ѱ̿Ǿǰȸ Ʈ
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Ǿǰ Ϻΰ()
óʼ(ֻ) 2 Ǿǰ ű ......
óʼ : ô ġ, Ű(SMN) ܹ Ű SMN2 ڿ RNA ü ö̽ ȭŰ Ƽ øŬƼ
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ǥڷ |
2017 Ǿǰȭȸ (ICH) յ ȸ ڷ
2017 Ǿǰȭȸ(ICH) յ ȸ ǥڷḦ Խմϴ.
Ͻ : 2017 7 5()
: ڿ EȦ
ǥڷ
- Ǿǰ(IPRF)/Ǿǰȭȸ(ICH) ȸ
- ICH ̵ Ȳ
- ӻ ̵...... |
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ڷ |
ľó, ġ κ֡ 㰡
ǰǾǰó(ó չ) ġ ó ߵ ġ ž κ֡ 7 12 㰡Ѵٰ .
ġ: ֱ Ͽ ϴ Ǵ ǰų Ե ϰ ִ Ǿǰ
̹ 㰡 ġ ۿ Ÿ TGF-1 ڡ Ե ּ ϸ, žδ 29°.
TGF-1: , ó ġ ۿϴ ܹ
̱, ֿ ༱ 㰡 ġ 4 ǰ 鿪ȯ, ȯ̳ ġḦ Ǹ, ༺ ȯ ġḦ ġ κְ ó̴.
ľó κָ 㰡ɻϴ ܰ迡 شǰ 㿬 ȿ ǰ ϴ ̻ ǰ 縦 ڴʰ Ÿ ̻ ڷḦ Ͽ, ߾Ӿȸ ڹ 㰡 Ͽ.
ľó 14 ̿ü ϱ Ͽ ߹ ϰ , ̹ ġ ߹ ǰ ּȭ ־ٰ ........
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Ǿǰ ֿⱹ 籹 û ũ ϴ(1:1) 㡹 (~7 21)
ǰǾǰ ȿ ֿ ⱹ þ, Ű, Űź 3 Ǿǰ ڱ ûϿ 8 23, (ڿ) ũ ϰ ϴ(1:1) ǽ Դϴ.
Ȯ ü ȸ ('17.7.27 ǽ )
̹ ũ þ, Ű, Űź Ǿǰ 㰡 籹ڸ ûϿ Ǿǰ 㰡ɻ ν ش Ǿǰ ϱ õǾϴ.
Ư, Ǿǰ ñ ַ ֽϴ....... |
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2017 ũξƼ ΰ յ Ƿ İ (~7/27ϱ)
: 2017 10, 34 () * İ ο 氡
湮 : ũξƼ(ڱ)
ֿȰ
- 籹 Ǻΰ MOU ü
- ֿλ
- , 1:1 Ͻ ȸ
- -ũξƼ Ƿ ̳
ǥ : Ǻ, ó, ѱǻ, , Ƿ ȸ
± : ܰ, ѱǻ, ѱ(KOTRA)......
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û |
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ǰ |
ӻ |
ܰ |
()Ʈ |
20170717 |
ǰ ڿ ٽָ 3 (CT-P16, ƹٽƾ, ̱ 㰡 ƹٽƾ) ൿа ϴ , ߴ, 3, ౺, ȸ
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1 |
CT-P16 |
ھƽ() |
20170717 |
Ǫ ſ ȯڿ CS20AT04 1 ӻ(CS20AT04-LN101) Ͽ |
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CS20AT04 |
ŸƮųڸ() |
20170717 |
ڸƼ̵ ٰ ִ Ҿ ڿ ȿ ϱ 3 , , , ౺ |
3 |
(Denosumab) |
ѱ() |
20170714 |
༺ ȯڸ ܵ Pembrolizumab MK-7684 ϴ 1 ӻ |
1 |
1. MK-8353,
2. Pembrolizumab |
()ѱ |
20170713 |
ʱ Ҽ(NSCLC) Ϻ縿 ʸ - 2 ȭп ϴ , , 3 |
3 |
Nivolumab |
() |
20170711 |
ȣ(AGHD) ȯڸ ALT-P1( ΰ ȣ) 4 , ൿ/ , ϱ, , ٱ 1b/2a ӻ
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1/2a |
ALT-P1 |
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FDA |
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Drug Name and
FDA Appl. # |
Active Ingredients |
Submission
Classification |
Company |
Approval Date |
TREMFYA
BLA #761061 |
GUSELKUMAB |
- |
JANSSEN BIOTECH |
07/13/2017 |
ZYPITAMAG
NDA #208379 |
PITAVASTATIN |
Labeling |
ZYDUS PHARMS USA INC |
07/14/2017 |
NERLYNX
NDA #208051 |
NERATINIB MALEATE |
Labeling |
PUMA BIOTECH INC |
07/17/2017 |
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EMA |
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Name |
Active Substance |
Therapeutic areaCompany |
Date of authorisation/ refusal |
Skilarence |
dimethyl fumarate |
Psoriasis |
23/06/2017 |
Besponsa |
inotuzumab ozogamicin |
Precursor Cell Lymphoblastic
Leukemia-Lymphoma |
29/06/2017 |
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Clinical.gov ̱ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03217747 |
Study to Evaluate the Safety and Tolerability of Avelumab in Combination With Other Anti-Cancer Therapies in Patients With Advanced Malignancies |
- Malignant Neoplasm of Breast
-
Malignant Neoplasms of Bone and Articular Cartilage
- Malignant Neoplasms of Digestive Organs
-
Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System
-
Malignant Neoplasms of Female Genital Organs ... |
Drug: Avelumab
Drug: Utomilumab
Drug: PF-04518600
Radiation: Radiation
Drug: Cisplatin |
- M.D. Anderson
Cancer Center
- Pfizer |
Phase 1
Phase 2 |
NCT03219359 |
Autologous Stem Cell Transplant for Crohn's Disease |
Crohn Disease |
Procedure: Autologous stem cell transplant
Drug: Vedolizumab
Drug: Cyclophosphamide
Drug: Cyclophosphamide
Drug: Thymoglobulin
Drug: Methylprednisolone |
Icahn School of Medicine at Mount Sinai |
Phase 2 |
NCT03215810 |
Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer |
Non Small Cell Lung Cancer |
Procedure: Tumor-infiltrating Lymphocytes
Drug: Nivolumab
Drug: Cyclophosphamide
Drug: Fludarabine
Other: Tumor-infiltrating
Lymphocyte Therapy
Drug: Interleukin-2 |
- H. Lee Moffitt Cancer Center and Research Institute
- Bristol-Myers Squibb
Prometheus Inc.
- Stand Up To Cancer |
Phase 1 |
NCT03219268 |
A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms |
- Advanced Solid Tumors
- Non-small Cell Lung Cancer
- Squamous Cell Carcinoma of the Head and Neck
- Small Cell Lung Cancer
-
Diffuse Large B Cell Lymphoma
-
Epithelial Ovarian Cancer |
Biological: MGD013 |
MacroGenics |
Phase 1 |
NCT03217734 |
MAP Study: Methotrexate and Adalimumab in Psoriasis |
Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic|Non-Hodgkin Lymphoma |
Biological: Adalimumab |
- Jeffrey J Crowley MD
- AbbVie
- Bakersfield Dermatology &
Skin Cancer Medical Group |
Phase 2
Phase 3 |
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Clinical.gov |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
Nation |
NCT03217643 |
CHP-BV Followed by Consolidation With High-dose Therapy / ASCT as Frontline Treatment of Patients With EATL Type 1. |
Enteropathy Associated T-cell Lymphoma |
Drug: Brentuximab Vedotin |
Imagine Institute |
Phase 2 |
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NCT03215706 |
A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy by Itself as the First Treatment Given for Stage IV Non-Small Cell Lung Cancer (NSCLC) |
Non-Small Cell Lung Cancer |
Biological: Ipilimumab
Biological: Nivolumab
Drug: Carboplatin
Drug: Paclitaxel
Drug: Pemetrexed
Drug: Cisplatin |
Bristol-Myers Squibb |
Phase 3 |
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Clinical.gov ߱ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03217812 |
A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy
(Asia Pacific Region) |
Multiple Myeloma
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Drug: Velcade
Drug: Melphalan
Drug: Prednisone
Drug: Daratumumab |
Janssen Research & Development, LLC |
Phase 3 |
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̿IT÷ '17 ű ȳ |
̿IT÷ 2017 ű |
2017 Ͽ 12 ܿ Ʈ, εþ, Űź 3 ߰ Դϴ. ɰ ̿ Ź 帳ϴ. |
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̿IT÷ ȳ |
2017 ֿ ǿ(̱, , ߱) ü 㰡 (2017 ÷ܹ̿Ǿǰ ؿ ̿IT÷ ) Ӱ ǽ Դϴ. û ٶϴ. |
'' ̶? |
̿Ǿǰ ؿ 㰡 ִ
1:1(ñ: Ƿ ü) |
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Ͻô ü ȸ Ǵ ̿IT÷ Ȩ ̿IT÷ û ȮϽð,
̿Ǿǰ ؿ Ƿڼ ۼϽþ ̸(bpis@kobia.kr) ûϽñ ٶϴ.
ִ 5 ȭ, (ܰ躰) Ƿڰ մϴ. |
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̿IT÷ () ٷΰ |
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̿IT÷ ٷΰ |
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