BioCentury | Dec 24, 2019
Company News

Regulatory roundup: BioMarin poised to have first U.S., EU hemophilia gene therapy; plus Allergan, Eisai, FibroGen, ViiV and Vero

...said FDA issued a complete response letter for the company's long-acting combination of cabotegravir and rilpivirine...
BioCentury | Jul 30, 2019
Company News

July 29 Company Quick Takes: Dupixent sales boost Sanofi; plus Twist, J&J, Alkermes and more

...Johnson (NYSE:JNJ) submitted an MAA to EMA for a once-monthly injectable two-drug regimen comprising Edurant rilpivirine...
BioCentury | Jun 24, 2019
Politics & Policy

June 24 P&P Quick Takes: Priority generics in China; plus CMS price transparency and more

...list includes breast cancer drug Faslodex fulvestrant from AstraZeneca plc (LSE:AZN; NYSE:AZN), HIV drug Edurant rilpivirine...
...Enhance Generic and Biosimilar Competition” ). Jonathan Block, Associate Editor; and Hongjiang Li, Staff Writer Edurant, rilpivirine (TMC278) Faslodex...
BioCentury | Apr 29, 2019
Company News

April 29 Quick Takes: Takeda, Emendo, ViiV, Zynquista, Benlysta and more

...U.K.) submitted an NDA for a once-monthly injectable two-drug regimen comprising its cabotegravir and Edurant rilpivirine...
BioCentury | Mar 19, 2019
Politics & Policy

FDA issues guidances for long-acting PrEP, pediatric HIV drug development

...Brentford, U.K.) that is in Phase III testing; and a long-acting injectable formulation of Edurant rilpivirine...
...Gates Foundation and NIH have tested in Phase II trials. Johnson & Johnson (NYSE:JNJ) markets Edurant...
...II data, and enroll pediatric cohorts in parallel, rather than series. Mary Romeo, Staff Writer Edurant, rilpivirine (TMC278) Long-acting...
BioCentury | Mar 15, 2019
Clinical News

ViiV planning submissions this year for two-drug HIV regimen

...applications this year for a once-monthly two-drug regimen comprising cabotegravir and Johnson & Johnson's Edurant rilpivirine...
...Conference on Retroviruses and Opportunistic Infections in Seattle. The company previously reported that cabotegravir plus Edurant...
...nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine. Brian Moy, Assistant Editor cabotegravir (GSK1265744, s/gsk1265744, s-1265744) Edurant, rilpivirine (TMC278) GlaxoSmithKline...
BioCentury | Jan 5, 2019
Finance

Ready to launch

...$1,279.0 $1,160.0 $1,546.7 21% Gilead Sciences Inc. (NASDAQ:GILD) / Johnson & Johnson (NYSE:JNJ) Odefsey emtricitabine/ rilpivirine/...
...CRPC) Australia, Canada, U.S. NA Johnson & Johnson (NYSE:JNJ) / Gilead Sciences Inc. (NASDAQ:GILD) Odefsey rilpivirine...
BioCentury | Nov 2, 2018
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...
...Pfizer Inc. (NYSE:PFE), New York, N.Y. Shionogi & Co. Ltd. (Tokyo:4507), Osaka, Japan Product: Edurant rilpivirine...
...at week 48 Status: Phase III data Milestone: NA Jaime De Leon cabotegravir (GSK1265744, s/gsk1265744, s-1265744) Edurant, rilpivirine (TMC278) Triumec...
BioCentury | Aug 17, 2018
Clinical News

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

...Brentford, U.K.) and Johnson & Johnson (NYSE:JNJ) said a two-drug regimen comprising cabotegravir and Edurant rilpivirine...
...Pfizer Inc. (NYSE:PFE), New York, N.Y. Shionogi & Co. Ltd. (Tokyo:4507), Osaka, Japan Product: Edurant rilpivirine...
...48 Status: Phase III data Milestone: Phase III data (2H18) Chris Lieu cabotegravir (GSK1265744, s/gsk1265744, s-1265744) Edurant, rilpivirine (TMC278) Johnson...
BioCentury | Jun 1, 2018
Clinical News

FDA issues MedWatch safety alert for dolutegravir

...markets the HIV integrase inhibitor dolutegravir alone as Tivicay, in a double combination as Juluca dolutegravir/rilpivirine...
...ViiV Healthcare Ltd., Brentford, U.K. Product: Tivicay dolutegravir Business: Infectious Mary Romeo Juluca, dolutegravir/rilpivirine (single-tablet tivicay dolutegravir/edurant rilpivirine) Tivicay...
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