ѱ̿Ǿǰȸ Ʈ
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Ϻΰ |
Ǿǰ ǥ Ϻΰ
. Һ ϹǾǰ ǥؼ (62, 1, 2)
. (7, 72, 9)
. Ȱũ Ȯ (9)...... |
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Ϻΰ |
Ǿǰ ۿ ر Ǿǰ Ϻΰ
Ǿǰ ۿ ر Կ ־ Ϻ ̺ ϰ, Ǿǰ ۿ ر Ǿǰ 3() ġ ϰ .
. ۿ ر ߰Ͽ Ȯȭ( 21)
. ر Ǿǰ ߰( 3)...... |
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Ϻΰ |
դǰ óϺΰ
ݿϿ ա ǰ з οó ϰ Ÿ Ϻ ̺ ϰ
. աǰ ƴϳ ʰ з Һи ǰ з ż(3, 7)
. ֱ ݿ աǰ з ߰(4)
. ǰȸ ż(14) ...... |
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ǰȸ |
̸ ġ ġ () ǰȸ (~8/7)
ֿ䳻
- Ϲݻ
- ,ȿ ڷ
- ȣۿ ڷῡ
- ġ Ȯ ӻ迡
- 㰡
ǰ
- : 2017. 08. 07 ()
- : ÷2.ǰ
- : info@kobia.kr
() Ȯ |
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ǰȸ |
躸DZⱸ(WHO) ̿ùз PQ ̵ ǰ (~8/7)
ǰǾǰó 躸DZⱸ(WHO) ̿Ǿǰ ǥȭ о ¼ͷμ ̵ . ϰ , Ǿǰ ̵
-
. WHO Pilot procedure for prequalification of similar biotherapeutic products.
. WHO Guidelines on submission of documentation for the pilot procedure for prequalification of similar biotherapeutic products approved by stringent regulatory authorties.
. WHO Guidelines on submission of documentation for the pilot procedure for prequalification of similar biotherapeutic products.
. Guidelines on procedures and data requirements for changes to approved biotherapeutic products.
ǰ
- : 2017. 08. 07 ()
- : 4 / 6
- : info@kobia.kr
̵() Ȯ |
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ڷ |
Ǿǰ ż 㰡ɻ [ ħ]
Ǿǰ ǰɻ ̵ [ο ȳ] |
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û |
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ǰ |
ӻ |
ܰ |
ֽȸ
ڸڸ |
20170801 |
ߵ Ǻο ƮŰ ܵ ECZTRA 2 - ſ ĺ ߵ Ǻο ڿ ƮŰ ܵ ȿ ϴ , ߴ, , 3 ӻ |
3 |
Tralokinumab APFS |
()Z Zﺴ |
20170731 |
ȯ̽ ִ PD-L1 ̼ ҼϿ Pembrolizumab ġ |
4 |
ŰƮ |
ѱǰֽȸ |
20170731 |
ġ Ұ ༺, Ǵ ̼ Ǽĵ ӻڿ Ϻ縿+ʸ Ǵ ÷ο+ýöƾ Ϻ縿 ÷ο+ýöƾ 3 ӻ |
3 |
ONO-4538 |
ѱȭ
() |
20170728 |
Ǵ ̸ Ŵ B (DLBCL) ڵ鿡 鿪 ۿ, ļ , CD20 /Ǵ ȭп ϴ ƺ縿(MSB0010718C) 1B ٱ ӻ |
1b |
з縿(Utomilumab), ƺ縿(Avelumab) |
ѱƽƮī) |
20170726 |
ʴ õȯڸ ߰뷮 뷮 ڸƼڽ̵ Ӽ 2-ȿ ߰ Benralizumab (MEDI-563) ȿ ϱ ٱ, , ߴ, ౺, , III ӻ
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ָ(MEDI-563) |
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FDA |
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Drug Name and
FDA Appl. # |
Active Ingredients |
Submission
Classification |
Company |
Approval Date |
BENLYSTA
BLA #761043 |
BELIMUMAB |
- |
GLAXOSMITHKLINE LLC |
07/20/2017 |
NITYR
NDA #209449 |
NITISINONE |
Ǵ |
CYCLE PHARMS LTD |
07/26/2017 |
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EMA |
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Name |
Active Substance |
Therapeutic areaCompany |
Date of authorisation/ refusal |
Rixathon |
rituximab |
Arthritis, Rheumatoid
Leukemia,
Lymphocytic, Chronic,
B-Cell
Lymphoma,
Non-Hodgkin Microscopic Polyangiitis
Wegener Granulomatosis |
15/06/2017 |
Oxervate |
recombinant human Nerve Growth factor (rhNGF) |
Keratitis |
06/07/2017 |
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Clinical.gov ̱ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03233724 |
The Immune Checkpoint Inhibitor Pembrolizumab in Combination With Oral Decitabine and Tetrahydrouridine as First-Line Therapy for Inoperable, Locally Advanced or Metastatic Non-small Cell Lung Cancer |
Carcinoma,
Non-Small-Cell Lung
Lung Cancer
Non-Small Cell Lung Cancer |
Drug: Decitabine (DAC)
Drug: Tetrahydrouridine (THU)
Drug: Pembrolizumab |
National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC) |
Phase 1
Phase 2 |
NCT03233854 |
CD19/CD22 Chimeric Antigen Receptor T Cells and Chemotherapy in Treating Patients With Recurrent or Refractory CD19 Positive Diffuse Large B-Cell Lymphoma or B Acute Lymphoblastic Leukemia |
B Acute Lymphoblastic Leukemia
CD19 Positive
Diffuse Large B-Cell Lymphoma
Associated With Chronic Inflammation... |
Biological: Chimeric Antigen Receptor T-Cell Therapy
Drug: Cyclophosphamide
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration |
David Miklos
Stanford University |
Phase 2 |
NCT03233711 |
Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer |
Anal Basaloid Carcinoma
Anal Canal Cloacogenic Carcinoma... |
Biological: Nivolumab |
National Cancer Institute (NCI) |
Phase 2 |
NCT03232307 |
Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL) |
Hematopoietic/Lymphoid Cancer
Mantle Cell Lymphoma |
Drug: Ibrutinib
Drug: Rituximab
Drug: Lenalidomide
Drug: Dexamethasone Sodium Sulfate |
M.D. Anderson Cancer Center
Celgene
Janssen Scientific Affairs, LLC |
Phase 2 |
NCT03233347 |
Doxorubicin Hydrochloride, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma |
Stage I Hodgkin Lymphoma
Stage IA Hodgkin Lymphoma.... |
Drug: Brentuximab Vedotin
Drug: Dacarbazine
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Biological: Nivolumab
Drug: Vinblastine |
Academic and Community Cancer Research United
National Cancer Institute (NCI) |
Phase 2 |
NCT03233698 |
Atezolizumab in Treating Patients With Newly Diagnosed and Metastatic Alveolar Soft Part Sarcoma That Cannot Be Removed by Surgery |
Metastatic Alveolar
Soft Part Sarcoma |
Drug: Atezolizumab
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study |
National Cancer Institute (NCI) |
Phase 2 |
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Clinical.gov |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
Nation |
NCT03232268 |
HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies |
Acute Myeloid Leukemia|Myelodysplastic Syndromes |
Biological: HLA-mismatched microtransplantation |
Institut Paoli-Calmettes |
Phase 1 |
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Clinical.gov Ϻ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03233217 |
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients 65 Years |
Influenza |
Biological: QIV-HD by IM
Biological: QIV-SD by SC
Biological: QIV-HD by SC |
Sanofi Pasteur, a Sanofi Company
Sanofi K.K.|Sanofi |
Phase 1
Phase 2 |
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ѱǻ Ʈʸ ȳ (AusBiotech, Bio-Europe) (Ͻ 8 7() 18:00) |
ѱǻ ǻо ȸ Ͽ
Ʈʸ(AusBiotech,BiO-EUROPE) Ʈʸ 50% ϰ ֽϴ. |
AusBiotech |
BIO-EUROPE 2017 |
Ͻ: '17.10.25 () ~ 27 (), (3ϰ)
: Adelaide Convention Centre, South Australia
Ϻ: 970,000 (, Ʈʸ, ۷, Ͻ ) |
Ͻ: '17.11.6 () ~ 8 (), (3ϰ)
: Berlin, Germany
Ϻ: 1,500,000 (, Ʈʸ, ۷, Ͻ ) |
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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 |
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