tzogani, Kyriaki, Papadouli, Irene, Pignatti, Francesco

“…Chimeric antigen receptor (CAR)–engineered T‐cell therapy is becoming one of the most promising approaches in the treatment of cancer. On June 28, 2018, the…”
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HTA307 Evolving Principles for Defining and Assessing the Economic and Societal Value of Cancer Therapies by Lee, M., Abrams, K., Baird, A.M., Brown, S., Bruns, J., Clark, R., Cortes, J., Curigliano, G., Ferris, A., Garrison, L., Lyman, G., Pani, L., Kanesvaran, R., Pemberton-Whiteley, Z., Salmonson, T., Sawicki, P., Stein, B., Suh, D., Velikova, G., Grueger, J.

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From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients by Eichler, H-G, Baird, LG, Barker, R, Bloechl-Daum, B, Børlum-Kristensen, F, Brown, J, Chua, R, Del Signore, S, Dugan, U, Ferguson, J, Garner, S, Goettsch, W, Haigh, J, Honig, P, Hoos, A, Huckle, P, Kondo, T, Le Cam, Y, Leufkens, H, Lim, R, Longson, C, Lumpkin, M, Maraganore, J, O'Rourke, B, Oye, K, Pezalla, E, Pignatti, F, Raine, J, Rasi, G, Salmonson, T, Samaha, D, Schneeweiss, S, Siviero, PD, Skinner, M, Teagarden, JR, Tominaga, T, Trusheim, MR, Tunis, S, Unger, TF, Vamvakas, S, Hirsch, G

“…The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and…”
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European Medicines Agency review of ataluren for the treatment of ambulant patients aged 5 years and older with Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene by Haas, Manuel, Vlcek, Viktor, Balabanov, Pavel, Salmonson, Tomas, Bakchine, Serge, Markey, Greg, Weise, Martina, Schlosser-Weber, Gabriele, Brohmann, Henning, Yerro, Concepcion Prieto, Mendizabal, Macarena Rodriguez, Stoyanova-Beninska, Violeta, Hillege, Hans L

“…Highlights • First in class medicine ataluren received conditional approval in Europe for treatment of Duchenne disease. • EMA used early approval mechanism to…”
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EMA Review of Panobinostat (Farydak) for the Treatment of Adult Patients with Relapsed and/or Refractory Multiple Myeloma by Tzogani, Kyriaki, van Hennik, Paula, Walsh, Ita, De Graeff, Pieter, Folin, Annika, Sjöberg, Jan, Salmonson, Tomas, Bergh, Jonas, Laane, Edward, Ludwig, Heinz, Gisselbrecht, Christian, Pignatti, Francesco

“…On August 28, 2015, a marketing authorization valid through the European Union was issued for panobinostat, in combination with bortezomib and dexamethasone,…”
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The pharmacokinetics of recombinant human erythropoietin after intravenous and subcutaneous administration to healthy subjects by Salmonson, T, Danielson, BG, Wikstrom, B

“…1. The pharmacokinetics of recombinant erythropoietin, r‐Epo, were evaluated after intravenous and subcutaneous administration of 50 u kg‐ 1 to six healthy…”
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EMA Review of Daratumumab for the Treatment of Adult Patients with Multiple Myeloma by Tzogani, Kyriaki, Penninga, Elisabeth, Schougaard Christiansen, Marie Louise, Hovgaard, Doris, Sarac, Sinan B., Camarero Jimenez, Jorge, Garcia, Isabel, Lafuente, Marta, Sancho‐López, Arantxa, Salmonson, Tomas, Gisselbrecht, Christian, Pignatti, Francesco

“…On May 20, 2016, a conditional marketing authorization valid through the European Union (EU) was issued for daratumumab as monotherapy for the treatment of…”
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Pharmacokinetic and pharmacodynamic studies on recombinant human erythropoietin by Salmonson, T

“…In order to optimize the treatment of anemia in uremic patients the pharmacokinetic and pharmacodynamic properties of recombinant erythropoietin (r-Epo) were…”
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The European Medicines Agency Approval of Axitinib (Inlyta) for the Treatment of Advanced Renal Cell Carcinoma After Failure of Prior Treatment With Sunitinib or a Cytokine: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use by Tzogani, Kyriaki, Skibeli, Venke, Westgaard, Ingunn, Dalhus, Marianne, Thoresen, Hege, Slot, Karsten Bruins, Damkier, Per, Hofland, Kenneth, Borregaard, Jeanett, Ersbøll, Jens, Salmonson, Tomas, Pieters, Ronny, Sylvester, Richard, Mickisch, Gerald, Bergh, Jonas, Pignatti, Francesco

“…Axitinib is a tyrosine kinase inhibitor of vascular endothelial growth factor receptor 1 (VEGFR‐1), VEGFR‐2, and VEGFR‐3. Based on the positive opinion from…”
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The European Medicines Agency Review of Carfilzomib for the Treatment of Adult Patients with Multiple Myeloma Who Have Received at Least One Prior Therapy by Tzogani, Kyriaki, Camarero Jiménez, Jorge, Garcia, Isabel, Sancho‐López, Arantxa, Martin, Marc, Moreau, Alexandre, Demolis, Pierre, Salmonson, Tomas, Bergh, Jonas, Laane, Edward, Ludwig, Heinz, Gisselbrecht, Christian, Pignatti, Francesco

“…On November 19, 2015, a marketing authorization valid through the European Union was issued for carfilzomib in combination with lenalidomide and dexamethasone…”
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The European Medicines Agency Review of Pertuzumab for the Treatment of Adult Patients With HER2‐Positive Metastatic or Locally Recurrent Unresectable Breast Cancer: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use by Boix‐Perales, Hector, Borregaard, Jeanett, Jensen, Kristina Bech, Ersbøll, Jens, Galluzzo, Sara, Giuliani, Rosa, Ciceroni, Cinzia, Melchiorri, Daniela, Salmonson, Tomas, Bergh, Jonas, Schellens, Jan H., Pignatti, Francesco

“…Pertuzumab is a recombinant humanized monoclonal antibody that specifically targets the extracellular dimerization domain (subdomain II) of HER2. Based on the…”
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