HIV treatment

The FDA has approved ViiV Healthcare's Cabenuva (cabotegravir, rilpivirine) for HIV-1 in virologically suppressed adolescents. The approval covers patients aged 12 years or older and weighing at least 35kg on a stable antiretroviral regimen, with no history of treatment failure...

The FDA has issued a complete response letter (CRL) for Gilead Sciences Inc's (NASDAQ: GILD) application for lenacapavir for heavily treated multi-drug resistant (MDR) HIV-1 infection. Lenacapavir is an investigational, long-acting HIV-1 capsid inhibitor. In the CRL, the...

Gilead Sciences Inc (NASDAQ: GILD) announced new one-year results from the ongoing Phase 2/3 CAPELLA trial evaluating lenacapavir in heavily pretreated multi-drug resistant HIV patients. The findings demonstrated that lenacapavir, administered every six months in combination with...

A woman in the New York City area appears to have been cured of an HIV infection, Wall Street Journal reported, providing a roadmap that could help researchers who are developing gene therapies to cure HIV. According to the woman's doctor, there were no detectable signs of the human...

The FDA has approved ViiV Healthcare's Apretude (cabotegravir extended-release injectable suspension) for use in adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.  ViiV...

Gilead Sciences Inc (NASDAQ: GILD) said an unauthorized network of drug distributors and suppliers sold pharmacies more than $250 million of counterfeit versions of its HIV treatments over the last two years. The alleged scheme was reported earlier by The Wall Street Journal. The Company...

The FDA has placed a clinical hold on Gilead Sciences Inc's (NASDAQ: GILD) injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV treatment and pre-exposure prophylaxis (PrEP).  The FDA's clinical hold is due to emerging concerns about...

The FDA has approved ViiV Healthcare's Apretude, the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option, to reduce the risk of sexually acquired HIV-1.  The long-acting injectable was approved for use in adults and adolescents weighing at least 35...

After the external data monitoring committee's recommendation, Merck & Co Inc (NYSE: MRK) has paused in enrollment for the IMPOWER 22 (MK-8591-022) and IMPOWER 24 (MK-8591-024) Phase 3 studies evaluating islatravir (ISL) for pre-exposure prophylaxis (PrEP) in people at...

Gilead Sciences Inc (NASDAQ: GILD) and Merck & Co Inc (NYSE: MRK) have temporarily paused enrollment in the Phase 2 study evaluating the combination regimen of islatravir and lenacapavir in HIV infection. The temporary pause has been implemented out of an abundance of...

Merck & Co Inc (NYSE: MRK) announced an update regarding the Phase 2 IMAGINE-DR trial (MK-8507-13), evaluating the combination of MK-8507 and islatravir (ISL) as a once-weekly oral treatment for HIV-1 infection.  Decreases in total lymphocyte and CD4+ T-cell counts were...

ViiV Healthcare, a joint venture between GlaxoSmithKline plc (NYSE: GSK), Pfizer Inc (NYSE: PFE), and Shionogi, presented three-year results from the TANGO study at IDWeek 2021. Phase 3 TANGO study assessed the antiviral efficacy and safety of switching to Dovato...

ViiV Healthcare, majority-owned by GlaxoSmithKline plc (NYSE: GSK), Pfizer Inc (NYSE: PFE), and Shionogi, has announced an exclusive collaboration and license agreement with Shionogi & Co Ltd for S-365598 for use in ultra long-acting HIV regimens. S-365598 is...

The FDA has accepted and granted Priority Review to ViiV Healthcare's marketing application seeking approval for injectable cabotegravir long-acting for pre-exposure prophylaxis (PrEP). The priority review designation sets ViiV up for a decision from the agency by January...

GlaxoSmithKline plc (NYSE: GSK), Pfizer Inc (NYSE: PFE), and Shionogi Limited owned ViiV Healthcare has collaborated with Halozyme Therapeutics Inc (NASDAQ: HALO) to gain access to Halozyme's Enhanze drug delivery technology for use against four HIV...