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  • ۼ 2017-08-14 16:27:37
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ľó, 2017 ÷翣ڹ Ͻ

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(8.11 ) Ͻ û ߳, Ľ𸣢 9 ü 2õ з ü 1,600 з, Ծü 400 з ûϿ.
3(A 2, B 1) 900 з, 4(A 2, B 2) 700 з ûǾ. 
3 100 з, 4 300 з ûǾ ...... 

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l  2017 8 17() 
ۼ ȸ ۺ yjlee@kobia.kr
: 02-725-8438

l  ÷  ...... Ȯϱ

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() 20170810 ǰ GC3107() dzֻϿ ȿ ϱ ϱ, , ϱ, 1 ӻ 1 GC3107
FDA
Drug Name and
FDA Appl. #
Active Ingredients Submission
Classification
Company Approval Date
NIKITA
NDA #209875
PITAVASTATIN ο ȿ LUPIN LTD 08/04/2017
EMA
Name Active Substance Therapeutic areaCompany Date of authorisation/ refusal
Trimbow beclometasone dipropionate /
formoterol fumarate dihydrate /
glycopyrronium bromide
Pulmonary Disease
Chronic Obstructive
17/07/2017
Clinical.gov ̱
NCT
Number
Title Conditions Interventions Sponsor
/Collaborators
Phases
NCT03247088 Study Of Sorafenib Added To Busulfan And Fludarabine Conditioning Regimen In Patients With Relapsed/Refractory AML Undergoing Stem Cell Transplantation

Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic|Acute Myeloid Leukemia

Drug: Sorafenib
Drug: Busulfan
Drug: Fludarabine
Procedure: Stem Cell Transplantation
Drug: Cyclophosphamide
Drug: Tacrolimus
Drug: Filgrastim

M.D. Anderson Cancer Center
Bayer
Phase 1
Phase 2
NCT03246958 Nivolumab Plus Ipilimumab in Thyroid Cancer Thyroid Cancer Drug: Nivolumab
Drug: Ipilimumab
Dana-Farber Cancer Institute
Bristol-Myers Squibb
Phase 2
NCT03246906 Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation

Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Aggressive Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma|....

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Cyclophosphamide
Drug: Cyclosporine
Other: Laboratory Biomarker Analysis
Drug: Mycophenolate Mofetil
Drug: Sirolimus
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Phase 2
NCT03245892 A Study of Carboplatin and Paclitaxel Chemotherapy With Nivolumab in Patients With Ovarian Cancer High Grade Serous Ovarian
Fallopian Tube
Primary Peritoneal Cancer
Drug: Carboplatin and Paclitaxel
Drug: Nivolumab
Procedure: cytoreductive surgery
Memorial Sloan Kettering Cancer Center
Bristol-Myers Squibb
Phase 1
NCT03245736 Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors Ovary Cancer|Cervix Cancer
Endometrium Cancer
Bladder Cancer
Prostate Cancer...
Drug: Tisotumab Vedotin Genmab Phase 2
Clinical.gov
NCT
Number
Title Conditions Interventions Sponsor
/Collaborators
Phases Nation
NCT03245736 Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors. Ovary Cancer
Cervix Cancer
Endometrium Cancer
Bladder Cancer
Prostate Cancer.....
Drug: Tisotumab Vedotin Genmab Phase 2
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̿IT÷ () ؿܹ̿Ǿǰ ޽ϴ.
ʿϽ ؿ ̿Ǿǰ ø, 缭 ۼϽþ
bpis@kobia.kr ۺֽʽÿ. (8 18ϱ)

[ؿܱ ϱ(缭 ÷)]

CPhI & BioPh Korea 2017 ѱ̿Ǿǰ ȸ ȫ ȳ

 ȸ   ȯ ݳ 8 22(ȭ) 3ϰ  ڿ ֵǴ 
̿ ȸ CPhI & BioPh Korea 2017 մϴ.

ȸ ۷ι  ϰ ѱ ̿Ǿǰ θ ؿܿ ȫϰ,
ȸ 
ν  ȸ Ұڷ( ν) ġϰ Ͽ
   ȸ    ۺθ Ź 帮ڽϴ.

 ̿ (02-725-8438 / yjlee@kobia.kr)
߼۱: ~8/18ϱ

     





288ȣ (2017.8.8)
Vol. 62 (August 21, 2017)

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