ѱ̿Ǿǰȸ Ʈ
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" ̿ " ̳ / ' ' ٰ ߳
Ƿ÷ ̱ ٿ ´ ' '? / 鿪 ȿ IL-2 , Ʈ ã´
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ǰ㰡ɻ Ϻΰ
ֿ
. .() Ǵ ӻ, ฮ , ó̳ ʿ ( 171, ǥ 52 ż)
. ġ ġ Ǵ ä ( 303ȣ(5) ż, 313ȣ)
泻 Ȯ
[ ǰ㰡ɻ ] Ȯ |
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Ǿǰ ӻ Ƿ (̵) ˸
Ǿǰ ӻ ŷڵ ȣ , ӻ Ƿڰ , ϰ, ߴϰ ̻ 츮 ó Կ ־ ؾ ϰ ̵ Ͽ
ӻ 'ߴϰ ̻' ľó ڹοâ ¶ ý Կ Ŵ Ͽ
̵ Ȯ
ڸŴ Ȯ |
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ǰȸ |
÷ܹ̿Ǿǰ ǰȸ(ǿ ǥ)(9 11ϱ)
÷ܹ̿Ǿǰ
ǰ : '17 9 11 ()
ǰó : info@kobia.kr
÷ܹ̿Ǿǰ Ȯ |
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Ǿǰ Ϻΰ
ICH OECD ذ ȭ Ͽ ߰ ϰ, Ȯ ֵ ϴ Ǿǰ ո Ϸ
ֿ䳻
. Ģ ǽؾ ϴ ǥ Ȯ(ǥ 4)
. ߰ ǽ ִ OECD (32)
Ǿǰ Ϻΰ Ȯ |
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û |
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ǰ |
ӻ |
ܰ |
()ѱἾ |
20170831 |
-TNF ڸ Ͽ, Ȱ Ǽ ִ ڿ Ϸ Guselkumab ȿ ϱ 3, ٱ, , , ӻ |
3 |
(CNTO 1959) 100mg |
ڹݽڸƼȸ |
20170831 |
̼ (콺 ) ȯڿ 鿪 ġ ȿ ϴ Ib/II , , ٱ, , ӻ |
1/2 |
ָ, ںƼ, PEGPH20, BL-8040 |
ѱ() |
20170831 |
ĵպ(Gastroesophageal Junction, GEJ) ȯڸ ź/ġμ Pembrolizumab (MK-3475) + ȭп(XP Ǵ FP) + ȭп(XP Ǵ FP) ϴ III, , ߴ ӻ
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3 |
MK-3475 |
ѱֺ |
20170829 |
ġῡ ߴ ߵ Ȱ ũк ȯڸ Risankizumab ȿ ϴ ٱ, , ߴ, , ӻ
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3 |
Űָ |
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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 |
Ź |
CHEMO RESEARCH SL |
08/29/2017 |
VABOMERE
NDA #209776 |
MEROPENEM;
VABORBACTAM |
Ź |
REMPEX PHARMS INC |
08/29/2017 |
AUSTEDO
NDA #209885 |
DEUTETRABENAZINE |
ο NDA - NDA |
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 ̱ |
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 |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
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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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