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 conditional...
22:27 , Mar 23, 2018 |  BC Extra  |  Company 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 conditional...
19:58 , Mar 9, 2018 |  BC Week In Review  |  Clinical News

Gilead's switching to Biktarvy non-inferior in Phase III to treat HIV-1 in women

Gilead Sciences Inc. (NASDAQ:GILD) reported data from the open-label, international Phase III GS-US-380-1961 trial in 470 virologically suppressed adult women with HIV-1 infection showing that switching from either a boosted protease inhibitor or boosted Vitekta...
19:58 , Mar 9, 2018 |  BC Week In Review  |  Clinical News

Gilead reports additional Phase III data from HIV switching trial of Biktarvy

Gilead Sciences Inc. (NASDAQ:GILD) reported additional data from the Phase III GS-US-380-1844 trial in 563 virologically suppressed adults with HIV-1 infection showing that switching from either Tivicay dolutegravir plus abacavir/lamivudine or Triumeq dolutegravir/abacavir/lamivudine to once-daily...