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A Multi-Center, Randomized, Prospective, Open-Label Phase III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Hepatitis C Immune Globulin Intravenous (Human), Civacir®, in Orthotopic Liver Transplant Recipients
The purpose of this study is to test the safety and efficacy of Civacir® to prevent the recurrence of Hepatitis C Virus (HCV) after liver transplant.
A Phase I/IIa Multi-dose Escalation Study of BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
The purpose of this study is to test safety and anti-tumor activity of BT062 in combination with lenalidomide and dexamethasone to define the best doses for treating patients with relapsed and refractory multiple myeloma.
A Phase I/IIa Multi-Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), Safety and Efficacy of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
This Phase I/IIa clinical study is to test safety and anti-tumor activity of BT062 to define the best dose in treating patients with relapsed or refractory multiple myeloma with multiple doses of BT062.
100 项与 BPC Plasma, Inc. 相关的临床结果
0 项与 BPC Plasma, Inc. 相关的专利（医药）
2012-01-01·Results in Immunology
Effective virus inactivation and removal by steps of Biotest Pharmaceuticals IGIV production process
Article
作者: Dougherty, Christopher J ; Kretschmar, Michael ; Dichtelmüller, Herbert O ; Sananes, Frank ; Flechsig, Eckhard
The virus validation of three steps of Biotest Pharmaceuticals IGIV production process is described here. The steps validated are precipitation and removal of fraction III of the cold ethanol fractionation process, solvent/detergent treatment and 35 nm virus filtration. Virus validation was performed considering combined worst case conditions. By these validated steps sufficient virus inactivation/removal is achieved, resulting in a virus safe product.
1989-01-01·Beitrage zur Infusionstherapie = Contributions to infusion therapy
[Virus safety of labile plasma products from the German viewpoint].
Review
作者: Stephan, W
Unstable plasma derivatives are sterilized in Germany according to three methods. Combined treatment with beta-propiolactone + UV irradiation: in use at Biotest since 1968; Pasteurisation in sulution, 10 h at 60 degrees C in the presence of a maltose-glycin stabilizer; in use at Behring Werke since 1980; Treatment with solvent + detergent (tri-n-butyl phosphate + Tween 80 (sodium cholate]: in use at DRK Hagen and Biotest since 1987/88. The safety of unstable plasma derivatives sterilized according to these methods has been shown in studies in chimpanzees as well as in clinical studies.
Contributions to infusion therapy
Virus safety of labile plasma products from the German viewpoint
作者: Stephan W
Unstable plasma derivatives are sterilized in Germany according to three methods. Combined treatment with beta-propiolactone + UV irradiation: in use at Biotest since 1968; Pasteurisation in sulution, 10 h at 60 degrees C in the presence of a maltose-glycin stabilizer; in use at Behring Werke since 1980; Treatment with solvent + detergent (tri-n-butyl phosphate + Tween 80 (sodium cholate]: in use at DRK Hagen and Biotest since 1987/88. The safety of unstable plasma derivatives sterilized according to these methods has been shown in studies in chimpanzees as well as in clinical studies.
1月9日，因为被英国对冲基因哥谭市研究（GothamCity Research）指控操纵其财务报告，西班牙化学及制药公司基立福（Grifols）美股盘前跌超45%。哥谭市研究是国际上著名的做空机构之一，2014年因就英国公司Quindell发表沽空报告而声名鹊起，2017年就电子明星股瑞声科技发表沽空报告后为中国投资者所知。对此，基立福在周二提交给美国证券交易委员会的文件中表示，哥谭市研究公司的指控是虚假信息和猜测。哥谭市研究在其报告中表示，它认为基立福的债务与收益比率比该公司报告的要差。如果其估计是正确的，它认为基立福的股票“不可投资”。作为回应，基立福拒绝并否认有关错误会计或报告做法的指控，并且其财务记录每年都会接受审计。“基立福作为一家上市公司，以最高水平的诚信和透明度报告并充分披露有关其所有重大交易的所有相关信息，以准确、公正地反映基立福合并财务报表。”基立福表示。哥谭市研究认为，分析师在估值过程中使用5到10年的EBITDA倍数时，错误评估了基立福。因为最近5到10年的数据是没有意义的，基立福的在过去的5年里发生根本性变化——来自非控股权益（NCI）的收益占收益的比例从2017年的近0%增长到了2023年全年的近100%。哥谭市研究公司表示，它发现了基立福与斯克兰顿企业（Scranton Enterprises）进行了几项未披露的关联交易。这些交易帮助公司降低了基立福的杠杆率至6.7倍，哥谭市研究认为真实的杠杆率在10到13倍之间，杠杆率越高，融资的成本就越高。2018年，基立福收购了BPC Plasma和Haema，然后将这两家公司出售给斯克兰顿。然而基立福和斯克兰顿都将这两家公司的财务完全合并，Gotham认为这“具有重大欺骗性和不正确性”。基立福在这两家公司中均未持有股份，2023年年初至今基立福的利润中有99%归因于非控制性权益（NCI）。2022年基立福来自NCI的利润中有 40.1%来自BPC和Haema。基立福在2018年向斯克兰顿提供了9500万美元的贷款，Gotham认为这与 BPC和Haema交易有关。然而，基立福没有在其财务报告中披露这笔贷款，而斯克兰顿则披露了。基立福表示，它否认了哥谭市对不当会计或财务报告做法的所有指控。并表示自2018年以来，哥谭市研究公司报告的关联方交易和披露已全面披露和审计，并向西班牙监管机构报告。参考来源：1.https://endpts.com/spains-grifols-accused-of-manipulating-finances-by-short-seller-gotham-city-stock-plummets/2.https://cn.bing.com/search?q=Grifols&sp=-1&lq=0&pq=grifols&sc=10-7&qs=n&sk=&cvid=417383E138384A8A9BF2ADCEBAA82807&ghsh=0&ghacc=0&ghpl=&FPIG=E96CD160869C478A91B9A70B1E6B28EE&first=36&FORM=PERE2本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处﹀ ········
100 项与 BPC Plasma, Inc. 相关的药物交易
100 项与 BPC Plasma, Inc. 相关的转化医学
