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Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies - A stakeholder meeting report.
Biologicals
January 2025
Centre for Human Drug Research (CHDR), Leiden, the Netherlands; Leiden University Medical Center (LUMC), Leiden, the Netherlands.
Inno4Vac, a public-private partnership funded by the IMI2/EU/EFPIA Joint Undertaking (IMI2 JU), brings together academic institutions, SMEs, and pharmaceutical companies to accelerate and de-risk vaccine development. The project has made significant strides in the selection and production of challenge agents for influenza, respiratory syncytial virus (RSV), and toxigenic Clostridioides difficile for controlled human infection model studies (CHIMs). A regulatory workshop held on March 20, 2024, addressed the standardisation of clinical procedures, ethical considerations, endpoints, and data integrity, highlighting the ongoing initiatives related to these CHIMs.
View Article and Find Full Text PDFRe-Engagement in Physical Activity Slows the Decline in Older Adults' Well-Being - A Longitudinal Study.
Inquiry
January 2025
School of Nursing and Health Sciences, Hong Kong Metropolitan University, Hong Kong.
Physical activity is recommended for older adults; however, the benefits of previous active engagement in physical activity that can be sustained after one becomes inactive remain to be determined. This study investigated the longitudinal associations between physical activity engagement patterns and older adults' well-being. This population-based cohort study used data from the China Health and Retirement Longitudinal Study between 2015 and 2020.
View Article and Find Full Text PDFLigand Design with Accelerated Disulfide Formation with Serum Albumin to Extend Blood Retention.
ACS Med Chem Lett
January 2025
Department of Applied Chemistry, Faculty of Engineering, Kyushu University, 744 Moto-oka, Nishi-ku, Fukuoka 819-0395, Japan.
We proposed a novel ligand for the interaction with human serum albumin (HSA) to extend the blood half-life of small molecular weight therapeutics. The ligand features an alkyl chain and an activated disulfide to allow binding to the hydrophobic pockets of HSA and the formation of disulfide to Cys34 of HSA, thereby minimizing the initial renal clearance. The dual nature of the ligand-HSA bonding was expected to give the ligand long blood retention.
View Article and Find Full Text PDFValue-Based Pricing for Drugs With Uncertain Clinical Benefits.
Health Econ
January 2025
Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
Policymakers can use cost-effectiveness analysis to set value-based prices (VBP) for new pharmaceuticals. However, the uncertainty of investigational drug benefits complicates this pricing strategy. Such complexity stems from decision-makers' risk aversion and the potential change in the estimated value with emerging evidence.
View Article and Find Full Text PDFκ/β-GaO Type-II Phase Heterojunction.
Adv Mater
January 2025
Advanced Semiconductor Laboratory, Electrical and Computer Engineering Program, Division of Computer, Electrical, and Mathematical Sciences and Engineering (CEMSE), King Abdullah University of Science and Technology (KAUST), Thuwal, 23955-6900, Kingdom of Saudi Arabia.
Ultrawide-bandgap gallium oxide (GaO) holds immense potential for crucial applications such as solar-blind photonics and high-power electronics. Although several GaO polymorphs, i.e.
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