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(ÁÖ)Çѱ¹¾á¼¾ |
20170831 |
ÀÌÀü¿¡ »ý¹°ÇÐÀû Ç×-TNF¥á Á¦Á¦¸¦ Åõ¿© ¹ÞÀº ½ÃÇè´ë»óÀÚ¸¦ Æ÷ÇÔÇÏ¿©, È°¼º °Ç¼±¼º °üÀý¿°ÀÌ ÀÖ´Â ½ÃÇè´ë»óÀÚ¿¡¼ ÇÇÇÏ·Î Åõ¿©ÇÑ GuselkumabÀÇ À¯È¿¼º ¹× ¾ÈÀü¼ºÀ» Æò°¡Çϱâ À§ÇÑ Á¦3»ó, ´Ù±â°ü, ¹«ÀÛÀ§ ¹èÁ¤, ÀÌÁß ´«°¡¸², À§¾à ´ëÁ¶ ÀÓ»ó½ÃÇè |
3»ó |
±¸¼¿Äí¸¿(CNTO 1959) 100mg |
ÄڹݽºÄÚ¸®¾Æ¼ºñ½ºÀ¯ÇÑȸ»ç |
20170831 |
ÀüÀ̼º Ãé°ü ¼±¾ÏÁ¾(¸ð¸£Æä¿ì½º ÃéÀå¾Ï) ȯÀÚ¿¡¼ ¿©·¯ °¡Áö ¸é¿ª¿ä¹ý ±â¹Ý Ä¡·á º´ÇÕÀÇ À¯È¿¼º°ú ¾ÈÀü¼ºÀ» Æò°¡ÇÏ´Â Ib/II »ó, °ø°³, ´Ù±â°ü, ¹«ÀÛÀ§ ¹èÁ¤, Æ÷°ý ÀÓ»ó½ÃÇè |
1/2»ó |
¾ÆÅ×Á¹¸®ÁÖ¸¿, ÄÚºñ¸ÞƼ´Õ, PEGPH20, BL-8040 |
Çѱ¹¿¥¿¡½ºµð(À¯) |
20170831 |
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3»ó |
MK-3475 |
Çѱ¹¾Öºêºñ |
20170829 |
°ú°Å »ý¹°ÇÐÀû Ä¡·á¿¡ ½ÇÆÐÇß´ø ÁßµîÁõ ³»Áö ÁßÁõÀÇ È°µ¿¼º Å©·Ðº´ ȯÀÚ¸¦ ´ë»óÀ¸·Î RisankizumabÀÇ À¯È¿¼º°ú ¾ÈÀü¼ºÀ» Æò°¡ÇÏ´Â ´Ù±â°ü, ¹«ÀÛÀ§¹èÁ¤, ÀÌÁß´«°¡¸², À§¾à ´ëÁ¶, À¯µµ¿ä¹ý ÀÓ»ó½ÃÇè
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FDA |
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Drug Name and
FDA Appl. # |
Active Ingredients |
Submission
Classification |
Company |
Approval Date |
BENZNIDAZOLE
NDA #209570 |
BENZNIDAZOLE |
½Å¹°Áú |
CHEMO RESEARCH SL |
08/29/2017 |
VABOMERE
NDA #209776 |
MEROPENEM;
VABORBACTAM |
½Å¹°Áú |
REMPEX PHARMS INC |
08/29/2017 |
AUSTEDO
NDA #209885 |
DEUTETRABENAZINE |
»õ·Î¿î ÀûÀÀÁõÀ¸·Î º°°³ÀÇ NDA Á¦Ãâ-½ÂÀÎÈÄ ¿ø·¡ÀÇ NDA¿Í ÅëÇÕ |
TEVA BRANDED PHARM |
08/30/2017 |
MYLOTARG
BLA #761060 |
GEMTUZUMAB OZOGAMICIN |
- |
WYETH PHARMS INC |
09/01/2017 |
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EMA |
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Drug Name and
FDA Appl. # |
Active Substance |
Therapeutic area |
Date of authorisation/ refusal |
Kisqali |
ribociclib succinate |
Breast Neoplams |
08/18/2017 |
Imraldi |
adalimumab |
Arthritis
Arthritis,
Psoriatic
Arthritis,
Rheumatoid Colitis,
Ulcerative
Crohn Disease
Hidradenitis
Suppurativa Psoriasis
Spondylitis,
Ankylosing
Uveitis |
08/18/2017 |
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Clinical.gov ¹Ì±¹ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03269552 |
Carfilzomib With or Without Rituximab in the Treatment of Waldenstrom Macroglobulinemia or Marginal Zone Lymphoma |
Marginal Zone Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Waldenstrom Macroglobulinemia
Waldenstrom Macroglobulinemia |
Drug: Carfilzomib
Other: Laboratory Biomarker Analysis
Biological: Rituximab |
University of Washington
National Cancer Institute (NCI) |
Phase 2 |
NCT03268603 |
Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS) |
ALS|Amyotrophic Lateral Sclerosis |
Drug: Autologous Adipose-derived Mesenchymal Stromal Cells |
Mayo Clinic
State of Minnesota Regenerative Medicine Minnesota |
Phase 2 |
NCT03267888 |
Pembrolizumab and Radiation Therapy in Patients With Relapsed or Refractory Multiple Myeloma |
ISS Stage I Plasma Cell Myeloma
ISS Stage II Plasma Cell Myeloma
ISS Stage III Plasma Cell Myeloma
Recurrent Plasma Cell Myeloma
Refractory Plasma Cell Myeloma |
Biological: Pembrolizumab
Radiation: Radiation Therapy |
Emory University
Merck Sharp & Dohme Corp. |
Phase 1 |
NCT03267836 |
Neoadjuvant Avelumab and Hypofractionated Proton Radiation Therapy Followed by Surgery for Recurrent Radiation-refractory Meningioma |
Meningioma|Meningioma, Adult |
Drug: Avelumab
Radiation: Proton Therapy
Procedure: Surgery |
Washington University School of Medicine
Pfizer |
Phase 1 |
NCT03269669 |
Obinutuzumab With or Without PI3K-delta Inhibitor TGR-1202, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma |
Grade 1 Follicular Lymphoma
Grade 2 Follicular Lymphoma
Grade 3a Follicular Lymphoma
Recurrent Follicular Lymphoma
Refractory Follicular Lymphoma |
Biological: Obinutuzumab
Drug: P13K-delta Inhibitor TGR-1202
Drug: Lenalidomide
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Vincristine Sulfate
Drug: Prednisone
Other: Laboratory Biomarker Analysis |
National Cancer Institute (NCI) |
Phase 2 |
NCT03268005 |
Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes |
Diabetes
Diabetes Mellitus, Type 2 |
Drug:
Faster-acting insulin aspart
Drug: Insulin aspart
Drug: Insulin degludec
Drug: Metformin |
Novo Nordisk A/S |
Phase 3 |
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Clinical.gov À¯·´ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
ºñ°í |
NCT03268005 |
Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes |
Diabetes
Diabetes Mellitus, Type 2 |
Drug: Faster-acting insulin aspart
Drug: Insulin aspart
Drug: Insulin degludec
Drug: Metformin |
Novo
Nordisk A/S |
Phase 3 |
µ¶ÀÏ |
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