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[국문] 300호 (2017.11.14.)
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  • 작성일 2017-11-17 17:20:19
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첨부파일 300.png
식품의약품안전처 소식
공지 17년 3차 첨단바이오의약품 허가교육 워크숍(국가 R&D 과제 수행자를 위한 기초교육)

■ 목적 : 첨단바이오의약품 국가 연구개발과제 수행자 대상 식약처 허가 절차·규정, 자료준비 등에 대한 교육을 통한 연구성과 달성 효율화 증대 및 제품화 지원

■ 대상 : 첨단바이오의약품 국가 연구개발과제
* 수행자 약 100명 /과기 정통부, 복지부 주관 연구과제

■ 일정 및 장소: ‘17.12.1()/ 인터컨티넨탈 서울 코엑스(삼성동 소재)

■교육 주요 내용: 첨단바이오의약품 허가심사 체계 기초 교육 및 상담

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▶ 교육 신청

건강보험심사평가원
의약품
정보소식
저가약 대체조제 장려금 지급대상 의약품 현황('17.10월 기준) 안내

17년 10월 약제급여목록 및 급여상한금액표 기준 저가약 대체조제 장려금 지급대상 의약품 현황 및 청구방법에 대한 안내

건강보험심사평가원 > 의료정보 > 의약품정보 > 자료공개 > 저가약대체조제 내용 참고
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국내 임상 현황
신청자 승인일 제품명 시험제목 단계
(주)셀트리온 20171113 면역억제 상태에 있는 A형 인플루엔자 하기도 감염 환자의 바이러스 부하에 대한 CT-P27과 뉴라미니다아제 억제제 병용 투여군과 뉴라미니다아제 억제제 단독 투여군 간의 제 2a상, 무작위배정, 이중 눈가림, 다기관, 위약대조, 평행군 시험 2a상 CT-P27
한국
엠에스디(유)
20171106

재발성 또는 전이성 두경부 편평세포암종에 대한 1차 치료로서 Pembrolizumab + Epacadostat, Pembrolizumab 단독요법, 그리고 EXTREME 요법의 유효성과 안전성을 평가하기 위한 제3상, 무작위배정, 라벨-공개 임상시험 (KEYNOTE-669/ECHO-304)

국소 진행성 또는 전이성 신세포암종(Metastatic Renal Cell Carcinoma, mRCC)에 대한 1차 치료로서의 Pembrolizumab (MK-3475) + Epacadostat의 유효성과 안전성을 표준치료(Sunitinib 또는 Pazopanib)와 비교 평가하는 무작위배정, 라벨-공개, 제3상 임상시험(KEYNOTE-679/ECHO-302)

PD-L1이 높은 수준으로 발현된 전이성 비소세포 폐암 환자를 대상으로 1차 치료로서의 Pembrolizumab (MK-3475) + Epacadostat (INCB024360) 을 Pembrolizumab + 위약과 비교 평가하는 제3상, 무작위배정, 이중눈가림 임상시험

3상 에파카도스태트 25mg, 100mg
해외의약품 허가현황
미국
Drug name Active Ingredients Submission Classification Company Approval date
Vyzulta (latanoprostene bunod ophthalmic solution), 0.024% NDA #207795 LATANOPROSTENE BUNOD 신물질 BAUSCH AND LOMB INC 11/02/2017
BORTEZOMIB
NDA #205004
BORTEZOMIB 신제형 또는 신제조원 FRESENIUS KABI USA 11/06/2017
PREVYMIS
NDA #209939
LETERMOVIR 신물질 MERCK SHARP DOHME 11/08/2017
Cinvanti (aprepitant) injectable emulsion NDA #209296 APREPITANT 신용량 HERON THERAPS INC 11/09/2017
해외바이오의약품 임상현황
미국
NCT Number Title Conditions Interventions Sponsor
Collaborators
Phases
NCT03339921 Botulinum for Chronic Exertional Compartment Syndrome Chronic Exertional Compartment Syndrome Drug: Botulinum toxin injections for chronic compartment syndrome|Procedure: surgical fasciotomy for chronic compartment syndrome 375th Medical Group,
Scott Air Force Base
Phase 2
Phase 3
NCT03338959 Pembrolizumab and Radiation Therapy in Treating Patients With Intermediate or High-Grade Soft Tissue Sarcoma Soft Tissue Sarcoma Biological: Pembrolizumab|Radiation: Radiation Therapy Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Phase 1
Phase 2
NCT03333590 Gene Transfer Clinical Trial to Deliver rAAVrh74.MCK.GALGT2 for Duchenne Muscular Dystrophy Duchenne Muscular Dystrophy Biological: rAAVrh74.MCK.GALGT2 Kevin Flanigan
Nationwide Children's Hospital
Phase 1
Phase 2
NCT03340558 Atezolizumab Monotherapy vs Atezolizumab Plus Cobimetinib in Liver Metastases From Colorectal Cancer Metastatic Colorectal Cancer Biological: Atezolizumab|Drug: Cobimetinib Niharika Mettu
Genentech/Roche
Duke University
Phase 2
NCT03339713 A Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and an Adenovirus Serotype 26- Based Vaccine Encoding for the Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF), With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health Healthy Biological: Ad26.RSV.preF|Biological: Fluarix|Biological: Placebo Janssen Vaccines & Prevention B.V. Phase 2
NCT03338972 Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma Recurrent Plasma Cell Myeloma|Refractory Plasma Cell Myeloma|TNFRSF17 Positive Biological: BCMA-specific CAR-expressing T Lymphocytes|Drug: Cyclophosphamide|Drug: Fludarabine|Other: Laboratory Biomarker Analysis|Procedure: Leukapheresis Fred Hutchinson Cancer Research Center
Juno Therapeutics, Inc.
National Cancer Institute (NCI)
Phase 1
NCT03337542 AR101 Real-World Open-Label Extension Study Peanut Allergy Biological: AR101 Aimmune Therapeutics, Inc. Phase 3
NCT03333616 Nivolumab Combined With Ipilimumab for Patients With Advanced Rare Genitourinary Tumors Genitourinary Cancer|Adrenocortical Carcinoma|Non-urothelial Bladder|Non-urothelial Upper Tract|Penile Cancer|Non-adenocarcinoma Prostate Cancer|Refractory Germ-cell Drug: Ipilimumab|Drug: Nivolumab Dana-Farber Cancer Institute
Bristol-Myers Squibb
Phase 2
NCT03336333 A Study Comparing BGB-3111 With Bendamustine Plus Rituximab in Patients With Previously Untreated CLL or SLL Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma Drug: BGB-3111|Drug: Bendamustine|Drug: Rituximab BeiGene Phase 3
NCT03336216 A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer Advanced Pancreatic Cancer Biological: Cabiralizumab|Drug: Nab-paclitaxel|Drug: Onivyde|Biological: Nivolumab|Drug: Fluorouracil|Drug: Gemcitabine|Drug: Oxaliplatin|Drug: Leucovorin Bristol-Myers Squibb Phase 2
NCT03337698 A Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Non-Small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Drug: Atezolizumab|Drug: Cobimetinib|Drug: RO6958688|Drug: Docetaxel|Drug: BL-8040|Drug: Tazemetostat|Drug: CPI-444|Drug: Pemetrexed|Drug: Carboplatin|Drug: Gemcitabine Hoffmann-La Roche Phase 1
Phase 2
NCT03338790 An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer Prostate Cancer Biological: Nivolumab|Drug: Docetaxel|Drug: Enzalutamide|Drug: Rucaparib|Drug: Prednisone Bristol-Myers Squibb
Clovis Oncology
Astellas Pharma Inc
Phase 2
NCT03337477 A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥6.0 . Hyperkalemia Drug: Placebo|Drug: Sodium Zirconium Cyclosilicate(ZS)|Drug: Insulin|Drug: Glucose AstraZeneca Phase 2
NCT03334617 Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy. Non-Small Cell Lung Cancer Drug: Durvalumab|Drug: AZD9150|Drug: AZD6738|Drug: Vistusertib|Drug: Olaparib AstraZeneca Phase 2
유럽
NCT Number Title Conditions Interventions Sponsor
Collaborators
Phases 비고
NCT03334656 Controlled and Double Blind Comparison of a Traditional Dressing Versus a Biologic Dressing Composed of Fetal Fibroblasts and Keratinocytes in Association With a Collagen Matrix on Skin Donor Sites Split Thickness Skin Graft|Wound Healing Biological: biological dressing|Other: Paraffin gauze dressing Nantes University Hospital Phase 1
Phase 2
프랑스
NCT03334695 An Exploratory Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-old Adults Healthy Biological: Ad26.RSV.preF|Drug: Placebo Janssen Vaccines & Prevention B.V. Phase 2 영국
NCT03339661 Secondary Prophylaxis After CMV Disease in Kidney Transplant Patients Targeted by γδ T Cells Immunomonitoring. Kidney Transplant Infection Drug: Group 1_No proph treatment|Drug: Group 2A_Proph treatment and γδ T cell expansion|Drug: Group 2B_Proph treatment and no γδ T cell expansion University Hospital, Bordeaux Phase 2 프랑스
NCT03339973 Allogeneic ABCB5-positive Stem Cells for Treatment of PAOD Peripheral Arterial Occlusive Disease Biological: allo-APZ2-PAOD|Drug: Placebo RHEACELL GmbH & Co. KG
FGK Clinical Research GmbH
TICEBA GmbH
Granzer Regulatory Consulting & Services
Phase 1
Phase 2
독일
NCT03337698 A Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Non-Small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Drug: Atezolizumab|Drug: Cobimetinib|Drug: RO6958688|Drug: Docetaxel|Drug: BL-8040|Drug: Tazemetostat|Drug: CPI-444|Drug: Pemetrexed|Drug: Carboplatin|Drug: Gemcitabine Hoffmann-La Roche Phase 1
Phase 2
영국,
프랑스
NCT03338790 An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer Prostate Cancer Biological: Nivolumab|Drug: Docetaxel|Drug: Enzalutamide|Drug: Rucaparib|Drug: Prednisone Bristol-Myers Squibb
Clovis Oncology
Astellas Pharma Inc
Phase 2 독일
NCT03334617 Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy. Non-Small Cell Lung Cancer Drug: Durvalumab|Drug: AZD9150|Drug: AZD6738|Drug: Vistusertib|Drug: Olaparib AstraZeneca Phase 2 독일
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