ѱ̿Ǿǰȸ Ʈ
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ǰȸ
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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 ִ.
<ֿ >
1. Ϲ (ȿ, )
2. ǰ㰡 û
3. ǰ㰡
<ǰ >
: 2017. 10. 19. ()
ó : info@kobia.kr
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Թ |
Ǿǰ Ģ Ϻΰ() Թ ˸
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Ǿǰ 㰡 Ͽ ǰ㰡(Ű) Ǿǰ ϱ Ǹϱ ߾ 忡 ʿ 㰡 ɻ û , 㰡 ǰ ϱ Ͽ ̹ ߱Ǿ ִ 㰡, ǰ ش ߾ 忡 ִ ٰŸ ϴ ,
ӻ ʷϰų ϴ ̻ ѿ ȥ ϱ Ͽ Ȯϰ ϴ ۿ Ÿ Ϻ ̺ ․ϰ
<ֿ䳻>
1. ȯ ġȸ Ȯ븦 ӻ ( 30 31)
ġ ȹ ȿ ž ӻ迡 ϴ ȯ ΰ ִ ȯڵ 鿡Դ ġȸ , ӻȹ ο ̷ ־ ̿ ټ ϰ ӻ ȿ Ȯ ϰ ӻ ٰŸ |
2. ()Ǿǰ ȸ ٰ ( 90)
3. Ǿǰ ǰ ߱ ( 96 )
Ǿǰǻȣ±ⱸ(PIC/S) (`14.7.) ȭ Ǿǰ ǰ(GMP) ߱ (`14.10.10. , `14.12.19. )Ǿ, ߱ ߱, °踦 ٰŰ Ǿǰ ڰ GMP ߱ н, ջǰų, 絵, ߱ Ǵ °ϰ ϴ ű GMP û δ ݵǴ¹, ̷ ؼϱ GMP ߱ °踦 ٰŸ
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4. ӻ ̻ Ȯȭ( ǥ 4)
<ǰ >
: 2017. 10. 26. ()
ó : info@kobia.kr
Ϻΰ() Ȯ |
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û |
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ǰ |
ӻ |
ܰ |
Z̿ǽ ֽȸ |
20170918 |
Ż Ȳݺ ִ ڿ SB11(Ϻָ Ǿǰ) 缾Ƽ? ȿ, , ൿ 鿪 ϴ 3, , , ౺, ٱ ӻ |
3 |
SB11 10
(
и/и)
SB11 |
() |
20170914 |
CELLECTRA? 2000 (Electroporation, EP) Ͽ dz(Intradermal, ID) ϴ GLS-5300 , ༺ 鿪 Žϱ , 뷮 , I/IIa ӻ |
1 |
GLS-5300 |
ѱֺ() |
20170914 |
1 ̻ Ƽ(DMARD) ̷ ִ Ȱ Ǽ ȯڸ ABT-494 Adalimumab ϴ 3, , ߴ ӻ - SELECT - PsA 1
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1 |
ABT494 |
ѱȭ() |
20170914 |
ٺ Բ ô Ĺ ռ ο Ȳ 4- (SA4Ag) ȿ ϱ 2b , , ߴ, ӻ |
2 |
PF-06290510 |
ѱν |
20170913 |
༺ BRAFV600 ȯڿ ںƼ + ָ VS Ѹָ ȿ ϴ 3, , ٱ, 2, ӻ |
1 |
ƼƮ(RO554-1267) |
ѱƽƮ
ī |
20170913 |
Ұ 1 ġμ Durvalumab Tremelimumab , , ٱ, III ӻ (HIMALAYA) |
3 |
MEDI4736, Tremelimumab
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FDA |
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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 |
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EMA |
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Name |
Active Substance |
Therapeutic area |
Date of authorisation/ refusal |
Mavenclad |
cladribine |
Multiple Sclerosis |
22/08/2017 |
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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 |
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Clinical.gov |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
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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 |
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