Gilead Sciences is aiming to win regulatory approval for the first HIV-1 treatment administered twice per year as the company submitted a New Drug Application to the U.S. Food and Drug Administration for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor.

On June 5, the United States and the rest of the world marks a grim milestone – the 40th anniversary of the HIV epidemic. While the virus has taken the lives of an estimated 35 million people over the last 40 years, an end could be in sight as biopharma researchers continue to develop safe and effective new treatments, with an eye toward a potential cure.

Two of the biggest drugmakers in the HIV space are teaming up on a combination therapy that has the potential to be a game-changer for patients diagnosed with the dangerous virus for which there is no known cure.

Gilead Sciences inked a collaboration, option and license deal with Gritstone Oncology to create a vaccine-based immunotherapy as a cure for HIV.

Novavax Inc. said the company’s coronavirus vaccine was 89.3% effective in preventing Covid-19 in a trial conducted in the United Kingdom, and was nearly as effective in protecting against the more highly contagious variant first discovered in the UK, according to a preliminary analysis.

Much of the attention on Pfizer, BioNTech, Moderna, Johnson & Johnson and AstraZeneca has been on their Covid-19 vaccine efforts, and here is a look at what else is going on with these companies.

The U.S. Food and Drug Administration approved ViiV Healthcare’s Cabenuva as the only complete long-acting regimen for the treatment of HIV-1 infection in adults.

Topline results from Gilead Sciences’ Phase II/III CAPELLA trial show that treatment with the company’s long-acting HIV-1 capsid inhibitor lenacapavir reduces HIV viral load better than placebo in heavily treated patients living with multidrug resistant HIV-1 infection.

The U.S. Food and Drug Administration granted various designations for Sanofi’s avalglucosidase alfa for Pompe disease, Sanofi’s rilzabrutinib for immune thrombocytopenia, and ViiV Healthcare’s cabotegravir for HIV prevention.

ViiV Healthcare announced that an independent data safety monitoring board (DSMB) recommended the early unblinding of data from the HIV Prevention Trials Network 084 trial of the investigational, long-acting injectable cabotegravir for HIV prevention in women.