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FDA批准MGB Biopharma的新型抗生素IND申请治疗艰难梭菌相关性腹泻

2019-01-25 MedSci MedSci原创

艰难梭菌相关性腹泻CDAD抗生素
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美国食品和药物管理局（FDA）和加拿大卫生部已经批准MGB Biopharma的候选药物MGB-BP-3的研究性新药申请（IND），用于治疗艰难梭菌相关性腹泻（CDAD）。

美国食品和药物管理局（FDA）和加拿大卫生部已经批准MGB Biopharma的候选药物MGB-BP-3的研究性新药申请（IND），用于治疗艰难梭菌相关性腹泻（CDAD）。

艰难梭菌一年内导致美国患者中近50万感染， MGB-BP-3是一种有效的杀菌抗生素，具有完全新颖的作用机制，对多种重要的多重耐药和易感革兰氏阳性病原体具有活性。MGB-BP-3通过杀死艰难梭菌，很可能为治疗CDAD提供新的范式药物。

用于评估MGB-BP-3治疗CDAD患者的IIa期试验有望在2019年第一季度开始。

卡尔加里阿尔伯塔大学卡明医学院的临床教授托马斯路易博士和该试验的首席研究员评论说：" 艰难梭菌感染是加拿大和美国医疗保健系统的主要负担。一种新的抗生素能够在它能够形成孢子之前杀死这种致命的病原体，将为遭受这种疾病的患者及其家人带来了新的希望。"

MGB-BP-3的口服制剂专门用于治疗CDAD，CDAD是发达国家医院中最常发生腹泻的一种感染。这些感染的死亡率很高，65岁以上的患者中，每11名中有1名在诊断后30天内死亡。

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    2019-02-07 shenxlcyp

    #相关性#

    0

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    2019-09-24 chentianping

    #pharma#

    0

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    2019-02-27 sunylz

    #Bio#

    0

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    2019-08-28 智者为医08

    #FDA批准#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1837631, encodeId=bbcb183e63175, content=<a href='/topic/show?id=3f34e253206' target=_blank style='color:#2F92EE;'>#相关性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72532, encryptionId=3f34e253206, topicName=相关性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a9de34, createdName=shenxlcyp, createdTime=Thu Feb 07 23:12:00 CST 2019, time=2019-02-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1908510, encodeId=fbeb1908510e2, content=<a href='/topic/show?id=a8d0141605e' target=_blank style='color:#2F92EE;'>#pharma#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14160, encryptionId=a8d0141605e, topicName=pharma)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f634250, createdName=chentianping, createdTime=Tue Sep 24 17:12:00 CST 2019, time=2019-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1918493, encodeId=a9e41918493b3, content=<a href='/topic/show?id=4f26341994' target=_blank style='color:#2F92EE;'>#Bio#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3419, encryptionId=4f26341994, topicName=Bio)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Wed Feb 27 03:12:00 CST 2019, time=2019-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839646, encodeId=d9b81839646ff, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Wed Aug 28 02:12:00 CST 2019, time=2019-08-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1676869, encodeId=b6cb16e68692a, content=<a href='/topic/show?id=63825823146' target=_blank style='color:#2F92EE;'>#新型抗生素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58231, encryptionId=63825823146, topicName=新型抗生素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8bab27396846, createdName=marongnuan, createdTime=Thu Feb 21 00:12:00 CST 2019, time=2019-02-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1707564, encodeId=a0641e07564bd, content=<a href='/topic/show?id=9f7c99e256' target=_blank style='color:#2F92EE;'>#IOP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9972, encryptionId=9f7c99e256, topicName=IOP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6bb031431834, createdName=124987c6m46暂无昵称, createdTime=Fri Sep 13 06:12:00 CST 2019, time=2019-09-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1787575, encodeId=70971e875752b, content=<a href='/topic/show?id=fa03141591e' target=_blank style='color:#2F92EE;'>#Pharm#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14159, encryptionId=fa03141591e, topicName=Pharm)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8942242, createdName=jj000001, createdTime=Sat Mar 30 10:12:00 CST 2019, time=2019-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1469127, encodeId=6ce4146912ed4, content=<a href='/topic/show?id=211f98250b' target=_blank style='color:#2F92EE;'>#IND#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9825, encryptionId=211f98250b, topicName=IND)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=16377007930, createdName=xiaogang319, createdTime=Sun Jan 27 04:12:00 CST 2019, time=2019-01-27, status=1, ipAttribution=)]
    2019-02-21 marongnuan

    #新型抗生素#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1837631, encodeId=bbcb183e63175, content=<a href='/topic/show?id=3f34e253206' target=_blank style='color:#2F92EE;'>#相关性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72532, encryptionId=3f34e253206, topicName=相关性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a9de34, createdName=shenxlcyp, createdTime=Thu Feb 07 23:12:00 CST 2019, time=2019-02-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1908510, encodeId=fbeb1908510e2, content=<a href='/topic/show?id=a8d0141605e' target=_blank style='color:#2F92EE;'>#pharma#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14160, encryptionId=a8d0141605e, topicName=pharma)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f634250, createdName=chentianping, createdTime=Tue Sep 24 17:12:00 CST 2019, time=2019-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1918493, encodeId=a9e41918493b3, content=<a href='/topic/show?id=4f26341994' target=_blank style='color:#2F92EE;'>#Bio#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3419, encryptionId=4f26341994, topicName=Bio)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Wed Feb 27 03:12:00 CST 2019, time=2019-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839646, encodeId=d9b81839646ff, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Wed Aug 28 02:12:00 CST 2019, time=2019-08-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1676869, encodeId=b6cb16e68692a, content=<a href='/topic/show?id=63825823146' target=_blank style='color:#2F92EE;'>#新型抗生素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58231, encryptionId=63825823146, topicName=新型抗生素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8bab27396846, createdName=marongnuan, createdTime=Thu Feb 21 00:12:00 CST 2019, time=2019-02-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1707564, encodeId=a0641e07564bd, content=<a href='/topic/show?id=9f7c99e256' target=_blank style='color:#2F92EE;'>#IOP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9972, encryptionId=9f7c99e256, topicName=IOP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6bb031431834, createdName=124987c6m46暂无昵称, createdTime=Fri Sep 13 06:12:00 CST 2019, time=2019-09-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1787575, encodeId=70971e875752b, content=<a href='/topic/show?id=fa03141591e' target=_blank style='color:#2F92EE;'>#Pharm#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14159, encryptionId=fa03141591e, topicName=Pharm)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8942242, createdName=jj000001, createdTime=Sat Mar 30 10:12:00 CST 2019, time=2019-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1469127, encodeId=6ce4146912ed4, content=<a href='/topic/show?id=211f98250b' target=_blank style='color:#2F92EE;'>#IND#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9825, encryptionId=211f98250b, topicName=IND)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=16377007930, createdName=xiaogang319, createdTime=Sun Jan 27 04:12:00 CST 2019, time=2019-01-27, status=1, ipAttribution=)]
    2019-09-13 124987c6m46暂无昵称

    #IOP#

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1837631, encodeId=bbcb183e63175, content=<a href='/topic/show?id=3f34e253206' target=_blank style='color:#2F92EE;'>#相关性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72532, encryptionId=3f34e253206, topicName=相关性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a9de34, createdName=shenxlcyp, createdTime=Thu Feb 07 23:12:00 CST 2019, time=2019-02-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1908510, encodeId=fbeb1908510e2, content=<a href='/topic/show?id=a8d0141605e' target=_blank style='color:#2F92EE;'>#pharma#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14160, encryptionId=a8d0141605e, topicName=pharma)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f634250, createdName=chentianping, createdTime=Tue Sep 24 17:12:00 CST 2019, time=2019-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1918493, encodeId=a9e41918493b3, content=<a href='/topic/show?id=4f26341994' target=_blank style='color:#2F92EE;'>#Bio#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3419, encryptionId=4f26341994, topicName=Bio)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Wed Feb 27 03:12:00 CST 2019, time=2019-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839646, encodeId=d9b81839646ff, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Wed Aug 28 02:12:00 CST 2019, time=2019-08-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1676869, encodeId=b6cb16e68692a, content=<a href='/topic/show?id=63825823146' target=_blank style='color:#2F92EE;'>#新型抗生素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58231, encryptionId=63825823146, topicName=新型抗生素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8bab27396846, createdName=marongnuan, createdTime=Thu Feb 21 00:12:00 CST 2019, time=2019-02-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1707564, encodeId=a0641e07564bd, content=<a href='/topic/show?id=9f7c99e256' target=_blank style='color:#2F92EE;'>#IOP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9972, encryptionId=9f7c99e256, topicName=IOP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6bb031431834, createdName=124987c6m46暂无昵称, createdTime=Fri Sep 13 06:12:00 CST 2019, time=2019-09-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1787575, encodeId=70971e875752b, content=<a href='/topic/show?id=fa03141591e' target=_blank style='color:#2F92EE;'>#Pharm#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14159, encryptionId=fa03141591e, topicName=Pharm)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8942242, createdName=jj000001, createdTime=Sat Mar 30 10:12:00 CST 2019, time=2019-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1469127, encodeId=6ce4146912ed4, content=<a href='/topic/show?id=211f98250b' target=_blank style='color:#2F92EE;'>#IND#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9825, encryptionId=211f98250b, topicName=IND)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=16377007930, createdName=xiaogang319, createdTime=Sun Jan 27 04:12:00 CST 2019, time=2019-01-27, status=1, ipAttribution=)]
    2019-03-30 jj000001

    #Pharm#

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=1837631, encodeId=bbcb183e63175, content=<a href='/topic/show?id=3f34e253206' target=_blank style='color:#2F92EE;'>#相关性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72532, encryptionId=3f34e253206, topicName=相关性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a9de34, createdName=shenxlcyp, createdTime=Thu Feb 07 23:12:00 CST 2019, time=2019-02-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1908510, encodeId=fbeb1908510e2, content=<a href='/topic/show?id=a8d0141605e' target=_blank style='color:#2F92EE;'>#pharma#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14160, encryptionId=a8d0141605e, topicName=pharma)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f634250, createdName=chentianping, createdTime=Tue Sep 24 17:12:00 CST 2019, time=2019-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1918493, encodeId=a9e41918493b3, content=<a href='/topic/show?id=4f26341994' target=_blank style='color:#2F92EE;'>#Bio#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3419, encryptionId=4f26341994, topicName=Bio)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Wed Feb 27 03:12:00 CST 2019, time=2019-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839646, encodeId=d9b81839646ff, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Wed Aug 28 02:12:00 CST 2019, time=2019-08-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1676869, encodeId=b6cb16e68692a, content=<a href='/topic/show?id=63825823146' target=_blank style='color:#2F92EE;'>#新型抗生素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58231, encryptionId=63825823146, topicName=新型抗生素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8bab27396846, createdName=marongnuan, createdTime=Thu Feb 21 00:12:00 CST 2019, time=2019-02-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1707564, encodeId=a0641e07564bd, content=<a href='/topic/show?id=9f7c99e256' target=_blank style='color:#2F92EE;'>#IOP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9972, encryptionId=9f7c99e256, topicName=IOP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6bb031431834, createdName=124987c6m46暂无昵称, createdTime=Fri Sep 13 06:12:00 CST 2019, time=2019-09-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1787575, encodeId=70971e875752b, content=<a href='/topic/show?id=fa03141591e' target=_blank style='color:#2F92EE;'>#Pharm#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14159, encryptionId=fa03141591e, topicName=Pharm)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8942242, createdName=jj000001, createdTime=Sat Mar 30 10:12:00 CST 2019, time=2019-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1469127, encodeId=6ce4146912ed4, content=<a href='/topic/show?id=211f98250b' target=_blank style='color:#2F92EE;'>#IND#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9825, encryptionId=211f98250b, topicName=IND)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=16377007930, createdName=xiaogang319, createdTime=Sun Jan 27 04:12:00 CST 2019, time=2019-01-27, status=1, ipAttribution=)]
    2019-01-27 xiaogang319

    #IND#

    0