BioCentury | Feb 22, 2018
Finance

Belgian Insights

Belgium has provided Europe with a host of pioneering biotechs, led by CEOs who have demonstrated resilience and stamina in the pursuit of homegrown innovation. The opening evening session on May 14 at Bio€quity Europe...
BC Week In Review | Jul 14, 2014
Clinical News

Eviplera emtricitabine/tenofovir/rilpivirine regulatory update

Germany’s Federal Joint Commission (G-BA) issued a final benefit assessment saying HIV drug Eviplera emtricitabine/tenofovir/rilpivirine from Gilead has “no additional benefit” vs. individualized antiretroviral therapy in previously treated HIV patients - an indication the European Commission...
BC Week In Review | Apr 7, 2014
Clinical News

Eviplera emtricitabine/tenofovir/rilpivirine regulatory update

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said in a preliminary benefit assessment that HIV drug Eviplera emtricitabine/tenofovir/rilpivirine from Gilead has "no additional benefit" vs. individualized antiretroviral therapy in previously treated HIV patients...
BC Week In Review | Dec 23, 2013
Clinical News

Complera regulatory update

FDA approved an sNDA from Gilead for Complera emtricitabine/tenofovir/rilpivirine for use as an alternative regimen for the treatment of HIV-1 infection in certain virologically suppressed (HIV-1 RNA <50 copies/mL) adult patients who are on a...
BC Week In Review | Nov 4, 2013
Clinical News

Eviplera emtricitabine/tenofovir/rilpivirine regulatory update

EMA's CHMP recommended amending the label of Eviplera emtricitabine/tenofovir/rilpivirine to treat HIV-1 infection to exclude its use in patients with known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or...
BC Week In Review | Aug 5, 2013
Clinical News

Eviplera emtricitabine/tenofovir/rilpivirine regulatory update

Gilead withdrew its application to extend the use of Eviplera emtricitabine/tenofovir/rilpivirine to treat HIV-1 infection in previously untreated adult patients to include those with a viral load between 100,000 and 500,000 copies/mL. The product is...
BC Week In Review | Dec 10, 2012
Clinical News

Complera: Phase IIIb data

The open-label Phase IIIb STaR (Study 110) trial in 786 treatment-naïve patients with HIV infection showed that once-daily Complera met the primary endpoint of non-inferiority to Atripla emtricitabine/tenofovir/efavirenz in the proportion of patients who achieved...
BioCentury | Sep 24, 2012
Strategy

Where innovation lives

Six months after becoming an LP in Index Ventures' first fund dedicated to life sciences, Johnson & Johnson is making a second move designed to significantly increase both the number of early stage deals it...
BC Week In Review | Sep 3, 2012
Clinical News

Stribild elvitegravir/cobicistat/emtricitabine/tenofovir regulatory update

FDA approved Gilead's Stribild to treat HIV-1 infection in treatment-naive adults. The once-daily tablet comprises elvitegravir, cobicistat and Truvada emtricitabine/tenofovir. Gilead launched Stribild last week with a wholesale acquisition cost (WAC) of about $28,500 per...
BC Week In Review | Aug 6, 2012
Clinical News

GS-7340/darunavir/cobicistat/emtricitabine: Phase II started

Gilead disclosed in its 2Q12 earnings that it began a double-blind, U.S. Phase II trial to compare a once-daily GS-7340/darunavir/cobicistat/emtricitabine vs. cobicistat-boosted Prezista darunavir plus Truvada emtricitabine/tenofovir in treatment-naïve patients with HIV-1 infection. GS-7340 is...
Items per page:
1 - 10 of 255
BioCentury | Feb 22, 2018
Finance

Belgian Insights

Belgium has provided Europe with a host of pioneering biotechs, led by CEOs who have demonstrated resilience and stamina in the pursuit of homegrown innovation. The opening evening session on May 14 at Bio€quity Europe...
BC Week In Review | Jul 14, 2014
Clinical News

Eviplera emtricitabine/tenofovir/rilpivirine regulatory update

Germany’s Federal Joint Commission (G-BA) issued a final benefit assessment saying HIV drug Eviplera emtricitabine/tenofovir/rilpivirine from Gilead has “no additional benefit” vs. individualized antiretroviral therapy in previously treated HIV patients - an indication the European Commission...
BC Week In Review | Apr 7, 2014
Clinical News

Eviplera emtricitabine/tenofovir/rilpivirine regulatory update

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said in a preliminary benefit assessment that HIV drug Eviplera emtricitabine/tenofovir/rilpivirine from Gilead has "no additional benefit" vs. individualized antiretroviral therapy in previously treated HIV patients...
BC Week In Review | Dec 23, 2013
Clinical News

Complera regulatory update

FDA approved an sNDA from Gilead for Complera emtricitabine/tenofovir/rilpivirine for use as an alternative regimen for the treatment of HIV-1 infection in certain virologically suppressed (HIV-1 RNA <50 copies/mL) adult patients who are on a...
BC Week In Review | Nov 4, 2013
Clinical News

Eviplera emtricitabine/tenofovir/rilpivirine regulatory update

EMA's CHMP recommended amending the label of Eviplera emtricitabine/tenofovir/rilpivirine to treat HIV-1 infection to exclude its use in patients with known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or...
BC Week In Review | Aug 5, 2013
Clinical News

Eviplera emtricitabine/tenofovir/rilpivirine regulatory update

Gilead withdrew its application to extend the use of Eviplera emtricitabine/tenofovir/rilpivirine to treat HIV-1 infection in previously untreated adult patients to include those with a viral load between 100,000 and 500,000 copies/mL. The product is...
BC Week In Review | Dec 10, 2012
Clinical News

Complera: Phase IIIb data

The open-label Phase IIIb STaR (Study 110) trial in 786 treatment-naïve patients with HIV infection showed that once-daily Complera met the primary endpoint of non-inferiority to Atripla emtricitabine/tenofovir/efavirenz in the proportion of patients who achieved...
BioCentury | Sep 24, 2012
Strategy

Where innovation lives

Six months after becoming an LP in Index Ventures' first fund dedicated to life sciences, Johnson & Johnson is making a second move designed to significantly increase both the number of early stage deals it...
BC Week In Review | Sep 3, 2012
Clinical News

Stribild elvitegravir/cobicistat/emtricitabine/tenofovir regulatory update

FDA approved Gilead's Stribild to treat HIV-1 infection in treatment-naive adults. The once-daily tablet comprises elvitegravir, cobicistat and Truvada emtricitabine/tenofovir. Gilead launched Stribild last week with a wholesale acquisition cost (WAC) of about $28,500 per...
BC Week In Review | Aug 6, 2012
Clinical News

GS-7340/darunavir/cobicistat/emtricitabine: Phase II started

Gilead disclosed in its 2Q12 earnings that it began a double-blind, U.S. Phase II trial to compare a once-daily GS-7340/darunavir/cobicistat/emtricitabine vs. cobicistat-boosted Prezista darunavir plus Truvada emtricitabine/tenofovir in treatment-naïve patients with HIV-1 infection. GS-7340 is...
Items per page:
1 - 10 of 255