19:55 , Nov 2, 2018 |  BC Week In Review  |  Clinical News

ViiV's two-drug HIV regimen meets again in Phase III

ViiV Healthcare Ltd. (Brentford, U.K.) said a once-monthly two-drug regimen comprising cabotegravir and Edurant rilpivirine met the primary endpoint in the Phase III FLAIR trial as maintenance treatment in HIV-1-infected, antiretroviral therapy-naïve patients who are...
18:50 , Oct 26, 2018 |  BC Week In Review  |  Clinical News

ViiV seeks FDA approval for two-drug HIV-1 regimen

ViiV Healthcare Ltd. (Brentford, U.K.) said it submitted an NDA to FDA for its single-tablet, two-drug regimen of dolutegravir and lamivudine to treat HIV-1 infection. The company used a Priority Review voucher to speed up...
17:24 , Aug 17, 2018 |  BC Week In Review  |  Clinical News

J&J, ViiV's two-drug regimen meets in Phase III for maintenance treatment of HIV-1 infection

ViiV Healthcare Ltd. (Brentford, U.K.) and Johnson & Johnson (NYSE:JNJ) said a two-drug regimen comprising cabotegravir and Edurant rilpivirine met the primary endpoint in the Phase III ATLAS trial as maintenance treatment in HIV-1-infected adults...
18:38 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

ViiV presents detailed Phase III primary endpoint data for two-drug HIV regimen

ViiV Healthcare Ltd. (Brentford, U.K.) presented pooled additional data from a pair of Phase III trials in HIV-1 infected patients showing that its two-drug regimen of dolutegravir and lamivudine led to HIV-1 RNA levels of...
19:29 , Jun 15, 2018 |  BC Week In Review  |  Clinical News

ViiV's two-drug HIV regimen meets in Phase III for HIV

ViiV Healthcare Ltd. (Brentford, U.K.) said its two-drug regimen of dolutegravir and lamivudine met the primary endpoint in a pair of Phase III trials to treat HIV-1 infection in treatment-naïve patients with baseline viral loads...
18:38 , Jun 14, 2018 |  BC Extra  |  Clinical News

ViiV's two-drug HIV regimen meets in Phase III for HIV

ViiV Healthcare Ltd. (Brentford, U.K.) said its two-drug regimen of dolutegravir and lamivudine met the primary endpoint in a pair of Phase III trials to treat HIV-1 infection in treatment-naïve patients with baseline viral loads...
19:58 , Jun 1, 2018 |  BC Week In Review  |  Clinical News

FDA issues MedWatch safety alert for dolutegravir

FDA issued a MedWatch safety alert for antiretroviral drug dolutegravir in which the agency stated that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies...
14:52 , May 25, 2018 |  BC Week In Review  |  Clinical News

ViiV, Janssen two-drug tablet approved in EU for HIV

ViiV Healthcare Ltd. (Brentford, U.K.) and Janssen Pharmaceutical Co. said the European Commission approved Juluca dolutegravir/rilpivirine to treat HIV-1 infection. The companies said Juluca, which FDA approved last year, is the first single-tablet, two-drug regimen...
17:33 , May 21, 2018 |  BC Extra  |  Company News

EC approves two-drug tablet for HIV from ViiV, Janssen

ViiV Healthcare Ltd. (Brentford, U.K.) and Janssen Pharmaceutical Co. said the European Commission approved Juluca dolutegravir/rilpivirine to treat HIV-1 infection. The companies said Juluca, which FDA approved last year, is the first single-tablet, two-drug regimen...
17:47 , Mar 30, 2018 |  BC Week In Review  |  Clinical News

Biosimilars, Clovis' Rubraca among CHMP recommendations

EMA's CHMP recommended approval of a basket of therapies including cancer drug Rubraca rucaparib from Clovis Oncology Inc. (NASDAQ:CLVS), two biosimilars and HIV therapy Juluca dolutegravir/rilpivirine from ViiV Healthcare Ltd. (Brentford, U.K.). CHMP backed Rubraca's...