Çѱ¹¹ÙÀÌ¿ÀÀǾàÇ°Çùȸ ´º½º·¹ÅÍ ±¹¹® Å×½ºÆ®ÆÄÀÏ
|
|
|
|
|
|
|
|
|
|
|
ÀÚ·á °øÀ¯ |
2017³â 1Â÷ ÷´Ü¹ÙÀÌ¿ÀÀǾàÇ° Çã°¡±³À° ¿öÅ©¼ó ¹ßÇ¥ÀÚ·á °øÀ¯
5¿ù 25ÀÏ~26ÀÏ, ¼¿ï ±×·£µåÄÁº¥¼Ç¼¾ÅÍ¿¡¼ °³ÃֵǾú´ø ÷´Ü¹ÙÀÌ¿ÀÀǾàÇ° Çã°¡±³À° ¿öÅ©¼ó ¹ßÇ¥ÀڷḦ È®ÀÎÇÒ ¼ö ÀÖ´Ù.
½Ä¾àó¿¡¼´Â »çÀü ÁúÀÇ Áß, ¼¼Æ÷À¯·¡¹°(¿¢¼ÒÁ» µî) °ü·ÃÇÏ¿© ÇâÈÄ ¼¼Æ÷À¯·¡¹°À» ÀÌ¿ëÇÑ Ä¡·áÁ¦ °³¹ß µ¿ÇâÀ» °í·ÁÇÏ¿© °¡À̵å¶óÀÎ °³¹ß °èȹ¿¡ ¹Ý¿µÇÒ ¿¹Á¤À̶ó°í ¹àÇû´Ù...... ´õ º¸±â |
|
|
¾È³» |
½Ä¾àó, 'Ç÷¾×Á¦Á¦ GMP ±³À°' ½Ç½Ã
6¿ù 14ÀÏ, Çѱ¹ÀÓ»ó½ÃÇè»ê¾÷º»ºÎ ±³À°Àå(¼¿ï½Ã ¸¶Æ÷±¸ ¼ÒÀç)¿¡¼ 'Ç÷¾×Á¦Á¦ Á¦Á¶ ¹× Ç°Áú°ü¸®±âÁØ (GMP) ±³À°'À» ½Ç½ÃÇÑ´Ù. ÁÖ¿ä ³»¿ëÀº ¡ãÇ÷¾×Á¦Á¦ GMP °³¿ä, ¡ã Á¶Á÷, ±âÁؼ, ¹ë¸®µ¥ÀÌ¼Ç µî GMP¿¡ ´ëÇÑ ÀÌÇØ, ¡ã Ç÷¾×¸Å°³ °¨¿°ÀÎÀÚ °Ë»ç, ÇåÇ÷ÀÚ ¼±Á¤¹èÁ¦ ±âÁØ, Á¦Á¶°øÁ¤, ·è¹é µî Ç÷¾×Á¦Á¦ ƯÀÌÀû »çÇ× µîÀÌ´Ù......... ´õ º¸±â |
|
|
|
|
½ÅûÀÚ |
½ÂÀÎÀÏ |
Á¦Ç°¸í |
ÀÓ»ó |
´Ü°è |
Çѱ¹¸±¸® |
20170609 |
ÁøÇ༺ÀÇ Àç¹ß¼º/ºÒÀÀ¼º °íÇü¾Ï¿¡¼ ´Üµ¶ Åõ¿©Çϰųª Ç×-PD-L1 Ç×üÀÎ LY3300054¿Í º´¿ë Åõ¿©ÇÑ Ç×-TIM-3 Ç×ü LY3321367ÀÇ Á¦1a/1b»ó ½ÃÇè |
1»ó |
LY3321367 |
»ï¼º
¼¿ïº´¿ø |
20170608 |
ÁøÇ༺ °£¼¼Æ÷¾Ï¿¡¼ sorafenib ½ÇÆÐ ÈÄ 2Â÷ Ä¡·á·Î¼ pembrolizumabÀÇ Á¦II»ó ÀÓ»ó½ÃÇè: ¿¹ÃøÀû ºÐÀÚ ¾ÆÇüÀ» È®ÀÎÇϱâ À§ÇÑ À¯Àüü ºÐ¼®ÀÇ ÅëÇÕ |
2»ó |
Å°Æ®·ç´Ù |
Çѱ¹
¾Öºêºñ |
20170608 |
¾ÈÁ¤ÀûÀÎ ¿ë·®ÀÇ ÀϹÝÀûÀÎ ÇÕ¼º Áúº´Á¶ÀýÇ×·ù¸¶Æ¼½ºÁ¦(csDMARD)·Î Ä¡·á¸¦ ¹Þ°í ÀÖÀ¸¸ç »ý¹°ÇÐÀû Áúº´Á¶ÀýÇ×·ù¸¶Æ¼½ºÁ¦(bDMARD)¿¡ ºÒÃæºÐÇÑ ¹ÝÀÀÀ» º¸À̰ųª ³»¾à¼ºÀÌ ¾ø´Â ÁßµîÁõ ³»Áö ÁßÁõÀÇ È°µ¿¼º ·ù¸¶Æ¼½º °üÀý¿° ȯÀÚ¸¦ ´ë»óÀ¸·Î ABT-494¸¦ Abatacept¿Í ºñ±³ Æò°¡ÇÏ´Â Á¦3»ó, ¹«ÀÛÀ§¹èÁ¤, È°¼º¾à ´ëÁ¶, ÀÌÁß´«°¡¸² ÀÓ»ó½ÃÇè |
3»ó |
ABT494 |
(ÁÖ)³ì½ÊÀÚ |
20170607 |
»ýÈÄ 6°³¿ù ÀÌ»ó ¸¸ 3¼¼ ¹Ì¸¸ÀÇ °Ç°ÇÑ ¿µÀ¯¾Æ¸¦ ´ë»óÀ¸·Î ¡®GC3110A (ÀÎÇ÷翣ÀÚºÐÇÒ¹é½Å)¡¯ÀÇ À¯È¿¼º(¸é¿ª¿ø¼º) ¹× ¾ÈÀü¼ºÀ» Æò°¡Çϱâ À§ÇÑ °ø°³(Part1), ´ÜÀϱº(Part1), ¹«ÀÛÀ§¹èÁ¤(Part2), ÀÌÁß´«°¡¸²(Part2), È°¼º´ëÁ¶(Part2) Á¦3»ó ÀÓ»ó½ÃÇè |
3»ó |
GC3110A |
º¸·ÉÁ¦¾à
(ÁÖ) |
20170607 |
¸¸ 16¼¼ ÀÌ»ó °Ç°ÇÑ Ã»¼Ò³â ¶Ç´Â ¼ºÀο¡¼ ºÒÈ°¼ºÈ AÇü °£¿° ¹é½ÅÀÇ ¸é¿ª¿ø¼º ¹× ¾ÈÀü¼ºÀ» Æò°¡Çϱâ À§ÇÑ ¹«ÀÛÀ§¹èÁ¤, ¾çÃø´«°¡¸², ´Ù±â°ü, È°¼º´ëÁ¶, º´Çà ¼³°è, Á¦ 3»ó ÀÓ»ó½ÃÇè |
3»ó |
º¸·ÉAÇü
°£¿°¹é½ÅÁÖ
(ÇÁ¸®Çʵå
½Ã¸°Áö)
(AÇü°£¿°¹é½Å) |
|
|
|
|
|
|
|
|
FDA |
|
Drug Name and
FDA Appl. # |
Active Ingredients |
Submission
Classification |
Company |
Approval Date |
NORVIR
NDA #209512 |
RITONAVIR |
½Å¿ë·® |
ABBVIE INC |
06/07/2017 |
GLEOLAN
NDA #208630
|
AMINOLEVULINIC ACID HYDROCHLORIDE |
½Å¿ë·® |
NICOX OPHTHALMICS INC |
06/06/2017 |
|
|
|
|
|
|
|
|
EMA |
|
Name |
Active Substance |
Therapeutic Area |
Dafe of
Authorisation
/ refusal |
Trumenba
|
Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp
(factor H binding protein)) subfamily A;
Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp
(factor H binding protein)) subfamily B |
Meningitis, Meningococcal |
24/05/2017 |
Emtricitabine/
Tenofovir disoproxil
Krka d.d. |
emtricitabine / tenofovir disoproxil succinate |
HIV Infections |
28/04/2017 |
|
|
|
|
|
|
|
|
Clinical.gov ¹Ì±¹ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03181100 |
Atezolizumab Combinations With Chemotherapy for Anaplastic and Poorly Differentiated Thyroid Carcinomas |
Malignant Neoplasms of Thyroid and Other Endocrine Glands|Anaplastic Thyroid Carcinoma|Poorly Differentiated Thyroid Cancer |
Drug: Nab-paclitaxel - INDUCTION COHORT
Drug: Paclitaxel - INDUCTION COHORT
Drug: Vemurafenib - COHORT 1
Drug: Cobimetinib - COHORT 1
Drug: Atezolizumab - COHORT 1
Drug: Bevacizumab - COHORT 3
Drug: Nab-paclitaxel - COHORT 4
Drug: Paclitaxel - COHORT 4
Drug: Cobimetinib - COHORT 2
Drug: Atezolizumab - COHORT 2
Drug: Atezolizumab - COHORT 3
Drug: Atezolizumab - COHORT 4 |
M.D. Anderson
Cancer Center
Genentech, Inc. |
Phase 2 |
NCT03179930 |
Combination Therapy With Entinostat and Pembrolizumab in Relapsed and Refractory Lymphomas |
Lymphoma
Relapsed
Refractory |
Drug: Entinostat
Drug: Pembrolizumab |
Memorial Sloan Kettering Cancer Center
Merck Sharp & Dohme Corp.
Syndax Pharmaceuticals |
Phase 2 |
NCT03179917 |
Pembrolizumab and Involved Site Radiation Therapy for Early Stage Relapsed or Primary Refractory Hodgkin Lymphoma |
Hodgkin Lymphoma |
Drug: Pembrolizumab
Radiation: Involved Site Radiation Therapy |
Memorial Sloan Kettering Cancer Center |
Phase 2 |
NCT03178552 |
A Study to Evaluate Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) |
Non-Small Cell Lung Cancer |
Drug: Alectinib
Drug: Atezolizumab
Drug: Pemetrexed
Drug: Cisplatin
Drug: Carboplatin
Drug: Gemcitabine |
Hoffmann-La Roche |
Phase 2
Phase 3 |
NCT03180684 |
VGX-3100 Followed by Electroporation Alone or in Combination With Imiquimod for the Treatment of Human Papilloma Virus HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Vulva |
Neoplasms, Vulvar |
Biological: VGX-3100
Drug: Imiquimod 5% cream
Device: CELLECTRA? 2000 |
Inovio Pharmaceuticals |
Phase 2 |
NCT03182686 |
AP-003-C Study to Confirm the Efficacy of Ampion??in Adults With Pain Due to Severe Osteoarthritis of the Knee |
Osteoarthritis, Knee
Knee Osteoarthritis
Knee Arthritis
Knee Pain Chronic |
Biological: Ampion
Other: Saline |
Ampio Pharmaceuticals. Inc. |
Phase 3 |
|
|
|
|
Clinical.gov À¯·´ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03178552 |
A Study to Evaluate Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) |
Non-Small Cell Lung Cancer |
Drug: Alectinib
Drug: Atezolizumab
Drug: Pemetrexed
Drug: Cisplatin
Drug: Carboplatin
Drug: Gemcitabine |
Hoffmann-La Roche |
Phase 2
Phase 3 |
|
|
|
|
Clinical.gov Áß±¹ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03183232
(NCT03183219)
(NCT03183206) |
Safety and Efficiency of ¥ã¥ä T Cell Against Lung Cancer |
Lung Cancer
Liver Cancer
Breast Cancer
|
Procedure: Cryosurgery or IRE surgery|Biological: ¥ã¥ä T cell|Other: ¥ã¥ä T cells/ A Cryosurgery or IRE |
Fuda Cancer Hospital, Guangzhou|Jinan University Guangzhou |
Phase 1
Phase 2 |
NCT03182816 |
CTLA-4 and PD-1 Antibodies Expressing EGFR-CAR-T Cells for EGFR Positive Advanced Solid Tumor |
Advanced Solid Tumor |
Biological: anti-CTLA-4/PD-1 expressing EGFR-CAR-T |
Shanghai Cell Therapy Research Institute |
Phase 1
Phase 2 |
NCT03180463
(NCT03180450) |
The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells |
Osteonecrosis of Femoral Head
Heart Failure |
Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
Procedure: core decompression |
Sclnow Biotechnology Co., Ltd. |
Phase 1
Phase 2 |
NCT03179007 |
CTLA-4 and PD-1 Antibodies Expressing MUC1-CAR-T Cells for MUC1 Positive Advanced Solid Tumor |
Advanced Solid Tumor |
Biological: Anti-CTLA-4/PD-1 expressing MUC1-CAR-T |
Shanghai Cell Therapy Research Institute |
Phase 1
Phase 2 |
NCT03182673 |
Phase I Study of SHR7390 Combined With SHR-1210 in Patients With Advanced Solid Tumors |
Solid Tumor |
Drug: SHR7390
Biological: SHR-1210 |
Jiangsu HengRui Medicine Co., Ltd. |
Phase 1 |
|
|
|
|
|
|
|
|
»õ Á¤ºÎ Ãâ¹ü, ¹ÙÀÌ¿ÀÀǾàÇ° »ê¾÷ÀÇ ³ª¾Æ°¥ ¹æÇâ Åä·Ðȸ
|
|
(ÃÖÀ±Èñ »ê¾÷¿¬±¸¿ø ¼±ÀÓ¿¬±¸À§¿øÀÌ ¹ÙÀÌ¿ÀÀǾà»ê¾÷ÀÇ ¹ßÀü¹æÇâ¿¡ ´ëÇØ Á¦¾ðÇÏ°í ÀÖ´Ù.) |
(»ç)Çѱ¹¹ÙÀÌ¿ÀÀǾàÇ°Çùȸ¿¡¼´Â '4Â÷ »ê¾÷Çõ¸í ½Ã´ëÀÇ ¹ÙÀÌ¿ÀÀǾàÇ° »ê¾÷°ú »õ Á¤ºÎÀÇ ¿ªÇÒ'À̶ó´Â ÁÖÁ¦·Î 6¿ù 12ÀÏ(È), ¿©Àǵµ¿¡ À§Ä¡ÇÑ Ä˽ÌÅÏÈ£ÅÚ¿¡¼ Åä·Ðȸ¸¦ °³ÃÖÇß´Ù.
- 4Â÷ »ê¾÷Çõ¸í ½Ã´ë¸¦ ¸ÂÀÌÇϱâ À§ÇÑ ¹ÙÀÌ¿ÀÀÇ¾à »ê¾÷ÀÇ ¹ßÀü ¹æÇâ
- ÆÄÀÌÇÁ¶óÀÎ È®´ë ¹× ¿øõ±â¼ú È®º¸
- ¹ÙÀÌ¿ÀÀǾà Àü¹®Àη À°¼ºÀü·«
ÁÖÁ¦¹ßÇ¥°¡ ÀÖ¾úÀ¸¸ç, ÀÌ¾î »êÇаü¿¬ Àü¹®°¡µé°ú ¾÷°è °ü·ÃÀÚµéÀÌ ¼¼½Ã°£¿¡ °ÉÃÄ ¿©·¯ ÁÖ¾ÈÁ¡À» ³íÀÇÇÏ¿´´Ù.
|
|
ÇöÀ彺ÄÉÄ¡ º¸·¯°¡±â
(»ç)Çѱ¹¹ÙÀÌ¿ÀÀǾàÇ°Çùȸ : www.kobia.kr
|
|
|
|
|
|
|
|
2017³â ¹ÙÀÌ¿ÀITÇ÷§Æû SNS °ø½Ä°èÁ¤ ¿î¿µ ¾Ë¸²
|
Çѱ¹¹ÙÀÌ¿ÀÀǾàÇ°Çùȸ¿¡¼´Â ¡®14³âµµºÎÅÍ ½ÄÇ°ÀǾàÇ°¾ÈÀüó ÃßÁø »ç¾÷ÀÇ ÀÏȯÀ¸·Î ±¹³» ¹ÙÀÌ¿ÀÀǾàÇ°ÀÇ ÇØ¿ÜÁøÃâÁö¿øÀ» À§ÇØ ÇØ¿Ü ±ÔÁ¦Á¤º¸¡¤»ê¾÷Á¤º¸¸¦ Á¦°øÇÏ´Â ¡º¹ÙÀÌ¿ÀITÇ÷§Æû(www.bpis.or.kr/)¡»À» ¿î¿µÇÏ°í ÀÖÀ¸¸ç, ´õ¿í ¼Õ½±°Ô Á¢±ÙÇÏ½Ç ¼ö ÀÖµµ·Ï ¹ÙÀÌ¿ÀITÇ÷§Æû °ø½Ä SNS¸¦ ¿ÀÇÂÇÏ¿´½À´Ï´Ù.
°ü·Ã ¾÷°è Á¾»çÀںР¶Ç´Â ÇØ´ç ºÐ¾ß Àü¹®°¡ºÐ²²¼´Â µ¿ °èÁ¤µéÀ» Æȷοì Çϼż ´õ¿í Æí¸®ÇÏ°Ô »õ ¼Ò½Ä(¾÷µ¥ÀÌÆ® ¾Ë¸²)À» ¹Þ¾Æº¸½Ã°í ´Ù¾çÇÑ Á¤º¸¸¦ ¿¶÷ÇϽñ⠹ٶø´Ï´Ù. |
<¹ÙÀÌ¿ÀITÇ÷§Æû Á¦°ø Á¤º¸> |
- ±ÔÁ¦Á¤º¸(¼¼°è ÁÖ¿ä 15±¹ ¹ý±Ô/°¡À̵å¶óÀÎ)
- ÇØ¿Ü 15±¹ ÀÎÇã°¡ ü°è(ÀýÂ÷ ¹× ½Åû ¼½Ä µî)
- ¹ÙÀÌ¿ÀÀǾàÇ° °ü·Ã ±Û·Î¹ú Çà»ç Á¤º¸
- ÁÖ¿ä±¹ Èñ±ÍÀǾàÇ°Á¦µµ Á¤º¸
- ¹ÙÀÌ¿ÀÀǾàÇ° ÀÎÇã°¡ ÄÁ¼³ÆÃ(ÀϹÝ) ½Åû
|
- ±Û·Î¹ú ±ÔÁ¦Á¤º¸ µ¿Çâ(ÃֽŠ°¡À̵å¶óÀÎ Á¦°³Á¤ ÇöȲ)
- Á¦Á¦º° »ê¾÷Á¤º¸(ÀÓ»ó, Çã°¡, ¸ÅÃâ¾×)
- ÇØ¿Ü ¹ÙÀÌ¿ÀÀǾàÇ° ÁÖ¿ä ±â¾÷ Á¤º¸(CRO Æ÷ÇÔ)
- 6´ë ¾àÀü ¹× 8´ë ÀǾàÇ°Áý Á¤º¸ |
|
|
|
|
|
|
|
|
|
|
|
|
|