| 查看: 3895 | 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
提取肿瘤组织消化后得到的肿瘤细胞死亡率过高
已经有0人回复
-
WoS一区Frontiers in Genome Editing基因编辑方法与应用方向专题邀稿（影响因子4.9）
已经有0人回复
-
药物学论文润色/翻译怎么收费?
已经有270人回复
-
WoS一区Frontiers in Genome Editing基因编辑方法与应用方向专题邀稿（影响因子4.9）
已经有0人回复
-
WoS一区Frontiers in Genome Editing基因编辑方法与应用方向专题邀稿（影响因子4.9）
已经有0人回复
-
WoS一区Frontiers in Genome Editing基因编辑方法与应用方向专题邀稿（影响因子4.9）
已经有0人回复
-
求购时间长一些的硝酸钍
已经有0人回复
-
跪求一支AAV293细胞
已经有1人回复
-
博导推荐
已经有2人回复
-
哪里做甘氨酸受体与配体结合率的试验
已经有0人回复
-
关于SCI杂志发表挂名
已经有32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