Results 121 to 130 of about 34,916 (281)
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola +5 more
wiley +1 more source
EMA – Publication of the EMA’s 2024 annual report
EMA’s annual report 2024 published today gives insights into the Agency’s strategic priorities and contributions to public and animal health in the European Union (EU). The digital report outlines the most important highlights regarding the evaluation and monitoring of human and veterinary medicines and a selection of key figures.
openaire +2 more sources
Efficacy, safety and cost‐effectiveness of CAR‐T therapy
CAR T‐cells demonstrate high efficacy in blood cancers, including ALL, MM and DLBCL. Innovations target solid tumours despite challenges such as antigen escape. Combination therapies enhance the delivery and infiltration of CAR T cells. Toxicity, cost and resistance remain major barriers to clinical use.
Emina Karahmet Sher +7 more
wiley +1 more source
Construction of airfield RESA by means of EMAS arrestor beds: design and case studies
embargoed_20270703Nella seguente tesi viene studiato il dimensionamento e la realizzazione di RESA aeroportuale con letti d'arresto di tipo EMAS con lo scopo di aumentare la sicurezza e ridurre le conseguenze in caso di overrun compiuto da un aeromobile ...
CARRER, ANDREA
core
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer +4 more
wiley +1 more source
Aim Metabolic liver disease, including nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis, is a major cause of chronic liver dysfunction worldwide, creating an urgent need for effective treatments. This systematic literature review (SLR) and network meta‐analysis (NMA) systematically reviews and compares the efficacy and safety ...
Andrej Belančić +8 more
wiley +1 more source
Ilustrasi berfungsi menyampaikan cerita dalam bentuk visual agar lebih mudah dipahami. Tujuan dari penelitian ini adalah menginterpretasikan narasi yang terbangun dari pertunjukan seni oleh seniman Serbia bernama Marina Abramovic, tahun 1974 di Italia ...
Thomas Hanandry Dewanto
doaj +1 more source
Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis +4 more
wiley +1 more source

