| 查看: 4046 | 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
非全日制公共管理求调剂
已经有0人回复
-
药学298分-一志愿中国海洋大学-求调剂
已经有2人回复
-
药理学论文润色/翻译怎么收费?
已经有104人回复
-
【#上海调剂急录#】能接受985联合培养的速来！带你发一区文章！
已经有4人回复
-
【上海调剂】985联合培养！别错过能送你去丹麦/交大/同济/中科院的神仙导师！
已经有0人回复
-
【调剂上岸】985联合培养！1007/1055/08/07等，不限专业，想联培的速来！
已经有3人回复
-
【上海调剂】985联合培养！别错过能送你去丹麦/交大/同济/中科院的神仙导师！
已经有14人回复
-
【#上海调剂急录#】能接受985联合培养的速来！带你发一区文章！
已经有5人回复
8楼2013-12-31 09:35:56
2楼2013-12-30 12:41:43
3楼2013-12-30 13:06:43
4楼2013-12-30 16:49:55
