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  • 中国生物等效性测试及对可靠的CRO需求日益增加得探究

    2018-02-01  来源:pharma intelligence

     尽管中国的仿制药价格售得更加高,但并非总是和个别的全球创新药一样可靠有效。针对2015和2016年的数据造假调查结果,国家食品药品监督管理总局(“CFDA”)重申对已审批的仿制药作出重新测试。市民已再次得到确保仿制药和创新药同样有效,并对任何使用虚假数据的人都会予以刑事处罚。随着仿制药公司被要求进行新的生物等效性(“BE”)测试,BE测试活动显著增加,同...[更多]

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  • FDA: 2017年度新药审批报告

    2018-02-01  来源:FDA

    Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) s...[更多]

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  • FDA指南:药物开发过程中IND发起人和FDA之间沟通的最佳实践

    2018-02-01  来源:FDA

    This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) onthis topic. It does not establish any rights for any person and is not binding ...[更多]

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  • 2017AACR癌症进展报告

    2018-02-01  来源:AACR

    The AACR Cancer Progress Report 2017 provides a comprehensive overview of the progress we are making because of research, much of which is supported by federal investments in the National Institutes of Health (NIH) including the National Cancer Institute (NCI). As highlighted in the report, the pac...[更多]

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  • Evaluatepharma:生物医药2018年展望

    2018-02-01  来源:EvaluatePharma

    The upward momentum seen in the pharma and biotech sectors during 2017 looks set to continue into 2018, with more novel medicines set to hit the market and investor support for th...[更多]

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  • CDER拒绝NDA和BLA申请行业指南

    2018-02-01  来源:FDA

    Comments and suggestions regarding this draft document should be submitted within 60 days ofpublication in the Federal Register of the notice announcing the availability of the draftguidance. Submit electronic comments to https://www.regulations.gov. Submit writtencomments to the Dockets Management...[更多]

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  • PhRMA:疫苗研发进展报告(2017)

    2018-02-01  来源:PhRMA

    Today, there are 264 vaccines in development by America’s biopharmaceutical companies to both prevent and treat diseases. These include 137 for infectious diseases, 101 for cancer, 10 for allergies, eight for autoimmune disease, four for Alzheimer’s disease and five for other diseases.[更多]

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  • PhRMA:精神疾病在研药物报告(2017)

    2018-02-01  来源:PhRMA

    Biopharmaceutical research companies are developing more than 140 medicines for mental illnesses. Mental illnesses exact a heavy human and economic toll in the United States. The National Institute of Mental Health (NIMH) estimates that nearly 18 percent of American adults and 20 percent of childre...[更多]

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  • 2017年度日本批准品种(新药)(2017年4月1日-2017年8月25日)

    2017-10-12  来源:日本PMDA

     平成29年4月1日から平成29年8月25日までの間に、総合機構の審査、薬事分科会の審議・報告を経て、厚生労働大臣によって承認された「新医薬品」は別表のとおりです。 ここで「新医薬品」とは、医療用に用いる、新有効成分含有医薬品、新医療用配合剤、新投与経路医薬品、新効能医薬品、新剤型医薬品、新用量医薬品などです。[更多]

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  • PhRMA:2017年在研阿尔兹海默治疗药物年度报告

    2017-10-12  来源:PhRMA

    America’s biopharmaceutical research companies are investigating or developing 85 medicines to help the more than 5 million patients in the United States who are living with Alzhe...[更多]

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