In a historic development for HIV treatment worldwide, Dr. Reddy’s Laboratories has announced a new partnership with Gilead Sciences to manufacture and commercialize a revolutionary drug called Lenacapavir. This voluntary licensing agreement, unveiled on October 2, 2024, grants Dr. Reddy’s rights to produce and market the drug in India and 120 other countries. The collaboration […]
Strides Pharma Science Limited has announced a significant achievement, with its wholly-owned subsidiary, Strides Pharma Global Pte. Limited in Singapore, receiving approval from the United States Food & Drug Administration (USFDA) for Efavirenz (600mg), Emtricitabine (200mg), Tenofovir Disproxil Fumarate (300mg) tablets, abbreviated as EET. This approval marks another milestone in Strides’ growing portfolio of products […]
ViiV Healthcare, majorly owned by GSK with Pfizer and Shionogi as shareholders, announced that the European Commission (EC) has authorized Apretude, also known as cabotegravir long-acting (LA) injectable and tablets, for HIV prevention. This revolutionary treatment is now the only approved HIV prevention option in the European Union that offers an alternative to 365 daily […]
Strides Pharma Science Limited (Strides) announced that its Singapore-based stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, has received tentative approval for Dolutegravir 50mg tablets from the United States Food & Drug Administration (FDA). The tentative approval, which deems the Dolutegravir 50mg tablets bioequivalent and therapeutically equivalent to Tivicay Tablets of ViiV Healthcare Company, […]
Aurobindo Pharma Limited has achieved a significant milestone by securing the US Food and Drug Administration (FDA)’s tentative nod under the PEPFAR program for its generic dispersible tablet, a fixed-dose combination of Abacavir 60mg, Lamivudine 30 mg, and Dolutegravir 5 mg (pALD). This formulation is pivotal for treating children afflicted with HIV, particularly those weighing […]
New data presented by Gilead Sciences, Inc. has highlighted the efficacy, safety, and patient tolerability of Sunlenca (lenacapavir), the first long-acting injectable HIV treatment administered twice yearly. The data came from the Phase 2/3 CAPELLA trial, including patient-reported outcomes (PRO), demonstrating lenacapavir’s potential in transforming HIV clinical care. The findings were unveiled at the 12th […]
Biocon has agreed to divest a stake of around 15% in its subsidiary — Biocon Biologics Limited (BBL) to Serum Institute Life Sciences Private Limited (SILS) at an enterprise value of around $4.9 billion. Serum Institute Life Sciences is a subsidiary of Serum Institute of India. The deal gives Biocon Biologics access to 100 million […]
Lupin Limited has been granted tentative approval by the US Food and Drug Administration (FDA) for its new drug application (NDA) for HIV drug cocktail – Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (TLD) Tablets, 50 mg/300 mg/300 mg, and antiretroviral fixed-dose combination (FDC). The TLD product, which has been approved under the US President’s Emergency […]
Rukobia FDA approval : ViiV Healthcare said that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets as a new treatment of HIV patients having limited treatment options. According to the FDA, Rukobia is a new type of antiretroviral medication for adult HIV patients who tried various HIV medications […]
Dovato EMA approval : The European Commission (EC) has approved ViiV Healthcare’s once-daily, single-pill, two-drug regimen Dovato (dolutegravir/lamivudine) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Dovato EMA approval The European approval for Dovato is for adults and adolescents aged over 12 years, weighing more than 40 kg, with no known or […]