• 03-31 2020
       这封信是应您的要求,即美国食品药物监督管理局(FDA)发出紧急使用授权(EUA),用于在2019年紧急使用磷酸氯喹和硫酸羟氯喹口服制剂治疗2019新型冠状病毒疾病(COVID-19)由卫生保健提供者(HCP)根据本函授权范围(第II节)中所述的持照从业人员的有效处方进行管理。 根据《联邦食品,药品和化妆品法》(该法)(美国法典第21卷360bb-3)第564条,授权的氯喹磷酸酯和羟氯喹硫酸盐仅限于从国家战略储备(SNS)供应给公共卫生部门的产品。来源:https://www.fda.gov/media/136534/download此前:抗新冠,FDA不计前嫌,解除印度药企Ipca进口禁令!为了硫酸羟氯喹和磷酸氯喹!据FiercePharma报道,近期美国FDA解除了印度制药企业Ipca的进口禁令,以便其能够提供未经批准的新冠肺炎治疗药物。FDA frees India's Ipca from import ban so it can ship unproven COVID-19 treatments。         鉴于Ipca致力于提供更多的新冠肺炎治疗药物/方案(虽然未经确认),美国食品药品监督管理局(FD...
  • 03-31 2020
           法匹拉韦新冠病毒有效药物的身份被再一次证实。       近日,来自科技部联防联控机制科研攻关组的消息,一项“法匹拉韦治疗新型冠状病毒肺炎(COVID-19)患者的安全性和有效性的临床研究”的结果已经出炉。研究显示法匹拉韦(Favipiravir)可能通过加快病毒清除,达到缓解新型冠状病毒肺炎进展的疗效。 要知道,病毒清除作为主要疗效指标,是评价抗病毒药物临床疗效的国际公认金标准。上述结果也意味着,法匹拉韦安全有效性已经获得初步证实,有望很快跻身新冠肺炎“救命药”行列。       正因如此,2月15日,法匹拉韦获得国家药监局有条件批准上市,成为疫情期间全国第一个批准上市的对新冠肺炎具有潜在疗效的药物。随后,山东省药采平台公示其挂网信息,挂网价格单片约为20元,最长一疗程费用近1600元。       目前,海正药业拥有法匹拉韦在中国的唯一批准文号。随着法匹拉韦与磷酸氯喹、克力芝、阿比多尔等药物一同被列入新冠肺炎临床治疗药物名单,在需求量激增...
  • 03-31 2020
            由军事科学院军事医学研究院陈薇院士领衔的科研团队自抵达武汉以来,就集中力量展开在疫苗研制方面的应急科研攻关,昨天(3月16日)20时18分,陈薇院士团队研制的重组新冠疫苗获批启动展开临床试验。        自1月26日抵达武汉以来,陈薇院士团队联合地方优势企业,在埃博拉疫苗成功研发的经验基础上,争分夺秒开展重组新型冠状病毒疫苗的药学、药效学、药理毒理等研究,快速完成了新冠疫苗设计、重组毒种构建和GMP条件下生产制备,以及第三方疫苗安全性、有效性评价和质量复核。昨天晚上,陈薇院士团队研制的新冠疫苗通过了临床研究注册审评,获批进入临床试验。       中国工程院院士、军事科学院军事医学研究院研究员陈薇在接受采访时介绍,按照国际的规范、国内的法规,疫苗已经做了安全、有效、质量可控、可大规模生产的前期准备工作。        来源 | 央视新闻客户端
  • 02-17 2020
    Recently, the Construction Office of Shandong new and old energy conversion Comprehensive Test Zone issued the notice on publishing the list of the first batch of preferred projects in the major project library of new and old energy conversion in 2020, which was published on the official website of Shandong development and Reform Commission. This batch of selected projects have been reviewed by experts of major projects, and all of them have been selected from the advanced reserve projects of new and old kinetic energy conversion major project library, with clear investment demand, good project foundation, broad market prospect, and good demonstration and driving role. The second phase project of SPB series high-end fine chemicals of Shandong Daoyi Pharmaceutical Technology Co., Ltd. is included in the first batch of optimization projects of the province's major proj...
  • 12-26 2019
    On December 16, the Safety Supervision Bureau and the evaluation team composed of four experts conducted a three-level evaluation on the safety production standardization of Shandong Daoyi Pharmaceutical Technology Co., Ltd., and Daoyi technology passed the evaluation successfully. Since the start-up and operation, Daoyi technology has taken the construction of safety production standardization as the starting point, firmly grasped safety and promoted development, built a safety production standardization system, established relevant rules and regulations of safety production such as code of conduct for employees' safety operation, established a leading working group of safety production management organization, and actively organized safety production training and special safety production drills to achieve“ Zero accident "is the general goal, and safety production ...
  • 12-12 2019
    Recently, Dongying science and Technology Bureau announced the list of key laboratories in Dongying in 2019, and Dongying Key Laboratory of green synthesis of anti-tumor molecular targeting drugs of Shandong Daoyi Pharmaceutical Technology Co., Ltd. was selected successfully. The key laboratory is an important part of the scientific and technological innovation system. It is an important base to carry out basic research on industry application, gather and cultivate scientific and technological talents, and carry out scientific and technological exchanges. It is also an important platform to develop common key technologies, enhance technological radiation ability, and promote the combination of production, learning and research.       The main task of the laboratory is to carry out core technology research, key process test research, relevan...
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