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(Ѹ 1360ȣ, 2017.1.26. / Ѹ 1378ȣ, 2017.2..2.8. )

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321ȣ ޿󿩺 򰡱  Ϻΰ 2017.9.30. Ƿῡ ġ Ǿǰ 򰡱ؿ ߰ ʿ

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300ȣ ޿󿩺 򰡱  Ϻΰ Ģ()

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Ⱓ: 2017.9.15.()~2017.9.21.(), 7ϰ
ó: Ȳ [Tel. 02-2182-8562 / Fax. 02-6710-5773 / E-mail. biobear@hira.or.kr]

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20170922 ǰ ڿڿ ȸ 뷮 ׸ ̷ B ̷ ȯڿ ȸ 뷮 RO7062931 , ༺, ൿ, ϴ , Ƿ , 1 RO7062931
ѱֺ() 20170922 Ȯ Ҽ ȯڸ 1 ȭп μ Rovalpituzumab Tesirine ϴ , ߴ, 3 ӻ (MERU) 3 ιָ ׽ø
 
 
 
 
FDA  
Drug Name and
FDA Appl. #
Active Ingredients Submission
Classification
Company Approval Date

XHANCE
NDA #209022

FLUTICASONE PROPIONATE Ǵ OPTNOSE US INC 09/12/2017
TRELEGY ELLIPTA
NDA #209482
FLUTICASONE FUROATE;UMECLIDINIUM;VILANTEROL Ǵ GLAXOSMITHKLINE 09/14/2017

EMA  
Name Active Substance Therapeutic area Date of authorisation/ refusal
Insulin lispro Sanofi insulin lispro Diabetes Mellitus 19/07/2017

Vosevi

sofosbuvir /
velpatasvir /
voxilaprevi
Hepatitis C, Chronic 22/08/2017
 
 
 
Clinicaltrials.gov ̱
NCT Number Title Conditions Interventions Sponsor/Collaborators Phases
NCT03290248 Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis Allergic Rhinitis|Allergic Rhinitis Due to Grass Pollen|Healthy Volunteers Biological: B244 suspension|Biological: Vehicle AOBiome LLC|Orange County Research Center|Integrium

Phase 1
Phase 2

NCT03290937 Clinical Trial Evaluating the Safety and Response With PF-05082566, Cetuximab and Irinotecan in Patients With Advanced Colorectal Cancer Malignant Neoplasms of Digestive Organs|Colorectal Cancer Drug: Irinotecan
Drug:PF-05082566
Drug: Cetuximab
M.D. Anderson Cancer Center|Pfizer Phase 1
NCT03290664 CD3-/CD19- vs CD3-/CD56+ Haplo NK for AML Pts Who Failed 1-2 Inductions Acute Myelogenous Leukemia Biological: CD3-/CD19-|Biological: CD3-/CD56+ Masonic Cancer Center, University of Minnesota|Miltenyi Biotec, Inc. Phase 2
NCT03290079 Pembrolizumab in Advanced Poorly Differentiated and/or High Grade Neuroendocrine Tumors/Carcinomas Neuroendocrine Tumors|Neuroendocrine Carcinoma|Neuroendocrine Cancer Drug: Pembrolizumab H. Lee Moffitt Cancer
Center and Research Institute|Merck Sharp & Dohme Corp.
Phase 2
NCT03291054 Epacadostat and Pembrolizumab in Patients With GIST Gastrointestinal Stromal Tumors Drug: Pembrolizumab|Drug: Epacadostat Richard D. Carvajal|Columbia University Phase 2
NCT03288493 P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM) Multiple Myeloma Biological: P-BCMA-101 CAR-T cells Poseida Therapeutics, Inc. Phase 1
NCT03292172 A Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RO6870810 and Atezolizumab (PD-L1 Antibody) in Participants With Advanced Ovarian Cancer or Triple Negative Breast Cancer Advanced Ovarian Cancer|Triple Negative Breast Cancer Drug: Atezolizumab|Drug: RO6870810 Hoffmann-La Roche Phase 1
NCT03290950 A Study of Daratumumab in Patients With Newly Diagnosed Multiple Myeloma Multiple Myeloma Drug: daratumumab|Drug: carfilzomib|Drug: lenalidomide|Drug: dexamethasone Memorial Sloan Kettering Cancer Center|Janssen Pharmaceuticals Phase 2
NCT03289962 A Study of RO7198457 (Personalized Cancer Vaccine [PCV]) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors Tumors Drug: RO7198457|Drug: Atezolizumab Genentech, Inc.|Biontech RNA Pharmaceuticals GmbH Phase 1
NCT03292588 A Trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthma Exacerbations in Urban Children Asthma Biological: Mepolizumab|Drug: Placebo National Institute of
Allergy and Infectious
Diseases (NIAID)
Inner-City Asthma Consortium
GlaxoSmithKline
Phase 2
 
Clinicaltrials.gov
NCT Number Title Conditions Interventions Sponsor/Collaborators Phases
NCT03289819 Neoadjuvant Pembrolizumab(Pbr)/Nab-Paclitaxel Followed by Pbr/Epirubicin/Cyclophosphamide in TNBC Malignant Neoplasm of Breast Drug: Pembrolizumab|Drug: nab-paclitaxel|Drug: Epirubicin|Drug: Cyclophosphamide Institut fuer Frauengesundheit|Merck Sharp & Dohme Corp.|Celgene Corporation Phase 2
NCT03287817 CD19/22 CAR T Cells (AUTO3) for the Treatment of Diffuse Large B Cell Lymphoma Diffuse Large B Cell Lymphoma|Relapsed Diffuse Large B-Cell Lymphoma|Refractory Diffuse Large B-Cell Lymphoma|DLBCL Biological: AUTO3 Autolus Limited Phase 1|Phase 2
NCT03287804 APRIL CAR T Cells (AUTO2) Targeting BCMA and TACI for the Treatment of Multiple Myeloma Multiple Myeloma Biological: AUTO2 Autolus Limited Phase 1|Phase 2
NCT03289455 CD19 /22 CAR T Cells (AUTO3) for the Treatment of B Cell ALL B Acute Lymphoblastic Leukemia|Recurrent Childhood Acute Lymphoblastic Leukemia|Refractory Childhood Acute Lymphoblastic Leukemia|B-cell Acute Lymphoblastic Leukemia Biological: AUTO3 (CD19/22 CAR T cells Autolus Limited Phase 1|Phase 2
NCT03291002 Phase I Study of Intratumoral CV8102 Melanoma (Skin)|Squamous Cell Carcinoma of the Skin|Carcinoma, Squamous Cell of Head and Neck|Carcinoma, Adenoid Cystic Biological: CV8102|Biological: CV8102 + anti-PD-1 therapy CureVac AG Phase 1
NCT03289962 A Study of RO7198457 (Personalized Cancer Vaccine [PCV]) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors Tumors Drug: RO7198457|Drug: Atezolizumab Genentech, Inc.|Biontech RNA Pharmaceuticals GmbH Phase 1 ,
Clinicaltrials.gov ߱
NCT Number Title Conditions Interventions Sponsor/Collaborators Phases
NCT03292185 A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects Diabetes|Diabetes Mellitus, Type 2 Drug: insulin degludec/liraglutide|Drug: insulin degludec|Drug: liraglutide Novo Nordisk A/S Phase 1
NCT03291444 CAR-T Cells Combined With Peptide Specific Dendritic Cell in Relapsed/Refractory Leukemia Leukemia, Acute Lymphocytic (ALL)|Leukemia, Acute Myelogenous (AML)|Myelodysplastic Syndromes Biological: Chimeric antigen receptor T cells|Biological: Eps8 peptide specific dendritic cell Zhujiang Hospital|Shenzhen Geno-Immune Medical Institute|Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Phase 1
Clinicaltrials.gov Ϻ
NCT Number Title Conditions Interventions Sponsor/Collaborators Phases
NCT03289533 A Study Of Avelumab In Combination With Axitinib In Advanced HCC Carcinoma, Hepatocellular Drug: Avelumab (MSB0010718C)|Drug: Axitinib (AG-013736) Pfizer Phase 1
 
 
 
 

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