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입법 예고 생물학적 제제 등의 제조·판매관리 규칙 일부개정령(안)

1. 개정이유
생물학적제제등의 전용 냉장고 보관 규정을 삭제하는 등 현행 제도의 운영상 나타난 일부 미비점을 개선ㆍ보완하려는 것임.

2. 주요내용
가. 제명을 ‘생물학적제제등의 제조·판매관리 규칙’으로 함
나. 생물학적제제등의 보관 방법 등 개선(안 제5조제1항)
생물학적제제등은 전용 냉장고 또는 냉동고에 보관하도록 규정되어 있어 판매자의 제품관리에 부담이 되므로 전용의 냉장고 또는 냉동고가 아닌 냉장고 또는 냉동고에 다른 의약품과 구분하여 보관할 수 있도록 함
다. 생물학적제제등의 판매제한에 대한 규정 개정(안 제7조제2항) 
판매자가 생물학적제제등을 일반인에게 판매할 수 있는 예외의 경우가 있어 동 규정을 삭제하여 현행에 맞게 규정을 정비 함

3. 의견제출
이 생물학적제제등의 제조·판매관리 규칙 일부개정령안에 대하여 의견이 있는 단체 또는 개인은 2017년 11월 20일까지 통합입법예고시스템을 통하여 온라인으로 의견을 제출하시거나, 다음 사항을 기재한 의견서를 협회로 제출(info@kobia.kr)하여 주시기 바랍니다.

식약처 원문 [Click]

검토의견서 양식 [Click]

의견 조회 국가필수의약품 지정 관련 (10월 30일까지)

「약사법」제2조제19호에서는 질병관리방사능 방재 등 보건의료상 필수적이나 시장 기능만으로는 안정적 공급이 어려운 의약품을 보건복지부장관과 식품의약품안전처장이 관계중앙행정기관의 장과 협의하여 국가필수의약품으로 지정하도록 함

 「약사법」제83조의3에 따른 국가필수의약품 안정공급 협의회는 지난 2017년 정기회의(‘17.6.30)에서 [붙임1]과 같이 국가필수의약품 목록을 지정하였음

 국가필수의약품 목록을 현행화하고자 하며추가 지정이 필요한 국가필수의약품 및 기존 지정 목록의 수정 등에 대한 의견이 있는 경우 [붙임2,3]의 양식에 따라 ‘17.10.30()까지 info@kobia.kr로 회신

국가필수의약품 목록 [Click]

의견 양식 [Click]

의견 조회 의원발의 『생명윤리 및 안전에 관한 법률』 일부개정법률안 (10월 25일까지)

국회 신용현 의원이 대표발의한   『생명윤리 및 안전에 관한 법률 일부개정법률안』에 대한
의견이 있는 경우 붙임 양식에 따라 작성후 '17.10.25(수)까지 협회(info@kobia.kr)로 회신
*기일 내에 회신이 없는 경우 이견이 없는 것으로 간주하여 처리할 예정임

의안번호 대표발의자
(발의일자)
주요내용
9825

신용현 의원
(2017.10.10.)

질병의 치료를 목적으로 하는 유전자 치료에 관한 연구인 경우 질병의
종류 및 대체 치료법 유무에 관계없이 허용(안 제47)


생명윤리및안전에관한법률 일부개정법률안 [Click]

의견 조회 '18년도 바이오의약품 분야 가이드라인 발간 제안 요청 (11월 17일까지)

식품의약품안전평가원(바이오생약심사부)에서는 가이드라인을 제공함에 있어 변화된 개발환경과 개발자의 수요를 적극적으로 반영하고 가이드라인 개발과정에서 외부 소통을 확대하고자 함

- 아 래 - 
o 의견 제출양식 : 발간 제안서(양식) (붙임 1)
* 바이오의약품, 한약(생약)제제, 의약외품, 화장품 분야 가이드라인 목록 (붙임 2) 참조
o 의견 제출처 : 바이오심사조정과(담당자: 김미애, e-mail : kimmiae@korea.kr)
o 의견 제출기한 : 2017. 10. 16(월) ~ 11. 17.(금)


제안요청 원문 [Click]

민원인안내서 「생물의약품 전문가용 사용상의 주의사항 작성요령에 대한 해설서」 제정 알림

식품의약품안전평가원 바이오생약심사부에서는 사용상의 주의사항에 독성정보 및 임상시험 정보 등에 대한 구체적인 작성 예시를 제공한 「생물의약품 전문가용 사용상의 주의사항 작성요령에 대한 해설서를 붙임과 같이 마련하여 배포함

주요내용
전문가용 사용상의 주의사항의 약리기전, 약동학적 정보, 비임상, 임상시험 정보에 대한 작성요령


전문 [Click]

공지 제4차 식·의약품 위기대응 국제 심포지엄 개최안내 (10월 20일)

식품의약품안전처에서는 국내외 식의약 안전이슈를 공유하고 미래 위기대응 전략 마련과 역량강화를 위하여 매년 [식·의약품 위기대응 국제심포지엄]을 개최하오니 많은 참여를 바랍니다.

 [제4차 식·의약품 위기대응 국제 심포지엄]

□ 주 제: 위기 커뮤니케이션의 새로운 경향과 미래
□ 일 시 2017년 10월 20일(금) (13:00 ~ 17:30)
□ 장 소 : 연세대학교 백양누리 그랜드볼룸 ( 서울 서대문구 ) 
□ 참가대상 : 정부, 유관기관, 학계, 협회, 산업계 등 소속 관계자
□ 참가신청 :  온라인 사전 신청 및 당일 현장등록

온라인 참가 신청[Click]

행사 안내[Click]

 
신청자 승인일 제품명 시험
제목
단계
주식회사 강스템바이오텍 20171010 중증 하지 허혈 환자에게 투여한 hUCB-MSCs 4 inj.의 최대내약용량 결정 및 안전성을 평가하기 위한 제 1상 임상시험 1상 동종제대혈유래
중간엽줄기세포4주(hUCB-MSC4 Inj.)
피피디디벨럽먼트피티이엘티디 20171010 조혈모세포 이식 수혜자들에서 거대세포바이러스(CMV) 감염의 치료에 대해 발간시클로버와 비교한 마리바비어의 유효성 및 안전성을 평가하기 위한 제3상, 다기관, 무작위배정, 이중눈가림, 이중위약, 활성대조 임상시험 3상 Maribavir
(주)씨엔알리서치 20170929 호르몬 수용체 양성 진행성 유방암 환자에서
내분비 요법과 엔티노스타트/위약의 병용에 관한 무작위배정 제 3상 시험
3상 Entinostat
사노피-아벤티스 코리아 20170929 이전에 1-3차 치료를 받은 재발성 및/또는 불응성 다발성 골수종 환자에서 카르필조밉(키프롤리스®) 및 덱사메타손과 병용한 이사툭시맙(isatuximab) vs  카르필조밉 및 덱사메타손 투여의 임상적 이득을 평가하는 무작위배정, 공개, 다기관 시험 3상 SAR650984
인벤티브헬스코리아(유) 20170929 혈관내 혈전제거술을 받은 급성 허혈성 뇌졸중 시험대상자에서 정맥 내 NA-1의 유효성 및 안전성을 결정하는 다기관, 무작위 배정, 이중눈가림, 위약대조, 평행군, 단일용량 설계 3상 NA-1
   
미국      
Approval Date Drug Name Active Ingredients Submission Classification Company
09/26/2017 CLOROTEKAL NDA #208791 CHLOROPROCAINE HYDROCHLORIDE 신제형 또는 신제조원 SINTETICA SA
09/28/2017 VERZENIO
NDA #208716
ABEMACICLIB 신물질 ELI LILLY AND CO
09/29/2017 FIASP
NDA #208751
INSULIN ASPART 신제형 또는 신제조원 NOVO NORDISK INC
10/02/2017 ASCOR
NDA #209112
ASCORBIC ACID 이미 시판되고 있는 의약품이나 기존에 NDA로 허가받지 않은 의약품 MCGUFF PHARMACEUTICALS INC
10/06/2017 ZILRETTA
NDA #208845
TRIAMCINOLONE ACETONIDE 신제형 또는 신제조원 FLEXION THERAPEUTICS INC
10/11/2017 LYRICA CR
NDA #209501
PREGABALIN 신제형 또는 신제조원 PFIZER INC
10/12/2017 FOSAPREPITANT NDA #210064 FOSAPREPITANT 신제형 또는 신제조원 TEVA PHARMS USA INC
유럽      
Name Active Substance Therapeutic area Date of authorisation
/ refusal
Cuprior trientine tetrahydrochloride Hepatolenticular Degeneration 05/09/2017
Lacosamide Accord lacosamide Epilepsy 18/09/2017 
Tecentriq atezolizumab Carcinoma, Non-Small-Cell Lung
Carcinoma, Transitional Cell
21/09/2017
Symtuza darunavir / cobicistat / emtricitabine / tenofovir alafenamide HIV Infections 21/09/2017
Entecavir Mylan entecavir monohydrate Hepatitis B 18/09/2017
Bavencio avelumab Neuroendocrine Tumors 18/09/2017
Dupixent dupilumab Dermatitis, Atopic 27/09/2017
   
미국      
NCT Number Title Conditions Interventions Sponsor/Collaborators Phases
NCT03304639 Pembrolizumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Merkel Cell Cancer Stage III Merkel Cell Carcinoma AJCC v7|Stage IIIA Merkel Cell Carcinoma AJCC v7|Stage IIIB Merkel Cell Carcinoma AJCC v7|Stage IV Merkel Cell Carcinoma AJCC v7 Biological: Pembrolizumab|Radiation: Stereotactic Body Radiation Therapy National Cancer Institute (NCI) Phase 2
NCT03302897 Phase 1 LEP-F1 + GLA-SE Vaccine Trial in Healthy Adult Volunteers Leprosy Biological: LEP-F1 + GLA-SE IDRI|American Leprosy Missions Phase 1
NCT03302247 Depletion of Myeloid Derived Suppressor Cells to Enhance Anti PD-1 Therapy Non Small Cell Lung Cancer Stage IIIB Biological: Nivolumab|Drug: Nivolumab+Gemcitabine Fox Chase Cancer Center Phase 2
NCT03301090 A Safety, Tolerability, Pharmacokinetics and Immunogenicity Trial of Co-administered MERS-CoV Antibodies REGN3048 and REGN3051 Corona Virus Infection Other: Placebo|Biological: REGN3048|Biological: REGN3051 National Institute of Allergy and Infectious Diseases (NIAID) Phase 1
NCT03300843 Ability of a Dendritic Cell Vaccine to Immunize Melanoma or Epithelial Cancer Patients Against Defined Mutated Neoantigens Expressed by the Autologous Cancer Melanoma|Gastrointestinal Cancer|Breast Cancer|Ovarian Cancer|Pancreatic Cancer Biological: Peptide loaded dendritic cell vaccine National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC) Phase 2
NCT03299946 Feasibility and Efficacy of Neoadjuvant Cabozantinib Plus Nivolumab (CaboNivo) Followed by Definitive Resection for Patients With Locally Advanced Hepatocellular Carcinoma (HCC) Locally Advanced Hepatocellular Carcinoma Drug: Cabozantinib|Drug: Nivolumab Sidney Kimmel Comprehensive Cancer Center|Exelixis|Bristol-Myers Squibb Phase 1
NCT03299088 Pembrolizumab and Trametinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer and KRAS Gene Mutations KRAS Gene Mutation|Metastatic Non-Squamous Non-Small Cell Lung Carcinoma|Recurrent Non-Squamous Non-Small Cell Lung Carcinoma|Stage IV Non-Small Cell Lung Cancer AJCC v7 Other: Laboratory Biomarker Analysis|Biological: Pembrolizumab|Drug: Trametinib University of California, Davis|Merck Sharp & Dohme Corp.|Novartis|National Cancer Institute (NCI) Phase 1
NCT03298464 Study of NGM313 in Obese Participants Obese Biological: NGM313|Drug: Pioglitazone NGM Biopharmaceuticals, Inc Phase 1
NCT03298048 Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI) Recurrent C. Difficile Infection Biological: Low fecal microbiota dose|Biological: Mid fecal microbiota dose|Biological: High fecal microbiota dose The University of Texas Health Science Center, Houston Phase 2
NCT03295227 Feasibility Trial of Pembrolizumab in Unresectable Thymoma and Thymic Carcinoma Thymoma|Thymic Cancer Drug: Pembrolizumab M.D. Anderson Cancer Center|Merck Sharp & Dohme Corp. Phase 1
NCT03300817 MUC1 Vaccine in Preventing Lung Cancer in Current and Former Smokers at High Risk for Lung Cancer Current Smoker|Former Smoker Other: Laboratory Biomarker Analysis|Biological: MUC1 Peptide-Poly-ICLC Vaccine National Cancer Institute (NCI) Phase 1
NCT03300544 Talimogene Laherparepvec, Capecitabine, and Chemoradiation Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer Rectal Adenocarcinoma|Stage III Rectal Cancer AJCC v7|Stage IIIA Rectal Cancer AJCC v7|Stage IIIB Rectal Cancer AJCC v7|Stage IIIC Rectal Cancer AJCC v7|Stage IV Rectal Cancer AJCC v7|Stage IVA Rectal Cancer AJCC v7|Stage IVB Rectal Cancer AJCC v7 Drug: Capecitabine|Drug: Fluorouracil|Other: Laboratory Biomarker Analysis|Drug: Oxaliplatin|Radiation: Radiation Therapy|Biological: Talimogene Laherparepvec National Cancer Institute (NCI) Phase 1
NCT03300050 Safety and Immunogenicity of a Live-attenuated Universal Flu Vaccine Followed by an Inactivated Universal Flu Vaccine Influenza|Vaccine Biological: cH8/1N1 LAIV|Biological: cH5/1N1 IIV + adjuvant|Biological: cH5/1N1 IIV|Biological: cH8/1N1 IIV + adjuvant|Biological: Normal saline|Biological: Phosphate buffered saline PATH|Icahn School of Medicine at Mount Sinai|Children's Hospital Medical Center, Cincinnati|Duke University|The EMMES Corporation|GlaxoSmithKline Phase 1
NCT03298399 Mesenchymal Stromal Cells for Haplo Hematopoietic Cell Transplantation for Sickle Cell Disease Sickle Cell Disease Biological: Autologous MSCs Emory University|National Heart, Lung, and Blood Institute (NHLBI) Phase 1
NCT03293498 Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu) Influenza Biological: NanoFlu|Biological: Fluzone HD - Day 0|Biological: Fluzone HD - Day 21|Other: Saline - Day 21 Novavax Phase 1
Phase 2
NCT03304080 Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in Her-positive, Her2-positive Metastatic Breast Breast Neoplasms|Breast Diseases Drug: Anastrozole|Drug: Palbociclib|Drug: Trastuzumab|Drug: Pertuzumab Icahn School of Medicine at Mount Sinai|Herbert Irving Comprehensive Cancer Center|Weill Medical College of Cornell University|New York University Langone Medical Center Phase 1
Phase 2
NCT03302234 Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-small Cell Lung Cancer (MK-3475-598/KEYNOTE-598) Carcinoma, Non-Small-Cell Lung Biological: pembrolizumab|Biological: ipilimumab|Other: placebo for ipilimumab Merck Sharp & Dohme Corp. Phase 3
NCT03301220 A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma Smoldering Multiple Myeloma Drug: Daratumumab SC Janssen Research & Development, LLC Phase 3
NCT03301051 Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Adults Virus Diseases|RNA Virus Infections|Respiratory Tract Diseases|Respiratory Tract Infections Biological: Quadrivalent VLP Vaccine|Biological: Placebo Medicago Phase 3
NCT03298451 Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma Hepatocellular Carcinoma Drug: Durvalumab|Drug: Tremelimumab (Regimen 1)|Drug: Tremelimumab (Regimen 2)|Drug: Sorafenib|Drug: Durvalumab (Regimen 1)|Drug: Durvalumab (Regimen 2) AstraZeneca Phase 3
NCT03298061 Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921 Churg-Strauss Syndrome Drug: Mepolizumab GlaxoSmithKline Phase 3
NCT03298867 Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study Thyroid Eye Disease|Graves' Orbitopathy Biological: Teprotumumab|Other: Placebo Horizon Pharma USA, Inc. Phase 3
NCT03301896 Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies Solid Tumors Drug: LHC165|Biological: PDR001 Novartis Pharmaceuticals|Novartis Phase 1
NCT03307603 Yttrium-90 Radioembolization + Nivolumab for Liver + Extra-hepatic Metastases From Colorectal Cancer Metastatic Colorectal Cancer Radiation: yttrium-90 radioembolization|Drug: Phase Ib - nivolumab|Drug: Phase II - nivolumab Case Comprehensive Cancer Center Phase 1
Phase 2
NCT03305445 Nivolumab/Ipilimumab-Primed Immunotransplant for DLBCL Relapsed Diffuse Large B-Cell Lymphoma|Refractory Diffuse Large B-Cell Lymphoma Drug: Ipilimumab|Drug: Nivolumab Icahn School of Medicine at Mount Sinai|Bristol-Myers Squibb Phase 1
Phase 2
NCT03311126 Bendamustine + Obinutuzumab Induction With Obinutuzumab Maintenance in Untreated Mantle Cell Lymphoma Mantle Cell Lymphoma|Non-hodgkin Lymphoma|Non Hodgkin Lymphoma Drug: Bendamustine|Drug: Obinutuzumab University of Wisconsin, Madison|Genentech, Inc.|National Cancer Institute (NCI) Phase 2
NCT03310567 A Study of Pembrolizumab in Combination With Epacadostat in Women With Recurrent/Metastatic Endometrial Carcinoma Recurrent/ Metastatic Endometrial Carcinoma Drug: Epacadostat + pembrolizumab Fox Chase Cancer Center Phase 2
NCT03310021 A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects Bleeding Biological: Andexanet alfa|Drug: Apixaban|Drug: Rivaroxaban|Drug: Edoxaban|Drug: Placebo Portola Pharmaceuticals Phase 2
NCT03308942 Phase 2, Multi-Arm Study of Niraparib Administered Alone and in Combination With PD-1 Inhibitor in Patients With Non-Small Cell Lung Cancer Lung Neoplasms Drug: Niraparib|Biological: PD-1 Inhibitor Tesaro, Inc.|INC Research|Covance|Myriad Genetics, Inc.|NeoGenomics Laboratories|DrugDev|Resolution Bioscience Phase 2
NCT03307915 A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infected Adults on Suppressive Antiretroviral Treatment Human Immunodeficiency Virus Biological: Ad26.Mos4.HIV|Biological: MVA-Mosaic|Biological: Clade C gp140 + Mosaic gp140|Drug: Placebo Janssen Vaccines & Prevention B.V.|Beth Israel Deaconess Medical Center|Ragon Institute|Military HIV Research Program Phase 1
NCT03307616 Study of Neoadjuvant Checkpoint Blockade in Patients With Surgically Resectable Undifferentiated Pleomorphic Sarcoma and Dedifferentiated Liposarcoma Systemic Connective Tissue Disorders Drug: Nivolumab|Drug: Ipilimumab|Radiation: Radiation Therapy M.D. Anderson Cancer Center|Bristol-Myers Squibb Phase 2
NCT03309111 Study of GBR 1342 in Subjects With Previously Treated Multiple Myeloma Multiple Myeloma Biological: GBR 1342 Glenmark Pharmaceuticals S.A. Phase 1
NCT03308968 An Efficacy and Safety Study of Fremanezumab in Adults With Migraine Migraine Prophylaxis Drug: Fremanezumab|Drug: Placebo Teva Branded Pharmaceutical Products, R&D Inc.|Teva Pharmaceutical Industries Phase 3
NCT03306277 Gene Replacement Therapy Clinical Trial for Patients With Spinal Muscular Atrophy Type 1 SMA - Spinal Muscular Atrophy|Gene Therapy Biological: AVXS-101 AveXis, Inc. Phase 3
유럽      
NCT Number Title Conditions Interventions Sponsor/Collaborators Phases 비고
NCT03303976 Phase I to Test a New Pneumococcal Vaccine Pneumococcal Pneumonia|Pneumonia, Bacterial Biological: Bioconjugate pneumococcal vaccine|Biological: Multivalent plain polysaccharide vaccine LimmaTech Biologics AG Phase 1 독일
NCT03293784 TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma Melanoma Combination Product: Nivolumab+Ipilimumab in combination with Anti TNF-α Certolizumab|Combination Product: Nivolumab+Ipilimumab in combination with Anti TNF-α Infliximab Institut Claudius Regaud Phase 1 프랑스
NCT03296397 Efficacy of Quadrivalent HPV Vaccine to Prevent Relapses of Genital Warts After Initial Therapeutic Response Genital Warts Biological: Vaccination with Gardasil|Biological: Injection of Normal Saline Assistance Publique - H척pitaux de Paris Phase 3 프랑스
NCT03303625 A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age Respiratory Syncytial Viruses|Respiratory Tract Infections Biological: Ad26.RSV.preF (1*10^11 vp)|Biological: Ad26.RSV.preF (5*10^10 vp)|Drug: Placebo Janssen Vaccines & Prevention B.V. Phase 1|Phase 2 영국
NCT03298893 Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months Cervical Cancer|Locally Advanced Cervical Cancer Drug: Nivolumab Injection|Drug: Cisplatin|Radiation: radiotherapy Institut Curie|Bristol-Myers Squibb Phase 1
Phase 2
프랑스
NCT03295383 Randomized Clinical Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid Severe Forms of Mucous Membrane Pemphigoid Drug: Rituximab 1g IV|Drug: Cyclophosphamide 50Mg Oral Tablet|Drug: Placebo of Rituximab|Drug: Placebo Oral Tablet University Hospital, Rouen Phase 3 프랑스
NCT03304093 Immunotherapy by Nivolumab for HIV+ Patients Non Small Cell Lung Cancer Metastatic|Non Small Cell Lung Cancer Stage IIIB|HIV/AIDS Drug: Nivolumab Injection Intergroupe Francophone de Cancerologie Thoracique|French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) Phase 2 프랑스
NCT03302234 Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-small Cell Lung Cancer (MK-3475-598/KEYNOTE-598) Carcinoma, Non-Small-Cell Lung Biological: pembrolizumab|Biological: ipilimumab|Other: placebo for ipilimumab Merck Sharp & Dohme Corp. Phase 3 프랑스,
독일
NCT03301220 A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma Smoldering Multiple Myeloma Drug: Daratumumab SC Janssen Research & Development, LLC Phase 3 영국,
프랑스,
독일
NCT03298061 Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921 Churg-Strauss Syndrome Drug: Mepolizumab GlaxoSmithKline Phase 3 영국,
프랑스,
독일
NCT03301051 Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Adults Virus Diseases|RNA Virus Infections|Respiratory Tract Diseases|Respiratory Tract Infections Biological: Quadrivalent VLP Vaccine|Biological: Placebo Medicago Phase 3 영국,
독일
NCT03298451 Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma Hepatocellular Carcinoma Drug: Durvalumab|Drug: Tremelimumab (Regimen 1)|Drug: Tremelimumab (Regimen 2)|Drug: Sorafenib|Drug: Durvalumab (Regimen 1)|Drug: Durvalumab (Regimen 2) AstraZeneca Phase 3 프랑스,
독일
NCT03301896 Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies Solid Tumors Drug: LHC165|Biological: PDR001 Novartis Pharmaceuticals|Novartis Phase 1 프랑스,
독일
NCT03298867 Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study Thyroid Eye Disease|Graves' Orbitopathy Biological: Teprotumumab|Other: Placebo Horizon Pharma USA, Inc. Phase 3 독일
NCT03306589 Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Challenge Study on Healthy Subjects Arthritis, Rheumatoid Biological: Cantharidin|Biological: Lipopolysaccharide|Biological: Granulocyte-Macrophage Colony-Stimulating Factor|Drug: Saline Solution GlaxoSmithKline Phase 1 영국
NCT03305822 A Study of LY900014 in Participants With Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Drug: LY900014|Drug: Insulin Lispro Eli Lilly and Company Phase 1 독일
NCT03308045 Evaluation of EYS606 in Patients With Non-infectious Posterior, Intermediate or Panuveitis Non-infectious Uveitis Biological: pEYS606 EYEVENSYS S.A.S. Phase 1
Phase 2
영국,
프랑스
NCT03309111 Study of GBR 1342 in Subjects With Previously Treated Multiple Myeloma Multiple Myeloma Biological: GBR 1342 Glenmark Pharmaceuticals S.A. Phase 1 독일
NCT03308968 An Efficacy and Safety Study of Fremanezumab in Adults With Migraine Migraine Prophylaxis Drug: Fremanezumab|Drug: Placebo Teva Branded Pharmaceutical Products, R&D Inc.|Teva Pharmaceutical Industries Phase 3 영국,
프랑스,
독일
중국      
NCT Number Title Conditions Interventions Sponsor/Collaborators Phases
NCT03303495 A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC Colorectal Neoplasms|Neoplasm Metastasis|Intestinal Neoplasms|Gastrointestinal Neoplasms|Digestive System Neoplasms Biological: Bevacizumab|Drug: CPT-11|Drug: 5-FU Bolus|Drug: 5-FU Infusion|Drug: l-LV (dl-LV) Sun Yat-sen University Phase 3
NCT03301688 The Pharmacokinetics and Safety of Single-dose and Parallel Comparisons in Patients With NSCLC Treated With JS001 NSCLC Biological: JS001 Shanghai Junshi Bioscience Co.,Ltd. Phase 1
NCT03294798 Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient Hepatitis B Virus Biological: Human Serum Albumin/interferon alpha2b fusion protein|Biological: Pegasys Tianjin SinoBiotech Ltd. Phase 1
NCT03294382 Botulinum Toxin to Improve Results in Epicanthoplasty Scar|Intercanthal Distance Ratio Drug: Botulinum toxin type A|Drug: Placebo Shanghai Jiao Tong University School of Medicine Phase 3
NCT03304288 The Combination of Low-dose Rituximab and ATRA as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia Immune Thrombocytopenia Drug: Rituximab|Drug: All-trans retinoic acid Peking University People's Hospital|Beijing Hospital|Navy General Hospital, Beijing|Beijing Tongren Hospital Phase 2
일본      
NCT Number Title Conditions Interventions Sponsor/Collaborators Phases
NCT03298451 Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma Hepatocellular Carcinoma Drug: Durvalumab|Drug: Tremelimumab (Regimen 1)|Drug: Tremelimumab (Regimen 2)|Drug: Sorafenib|Drug: Durvalumab (Regimen 1)|Drug: Durvalumab (Regimen 2) AstraZeneca Phase 3
NCT03298061 Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921 Churg-Strauss Syndrome Drug: Mepolizumab GlaxoSmithKline Phase 3
NCT03301896 Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies Solid Tumors Drug: LHC165|Biological: PDR001 Novartis Pharmaceuticals|Novartis Phase 1
   
나고야의정서 현황 171012 업데이트 자료

한국바이오의약품에서 나고야의정서 관련 현황 업데이트 자료를 안내드립니다. 
본 자료는 복지부 2017년 제3차 나고야의정서 전문가 간담회(17/09) 자료를 토대로 작성되었음을 안내드립니다. 

▶ [KoBIA] 나고야의정서 현황 업데이트_1710(공개).pdf

   
Pharma Cold Chain Workshop (Incheon & Osong Biopark)
일시 및 장소 2017. 10. 25.(수) / 인천국제공항 자유무역지역 행정지원센터 1층 대회의실
2017. 10. 26.(목) / 밸류호텔 세종시티 4층 회의실
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Moving Pharma Forward Korea
일시 및 장소 2017. 10. 27.(금) 13:00-18:10 / JW 메리어트 호텔 서울
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세부프로그램 [Click]    
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이전글 Vol. 65 (October 16, 2017)
다음글 297호 (2017.10.24.)