In this new series reviewing recent developments in market access, we highlight publications investigating health technology assessment (HTA) guidance, review processes and outcomes across the world and discuss how forthcoming changes in the HTA and regulatory environment in the European Union may allow for more consistency in decision making.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10690433 | PMC |
| http://dx.doi.org/10.57264/cer-2023-0129 | DOI Listing |
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CAR T-cell-associated secondary malignancies challenge current pharmacovigilance concepts.
EMBO Mol Med
January 2025
Safety of Biomedicines and Diagnostics, Paul-Ehrlich-Institut, Langen, Germany.
Suspected adverse reactions following chimeric antigen receptor T-cell (CAR T) treatment include more and more cases of secondary T-cell malignancies. The causality assessment of such suspected reactions challenges established evaluation practices due to (i) patient and product-specific risk factors and (ii) incomplete data available with post-marketing reports submitted to competent authorities. This is of particular relevance for gene therapy products that integrate into the host genome.
View Article and Find Full Text PDFAlgae- and bacteria-based biodegradation of phthalic acid esters towards the sustainable green solution.
World J Microbiol Biotechnol
January 2025
Institute of Biotechnology, College of Natural Sciences, University of Rzeszów, Pigonia 1 St, Rzeszow, 35-310, Poland.
Phthalic acid esters are widely used worldwide as plasticizers. The high consumption of phthalates in China makes it the world's largest plasticizer market. The lack of phthalic acid ester's chemical bonding with the polymer matrix facilitates their detachment from plastic products and subsequent release into the environment and causes serious threats to the health of living organisms.
View Article and Find Full Text PDFSpatiotemporal expansion of dengue in Brazilian Amazon between 2001 and 2021.
Sci Rep
January 2025
Laboratory of Veterinary Epidemiology, Graduate Program in Veterinary Medicine, Universidade Federal de Pelotas, University Campus, Building 42, Post Office Box 354, Capão do Leão, RS, CEP 96010-900, Brazil.
Dengue remains a significant public health concern in Brazil, with all federative units registering occurrences of the disease within their territories despite constant measures to control the Aedes aegypti vector. This study aimed to evaluate the profile of notified dengue cases in the Brazilian Legal Amazon from 2001 to 2021, analyzing National System of Notifiable Diseases (SINAN) data on the disease to assess the risks for its occurrence. Subsequently, statistical analyses were conducted to identify incidence and lethality rates.
View Article and Find Full Text PDFAssociation between thyroid dysfunction and insulin resistance: a retrospective cohort study.
BMJ Open
January 2025
Vibrant Sciences LLC, Santa Clara, California, USA.
Objective: To evaluate the association between thyroid disease and diabetes markers.
Design: Retrospective cohort study.
Setting: The study was conducted in a diagnostic setting where the primary care providers recommended the patients to test for thyroid and diabetes panels.
Shanxi province food security evaluation research.
Sci Rep
January 2025
School of Economics Management, Chongqing Normal University, Chongqing, 401131, China.
Food security is the foundation of national security, which is related to economic development and social stability. Shanxi Province, as China's grain production and marketing balance area, has rich agricultural resources and profound farming civilization, its food security situation is not only related to its own economic development, but also has a strategic position that can not be ignored in the national food security system. Based on the concept and goal of the development of food security in Shanxi Province, from the five aspects of quantity security, economic security, policy security, resource sustainability and ecological sustainability, this paper constructs the evaluation index system of food security in Shanxi Province, including the fluctuation rate of grain production and the sown area of grain, and establishes the entropy TOPSIS model to evaluate the development level of food security in Shanxi Province.
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