Baidu
map

FDA:葛兰素史克向欧盟提交Votrient新适应症申请

2013-08-08 tomato 生物谷

葛兰素史克(GSK)今天宣布,已向欧洲药品管理局(EMA)提交了Votrient(帕唑帕尼,pazopanib)新适应症申请,将votrient用于接受一线化疗后病情未恶化的II-IV阶段卵巢癌、输卵管癌、原发性腹膜癌患者的维持治疗。 这一申请,是votrient不到5年时间在欧盟提交的第3个适应症。 原始出处: GSK announces EU submission seeking a

葛兰素史克(GSK)今天宣布,已向欧洲药品管理局(EMA)提交了Votrient(帕唑帕尼,pazopanib)新适应症申请,将votrient用于接受一线化疗后病情未恶化的II-IV阶段卵巢癌、输卵管癌、原发性腹膜癌患者的维持治疗。

这一申请,是votrient不到5年时间在欧盟提交的第3个适应症。

原始出处:

GSK announces EU submission seeking additional indication for Votrient? as maintenance therapy for advanced ovarian cancer

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (4)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1315725, encodeId=e8f31315e2552, content=<a href='/topic/show?id=6f0188218ee' target=_blank style='color:#2F92EE;'>#葛兰素史克#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88218, encryptionId=6f0188218ee, topicName=葛兰素史克)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d58a435, createdName=sjq027, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336670, encodeId=f4a913366e04d, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=99, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416180, encodeId=17421416180d6, content=<a href='/topic/show?id=a24f58e0879' target=_blank style='color:#2F92EE;'>#新适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58708, encryptionId=a24f58e0879, topicName=新适应症)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=613c3147617, createdName=sunyl08, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631245, encodeId=df141631245b2, content=<a href='/topic/show?id=0d2b1353679' target=_blank style='color:#2F92EE;'>#OTR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13536, encryptionId=0d2b1353679, topicName=OTR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fb2621702447, createdName=jichang, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=)]
  2. [GetPortalCommentsPageByObjectIdResponse(id=1315725, encodeId=e8f31315e2552, content=<a href='/topic/show?id=6f0188218ee' target=_blank style='color:#2F92EE;'>#葛兰素史克#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88218, encryptionId=6f0188218ee, topicName=葛兰素史克)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d58a435, createdName=sjq027, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336670, encodeId=f4a913366e04d, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=99, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416180, encodeId=17421416180d6, content=<a href='/topic/show?id=a24f58e0879' target=_blank style='color:#2F92EE;'>#新适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58708, encryptionId=a24f58e0879, topicName=新适应症)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=613c3147617, createdName=sunyl08, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631245, encodeId=df141631245b2, content=<a href='/topic/show?id=0d2b1353679' target=_blank style='color:#2F92EE;'>#OTR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13536, encryptionId=0d2b1353679, topicName=OTR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fb2621702447, createdName=jichang, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=)]
  3. [GetPortalCommentsPageByObjectIdResponse(id=1315725, encodeId=e8f31315e2552, content=<a href='/topic/show?id=6f0188218ee' target=_blank style='color:#2F92EE;'>#葛兰素史克#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88218, encryptionId=6f0188218ee, topicName=葛兰素史克)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d58a435, createdName=sjq027, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336670, encodeId=f4a913366e04d, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=99, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416180, encodeId=17421416180d6, content=<a href='/topic/show?id=a24f58e0879' target=_blank style='color:#2F92EE;'>#新适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58708, encryptionId=a24f58e0879, topicName=新适应症)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=613c3147617, createdName=sunyl08, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631245, encodeId=df141631245b2, content=<a href='/topic/show?id=0d2b1353679' target=_blank style='color:#2F92EE;'>#OTR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13536, encryptionId=0d2b1353679, topicName=OTR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fb2621702447, createdName=jichang, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=1315725, encodeId=e8f31315e2552, content=<a href='/topic/show?id=6f0188218ee' target=_blank style='color:#2F92EE;'>#葛兰素史克#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88218, encryptionId=6f0188218ee, topicName=葛兰素史克)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d58a435, createdName=sjq027, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336670, encodeId=f4a913366e04d, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=99, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416180, encodeId=17421416180d6, content=<a href='/topic/show?id=a24f58e0879' target=_blank style='color:#2F92EE;'>#新适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58708, encryptionId=a24f58e0879, topicName=新适应症)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=613c3147617, createdName=sunyl08, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631245, encodeId=df141631245b2, content=<a href='/topic/show?id=0d2b1353679' target=_blank style='color:#2F92EE;'>#OTR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13536, encryptionId=0d2b1353679, topicName=OTR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fb2621702447, createdName=jichang, createdTime=Sat Aug 10 07:39:00 CST 2013, time=2013-08-10, status=1, ipAttribution=)]
    2013-08-10 jichang

相关资讯

FDA顾问委员会建议批准拜耳肺动脉高压药物riociguat

拜耳(Bayer)8月6日宣布,FDA心血管和肾脏药物顾问委员会(CRDAC)以11:0的投票结果,建议批准实验性肺动脉高压药物riociguat用于治疗WHO分级I肺动脉高压(PAH),同时也以11:0的投票结果建议批准riociguat用于WHO分级IV慢性阻塞性肺动脉高压(CTEPH)的治疗。FDA在审查riociguat时,将考虑顾问委员会的意见。 拜耳于2013年2月提交了rioc

EMA:Aegerion高胆固醇血症新药Lojuxta获EMA批准

美国生物制药公司Aegerion制药今天宣布,欧洲药品管理局(EMA)已批准将Lojuxta(lomitapide)硬胶囊作为低脂肪饮食及其他降脂药用产品的一种辅助药物,用于纯合子家族性高胆固醇血症(HoFH)成人患者的治疗。 纯合子家族性高胆固醇血症(HoFH)是一种极罕见的常染色体显性遗传性疾病,发病机制为细胞膜表面的低密度脂蛋白(LDL)受体缺如或异常,导致体内LDL代谢异常,造成血浆

大冢多囊肾药物tolvaptan遭FDA顾问委员会否决

FDA心血管和肾脏药物顾问委员会以9:6的投票结果,建议不批准大冢制药(Otsuka)托伐普坦(tolvaptan)用于常染色体显性多囊肾(ADPKD)的治疗。 今年早些时候,FDA接受了大冢tolvaptan的新药申请(NDA),并授予了优先审查资格,该药的处方药用户收费法(PDUFA)目标日期为2013年9月1日。 英文原文:U.S. Food and Drug Administrat

EMA:III期试验成功—Medicines耗资$2.4亿收购ProFibrix

Medicines公司今天公布了生物制剂Fibrocaps的关键性III期临床试验FINISH-3的数据,该项试验在美国和西欧的65个站点开展,涉及719例患者,在4个不同的手术适应症脊柱外科、肝切除、软组织剥离、血管手术中,均达到了所有主要和次要止血疗效终点。 Fibrocaps是荷兰生物技术公司ProFibrix开发的一种生物制剂,这是一种干粉外用配方的纤维蛋白原和凝血酶,开发用于手术过

阿尔茨海默病国产新药美金刚获批上市

近期,国家食品药品监督管理总局批准国产盐酸美金刚溶液和盐酸美金刚片用于中重度至重度阿尔茨海默型痴呆的治疗。 阿尔茨海默型痴呆(Alzheimer disease,以下简称AD),是一种中枢神经系统退行性疾病,是老年期痴呆最常见的一种类型。起病隐袭,病程呈慢性进行性,发病率随年龄增加而增高。临床表现为认知能力下降、精神行为异常、日常生活能力降低等。研究发现,AD发病机制与中枢胆碱能损伤和兴奋性氨基

拜耳Eylea 2个III期糖尿病性黄斑水肿试验均达主要终点

Regeneron制药和拜耳(Bayer)今天宣布,有关眼科药物Eylea(aflibercept,阿柏西普注射液)治疗糖尿病性黄斑水肿(DME)的2个III期试验VIVID-DME和VISTA-DME均达到了研究的主要终点。治疗52周时,最佳矫正视力(BCVA)从基线的变化,与激光光凝(laser photocoagulation)相比,Eylea治疗组取得了显着的更大改善。2项试验中,Ey

Baidu
map
Baidu
map
Baidu
map