16:13 , Feb 20, 2019 |  BC Innovations  |  Distillery Techniques

Disease models; drug properties

TECHNOLOGY: Transgenics and knockouts; pharmacokinetics/pharmacodynamics Rats expressing human UGT2 or CYP3A gene clusters could be used to predict the PK of drug compounds metabolized by the two enzyme families. Rats engineered to express the entire...
16:53 , Jul 20, 2018 |  BC Week In Review  |  Clinical News

FDA approves J&J's Symtuza for HIV-1 infection in adults

FDA approved Symtuza darunavir/cobicistat/emtricitabine/tenofovir alafenamide from Johnson & Johnson (NYSE:JNJ) to treat HIV-1 infection in adults who have not previously received antiretroviral therapy (ART) or who have HIV-1 RNA levels of less than 50 copies/mL...
19:05 , Oct 27, 2017 |  BC Week In Review  |  Clinical News

EC approves Symtuza for HIV-1, Janssen submits NDA to FDA

Johnson & Johnson (NYSE:JNJ) said in September its Janssen Research & Development LLC unit submitted an NDA to FDA for a once-daily fixed-dose combination of darunavir/cobicistat/emtricitabine/tenofovir alafenamide to treat HIV-1 infection in patients ages 12...
00:41 , Feb 3, 2017 |  BC Week In Review  |  Clinical News

Stribild regulatory update

FDA approved an sNDA from Gilead for Stribild elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate to treat HIV-1 infection in pediatric patients ages ≥12 weighing ≥35 kg. The drug is approved in adults who have no history of antiretroviral...
07:00 , Sep 19, 2016 |  BC Week In Review  |  Clinical News

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide regulatory update

Johnson & Johnson’s Janssen-Cilag International N.V. unit submitted an MAA to EMA for a once-daily fixed-dose combination of darunavir/cobicistat/emtricitabine/tenofovir alafenamide to treat HIV-1 infection in patients ages >=12 weighing >=40 kg. The regimen comprises Prezista...
07:00 , Sep 5, 2016 |  BioCentury  |  Strategy

Back to School: Haste, not waste

As researchers in industry and academia rapidly unravel molecular disease mechanisms and drug developers become more adept at intervening in disease pathways with drugs targeted to specific populations, the current clinical development paradigm cannot keep...
07:00 , Aug 8, 2016 |  BioCentury  |  Regulation

Better Modeling Through PDUFA

During negotiations over PDUFA VI FDA and industry agreed on initiatives to advance the agency's capability to accommodate "model-informed drug development" and novel clinical trial designs, two domains that could dramatically improve the speed and...
08:00 , Feb 15, 2016 |  BC Week In Review  |  Company News

Gilead, Japan Tobacco, AIDS Healthcare Foundation, Emory University infectious news

The foundation filed a lawsuit in the U.S. District Court for the Northern District of California alleging that Gilead “manipulated the patent system and engaged in anticompetitive practices” to block generic entry and maintain inflated...
08:00 , Dec 7, 2015 |  BC Week In Review  |  Clinical News

Tenofovir alafenamide fumarate regulatory update

The European Commission approved an MAA for Genvoya tenofovir alafenamide fumarate (TAF)/elvitegravir/cobicistat/emtricitabine from Gilead to treat HIV infection in patients ages >=12 with a body weight of >=35 kg. The single, once-daily tablet containing 10...
08:00 , Nov 23, 2015 |  BC Week In Review  |  Clinical News

Genvoya tenofovir alafenamide fumarate regulatory update

FDA approved an NDA from Gilead for Genvoya tenofovir alafenamide fumarate/elvitegravir/cobicistat/emtricitabine from Gilead to treat HIV-1 infection in patients ages >=12. Gilead launched the drug at an annual wholesale acquisition cost (WAC) of $31,362. In...