Trillions of microorganisms transit through and reside in the mammalian gastrointestinal tract each day, collectively producing thousands of small molecules and metabolites with local and systemic effects on host physiology. Identifying effector microorganisms that causally affect host phenotype and deciphering the underlying mechanisms have become foci of microbiome research and have begun to enable the development of microbiota-based therapeutics. Two complementary, reductionist approaches have commonly been used: the first starts with an immune phenotype and narrows down the microbiota to identify responsible effector bacteria, while the second starts with bacteria-derived molecules and metabolites and seeks to understand their effects on the host immune system. Together, these strategies provide the basis for the rational design of microbial and metabolite-based therapeutics that target and ameliorate immune deficits in patients. The intestinal microbiota profoundly shapes host physiology through its production of small molecules and metabolites. Here, Honda and colleagues discuss how these microbial products shape immune function. They further consider the potential of ‘mining’ the microbiota for new microbial and metabolite-based immunotherapies.

Mining the Microbiota for Microbial and Metabolite-Based Immunotherapies

The Repurposing Drugs in Oncology (ReDO) Project seeks to repurpose well-known and well-characterised non-cancer drugs for new uses in oncology. The rationale for this project is presented, examining current issues in oncological drug development, challenges for health systems, and existing and future patient needs. In addition to discussing the advantages of repurposing, the paper also outlines some of the characteristics used in the selection of drug candidates by this project. Challenges in moving candidate drugs into clinical trial and subsequent practice are also discussed.

/pdf/the-repurposing-drugs-in-oncology-redo-project-51ogwdbqry.pdf

The Repurposing Drugs in Oncology (ReDO) Project

Cell therapies offer the promise of treating and altering the course of diseases which cannot be addressed adequately by existing pharmaceuticals. Cell therapies are a diverse group across cell types and therapeutic indications and have been an active area of research for many years but are now strongly emerging through translation and towards successful commercial development and patient access. In this article, we present a description of a classification of cell therapies on the basis of their underlying technologies rather than the more commonly used classification by cell type because the regulatory path and manufacturing solutions are often similar within a technology area due to the nature of the methods used. We analyse the progress of new cell therapies towards clinical translation, examine how they are addressing the clinical, regulatory, manufacturing and reimbursement requirements, describe some of the remaining challenges and provide perspectives on how the field may progress for the future.

/pdf/cell-based-therapy-technology-classifications-and-lb7yrvwitf.pdf

Cell-based therapy technology classifications and translational challenges.

After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns. We examined whether the frequency of these safety problems has increased since 1992, when the Prescription Drug User Fee Act, legislation designed to accelerate the drug approval process at the Food and Drug Administration, was passed. We found that drugs approved after the act’s passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up). We could not establish causality, however. Our findings suggest the need for reforms to reduce patients’ exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was approved only recently.

Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box Warnings And Market Withdrawals

In July 2012, the FDA Safety and Innovation Act created the “breakthrough therapy” designation to expedite development of therapies for serious diseases when evidence suggests substantial superiority over existing options. The authors discuss implications of the new designation.

/pdf/new-fda-breakthrough-drug-category-implications-for-patients-4vo9bkfebd.pdf

New FDA Breakthrough-Drug Category — Implications for Patients

The FDA's new “breakthrough therapy” designation for investigational drugs adds to the agency's portfolio of expedited programs for serious conditions. The designation requires preliminary clinical evidence demonstrating substantial improvement over existing therapies.

Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation

Pathological prognosis classification of patients with neuroblastoma using computational pathology analysis

Corrigendum7 March 2022Open Access Source Data Epigenetic silencing of SALL2 confers tamoxifen resistance in breast cancer Liping Ye Liping Ye orcid.org/0000-0002-2263-0631 Search for more papers by this author Chuyong Lin Chuyong Lin Search for more papers by this author Xi Wang Xi Wang Search for more papers by this author Qiji Li Qiji Li orcid.org/0000-0001-7949-299X Search for more papers by this author Yue Li Yue Li Search for more papers by this author Meng Wang Meng Wang Search for more papers by this author Zekun Zhao Zekun Zhao Search for more papers by this author Xianqiu Wu Xianqiu Wu Search for more papers by this author Dongni Shi Dongni Shi Search for more papers by this author Yunyun Xiao Yunyun Xiao Search for more papers by this author Liangliang Ren Liangliang Ren Search for more papers by this author Yunting Jian Yunting Jian Search for more papers by this author Meisongzhu Yang Meisongzhu Yang Search for more papers by this author Ruizhang Ou Ruizhang Ou Search for more papers by this author Guangzheng Deng Guangzheng Deng Search for more papers by this author Ying Ouyang Ying Ouyang Search for more papers by this author Xiangfu Chen Xiangfu Chen Search for more papers by this author Jun Li Jun Li orcid.org/0000-0003-0572-1344 Search for more papers by this author Libing Song Corresponding Author Libing Song [email protected] orcid.org/0000-0002-5315-771X Search for more papers by this author Liping Ye Liping Ye orcid.org/0000-0002-2263-0631 Search for more papers by this author Chuyong Lin Chuyong Lin Search for more papers by this author Xi Wang Xi Wang Search for more papers by this author Qiji Li Qiji Li orcid.org/0000-0001-7949-299X Search for more papers by this author Yue Li Yue Li Search for more papers by this author Meng Wang Meng Wang Search for more papers by this author Zekun Zhao Zekun Zhao Search for more papers by this author Xianqiu Wu Xianqiu Wu Search for more papers by this author Dongni Shi Dongni Shi Search for more papers by this author Yunyun Xiao Yunyun Xiao Search for more papers by this author Liangliang Ren Liangliang Ren Search for more papers by this author Yunting Jian Yunting Jian Search for more papers by this author Meisongzhu Yang Meisongzhu Yang Search for more papers by this author Ruizhang Ou Ruizhang Ou Search for more papers by this author Guangzheng Deng Guangzheng Deng Search for more papers by this author Ying Ouyang Ying Ouyang Search for more papers by this author Xiangfu Chen Xiangfu Chen Search for more papers by this author Jun Li Jun Li orcid.org/0000-0003-0572-1344 Search for more papers by this author Libing Song Corresponding Author Libing Song [email protected] orcid.org/0000-0002-5315-771X Search for more papers by this author Author Information Liping Ye, Chuyong Lin, Xi Wang, Qiji Li, Yue Li, Meng Wang, Zekun Zhao, Xianqiu Wu, Dongni Shi, Yunyun Xiao, Liangliang Ren, Yunting Jian, Meisongzhu Yang, Ruizhang Ou, Guangzheng Deng, Ying Ouyang, Xiangfu Chen, Jun Li and Libing Song * EMBO Mol Med (2022)14:e15618https://doi.org/10.15252/emmm.202115618 This article corrects the following: Epigenetic silencing of SALL2 confers tamoxifen resistance in breast cancer28 October 2019 PDFDownload PDF of article text and main figures. ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinked InMendeleyWechatReddit Figures & Info The authors became aware that the representative Ki67-staining image of the ipatasertib tumor had been displayed twice in the figure set. The authors state that the image displayed in Figure 5G, 5G was incorrect and that this correction does not affect the description, interpretation, or conclusions of the manuscript. The authors apologize for this error and any confusion it may have caused. Figure 5G. Original Download figure Download PowerPoint Figure 5G. Corrected Source data are available online for this figure. Download figure Download PowerPoint Supporting Information Previous ArticleNext Article Read MoreAbout the coverClose modalView large imageVolume 14,Issue 3,7 March 2022This month's cover highlights the article Allosteric inhibition of SHP2 uncovers aberrant TLR7 trafficking in aggravating psoriasis by Yuyu Zhu, Zhigui Wu, Wei Yan, Fenli Shao, Yang Sun and colleagues. [Caption: This image depicts the process of the boat traveling in the river as a metaphor for TLR7 trafficking in cells. When TLR7 is phosphorylated, the boat cannot continue sailing. SHP2 promotes TLR7 trafficking to endosomes and activates the downstream NF‐κB pathway through dephosphorylation of TLR7, thus exacerbating the pathogenesis of psoriasis.] (Scientific image by the authors) Volume 14Issue 37 March 2022In this issue FiguresRelatedDetailsLoading ... 

Epigenetic silencing of SALL2 confers tamoxifen resistance in breast cancer

with nonHis-panics with lung cancer (6.2 from 4.8 per million persons, 36%) and breast cancer (5.0 from 4.4 per million persons, 30%) (online Supplementary Figure 1). This retrospective national database analysis demonstrated AAMR for PE in cancer increased by 43% and there are persistent and significant racial disparities in these rates, with Black individuals experiencing 29–171% higher rates with-out significant change over time. Understanding the burden of PE mortality is essential for identifying and developing risk stratification tools and treatment algorithms to improve outcomes. Currently, cancer-specific VTE risk assessment tools may underestimate the risk of thrombosis in Black and Hispanic patients. 8 Mechanisms underpinning these findings remain speculative, but are likely multifactorial. An increased recognition and improved testing modalities may play a role in the growing AAMR. Furthermore, the new biologic and

Trends and disparities in pulmonary embolism mortality among patients with cancer

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Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation

Pathological prognosis classification of patients with neuroblastoma using computational pathology analysis

Epigenetic silencing of SALL2 confers tamoxifen resistance in breast cancer

Trends and disparities in pulmonary embolism mortality among patients with cancer