1,721,131 research outputs found
Innovative medicines: New regulatory procedures for the third millennium
No full textDespite tremendous progress in science and increasing investment in research and development, patients' access to innovative medicines remains limited. This is in part due to increasing regulatory requirements for product authorisation and cost-constrained national health systems. At the European Medicines Agency (EMA), we have tried to address these constraints by adapting our organisation and activities to changing business models, new technologies, and the current and emerging health needs in Europe. The main EMA initiatives to provide patients with effective, safe and affordable medicines are reviewed
A new tumour associated antigen of non-small cell lung cancer: Tumour liberated proteins (TLP) - A possible new tumor marker
No full textTLP (Tumour Liberated Proteins) is a 214 kDa protein, isolated from lung cancer tissue and synthetic nonapeptide CSH-275 is a major epitope identified on a 100 kDa TLP fragment and used to create antibodies in rabbit (antiserum termed CSH-419). CSH-419 antiserum, labelled or conjugated as necessary, was used to detect TLP on sera from NSCLC patients by a new ELISA test set up as a 1 step sandwich format test. this ELISA was performed on sera from 534 individuals. TLP was detected in 53.1% of NSCLC patients, with a 0% response in patients with cancers other than NSCLC, 7.6% response in unknown blood donors, and 17.4% response in patients with chronic lung diseases correlated with an elevated risk for lung cancer. TLP was particularly present in early stages of disease: 75% in stage I, 56% in stage II and II and 45% in stage IV. The presence of TLP antigen in sera from NSCLC patients indicates that TLP could represent an useful tumour marker
Pharmacovigilance 2030: Invited Commentary for the January 2020 “Futures” Edition of Clinical Pharmacology and Therapeutics
No full textA new healthcare system is emerging that encompasses systems approaches to biology and medicine, radically enhanced capabilities for collecting, integrating, storing, analyzing, and communicating data and information, and increasing numbers of networked and activated patients and consumers
Thymosin alpha 1 in the treatment of cancer: from basic research to clinical application
No full textMany studies have explored the effects of immunotherapy, alone or in combination with conventional therapies, on both experimental and human cancers. Evidence has been provided that combined treatments with thymosin alpha 1 (T alpha 1) and low doses of interferon (IFN) or interleukin (IL)-2 are highly effective in restoring several immune responses depressed by tumor growth and/or cytostatic drugs. In addition, when combined with specific chemotherapy, they are able to increase the anti-tumor effect of chemotherapy while markedly reducing the general toxicity of the treatment. The advantages of using this combined chemo-immunotherapeutic approach in experimental and human cancers are reviewed in this issue. (C) 2000 International Society for Immunopharmacology. Published by Elsevier Science Ltd. All rights reserved
Drug policy for an aging population--the European Medicines Agency's geriatric medicines strategy
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