| 查看: 4056 | 回复: 16 | ||||
| 当前只显示满足指定条件的回帖，点击这里查看本话题的所有回帖 | ||||
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
金属材料多尺度计算模拟技术与应用：微观机理到宏观性能的集成工作
已经有0人回复
-
江西科技师范大学07生物学和08生物与医药
已经有28人回复
-
药物学论文润色/翻译怎么收费?
已经有157人回复
-
药理学、临床药学方向 调剂
已经有1人回复
-
药学专硕申博
已经有10人回复
-
【招聘】清北（济南）生物科技招聘AI制药研发计算人才
已经有18人回复
-
可能上不了岸？有条件的可以考虑其他出路
已经有0人回复
-
100701药学专业招调剂，5个名额，药物化学专业，主要是天然药物化学方向加药理
已经有4人回复
-
【2026 硕士调剂】 全国重点实验室 药学 化学 生物学 生物与医药
已经有0人回复
-
药学 化学 生物学 生物与医药 河南师范大学抗病毒性传染病创新药物全国重点实验室
已经有0人回复
-
江西师大化学工程学院调剂今晚0点开放！ 缺额100个，速冲！
已经有13人回复
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
3楼2013-12-30 13:06:43
4楼2013-12-30 16:49:55
