첨단바이오 포커스

국민의 안전과 건강을 지키는 한국의약품안전관리원

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첨단바이오 포커스 제13호

등록자

hyj0117

등록일

2022-01-28

조회수

935

Reference

1. 보건복지부 홈페이지

Available from: http://www.mohw.go.kr/react/al/sal0301vw.jsp?PAR_MENU_ID=04&MENU_ID =0403&page=1&CONT_SEQ=369207

2. 식품의약품안전처 홈페이지

Available from: https://www.mfds.go.kr/brd/m_99/view.do?seq=45965

3. 보건복지부 홈페이지

Available from: http://www.mohw.go.kr/react/al/sal0301vw.jsp?PAR_MENU_ID=04&MENU_ID =0403&CONT_SEQ=368818

4. 식품의약품안전처 홈페이지

Available from: https://www.mfds.go.kr/brd/m_1059/view.do?seq=14873

5. 박희윤 기자 “KBIOHealth, 범부처재생의료기술개발사업단 맞손 서울경제” (’21.12.16)

Available from: https://www.sedaily.com/NewsVIew/22VBDBP6Y2

6. 범부처재생의료기술개발사업단 홈페이지

Available from: http://www.kfrm.org/doc/html/information/newsView.asp?BOARD_IDX=191

7. 산업통상자원부 홈페이지

Available from: http://www.motie.go.kr/motie/ne/presse/press2/bbs/bbsView.do?bbs_cd_n=81&bbs_seq_n=164970

8. 김진우 기자 “한국제약바이오협회, 제6회 바이오 오픈 플라자 개최” 의약통신(’21.12.14)

Available from: http://www.kmpnews.co.kr/news/articleView.html?idxno=46002

9. 이상철 기자 “서울성모병원, 국내 유일 첨단재생바이오법 전 부문 승인” 후생신보(’21.12.22)

Available from: http://www.whosaeng.com/132775

10. 김진우 기자 “서울대병원, 소아백혈병 CAR-T 치료제, 국내 최초 생산” 의약통신(’21.12.10)

Available from: http://www.kmpnews.co.kr/news/articleView.html?idxno=45945

11. “FDA extends review of &, Legend’s cell theraphy for multiple myeloma” Biopharmadive. Last modiﬁed Nov 2. 2021, Accessed Nov 3. 2021,

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Available from: https://www.fda.gov/news-events/regenerative-medicine-101-webinar- information-patients-caregivers-advocates-11162021-11162021

13. “Regenerative Medicine 101: Information for Patients, Caregivers & Advocates” US FDA, Last modiﬁed Dec 8. 2021, Accessed Dec 10. 2021,

Available from: https://fda.zoomgov.com/rec/play/fVlSwsgD7Pi5ZQLXrg7uQcN7x1vlmR3Ris0

nYR0H7bMet_abeUD7exXGko4JLSouVpu6mEYUiCgiiuzA.k5BRYx6acXFEu6TT?startTime=1637078375000

14. “Regenerative Medicine 101: Information for Patients, Caregivers & Advocates” US FDA, Last modiﬁed Dec 8. 2021, Accessed Dec 10. 2021,

Available from: https://www.fda.gov/media/154665/download

15. “Beam gets green light to begin ﬁrst clinical test of base editing” Biopharmadive. Last modiﬁed Nov 8. 2021, Accessed Nov 9. 2021,

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16. “2021 Untitled Letter-NYC Regenerative Medicine, Inc. dba Colts Neck Stem Cells and Regenerative Medicine” US FDA, Last modiﬁed Nov 5. 2021, Accessed Nov 8. 2021,

Available from: https://www.fda.gov/media/154054/download

17. “Statistical Review-TECARTUS”, US FDA, Last modiﬁed Nov 17. 2021, Accessed Nov 19. 2021,

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18. “Pharmacology/Toxicology Branch TECARTUS”, US FDA, Last modiﬁed Nov 17. 2021, Accessed Nov 19. 2021,

Available from: https://www.fda.gov/media/154234/download, https://www.fda.gov/media/ 154234/download

19. “Clinical Review and Evaluation-TECARTUS”, US FDA, Last modiﬁed Nov 17. 2021, Accessed Nov 19. 2021,

Available from: https://www.fda.gov/media/154233/download

20. “Bluebird, after delays, gets speedy FDA review for beta thalassemia gene therapy”, Biopharmadive. Last modiﬁed Nov 22. 2021, Accessed Nov 24. 2021,

Available from: https://www.biopharmadive.com/news/bluebird-beti-cel-fda-ﬁling-beta- thalassemia/610441/

21. “CRISPR Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to CTX110™ for the Treatment of Relapsed or Refractory CD19+ B-cell malignancies” CRISPR Therapeutics, Last modiﬁed Nov 22. 2021, Accessed Nov 24. 2021, Last modiﬁed Nov 22. 2021, Accessed Nov 24. 2021,

Available from: https://crisprtx.gcs-web.com/news-releases/news-release-details/crispr- therapeutics-announces-fda- regenerative-medicine-advanced

22. “Krystal Biotech Announces Positive Topline Results from GEM-3 Pivotal Trial of VYJUVEK™ in Patients with Dystrophic Epidermolysis Bullosa”, BioSpace, Last modiﬁed Nov 22. 2021, Accessed Nov 24. 2021,

Available from: https://www.biospace.com/article/releases/krystal-biotech-announces-

positive-topline-results-from-gem-3-pivotal-trial-of-vyjuvek-in-patients-with-dystrophic- epidermolysis-bullosa/

23. “FDA In Brief: FDA Takes New Steps Aimed at Advancing Development of Individualized Medicines to Treat Genetic Diseases”,US FDA Last modiﬁed Dec 7. 2021, Accessed Dec 10. 2021,

Available from: https://www.fda.gov/news-events/press-announcements/fda-brief-fda-takes -new-steps-aimed-advancing-development-individualized-medicines-treat-genetic

24. “December 8, 2021 Approval Letter ‒ IMLYGIC” US FDA, Last modiﬁed Dec 8. 2021, Accessed Dec 10. 2021,

Available from: https://www.fda.gov/media/154750/download

25. “Fresh data show UniQure's hemophilia gene therapy appears to hold up” Biopharmadive. Last modiﬁed Dec 9. 2021, Accessed Dec 11. 2021,

Available from: https://www.biopharmadive.com/news/uniqure-gene-therapy-hemophilia- durability/611264/

26. “December 16, 2021 Untitled Letter - Aspen Institute for Regenerative Medicine and Anti-Aging, LLC”, US FDA, Last modiﬁed Dec 16. 2021, Accessed Dec 17. 2021,

Available from: https://www.fda.gov/media/154986/download

27. “Duchenne patient dies in Pﬁzer gene therapy study”, Biopharmadive. Last modiﬁed Dec 21. 2021, Accessed Dec 24. 2021,

Available from: https://www.biopharmadive.com/news/pﬁzer-duchenne-muscular-dystrophy -gene-therapy-death/616421/

28. “Regulatory Submissions in Electronic and Paper Format for CBER-Regulated Products” US FDA, Last modiﬁed Dec 22. 2021, Accessed Dec 24. 2021,

Available from: https://www.fda.gov/about-fda/center-biologics-evaluation-and-research- cber/regulatory-submissions-electronic-and-paper-format-cber-regulated-products

29. “KOLON TISSUEGENE RESUMES TG-C PHASE III STUDIES IN THE U.S.”, yahoo!ﬁnance, Last modiﬁed Dec 29. 2021, Accessed Dec 30. 2021,

Available from: https://ﬁnance.yahoo.com/news/kolon-tissuegene-resumes-tg-c-150900038.html

30. 유럽의약품청 EMA 홈페이지

Available from: https://www.ema.europa.eu/en/ich-guideline-s12-nonclinical-biodistribution -considerations-gene-therapy-products-step-2b

31. 유럽의약품청 EMA 홈페이지

Available from: https://www.ema.europa.eu/en/ich-q9-quality-risk-management

32. 유럽의약품청 EMA 홈페이지

Available from: https://www.ema.europa.eu/en/events/ema-eatris-webinar-navigating- regulatory-requirements-advanced-therapy-medicinal-products-atmps

33. 유럽의약품청 EMA 홈페이지

Available from: https://www.ema.europa.eu/en/documents/chmp-annex/recommendations -eligibility-prime-scheme-adopted-chmp-meeting-13-16-december-2021_en.pdf

34. “ Committee for Advanced Therapies (CAT): work-plan-2021-Nov” EMA., Last modiﬁed Nov 3, Accessed Dec 16, 2021

Available from: https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-3-5 -november-2021-meeting_en.pdf

35. “Orphan designations-eu3212474” EMA. Last modiﬁed Nov 16, Accessed Jun. 24, 2021

Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2474

36. “Orphan designations-eu3212478” EMA. Last modiﬁed Nov 16, Accessed Jun. 24, 2021

Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2478

37. “Orphan designations-eu3212477” EMA. Last modiﬁed Nov 16, Accessed Jun. 24, 2021

Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2477

38. “Orphan designations-eu3212473” EMA. Last modiﬁed Nov 16, Accessed Jun. 24, 2021

Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2473

39. “Orphan designations-eu3212472” EMA. Last modiﬁed Nov 16, Accessed Dec 24, 2021

Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2472

40. “Orphan designations-eu3182063” EMA. Last modiﬁed Nov 16, Accessed Dec 24, 2021

Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-18-2063

41. “Orphan designations-eu3171863” EMA. Last modiﬁed Dec 3, Accessed Dec 30, 2021

Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-17-1863

42. “Orphan designations-eu3141263” EMA. Last modiﬁed Dec 3, Accessed Dec 30, 2021

Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-14-1263

43. “Luxturna” EMA. Last modiﬁed Nov 11, Accessed Dec 24, 2021

Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/luxturna

44. “Zynteglo” EMA. Last modiﬁed Dec 10, Accessed Dec 30, 2021

Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/zynteglo

45. PMDA 홈페이지

Available from: https://www.pmda.go.jp/int-activities/symposia/0106.html

46. 이한기 기자 “아스텔라스, 다이노와 차세대 유전자치료제 개발 제휴” 의약뉴스 (’21.12.03)

Available from: http://www.newsmp.com/news/articleView.html?idxno=219617

47. “인간 ES 세포의 새로운 세포주를 수립” (’21.12.08)

Available from: https://www.ncchd.go.jp/press/2021/211208.html

48. 眼科領域における国内第2号の再生医療等製品自家培養口腔粘膜上皮「オキュラルⓇ」を発売(’21.12.10)

Available from: https://prtimes.jp/main/html/rd/p/000000031.000037877.html

49. 제6회 재생 의료 산학관 제휴 심포지엄 개최 (’21.12.14)

Available from: https://www.jsrm.jp/news/news-10952/

50. 일본재생의료학회 홈페이지

Available from: https://www.jsrm.jp/news/news-10943/

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첨단바이오 포커스 제13호 (22년 1월).pdf [2499872 byte]