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[] 294ȣ (2017.9.19.)
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ֻ 鿪۷κҸ ȿ ̵Ρ () ǰȸ(~10/19)

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IVIG ӻ ȹ 򰡹 ӻ ǽÿ ʿ ǰ ӻ ڿ ԰ ÿ ӻ ȹ ɻ翡 ȰϿ ӻ ǥȭ⋅ȭν, ǰ ȿ Ȯϴ ִ.

 

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1. Ϲ (ȿ, )
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: 2017. 10. 19. ()
ó : info@kobia.kr

 

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ӻ ʷϰų ϴ ๰̻ ߻ ѿ ȥ ߻ ϱ Ͽ Ȯϰ ϴ ۿ  Ÿ Ϻ ̺ ․ϰ  

 

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4. ӻ ๰̻ Ȯȭ( ǥ 4)

 

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: 2017. 10. 26. ()
ó : info@kobia.kr

 

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Z̿ǽ ֽȸ 20170918 Ż Ȳݺ ִ ڿ SB11(Ϻָ Ǿǰ) 缾Ƽ? ȿ, , ൿ 鿪 ϴ 3, , , ౺, ٱ ӻ 3 SB11 10
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ѱֺ() 20170914  1 ̻ ׷Ƽ(DMARD) ̷ ִ Ȱ Ǽ ȯڸ ABT-494 Adalimumab ϴ 3, , ߴ ӻ - SELECT - PsA 1
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20170913 Ұ 1 ġμ Durvalumab Tremelimumab , , ٱ, III ӻ (HIMALAYA) 3 MEDI4736, Tremelimumab
 
 
 
 
FDA  
Drug Name and
FDA Appl. #
Active Ingredients Submission
Classification
Company Approval Date

DAPTOMYCIN
NDA #208385

DAPTOMYCIN Ǵ SAGENT PHARMS 09/12/2017
ALIQOPA
NDA #209936
COPANLISIB Ź BAYER HEALTHCARE PHARMS 09/14/2017
MVASI
BLA #761028
BEVACIZUMAB-AWWB - AMGEN INC 09/14/2017
ADZENYS ER
NDA #204325
AMPHETAMINE ſ뷮 NEOS THERAPS INC 09/15/2017
SOLOSEC
NDA #209363
SECNIDAZOLE Ź SYMBIOMIX THERAPEUTICS LLC 09/15/2017
EMA  
Name Active Substance Therapeutic area Date of authorisation/ refusal

Mavenclad

cladribine Multiple Sclerosis 22/08/2017
 
 
 
 
Clinical.gov ̱
NCT
Number
Title Conditions Interventions Sponsor
/Collaborators
Phases
NCT03285607 MCS110 Combined With Neoadjuvant Doxorubicin, Cyclophosphamide, and Weekly Paclitaxel in Patients With Hormone-Receptor Positive and HER2- Breast Cancer

Breast Cancer
Cancer of Breast

Biological: MCS110
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Paclitaxel
Procedure: Bone marrow aspirate
Procedure: Peripheral blood samples
Procedure: Tumor tissue
Washington University School of Medicine|Novartis Pharmaceuticals Phase 1
NCT03283917 Study of Daratumumab, Ixazomib, and Dexamethasone in Previously Treated Amyloid Light Chain (AL) Amyloidosis Hematopoietic
/Lymphoid Cancer
Amyloid Light Chain (AL) Amyloidosis
Drug: Daratumumab
Drug: Ixazomib
Drug: Dexamethasone
M.D. Anderson Cancer Center
Janssen Scientific Affairs, LC
Takeda
Phase 1
NCT03283631 Intracerebral EGFR-vIII CAR-T Cells for Recurrent GBM Recurrent Glioblastoma Multiforme
Recurrent Brain Tumor, Adult
Biological: EGFRvIII-CARs Gary Archer Ph.D.
National Cancer Institute (NCI)
Duke Cancer Institute
Duke University
Phase 1
NCT03283137 Combination of Pembrolizumab With TGR-1202 in Patients With Relapsed/Refractory CLL and B-cell NHL CLL
B-cell Non Hodgkin Lymphoma
Drug: TGR-1202
Drug: Pembrolizumab
University of Chicago Phase 1
NCT03283046 Study of Lenalidomide/Dexamethasone With Nivolumab and Ipilimumab in Patients With Newly Diagnosed Multiple Myeloma Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic|Multiple Myeloma Drug: Nivolumab
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Ipilimumab
M.D. Anderson Cancer Center|Bristol-Myers Squibb Phase 1
NCT03282344 A Study of NKTR-214 in Combination With Nivolumab in Patients With Metastatic and/or Locally Advanced Sarcoma SARCOMA Drug: NKTR-214
Drug: Nivolumab
Memorial Sloan Kettering Cancer Center
M.D. Anderson Cancer Center
Phase 2
NCT03283319 Panblok H7 Vaccine Adjuvanted With AS03 or MF59 Antigens Influenza, Human Biological: 3.75 ug Panblok H7
Biological: 7.5 ug Panblok H7
Biological: 15 ug Panblok H7
Biological: MF59
Biological: AS03
Biomedical Advanced Research and Development Authority
Rho, Inc.
Phase 2
NCT03282240 Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants 65 Years in the US Influenza Biological: QIV-HD
Biological: Licensed TIV-HD1
Biological: Investigational TIV-HD2
Sanofi Pasteur, a Sanofi Company
Sanofi
Phase 3
Clinical.gov


NCT
Number
Title Conditions Interventions Sponsor
/Collaborators
Phases
NCT03286751 A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants Diabetes Mellitus, Type 2 Drug: LY900014
Drug: Insulin Lispro
Eli Lilly and Company Phase 1
 
 
 
 
 
 
 

     





293ȣ (2017.9.12)
Vol. 64 (September 26, 2017)

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