BioCentury | Aug 30, 2019
Politics & Policy

FDA urged to expand on integrated review

...of the new and old templates for stakeholders. It also posted a review of Dovato dolutegravir/lamivudine...
...to an inquiry regarding when it expects to finalize the review template. Allison Johnson, Senior Writer Dovato, dolutegravir/lamivudine Pifeltro...
BioCentury | Aug 2, 2019
Regulation

FDA revamps NDA process to get top problems to sponsors faster

...Gottlieb told BioCentury. The agency has prospectively used the process and template to review Dovato dolutegravir/lamivudine...
...and Drug Administration (FDA), Silver Spring, Md. ViiV Healthcare Ltd., Brentford, U.K. Allison Johnson, Senior Writer Dovato, dolutegravir/lamivudine Pifeltro...
BioCentury | Jul 10, 2019
Clinical News

July 10 Clinical Quick Takes: Darzalex quad combo raises MM complete response, plus Geneos and ViiV

...regimen non-inferior to triple combos for controlling HIV-1 ViiV Healthcare Ltd. (Brentford, U.K.) said Dovato dolutegravir/lamivudine...
...International AIDS Society Conference on HIV Science this month. Sandi Wong, Staff Writer Darzalex, daratumumab (JNJ-54767414, humax-cd38) Dovato, dolutegravir/lamivudine Geneos...
BioCentury | Jul 3, 2019
Company News

July 3 Company Quick Takes: Dovato approved in Europe for HIV; plus Alexion, RedHill and Insys

...EC approves Dovato for HIV The European Commission approved once-daily Dovato dolutegravir/lamivudine from ViiV Healthcare Ltd...
...sale of almost all its assets, which it expects to complete within 90 days. BC Staff Dovato, dolutegravir/lamivudine Talicia...
BioCentury | Jun 29, 2019
Finance

Biotech backs down in 2Q19

...it was previously approved in patients 12 and older ViiV Healthcare Ltd. FDA approves Dovato dolutegravir/lamivudine...
BioCentury | Apr 26, 2019
Company News

European regulatory roundup: CHMP opinions and a Portola approval

...EMA's CHMP recommended a basket of approvals, including Dovato dolutegravir/lamivudine, Libtayo cemiplimab and two orphan therapies...
...cell death 1 Sandi Wong, Staff Writer Andexxa, Indexxa, Ondexxya, andexanet alfa (PRT064445, PRT4445) Doptelet, avatrombopag (AKR-501, E5501) Dovato, dolutegravir/lamivudine Jeuveau...
BioCentury | Apr 12, 2019
Company News

FDA approves ViiV's two-drug HIV regimen

...FDA approved Viiv's Dovato dolutegravir/lamivudine for HIV-1 infection in treatment-naïve adults. The product is a once-daily...
...GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), Pfizer Inc. (NYSE:PFE) and Shionogi & Co. Ltd. (Tokyo:4507). Sandi Wong, Staff Writer dolutegravir/lamivudine ViiV...
BioCentury | Mar 15, 2019
Clinical News

ViiV planning submissions this year for two-drug HIV regimen

...switching to cabotegravir plus Edurant every four weeks was non-inferior to continuing once-daily oral Triumeq abacavir/dolutegravir/lamivudine...
BioCentury | Nov 2, 2018
Clinical News

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

...ViiV said switching to cabotegravir and Edurant showed similar efficacy to continuing once-daily oral Triumeq abacavir/dolutegravir/lamivudine...
BioCentury | Oct 26, 2018
Clinical News

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

...tenofovir. Lamivudine is a generic NRTI. In September, ViiV submitted an MAA to EMA for dolutegravir/lamivudine...
...and Shionogi & Co. Ltd. (Tokyo:4507). ViiV Healthcare Ltd., Brentford, U.K. Product: Dolutegravir/lamivudine Business: Infectious Jennie Walters dolutegravir/lamivudine ViiV...
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