里程碑milestone

里程碑milestone

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$复星医药(02196)$
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$美团-W(03690)$ 难的路对谁都是难的,商业壁垒的本质是合法垄断市场的生命周期,TMT行业最难的是在没有专利保护的红海里面搏杀形成这个结果;专利产品则是相反的一个商业过程,是通过先声明一个技术独占市场防止其他对手利用同一个技术进入市场,然后去验证这一过程。
对比这两种商业现象,前...

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$木薯科学(SAVA)$ On March 31, 2024,{Cassava Sciences} will announce top-line results for their recent Phase 3 trial for Simufilam - (CMS).
2023年5月11日,Cassava Sciences, Inc.宣布Simufilam在超过125名阿尔茨海默病患者中进行的为期6个月的随机对照试验完成患者给药。这项试验被...

2023-10月美股医药里程碑4

05/10/2023 ET LUMAKRAS (Sotorasib) - (CodeBreaK 200) $安进(AMGN)$ $256.71 FDA Oncologic Drugs Advisory Committee (ODAC) will review data supporting on October 5, 2023. PDUFA date on December 24, 2023. 网页链接

2023-10月美股医药里程碑3

22/10/2023 ET Dupixent (dupilumab) - (LIBERTY-CUPID) $再生元制药(REGN)$ $831.63 ,SNY $53.13 PDUFA action date of October 22, 2023. 网页链接
26/10/2023 ET Vamorolone - (VISION-DMD) $催化...

2023-10月美股医药里程碑2

17/10/2023 ET XPHOZAH (tenapanor) $Ardelyx(ARDX)$ $4.82 NDA resubmitted April 18, 2023. FDA issued CRL on July 29 2021. Advisory committee recommended approval of tenapanor, noted November 16, 2022. Appeal for CRL granted December 29, 2022. NDA resubmission accepted by FDA, n...

2023-10月美股医药里程碑1

08/10/2023 ET ONPATTRO (patisiran) - (APOLLO-B) $阿里拉姆制药(ALNY)$ $201.17 PDUFA date of October 8, 2023, with an advisory committee meeting planned for September 13, 2023.
网页链接
13/10/2023 ET OPDIVO (nivolumab) - ...

2023-9月美股医药里程碑3

28/09/2023 ET
Nyxol Eye Drops $Ocuphire Pharma(OCUP)$ $3.92
PDUFA date of September 28, 2023.
网页链接{Ocuphire Pharma Announces Financial Results for Second Quarter 2...

2023-9月美股医药里程碑2

16/09/2023 ET
Momelotinib - (MOMENTUM)$葛兰素史克(GSK)$ $35.03
PDUFA/NDA review extended by FDA until September 16, 2023.
网页链接{q2-2023-results-announcement.pdf (gsk.com)}
19/09/2023 ET
Neffy (epi...

2023-9月美股医药里程碑1

07/09/2023 ET
PREVYMIS (Letermovir) $默沙东(MRK)$ $109.84
PDUFA date is expected on September 7, 2023.
网页链接{U.S. FDA Accepts for Priority Review the Supplemental New Drug Application for Merck’s PREVYMIS™ f...

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$奥洛兹美疗法(HALO)$ In January 2023, the FDA accepted the Biologics License Application (“BLA”) for the SC formulation of Tecentriq with a PDUFA goal date of September 15, 2023.网页链接{Inl...

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$BioLineRx(BLRX)$ PDUFA target action date set for September 9, 2023. NDA accepted, noted November 10, 莫替福肽用于多发性骨髓瘤 (MM) 自体移植的干细胞动员 (SCM) Motixafortide in Stem Cell Mobilization (SCM) for Autologous Transplantation in Multiple Myeloma (MM)。 网页链接

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$默沙东(MRK)$ PDUFA date is expected on September 7, 2023.美国FDA接受优先审查默克公司PREVYMIS™在高危肾移植受者中预防巨细胞病毒病的补充新药申请 网页链接{U.S. FDA Accepts for Priority Review the Supplemental New Drug Applicati...

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$云顶新耀-B(01952)$ 上市后产品CSO授权不值钱,lincence in临床阶段就价格很高?国内的逻辑有点过了

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$键凯科技(SH688356)$ 这哪里是材料、辅料公司,peg可是长效技术里面非常常用的一种偶联物,me-better的组成部分