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2017 1 ÷ܹ̿Ǿǰ 㰡 ũ ǥڷ
5 25~26, ǼͿ ֵǾ ÷ܹ̿Ǿǰ 㰡 ũ ǥڷḦ Ȯ ִ.
ľó , ( ) Ͽ ̿ ġ Ͽ ̵ ȹ ݿ ̶ ...... |
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ľó, ' GMP ' ǽ
6 14, ѱӻ ( ) ' ǰ (GMP) ' ǽѴ. ֿ GMP , , ؼ, 븮̼ GMP , Ű ˻, , , Ư ̴......... |
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ܰ |
ѱ |
20170609 |
༺ / Ͽ ܵ ϰų -PD-L1 ü LY3300054 -TIM-3 ü LY3321367 1a/1b |
1 |
LY3321367 |
Z
ﺴ |
20170608 |
༺ Ͽ sorafenib 2 ġμ pembrolizumab II ӻ: Ȯϱ ü м |
2 |
ŰƮ |
ѱ
ֺ |
20170608 |
뷮 Ϲ ռ Ƽ(csDMARD) ġḦ ް Ƽ(bDMARD) ̰ų ༺ ߵ Ȱ Ƽ ȯڸ ABT-494 Abatacept ϴ 3, , Ȱ , ߴ ӻ |
3 |
ABT494 |
() |
20170607 |
6 ̻ 3 ̸ ǰ Ƹ GC3110A (÷翣ںҹ) ȿ(鿪) ϱ (Part1), ϱ(Part1), (Part2), ߴ(Part2), Ȱ(Part2) 3 ӻ |
3 |
GC3110A |
()
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20170607 |
16 ̻ ǰ ûҳ Ǵ ο Ȱȭ A 鿪 ϱ , , ٱ, Ȱ, , 3 ӻ |
3 |
A
(ʵ
ø)
(A) |
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FDA |
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Drug Name and
FDA Appl. # |
Active Ingredients |
Submission
Classification |
Company |
Approval Date |
NORVIR
NDA #209512 |
RITONAVIR |
ſ뷮 |
ABBVIE INC |
06/07/2017 |
GLEOLAN
NDA #208630
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AMINOLEVULINIC ACID HYDROCHLORIDE |
ſ뷮 |
NICOX OPHTHALMICS INC |
06/06/2017 |
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EMA |
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Name |
Active Substance |
Therapeutic Area |
Dafe of
Authorisation
/ refusal |
Trumenba
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Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp
(factor H binding protein)) subfamily A;
Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp
(factor H binding protein)) subfamily B |
Meningitis, Meningococcal |
24/05/2017 |
Emtricitabine/
Tenofovir disoproxil
Krka d.d. |
emtricitabine / tenofovir disoproxil succinate |
HIV Infections |
28/04/2017 |
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Clinical.gov ̱ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03181100 |
Atezolizumab Combinations With Chemotherapy for Anaplastic and Poorly Differentiated Thyroid Carcinomas |
Malignant Neoplasms of Thyroid and Other Endocrine Glands|Anaplastic Thyroid Carcinoma|Poorly Differentiated Thyroid Cancer |
Drug: Nab-paclitaxel - INDUCTION COHORT
Drug: Paclitaxel - INDUCTION COHORT
Drug: Vemurafenib - COHORT 1
Drug: Cobimetinib - COHORT 1
Drug: Atezolizumab - COHORT 1
Drug: Bevacizumab - COHORT 3
Drug: Nab-paclitaxel - COHORT 4
Drug: Paclitaxel - COHORT 4
Drug: Cobimetinib - COHORT 2
Drug: Atezolizumab - COHORT 2
Drug: Atezolizumab - COHORT 3
Drug: Atezolizumab - COHORT 4 |
M.D. Anderson
Cancer Center
Genentech, Inc. |
Phase 2 |
NCT03179930 |
Combination Therapy With Entinostat and Pembrolizumab in Relapsed and Refractory Lymphomas |
Lymphoma
Relapsed
Refractory |
Drug: Entinostat
Drug: Pembrolizumab |
Memorial Sloan Kettering Cancer Center
Merck Sharp & Dohme Corp.
Syndax Pharmaceuticals |
Phase 2 |
NCT03179917 |
Pembrolizumab and Involved Site Radiation Therapy for Early Stage Relapsed or Primary Refractory Hodgkin Lymphoma |
Hodgkin Lymphoma |
Drug: Pembrolizumab
Radiation: Involved Site Radiation Therapy |
Memorial Sloan Kettering Cancer Center |
Phase 2 |
NCT03178552 |
A Study to Evaluate Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) |
Non-Small Cell Lung Cancer |
Drug: Alectinib
Drug: Atezolizumab
Drug: Pemetrexed
Drug: Cisplatin
Drug: Carboplatin
Drug: Gemcitabine |
Hoffmann-La Roche |
Phase 2
Phase 3 |
NCT03180684 |
VGX-3100 Followed by Electroporation Alone or in Combination With Imiquimod for the Treatment of Human Papilloma Virus HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Vulva |
Neoplasms, Vulvar |
Biological: VGX-3100
Drug: Imiquimod 5% cream
Device: CELLECTRA? 2000 |
Inovio Pharmaceuticals |
Phase 2 |
NCT03182686 |
AP-003-C Study to Confirm the Efficacy of Ampion??in Adults With Pain Due to Severe Osteoarthritis of the Knee |
Osteoarthritis, Knee
Knee Osteoarthritis
Knee Arthritis
Knee Pain Chronic |
Biological: Ampion
Other: Saline |
Ampio Pharmaceuticals. Inc. |
Phase 3 |
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Clinical.gov |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03178552 |
A Study to Evaluate Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) |
Non-Small Cell Lung Cancer |
Drug: Alectinib
Drug: Atezolizumab
Drug: Pemetrexed
Drug: Cisplatin
Drug: Carboplatin
Drug: Gemcitabine |
Hoffmann-La Roche |
Phase 2
Phase 3 |
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Clinical.gov ߱ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03183232
(NCT03183219)
(NCT03183206) |
Safety and Efficiency of T Cell Against Lung Cancer |
Lung Cancer
Liver Cancer
Breast Cancer
|
Procedure: Cryosurgery or IRE surgery|Biological: T cell|Other: T cells/ A Cryosurgery or IRE |
Fuda Cancer Hospital, Guangzhou|Jinan University Guangzhou |
Phase 1
Phase 2 |
NCT03182816 |
CTLA-4 and PD-1 Antibodies Expressing EGFR-CAR-T Cells for EGFR Positive Advanced Solid Tumor |
Advanced Solid Tumor |
Biological: anti-CTLA-4/PD-1 expressing EGFR-CAR-T |
Shanghai Cell Therapy Research Institute |
Phase 1
Phase 2 |
NCT03180463
(NCT03180450) |
The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells |
Osteonecrosis of Femoral Head
Heart Failure |
Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
Procedure: core decompression |
Sclnow Biotechnology Co., Ltd. |
Phase 1
Phase 2 |
NCT03179007 |
CTLA-4 and PD-1 Antibodies Expressing MUC1-CAR-T Cells for MUC1 Positive Advanced Solid Tumor |
Advanced Solid Tumor |
Biological: Anti-CTLA-4/PD-1 expressing MUC1-CAR-T |
Shanghai Cell Therapy Research Institute |
Phase 1
Phase 2 |
NCT03182673 |
Phase I Study of SHR7390 Combined With SHR-1210 in Patients With Advanced Solid Tumors |
Solid Tumor |
Drug: SHR7390
Biological: SHR-1210 |
Jiangsu HengRui Medicine Co., Ltd. |
Phase 1 |
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, ̿Ǿǰ ư ȸ
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( ӿ ̿Ǿ ϰ ִ.) |
()ѱ̿Ǿǰȸ '4 ô ̿Ǿǰ '̶ 6 12(ȭ), ǵ ġ ˽ȣڿ ȸ ߴ.
- 4 ô븦 ϱ ̿Ǿ
- Ȯ õ Ȯ
- ̿Ǿ η
ǥ ־, ̾ а ڵ ð ־ Ͽ.
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彺ġ
()ѱ̿Ǿǰȸ : www.kobia.kr
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2017 ̿IT÷ SNS İ ˸
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ѱ̿Ǿǰȸ 14 ǰǾǰó ȯ ̿Ǿǰ ؿ ؿ ϴ ̿IT÷(www.bpis.or.kr/) ϰ , ս Ͻ ֵ ̿IT÷ SNS Ͽϴ.
ں Ǵ ش о в ȷο ϼż ϰ ҽ(Ʈ ˸) ƺð پ Ͻñ ٶϴ. |
<̿IT÷ > |
- ( ֿ 15 /̵)
- ؿ 15 㰡 ü( û )
- ̿Ǿǰ ۷ι
- ֿ䱹 Ǿǰ
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- ۷ι (ֽ ̵ Ȳ)
- (ӻ, 㰡, )
- ؿ ̿Ǿǰ ֿ (CRO )
- 6 8 Ǿǰ |
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