The biosimilar pathway in the USA: An analysis of the innovator company and biosimilar company perspectives and beyond

In order to improve access to costly biological treatments, a biosimilar pathway in the United States of America (USA) was enacted under the Biologics Price Competition and Innovation Act (BPCI Act) of 2009. The aim of the present study was to investigate how the health policy, the establishment of the biosimilar pathway, influenced related companies by studying their respective perspectives and strategies revealed in literatures and publicly available resources. Perspectives of companies reveal the points of concern for the biosimilar pathway, such as data requirements, patents, interchangeability, naming, and exclusivity. Innovator companies may utilize expedited programs for serious conditions, enhance patent protection, launch programs for life-cycle extension, and develop biosimilars as well. The biosimilar companies overcoming technical barriers might need to gather convincing evidence to facilitate market penetration as well as to distinguish their products from those of other biosimilar competitors. More challenges are expected for innovator companies if international harmonization takes place, which might be worth further investigation.     

不同影像检查在乳腺结构扭曲中的研究进展

我国乳腺癌的发病率占女性恶性肿瘤疾病的首位,结构扭曲病变(architectural distortion,AD)作为触诊阴性乳腺癌的第三最常见影像学表现,也是乳腺癌最早出现的征象,具有重要的临床价值。AD具有较高的漏诊率及假阳性率。本文通过查阅文献,针对超声、乳腺X线摄影、乳腺数字三维断层摄影技术及核磁共振成像技术在乳腺结构扭曲病变中的研究进展及优缺点进行分析,进一步指导科学研究及临床工作。     

煮炸鹿茸加工过程中晚期糖基化终产物生成规律及动力学分析

目的研究煮炸鹿茸加工过程中晚期糖基化终产物的生成规律及动力学参数。方法通过构建葡萄糖与赖氨酸模拟煮炸鹿茸加工过程美拉德(Maillard)反应体系,分别采用紫外-可见分光光度法和UPLC-MS/MS法测定体系褐变指数和典型晚期糖基化终产物(羧甲基赖氨酸和羧乙基赖氨酸)含量变化,探讨晚期糖基化终产物的生成规律和动力学参数。结果鹿茸加工过程中煮炸时发生褐变反应,生成羧甲基赖氨酸和羧乙基赖氨酸反应的活化能分别为5.07、40.44、78.47 kJ/mol,且均为零级反应;烘烤时相应反应的活化能分别为6.72、89.34、164.77 kJ/mol,也均为零级反应。相对于生成羧甲基赖氨酸而言,生成羧乙基赖氨酸所需能量更高,反应更难发生。结论烘烤过程温度变化对晚期糖基化终产物的动力学参数影响显著高于煮炸过程,长时间较高温度的烘烤使鹿茸中产生了较多的晚期糖基化终产物,这些结果为鹿茸加工过程中晚期糖基化终产物的阻断、抑制策略提供了理论基础,对生产绿色安全的鹿茸及加强中药安全具有重要意义。     

Role of macrophages in peripheral nerve injury and repair

Resident and inflammatory macrophages are essential effectors of the innate immune system. These cells provide innate immune defenses and regulate tissue and organ homeostasis. In addition to their roles in diseases such as cancer, obesity and osteoarthritis, they play vital roles in tissue repair and disease rehabilitation. Macrophages and other inflammatory cells are recruited to tissue injury sites where they promote changes in the microenvironment. Among the inflammatory cell types, only macrophages have both pro-inflammatory(M1) and anti-inflammatory(M2) actions, and M2 macrophages have four subtypes. The co-action of M1 and M2 subtypes can create a favorable microenvironment, releasing cytokines for damaged tissue repair. In this review, we discuss the activation of macrophages and their roles in severe peripheral nerve injury. We also describe the therapeutic potential of macrophages in nerve tissue engineering treatment and highlight approaches for enhancing M2 cell-mediated nerve repair and regeneration.     

Allergic fetal priming leads to developmental,behavioral and neurobiological changes in mice

The state of the mother''s immune system during pregnancy has an important role in fetal development and disruptions in the balance of this system are associated with a range of neurologic, neuropsychiatric and neurodevelopmental disorders. Epidemiological and clinical reports reveal various clues that suggest a possible association between developmental neuropsychiatric disorders and family history of immune system dysfunction. Over the past three decades, analogous increases have been reported in both the incidence of neurodevelopmental disorders and immune-related disorders, particularly allergy and asthma, raising the question of whether allergic asthma and characteristics of various neurodevelopmental disorders share common causal links. We used a mouse model of maternal allergic asthma to test this novel hypothesis that early fetal priming with an allergenic exposure during gestation produces behavioral deficits in offspring. Mothers were primed with an exposure to ovalbumin (OVA) before pregnancy, then exposed to either aerosolized OVA or vehicle during gestation. Both male and female mice born to mothers exposed to aerosolized OVA during gestation exhibited altered developmental trajectories in weight and length, decreased sociability and increased marble-burying behavior. Moreover, offspring of OVA-exposed mothers were observed to have increased serotonin transporter protein levels in the cortex. These data demonstrate that behavioral and neurobiological effects can be elicited following early fetal priming with maternal allergic asthma and provide support that maternal allergic asthma may, in some cases, be a contributing factor to neurodevelopmental disorders.     

A population-based analysis of pediatric breast cancer

Purpose

The purpose of this study was to evaluate trends in demographics and outcomes of pediatric breast cancer in a United States population-based cohort.