Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe [PDF]
Frontiers in Medicine, 2017 In 2008, the European Union introduced the Advanced Medicines Regulation aiming to improve regulation of advanced therapy medicinal products (ATMPs).
Andreas M. Farkas +8 more
doaj +2 more sources
Improvement of the inactivated SARS-CoV-2 vaccine potency through formulation in alum/naloxone adjuvant; Robust T cell and anti-RBD IgG responses [PDF]
Iranian Journal of Basic Medical Sciences, 2022 Objective(s): SARS-CoV-2, emerging as a major threat to public health, has to be controlled through vaccination. Naloxone (NLX), an opioid receptor antagonist, demonstrated its adjuvant activity for microbial vaccines. In this study, inactivated SARS-CoV-
Melika Haghighi +3 more
doaj +1 more source
From discovery to approval of an advanced therapy medicinal product-containing stem cells, in the EU. [PDF]
Regen Med, 2016 In 1997, the human corneal epithelium was reconstructed in vitro and transplanted on patients. Later, it became a routine treatment, before regulations considered advanced therapy medicinal products and drugs on the same lines.
Pellegrini G +7 more
europepmc +2 more sources
Glucomannan as a Dietary Supplement for Treatment of Breast Cancer in a Mouse Model
Vaccines, 2022 Konjac glucomannan (KGM) is a water-soluble polysaccharide derived from the Amorphophallus’s tuber and, as herbal medicine has shown, can suppress tumor growth or improve health.
Nioosha Ahmadi +4 more
doaj +1 more source
Whither Advanced Therapy Medicinal Products? [PDF]
Transfusion Medicine and Hemotherapy, 2013 The topic of this special issue of Transfusion Medicine and Hemotherapy is advanced therapies and tissue engineering. The legislative framework that regulates these fields in Europe is based on two Directives (and their amendments) of the European Commission [1, 2] and has been legally binding in all EC member states since December 2008.
Mark D, Smith +3 more
openaire +2 more sources
‘Relais actors’ and co-decision first reading agreements in the European Parliament : the case of the advanced therapies regulation [PDF]
, 2011 The processing of the advanced therapies regulation is of particular interest to scholars of the European Union's (EU) legislative process and students of the European Parliament (EP) because it provides a case study which throws light upon assumptions ...
Judge, D., Earnshaw, D.
core +4 more sources
A pipeline analysis of advanced therapy medicinal products
Drug Discovery Today, 2023 Advanced therapy medicinal products (ATMPs) are innovative biological products categorised as either gene, somatic cell, tissue-engineered or combined therapies. As of March 2022, 12 ATMPs are marketed in the EU and UK. We identified 482 unique ATMPs within 616 technology records from the National Institute for Health and Care Research Innovation ...
Georgina C. Wilkins +5 more
openaire +3 more sources
Is the Conjunctiva a Potential Target for Advanced Therapy Medicinal Products? [PDF]
Pharmaceutics, 2021 The conjunctiva is a complex ocular tissue that provides mechanical, sensory, and immune protection for the ocular surface. It is affected by many diseases through different pathological mechanisms. If a disease is not treated and conjunctival function is not fully restored, the whole ocular surface and, therefore, sight is at risk.
Diebold Luque, María Yolanda +1 more
openaire +4 more sources
Clinical Applications and Anticancer Effects of Antimicrobial Peptides: From Bench to Bedside
Frontiers in Oncology, 2022 Cancer is a multifaceted global health issue and one of the leading causes of death worldwide. In recent years, medical science has achieved great advances in the diagnosis and treatment of cancer.
Ameneh Jafari +5 more
doaj +1 more source
Advanced Therapy Medicinal Products - a Multiple Challenge [PDF]
Transfusion Medicine and Hemotherapy, 2013 The passage of European Union Regulation 1394/2007/EC [1] on Advanced Therapy Medicinal Products (ATMPs) complements the European Community code relating to medicinal products for human use [2, 3]. This regulation is thus immediately valid in all member states of the European Union for gene therapeutics, somatic cellular therapeutics, and tissue ...
Axel, Pruss, Henk, Garritsen
openaire +2 more sources