분자유전학실험실 (단국대학교 분자생물학과)



 이성욱 ( 2014-04-24 10:00:38 , Hit : 1438
 Anti-viral regimen to treat adults with HCV awaits FDA approval


April 22, 2014


AbbVie submitted a new drug application to the FDA for approval of an investigational regimen to treat adults with chronic genotype 1 hepatitis C virus infection, according to a press release from the biopharmaceutical company.


  
The direct-acting antiviral (DAA) treatment consists of a fixed-dose combination of ritonavir (ABT-450) at 150/100mg co-formulated with 25 mg of ombitasvir (ABT-267), dosed once daily, and 250mg of dasabuvir (ABT-333) with or without ribavirin, dosed twice daily, according to the release.

“This [New Drug Application] is a significant advancement for AbbVie’s HCV development program,” Scott Brun, MD, vice president of pharmaceutical development at AbbVie, said in the release. “Based on the robust data that have been generated in our international phase 3 HCV program, we believe our all-oral, interferon-free regimen holds the potential to be a promising new therapy for patients living with this chronic infection.”

Six phase 3 studies with more than 2,300 patients were conducted in over 25 countries, according to the release. The FDA assigned the DAA breakthrough therapy designation in May 2013, giving it priority review status as a potential major treatment advance.

AbbVie plans to submit an application for approval in the European Union in May, according to the release.







867   실험쥐가 남성 연구자로부터 받는 스트레스?  이성욱 2014/05/02 2128
866   세계의 과학자들, 성인의 세포를 이용해 배아줄기세포를 만드는 데 잇달아 성공  이성욱 2014/04/30 1574
865   백신 개발을 위한 HIV의 취약 부위의 발견  이성욱 2014/04/30 1630
864   다운 증후군과 백혈병 사이의 연관성을 밝혀주는 연구 결과  이성욱 2014/04/24 2099
863   다시 뛰는 RNAi: 10억 달러 들여 신약 개발, 150가지 요법 임상시험  이성욱 2014/04/24 2791
  Anti-viral regimen to treat adults with HCV awaits FDA approval  이성욱 2014/04/24 1438
861   Tales of Aptamer Selection: Astute Observation and Thoughtful Experimentation or Serendipity?  이성욱 2014/04/23 2497
860   암 줄기세포의 항암제 저항성과의 연관성  이성욱 2014/04/23 2315
859   CTLA-4 항체의 항암 효과를 높이는 새로운 혼합치료  이성욱 2014/04/21 2102
858   난자와 정자의 결합을 가능하게 하는 단백질 발견  이성욱 2014/04/21 2068
857   HPV가 만든 인간 유전체의 고리가 암으로 진행  이성욱 2014/04/21 1907
856   First Patent Issued on CRISPR-Cas9  이성욱 2014/04/18 2005
855   왜 여성은 남성보다 더 알츠하이머 질환에 취약한가?  이성욱 2014/04/16 1898
854   트라우마의 추억 - 트라우마의 표지를 운반하는 정자의 miRNA  이성욱 2014/04/16 1923
853   Bristol-Myers hepatitis C treatment cures up to 90 pct -study  이성욱 2014/04/12 1601
852   Celladon Gets FDA’s “Breakthrough Therapy” Status for Gene Therapy  이성욱 2014/04/11 1822
851   나쁜 환경의 스트레스가 텔로미어 길이 단축할까  이성욱 2014/04/11 2285
850   FDA grants priority review for ledipasvir/sofosbuvir  이성욱 2014/04/10 1917
849   일본 STAP 세포연구의 세포주 불일치 발견과 조사위원회의 과학적 위법행위 발표  이성욱 2014/04/03 2017
848   STAP 논문, 결국 62일 만에...  이성욱 2014/04/02 1658

[이전 10개] [1].. 21 [22][23][24][25][26][27][28][29][30]..[64] [다음 10개]
 

Copyright 1999-2021 Zeroboard / skin by ROBIN