01:48 , Dec 3, 2015 |  BC Extra  |  Company News

FDA reviewing once-daily Viekira Pak

AbbVie Inc. (NYSE:ABBV) said FDA accepted an NDA for a once-daily fixed-dose formulation of Viekira Pak to treat chronic HCV genotype 1. AbbVie said it expects a decision on the candidate in 2H16, but did...
00:57 , Oct 21, 2015 |  BC Extra  |  Clinical News

Shorter ABT-493/ABT-530 regimen yields 100% SVR4

An abstract released ahead of the American Association for the Study of Liver Diseases (AASLD) meeting showed an eight-week regimen of ABT-493 from AbbVie Inc. (NYSE:ABBV) and Enanta Pharmaceuticals Inc. (NASDASQ:ENTA) plus AbbVie's ABT-530 led...
23:57 , Apr 8, 2015 |  BC Extra  |  Top Story

Enanta gains on Phase II HCV data

Enanta Pharmaceuticals Inc. (NASDAQ:ENTA) gained $3.71 (11%) to $36.38 on Wednesday after partner AbbVie Inc. (NYSE:ABBV) reported preliminary data from a Phase IIb trial of a once-daily oral combo of the biotech's ABT-493 plus ABT-530...
07:00 , Mar 16, 2015 |  BC Week In Review  |  Clinical News

Viekirax regulatory update

AbbVie submitted an NDA to Japan’s Ministry of Health, Labor and Welfare (MHLW) for an all-oral, interferon-free treatment of ombitasvir/paritaprevir/ritonavir to treat chronic HCV genotype 1 infection. The company said the NDA is supported by...
08:00 , Feb 9, 2015 |  BC Week In Review  |  Clinical News

Viekirax: Phase II data

Top-line data from the Japanese Phase III GIFT-1 trial in 363 patients with chronic HCV genotype 1b infection showed that ombitasvir/paritaprevir/ritonavir for 12 weeks led to an SVR 12 weeks after the end of treatment...
02:32 , Jan 28, 2015 |  BC Extra  |  Company News

Express Scripts' Miller says HCV deals will save billions

Steve Miller, SVP and CMO of Express Scripts Holding Co. (NASDAQ:ESRX), wrote in a AbbVie Inc. (NYSE:ABBV) covering HCV treatment Viekira Pak will save its clients "more than $1 billion this year" on HCV treatments....
08:00 , Jan 26, 2015 |  BC Week In Review  |  Company News

AbbVie sales and marketing update

AbbVie entered an agreement with the ADAP Crisis Task Force (ACTF) to provide its HCV regimen Viekira Pak at an undisclosed discount to state AIDS Drug Assistance Programs (ADAPs). In December, FDA approved Viekira...
08:00 , Jan 26, 2015 |  BC Week In Review  |  Company News

Gilead, Aetna sales and marketing update

Aetna has selected Gilead’s Harvoni ledipasvir/sofosbuvir to treat HCV genotype 1 infection and Sovaldi sofosbuvir to treat HCV genotypes 2, 3 and 4 infection as preferred therapies for Aetna’s commercial customers. Aetna will...
04:58 , Jan 21, 2015 |  BC Extra  |  Company News

AbbVie discounts Viekira Pak for ADAPs

AbbVie Inc. (NYSE:ABBV) entered an agreement with the ADAP Crisis Task Force (ACTF) to provide its HCV regimen Viekira Pak at an undisclosed discount to state AIDS Drug Assistance Programs (ADAPs). In December, FDA approved...
08:00 , Jan 19, 2015 |  BC Week In Review  |  Clinical News

Viekirax paritaprevir regulatory update

Enanta and AbbVie said the European Commission approved an all-oral, interferon-free treatment of Exviera dasabuvir and Viekirax ombitasvir/paritaprevir/ritonavir with or without ribavirin to treat chronic HCV genotype 1 infection and with ribavirin to treat...