| 查看: 3955 | 回复: 16 | ||||
wachina至尊木虫 (知名作家)
|
[交流]
武田fasiglifam (TAK-875)宣告失败，恒瑞呋格列泛齿亡唇寒 已有16人参与
|
|||
|
Takeda terminates development activities for fasiglifam (TAK-875) Takeda Pharmaceutical Company Limited (Takeda) announced that it has decided voluntarily to terminate the development activities for fasiglifam (TAK-875), an investigational treatment for type 2 diabetes, due to concerns about liver safety. Patient safety is Takeda's highest priority. The company has worked with three independent panels of experts to provide for the safety of trial participants and ensure independent safety oversight for the clinical trials throughout the duration of the fasiglifam (TAK-875) Phase 3 development program. The expert panels include the independent Data Monitoring Committee (DMC), a committee that oversees the fasiglifam global clinical development program, reviews the unblinded clinical data from program trials and provides continual safety oversight of trial subjects and recommendations. The DMC is comprised of clinical experts in endocrinology, cardiology and hepatology as well as a statistician. The independent Liver Safety Evaluation Committee (LSEC) is comprised of five hepatologists with expertise in drug-induced liver injury. While remaining blinded to treatment information, the LSEC regularly evaluates data on liver enzymes elevations and adjudicates cases that impacted the liver. In addition, an independent Executive Committee (EC) provides additional oversight for the fasiglifam (TAK-875) cardiovascular outcomes trial. After careful consideration of the data emerging from all the clinical trials and in consultation with these panels, the company has reached the conclusion that, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks. For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam. 作为慢性疾病：糖尿病的治疗，肝毒性太致命了，难怪武田挥泪斩马谡。值得一提的是，恒瑞也向CFDA申报了GPR-40激动剂呋格列泛，现在心里估计也是拔凉拔凉的 |
回复此楼» 收录本帖的淘帖专辑推荐
 新药仿药 |
» 猜你喜欢
生物组织中有目标分析物，专属性怎么做
已经有0人回复
-
CSC改派-博士生交流访学
已经有19人回复
-
药物学论文润色/翻译怎么收费?
已经有265人回复
-
中山大学-第七医院-招科研助理1名（基因设计和克隆、RNA合成）
已经有0人回复
-
中山大学-第七医院-招科研助理1名（基因设计和克隆、RNA合成）
已经有1人回复
-
巴黎萨克雷大学与国家留学基金委合作博士研究生项目-脂质纳米药物/生物材料/多酚递送
已经有10人回复
-
2026年山东大学海洋学院生物与医药博士招生-李霞课题组
已经有0人回复
-
博士研究生招生
已经有0人回复
-
药理学、临床药学方向 调剂
已经有1人回复
-
锦州医科大学药用生物材料（专业代码1007Z1）招收调剂考生
已经有0人回复
-
锦州医科大学药用生物材料（专业代码1007Z1）招收调剂考生
已经有1人回复
3楼2013-12-30 13:06:43
4楼2013-12-30 16:49:55
mengdragon
木虫 (著名写手)
muchong
- 应助: 61 (初中生)
- 金币: 3372.3
- 散金: 54
- 红花: 13
- 帖子: 1806
- 在线: 356.2小时
- 虫号: 203914
- 注册: 2006-03-02
- 性别: GG
- 专业: 合成药物化学
6楼2013-12-30 22:13:49
2楼2013-12-30 12:41:43
| 哎！！！！！！！ |
5楼2013-12-30 17:02:55
091602
铁杆木虫 (小有名气)
- 应助: 65 (初中生)
- 金币: 11932.2
- 散金: 9
- 红花: 4
- 帖子: 203
- 在线: 2295.2小时
- 虫号: 826350
- 注册: 2009-08-12
- 性别: GG
- 专业: 药物合成
7楼2013-12-31 08:51:06
8楼2013-12-31 09:35:56
lu198799
金虫 (正式写手)
- 应助: 7 (幼儿园)
- 金币: 1362.5
- 散金: 2
- 帖子: 454
- 在线: 127.5小时
- 虫号: 775421
- 注册: 2009-05-20
- 性别: GG
- 专业: 合成药物化学
9楼2013-12-31 10:00:56
gwmgyp
版主 (知名作家)
搬砖将
- DRDEPI: 8
- 应助: 820 (博后)
- 贵宾: 3.006
- 金币: 17161.9
- 散金: 13
- 红花: 67
- 沙发: 1
- 帖子: 5612
- 在线: 944.5小时
- 虫号: 1272275
- 注册: 2011-04-21
- 专业: 药物分析
- 管辖: 新药研发
10楼2013-12-31 10:12:11
