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Objective: To evaluate the trend in nonresearch payments made by the industries to the infectious disease physicians in the United States since the launch of the Open Payments Database and during the COVID-19 pandemic., Methods: Descriptive analysis was performed for the nonresearch payments made to all infectious disease physicians listed in the Open Payments Database between 2014 and 2020. Using the generalized estimating equation models with panel data of monthly and yearly payment per physician, the payment trend since the inception of the Open Payments Database and during the early stage of the COVID-19 pandemic were evaluated., Results: A total of 7901 (81.5%) infectious disease physicians received $156 837 987 in nonresearch payments between 2014 and 2020. Median annual payments were $197 to $220. Monthly nonresearch per-physician payments and number of physicians with payments rapidly decreased by 58.6% (95% CI: 49.7%‒65.9%, p < 0.001) and by 54.4% (95% CI: 52.7%‒56.1%, p < 0.001) at the beginning of the COVID-19 pandemic, respectively. However, the per-physician payments and number of physicians with payments slightly increased every month right after onset of the pandemic. Both per-physician payments and the number of physicians with payments decreased by 2.6% (95% CI: 0.45‒4.7, p 0.018) and 2.0% (95% CI: 1.6%‒2.4%, p < 0.001) since the inception of the Open Payments Database, respectively., Discussion: The nonresearch payments and number of infectious disease physicians accepting payments had decreased since the inception of the Open Payments Database. Furthermore, the non-research payments to infectious disease physicians suddenly decreased by more than half due to the COVID-19 pandemic., (Copyright © 2022 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

The prompt and appropriate safety assessment of drug metabolite(s) was mentioned in regulatory guidances such as an International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance, entitled "Guidance on Non-clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals" (ICH M3(R2)) implemented in January 1 of 2011 in Japan, and has become a significant issue in the drug development. Upon release of ICH M3(R2) Step 4, a survey was conducted between March and April 2010 on the safety assessment of drug metabolites in 63 member companies of the Japan Pharmaceutical Manufacturers Association (JPMA). The Pharmacokinetics Team in the Non-Clinical Evaluation Expert Committee in JPMA conducted a questionnaire survey and compiled the results to comprehend how safety of drug metabolites are currently assessed at research-based pharmaceutical companies in Japan. The assessment of "Metabolites in Safety Testing" (MIST) can be divided into three stages based on the research purpose as follows: MIST 1 is a stage of estimating human drug metabolites and predicting their potential risks, MIST 2 is a stage of deciding the necessity for non-clinical safety studies, and MIST 3 is a stage of conducting non-clinical safety studies. In this paper, we propose typical approaches on safety assessment of metabolites that meet the purpose of each stage, considering the current level of scientific technology. Our proposals are based on the results from our survey and a symposium about the safety assessment of drug metabolites at the 37th annual meeting of the Japanese Society of Toxicology held in June 2010.

The betaherpesvirus human herpesvirus 6 (HHV-6) has two variants. The U83 gene product of strain HST is a chemoattractant for monocytes. Here, we describe U83 gene variations that accumulated in variants A and B. A gene-variation hot spot was examined in 36 different strains and one donor DNA sample. U83 gene variations accumulated in variant A and in reactivated variant B after transplantation. None of the variant-A viruses encoded the signal peptide found in the B variant. U83 gene sequencing suggested that the variant A and B groups were separate, and that the variant B viruses could be further divided into the HST-Z29 type and another type with a shorter signal peptide. In a eukaryotic expression system, the HST-Z29 type of U83 gene product was secreted into the medium, a frame-shifted HST-Z29 type was partially secreted, and the variant-A type and a first-methionine knockout of the HST-Z29 type were not secreted.

Two strains of feline immunodeficiency virus (FIV) were isolated directly from peripheral blood mononuclear cells (PBMCs) of Japanese domestic cats or indirectly from PBMCs of specific pathogen free (SPF) cats inoculated with whole blood from naturally infected cats with FIV by cocultivation with primary PBMCs from SPF cats. Two isolates, designated as FIV TM 1 and FIV TM 2, had a lentivirus-like morphology by electron microscopy, a tropism for interleukin-2 dependent T-lymphocytes and Mg2+-dependent reverse transcriptase activity. By immunoblotting the isolates gave bands at 130, 48, 44, 40, 28, 17, and 13 kDa, and these bands except 130 kDa were detected in FIV Petaluma strain when reacted with the plasma of cats infected naturally with FIV TM 1 strain.