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ViiV Healthcare announces the authorization of Vocabria (cabotegravir injection and tablets) in combination with Johnson & Johnson (JNJ) unit, Janssen Pharmaceuticals' Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), in the European Union ((EU)), for the treat...
The European Medicines Agency's advisory group CHMP has issued a positive opinion recommending approval of ViiV Healthcare's Rukobia (fostemsavir) 600 mg extended-release tablets for the treatment of HIV-1 infection.Final marketing authorization from the European Commission is anticipated in ...
The FDA grants Breakthrough Therapy Designation to ViiV Healthcare's long-acting, injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP).Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel ...
Five-year data from the Phase 2b LATTE-2 study and 12-month data from the Phase 2b POLAR rollover study showed sustained benefits from ViiV Healthcare's doublet injectable HIV regimen of cabotegravir and rilpivirine, potentially reducing the number of treatment days to six from 365 while main...
Three year data from the Phase 3 GEMINI 1 and GEMINI 2 studies evaluating ViiV Healthcare's two-drug regimen of dolutegravir and lamivudine (branded as Dovato) showed it to be non-inferior (no worse than) to the three-drug regimen of dolutegravir plus two nucleoside reverse transcriptase...
A Delaware district court judge has denied a motion from Gilead Sciences ( GILD +3.4% ) that HIV triple combo pill Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) does not infringe on a ViiV Healthcare patent covering rival HIV med Tivicay (dolutegravir). More news on: Gilea...
The following slide deck was published by Shionogi & Co., Ltd. in conjunction with their 2020 Q1 earnings Read more ...
ViiV Healthcare, majority owned by GSK, with Pfizer and Shionogi as shareholders, announced the FDA nod for Rukobia (fostemsavir), a human immunodeficiency virus type 1 gp120-directed attachment inhibitor, in combination with other antiretrovirals, for HIV-1 infection More news on: Glaxo...
The FDA approves ViiV Healthcare's Tivicay (dolutegravir) for the treatment of HIV-1 infection in children as young as four weeks old and weighing at least 3 kg, in combination with other antiretroviral treatments. More news on: GlaxoSmithKline plc, Pfizer Inc., Shionogi & Co., Ltd.,...
Genocea Biosciences (NASDAQ: GNCA ) inks a material transfer agreement (MTA) and exclusive license option with Shionogi & Co., Ltd. ( OTCPK:SGIOY ) to develop a novel herpes simplex virus type 2 (HSV-2) vaccine. More news on: Genocea Biosciences, Inc., Shionogi & Co., Ltd., Healt...
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