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ڷ
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4 ߽, ̿Ǿǰ νְ ¾ پ
ǰǾǰó(ó չ) η ǰ ϴ ̿Ǿǰ ߿伺 ˸ ̿Ǿǰ 츮 ̷ ٽɻ ϱ ϱ Ͽ 26Ϻ 30ϱ ̿ν ְ ϰ پ 縦 Ѵٰ .
̹ ְ 4 ߽ λ ̿Ǿǰ ߿伺 븦 ϰ, ϱ Ͽ ó Ǿ, е ʴϿ ̿Ǿǰ ߰ ֽ Ѵ.
̹ ̿ν ְ ֿ Ǿǰǻȣ±ⱸ(PIC/S) а ȸ WHO 1:1 ÷ܹ̿Ǿǰ Ưڹ ۷ι̿۷̴.
۷ι̿۷(6.28-6.30) 4 ߽, ̿Ǿǰ ̿Ǿǰ о , 籹ڵ Բ 츮 ̿Ǿǰ 귣 ϱ İ Ѵ.
- Ư ۷ιభ ̿コɾ ο з Ŭ ̳ IBM コɾ Ƿ å ǥѴ.
- , ġ, ̿Ǿǰ оߺ GMP, ü ֵǸ, Ư 簡 ϴ ؿ 籹ڿ 1:1 ּѴ.......
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ڷ
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ľó, ̿ùз 㰡ɻ о ٽ
- Ǿǰ ̿ùз ŷ 屹 -
ǰǾǰó(ó չ) 2017 ݱ Ǿǰ(IPRF) Ǿǰȭȸ(ICH) ȸ 츮 IPRF ̿ùз ŷ 屹 ӵǾٰ .
̿ùз ŷ : ̱, 11 3 ü Ҽ 32
ICH ȸ: ij Ʈ (5.286.1)
̹ 츮 ̿ùз 㰡ɻ о߿ ٽѹ , 19 ̿ùз о ȭ ϰ ȴ.
IPRF Ǿǰ ȯ ȣ 籹ڰ ȸüμ ̿ùз, ġ 4 ŷ ϰ ִ.
- 츮 ʷ ü ̿ùз 㰡ϴ ŷڼ 14 ICH ȸ δ ó ̿ùз ŷ 屹 Ǿ..........
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ǰ㰡ɻ Ϻΰ
ֿ
. ߵǰ ִ ġ Ư ݿ ( 215ȣ)
. ̿Ǿǰ 㰡ɻ żӼ ǰ㰡 ɻ ڷ ̺ο ż 並 ɻ ( 225ȣ, 381 ż)).......
ǰ㰡ɻ
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Ǿǰ Ϻΰ
ֿ
. ߰ٱ⼼ ߴܰ Ǿǰ ű ϰ ̹ Ǿǰ Ƽ ȯ .( ǥ 1 ǥ 2)
1) 幰 üǾǰ ʿ Ǿǰ Ǿǰ ߰ ʿ䰡 .
2) ߰ٱ⼼ ߴܰ Ǿǰ Ӱ ϰ, ̹ Ǿǰ Ƽ ȯ .
3) Ǿǰ Ȯν ȯ ȯ ġ ȸ Ŀ . ........
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ǰȸ
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ǿ ʼǾǰ () ǰȸ (ǹ ǿ ǥ)
ֿ
ʼǾǰհȹ ʼǾǰ ߿ ϱ Ͽ Ѹ Ҽ ʼ ǰȸ ΰ, ̿ , . ǺҼ 縦 ϰ ʼǾǰ ް ϵ
ǰ : '17. 06. 28()
ȸ Ȩ ȮϽñ ٶϴ........
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ä
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ǰǾǰó (ǰǾǰ) '17 2ȸ ɻ ä
: ǰǾǰ ɻ ä
Ⱓ: '17.6.22.() ~ 7.7.() 18:00
: ľó äý ¶ .......ٷ
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û |
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ǰ |
ӻ |
ܰ |
б |
20170623 |
/ ̼ ΰ Ǿ ȯڸ ߷ʰ ġ ߷ ƮḮ¸ ġ 2 ӻ |
2 |
MEDI4736,
Tremelimumab |
Ͼǰ()
|
20170621 |
ǰ Ҿ, ûҳ 'Ͼ ÷翣 ҹ 4' 鿪 ϱ (Part1), ϱ(Part1), (Part2,Part3), ߴ(Part2,Part3), Ȱ(Part2,Part3) 3 ӻ |
3 |
Ͼ÷4
(÷翣ںҹ) |
ŸƮųڸ() |
20170620 |
Ǵ ̼ ΰ Ǽ ġḦ Ѹָ Ż ķ 1b/3 ٱ, ӻ |
1/3 |
Ż ķ (Talimogene Laherparepvec) |
() |
20170616 |
HER2 缺 ǥġ ̸ ༺ Ǵ ȯڸ ALT-P7 , ༺ ൿ ϱ , ܰ , 1 ӻ |
1 |
ALT-P7 |
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FDA |
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Drug Name and
FDA Appl. # |
Active Ingredients |
Submission
Classification |
Company |
Approval Date |
COTEMPLA XR-ODT
NDA #205489 |
METHYLPHENIDATE |
ſ뷮 |
NEOS THERAP INC |
06/19/2017 |
MYDAYIS
NDA #022063 |
MIXED SALTS OF A SINGLE-ENTITY AMPHETAMINE |
ſ뷮 |
SHIRE DEV LLC |
06/20/2017 |
RITUXAN HYCELA
BLA #761064 |
HYALURONIDASE
RITUXIMAB |
- |
GENENTECH INC |
06/22/2017 |
BEVYXXA
NDA #208383 |
BETRIXABAN |
Ź |
PORTOLA PHARMA INC |
06/23/2017 |
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EMA |
|
Name |
Active Substance |
Therapeutic areaCompany |
Date of authorisation
/refusal |
Spinraza |
nusinersen sodium |
Muscular Atrophy, Spinal |
30/05/2017 |
Brineura |
cerliponase alfa |
Neuronal Ceroid-Lipofuscinoses |
30/05/2017 |
Elmiron |
pentosan polysulfate sodium |
Cystitis, Interstitial |
02/06/2017 |
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Clinical.gov ̱ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03197506 |
Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma |
Glioblastoma
Gliosarcoma
Supratentorial Glioblastoma
|
Radiation: External Beam Radiation Therapy
Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab
Radiation: Radiation Therapy
Drug: Temozolomide
Procedure: Therapeutic
Conventional Surgery
|
Mayo Clinic
National Cancer Institute (NCI) |
Phase 2 |
NCT03197025 |
Immunotherapy With
E6 T Cell Receptor (TCR)
T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions |
Human Papillomavirus
HPV-16
High Grade Squamous Intraepithelial Lesion |
Drug: Aldesleukin
Biological: E6 TCR |
Memorial Sloan Kettering Cancer Center
Y-Mabs, Inc |
Phase 1 |
NCT03196232 |
Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer |
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Recurrent Esophageal Carcinoma
Recurrent Gastric Carcinoma
Stage IV Esophageal Cancer AJCC v7
Stage IV Gastric Cancer AJCC v7
Unresectable Esophageal Carcinoma |
Drug: Epacadostat
Other: Laboratory
Biomarker Analysis
Biological: Pembrolizumab
|
Pamela L. Kunz
Stanford University |
Phase 2 |
NCT03196401 |
A Study of Immunotherapy Plus Radiation Therapy to Stimulate Immunity in Solitary Bone Plasmacytoma |
Solitary Bone Plasmacytoma |
Biological: Peri-urethral and clitoral injections |
Center for Vulvovaginal Disorders |
Phase 2 |
NCT03197935 |
A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer |
Triple-negative
Breast Cancer |
Drug: Atezolizumab (MPDL3280A),
an engineered anti-PDL1 antibody
Drug: Placebo
Drug: Nab-paclitaxel
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Filgrastim
Drug: Pegfilgrastim |
Hoffmann-La Roche |
Phase 3 |
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Clinical.gov |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03197467 |
Neoadjuvant Anti PD-1 Immunotherapy in Resectable Non-small Cell Lung Cancer |
Non-small Cell Lung Cancer (NSCLC) |
Drug: Pembrolizumab |
AIO-Studien-gGmbH|Merck Sharp & Dohme Corp. |
Phase 2 |
NCT03197935 |
A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer |
Triple-negative Breast Cancer |
Drug: Atezolizumab (MPDL3280A),
an engineered anti-PDL1 antibody
Drug: Placebo
Drug: Nab-paclitaxel
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Filgrastim
Drug: Pegfilgrastim |
Hoffmann-La Roche |
Phase 3 |
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Clinical.gov ߱ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03198052
|
PSCA-CAR-T or MUC1-CAR-T for Cancer With PSCA/MUC1 Expression |
Lung Cancer
Cancer
Immunotherapy
CAR-T Cell |
Genetic: PSCA or MUC1 targeting CAR-T cells |
Second Affiliated Hospital of Guangzhou Medical University |
Phase 1 |
NCT03196986 |
MIL60 Versus Bevacizumab in Patients With Treatment-naïve Non-squamous Non-small Cell Lung Cancer |
Non-small Cell Lung Cancer |
Drug: MIL60
Drug: Bevacizumab |
Beijing Mabworks Biotech Co., Ltd. |
Phase 3 |
NCT03196830 |
CAR-T for R/R B-NHL |
Relapsed Non Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
CAR - T CD19/CD20/CD22/CD30 |
Biological: CAR-T |
The First Affiliated Hospital of Soochow University
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd |
Phase 2 |
NCT03195491 |
A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia |
Lung Cancer
Non-Small Cell Lung Cancer |
Biological: Nivolumab |
Bristol-Myers Squibb |
Phase 3 |
NCT03195478 |
Study of Nivolumab in Combination With Ipilimumab in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors |
Solid Tumor |
Drug: Nivolumab
Drug: Ipilimumab |
Bristol-Myers Squibb |
Phase 1 |
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Clinical.gov Ϻ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03197935
|
A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer |
Triple-negative Breast Cancer |
Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Drug: Placebo
Drug: Nab-paclitaxel
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Filgrastim
Drug: Pegfilgrastim |
Hoffmann-La Roche |
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.
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'' ̶? |
̿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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