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Advancing rare disease treatment: EMA's decade-long insights into engineered adoptive cell therapy for rare cancers and orphan designation.

Autor: Kalland ME; Norwegian Medical Products Agency, Grensesvingen 26, 0663, Oslo, Norway. maria.kalland@noma.no.; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands. maria.kalland@noma.no., Pose-Boirazian T; Orphan Medicines Office, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands., Palomo GM; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.; Agencia Española de Medicamentos y Productos Sanitarios, Calle Campezo n° 1, Edificio 8, 28022, Madrid, Spain., Naumann-Winter F; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.; Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany., Costa E; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.; Agenzia Italiana del Farmaco, Via del Tritone, 181, 00187, Rome, Italy., Matusevicius D; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.; Swedish Medical Products Agency, Dag Hammarskjölds väg 42, 752 37, Uppsala, Sweden., Duarte DM; INFARMED - National Authority of Medicines and Health Products, I.P., Avenida do Brasil 53, 1749-004, Lisbon, Portugal.; Universidade de Lisboa, Faculdade de Farmácia, Avenida Professor Gama Pinto, 1649-003, Lisbon, Portugal., Malikova E; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.; State Institute for Drug Control, Kvetná 11, 825 08, Bratislava, Slovakia.; Department of Pharmacology and Toxicology, Comenius University, Odbojárov 10, 832 32, Bratislava, Slovakia., Vitezic D; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.; University of Rijeka, Faculty of Medicine, and University Hospital Centre Rijeka, Braće Branchetta 20/1, 51000, Rijeka, Croatia., Larsson K; Orphan Medicines Office, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands., Magrelli A; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.; National Center for Drug Research and Evaluation, Istituto Superiore di Sanità, Viale Regina Elena, 299, 00161, Rome, Italy., Stoyanova-Beninska V; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.; College ter Beoordeling van Geneesmiddelen, Graadt van Roggenweg 500, 3531 AH, Utrecht, The Netherlands., Mariz S; Orphan Medicines Office, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.

Publikováno v: Gene therapy [Gene Ther] 2024 Jul; Vol. 31 (7-8), pp. 366-377. Date of Electronic Publication: 2024 Mar 14.

The European landscape for gene therapies in orphan diseases: 6-year experience with the EMA Committee for Orphan Medicinal Products.

Autor: Palomo GM; Agencia Española de Medicamentos y Productos Sanitarios, Calle Campezo 1 Edificio 8, 28022 Madrid, Spain; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands. Electronic address: gpalomo@aemps.es., Pose-Boirazian T; Orphan Medicines Office, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands., Naumann-Winter F; Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, Germany; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands., Costa E; Agenzia Italiana del Farmaco, Via del Tritone 181, 00187 Rome, Italy; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands., Duarte DM; INFARMED - National Authority of Medicines and Health Products, I.P., Avenida do Brasil 53, 1749-004 Lisbon, Portugal; Universidade de Lisboa, Faculdade de Farmácia, Avenida Professor Gama Pinto, 1649-003 Lisbon, Portugal; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands., Kalland ME; Statens Legemiddelverk/The Norwegian Medicines Agency, Grensesvingen 26, 0663 Oslo, Norway; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands., Malikova E; State Institute for Drug Control, Kvetná 11, 825 08 Bratislava, Slovakia; Department of Pharmacology and Toxicology, Comenius University, Odbojárov 10, 832 32 Bratislava, Slovakia; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands., Matusevicius D; Läkemedelsverket, Dag Hammarskjölds väg 42, 75237 Uppsala, Sweden; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands., Vitezic D; Rijeka University School of Medicine and University Hospital Centre Rijeka, Braće Branchetta 20, 51000 Rijeka, Croatia; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands., Larsson K; Orphan Medicines Office, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands., Magrelli A; National Center for Drug Research and Evaluation, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands., Stoyanova-Beninska V; College ter Beoordeling van Geneesmiddelen, Graadt van Roggenweg 500, 3531 AH Utrecht, the Netherlands; Committee for Orphan Medicinal Products, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands., Mariz S; Orphan Medicines Office, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands. Electronic address: segundo.mariz@ema.europa.eu.

Publikováno v: Molecular therapy : the journal of the American Society of Gene Therapy [Mol Ther] 2023 Dec 06; Vol. 31 (12), pp. 3414-3423. Date of Electronic Publication: 2023 Oct 04.

Influence of Surface Roughness on the Dynamics and Crystallization of Vapor-Deposited Thin Films.

Autor: Beena Unni A; Institute of Physics, University of Silesia, 75 Pulku Piechoty 1a, 41-500 Chorzow, Poland.; Silesian Center for Education and Interdisciplinary Research (SMCEBI), 75 Pulku Piechoty 1a, 41-500 Chorzow, Poland., Winkler R; Institute of Physics, University of Silesia, 75 Pulku Piechoty 1a, 41-500 Chorzow, Poland.; Silesian Center for Education and Interdisciplinary Research (SMCEBI), 75 Pulku Piechoty 1a, 41-500 Chorzow, Poland., Duarte DM; Institute of Physics, University of Silesia, 75 Pulku Piechoty 1a, 41-500 Chorzow, Poland.; Silesian Center for Education and Interdisciplinary Research (SMCEBI), 75 Pulku Piechoty 1a, 41-500 Chorzow, Poland., Chat K; Institute of Physics, University of Silesia, 75 Pulku Piechoty 1a, 41-500 Chorzow, Poland.; Silesian Center for Education and Interdisciplinary Research (SMCEBI), 75 Pulku Piechoty 1a, 41-500 Chorzow, Poland., Adrjanowicz K; Institute of Physics, University of Silesia, 75 Pulku Piechoty 1a, 41-500 Chorzow, Poland.; Silesian Center for Education and Interdisciplinary Research (SMCEBI), 75 Pulku Piechoty 1a, 41-500 Chorzow, Poland.

Publikováno v: The journal of physical chemistry. B [J Phys Chem B] 2022 Oct 13; Vol. 126 (40), pp. 8072-8079. Date of Electronic Publication: 2022 Sep 28.