Data mining of adverse drug event signals with Nirmatrelvir/Ritonavir from FAERS.

Nirmatrelvir/Ritonavir, acting as an effective agent against COVID-19, has achieved considerable results in clinical studies in terms of drug efficacy. However, there is little research about its medication safety. Based on the FDA adverse event reporting system (FAERS) database, this study aims to mine the adverse reaction signals of the latest major recommended drug Nirmatrelvir/Ritonavir for the antiviral treatment of COVID-19, so as to provide a basis for safe and rational drug use.

Direct detection of 4-dimensions of SARS-CoV-2: infection (vRNA), infectivity (antigen), binding antibody, and functional neutralizing antibody in saliva.

We developed a 4-parameter clinical assay using Electric Field Induced Release and Measurement (EFIRM) technology to simultaneously assess SARS-CoV-2 RNA (vRNA), nucleocapsid antigen, host binding (BAb) and neutralizing antibody (NAb) levels from a drop of saliva with performance that equals or surpasses current EUA-approved tests. The vRNA and antigen assays achieved lower limit of detection (LOD) of 100 copies/reaction and 3.5 TCID₅₀/mL, respectively.

The Open Hand Initiative: Facilitating the Use of Real-World Evidence in Regulatory Submissions Through Collaboration and Transparency.

Real-world data (RWD) collected to generate real-world evidence (RWE) holds promise for expediting patient and healthcare provider access to new in vitro diagnostics (IVDs) by serving as evidence to demonstrate test performance or utility. However, uncertainties remain for IVD developers (device manufacturers), regulators, and other healthcare stakeholders on the specifics of collecting fit-for-purpose RWD and using RWE for regulatory decision-making. We report on a unique approach to medical device regulatory review called the Open Hand Initiative, by which the US Food and Drug Administration (FDA) and device manufacturers collaborate to ensure the appropriate use of RWD/RWE to support regulatory decision-making.

Physical activity patterns in adolescents: A longitudinal study.

The present study aimed at describing and comparing the physical activity (PA) patterns of adolescents from a middle-income country over a 4-year period. This is a longitudinal observational study (four waves of data collection, 2014-2017) with 668 adolescents aged 10-13 years in 2014 (mean age of 11.8 ± 0.

Elevated uric acid level and metabolic syndrome in Non-Hispanic Black American adults.

Objectives: To ascertain the direct and indirect link between elevated uric acid (eUA) and metabolic syndrome (MetSyn) in Non-Hispanic Black (NHB) American adults.

Design: Structural equation modeling (SEM) was used to disentangle the U.S.

Attribute ranging as a coordinated strategy between drug substance and drug product to accelerate commercial process nomination.

To make investigational drug candidates available to patients sooner, timelines for drug development are becoming shorter. Synthesis route scouting for active pharmaceutical ingredients (API) and drug product development often must occur simultaneously, requiring formulators to make decisions regarding drug product process selection before commercial API route finalization. Alternatively, the formulation strategy may be locked, thereby constraining drug substance processes with strict API attribute requirements.

Rosa dos Ventos Multicenter Cohort Study of Patients with Reduced or Mildly Reduced Ejection Fraction Heart Failure in Brazil: Rationale and Design.

Background: Brazil is a country with different biomes and social disparities. There are limited data available on regional differences and prognosis of heart failure (HF) in the country.

Objective: The Rosa dos Ventos study aims to investigate regional differences and the current prognosis of HF outpatients with reduced or mildly reduced ejection fraction in Brazil.

Scientific and Regulatory Lessons Learnt on Building a Chemistry, Manufacturing, and Controls (CMC) Package for COVID-19 Variant Vaccine Updates in the EU-A Regulator's Perspective.

During the COVID-19 pandemic, eight COVID-19 vaccines were authorised in the European Union (EU); as a result of emerging SARS-CoV-2 variants and waning immunity, some of these have been adapted to broaden the immunity against circulating variants. The pace at which variants emerge challenges the technical feasibility to make adapted vaccines available in a suitable timeframe and in sufficient quantities. Despite the current absence of a clear-cut seasonal spread for COVID-19, the EU regulatory approach thus far is a pragmatic approach following a pathway similar to that of seasonal influenza.

Outcomes of coronoid-first repair through an anterior approach in patients with terrible triad injury of the elbow: a prospective study with a minimum 2-year follow-up.

Background: In the treatment of terrible triad injury of the elbow (TTIE), the indication and the appropriate approach and sequence for coronoid process (CP) fixation remain debatable. No gold standard protocol has been established for CP fixation. In this study, we evaluated the midterm outcomes of coronoid-first repair through an anterior approach in patients with unstable TTIE.

Investigating the Safety Profile of Fast-Track COVID-19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study.

Background: The US Food and Drug Administration (US FDA) granted emergency use authorization (EUA) for multiple coronavirus disease 2019 (COVID-19) drugs as a medical countermeasure during the COVID-19 pandemic. Despite these drugs' fast-track nature, concerns persist regarding their efficacy and potential adverse effects. Thus, the continuous surveillance and understanding of these drugs' safety profiles are crucial in such scenarios.

Low antiviral uptake of nirmatrelvir/ritonavir and molnupiravir in adult patients with COVID-19 in Taiwan in 2022.

Background: Antivirals are effective in reducing hospitalisation and death in mild-to-moderate coronavirus 2019 (COVID-19) patients. We estimated the antiviral uptake of nirmatrelvir/ritonavir and molnupiravir in adult patients with a syndrome coronavirus 2 (SARS-CoV-2) infection during the Emergency Use Authorization (EUA) period in Taiwan.

Methods: A retrospective cohort study was conducted in Taiwan between January 2022 and December 2022.

Unveiling the Interplay-Vitamin D and ACE-2 Molecular Interactions in Mitigating Complications and Deaths from SARS-CoV-2.

The interaction of the SARS-CoV-2 spike protein with membrane-bound angiotensin-converting enzyme-2 (ACE-2) receptors in epithelial cells facilitates viral entry into human cells. Despite this, ACE-2 exerts significant protective effects against coronaviruses by neutralizing viruses in circulation and mitigating inflammation. While SARS-CoV-2 reduces ACE-2 expression, vitamin D increases it, counteracting the virus's harmful effects.