A5004180407- Pharmaceutical Economics and Policy
- Acute Myeloid Leukemia Research
- Biosimilars and Bioanalytical Methods
- Biomedical Ethics and Regulation
- Cancer Genomics and Diagnostics
- CAR-T cell therapy research
- Retinoids in leukemia and cellular processes
- Health Systems, Economic Evaluations, Quality of Life
- Pharmaceutical studies and practices
- Lymphoma Diagnosis and Treatment
- Advanced Breast Cancer Therapies
- Chronic Lymphocytic Leukemia Research
- Cancer Treatment and Pharmacology
- Economic and Financial Impacts of Cancer
- HER2/EGFR in Cancer Research
- Acute Lymphoblastic Leukemia research
- Drug-Induced Ocular Toxicity
- Science, Research, and Medicine
- Statistical Methods in Clinical Trials
- Neutropenia and Cancer Infections
- BRCA gene mutations in cancer
- Transplantation: Methods and Outcomes
- Eosinophilic Disorders and Syndromes
- Lung Cancer Treatments and Mutations
- Telomeres, Telomerase, and Senescence
The University of Tokyo
2007-2025
Kyoto University Hospital
2013-2025
Kyoto University
2023
University Hospital of Basel
2023
Pharmaceuticals and Medical Devices Agency
2012-2022
University of South Carolina
2022
University of Tokyo Hospital
2018-2021
Ibero American University
2019
Ministry of Food and Drug Safety
2018
Kure Medical Center
2013
Abstract Cyclin E1 (CCNE1) amplification is associated with poor prognosis of ovarian carcinomas across histological subtypes. Inhibitors targeting PLK1 or WEE1 are emerging as promising therapeutic agents for cancer treatment that disrupt the critical G2/M checkpoint, leading to cell death. However, biomarkers predict response these inhibitors not well defined. Here, we evaluated efficacy inhibitor, volasertib, and adavosertib, along biomarker potential cyclin in cells. Both suppressed...
Chimeric antigen receptor (CAR)‐T cell and bispecific antibodies (BsAb) have substantially improved outcomes for lymphoid neoplasms (LN); however, a comprehensive analysis regarding the regulatory approval these products is not available; therefore, we aimed to address this research gap. We identified all indications CAR‐T BsAb LN approved in United States, European Union, or Japan between January 2010 September 2023 using public databases. The States was most frequent region of first both...
BackgroundThe onset of invasive aspergillosis (IA) after allogeneic haematopoietic stem cell transplantation (HSCT) is bimodal. However, IA early HSCT has become less frequent due to the shortened neutropenic period, and clinical significance empirical treatment for based on persistent febrile neutropenia (FN) became clear. Therefore, we started a presumptive strategy, in which anti-Aspergillus agents were when patients developed positive serum test and/or infiltrates or nodules X-ray...
Abstract Biosimilar filgrastims are primarily indicated for chemotherapy-induced neutropenia prevention. They less expensive formulations of branded filgrastim, and biosimilar filgrastim was the first oncology drug administered in European Union (EU) countries, Japan, U.S. Fourteen have been marketed EU U.S., Canada since 2008, 2012, 2015, 2016, respectively. We reviewed experiences policies markets countries where uptake has rapid, Canada, experience is rapidly emerging. regulations...
The number of drugs developed by non‐global companies, including biotech start‐ups, has increased; however, their characteristics and impact on global regulatory approval are not well understood. Using a public database, we identified new molecular entities (NMEs) approved for hematologic malignancies in the US from January 2011 to December 2022. They were divided into those submitted companies (non‐global group) (global group). We 48 NMEs, which 19 (40%) classified as non‐global. Of these,...
In Japan, the Pharmaceuticals and Medical Devices Law was passed in 2014. this new law, regenerative medical products were defined, a conditional term-limited approval system only for instituted. Therefore, can be approved based on phase I and/or II trials. Gene therapy adoptive cellular are categorized as products. This law is intended registration trials marketing authorization. The Act Safety of Regenerative Medicine also implemented act clinical research practice involving processed...
Advances in genetic sequencing and other diagnostic technologies have enabled the use of precision medicine clinical cancer care, as well development novel therapies that are targeted to specific molecular drivers cancer. Developing these new agents making them accessible patients requires global studies regulatory review approval by different national agencies. Whereas trials present challenges for drug developers who conduct agencies oversee them, they also raise practical issues about...
This Viewpoint discusses obstacles that limit the use of biosimilar filgrastim in United States compared with countries European Union and Japan strategies might help become more widespread.
Summary Differences in regulatory actions between Japan, the European Union ( EU ) and United States US regarding approval date primary endpoints of pivotal trials have never been analysed comprehensively. This study aimed to examine such differences haematological malignancy indications not only applications for new molecular entity agents but also supplemental additional indications. A total 101 were examined 58 drugs. Only 30 approved by agencies all three regions with 25, 9 67 being...