GILEAD SCIENCES SL

The global biotechnology market is projected to grow from US$ 550.83 billion in 2024 to US$ 2667.36 billion by 2034, driven by advancements in synthetic biology, CRISPR gene editing, and genomic sequencing. Increasing health issues and genetic abnormalities are boosting demand for biopharmaceuticals. North America leads in market share, while India's agricultural biotechnology sector is rapidly expanding.

Gilead Sciences seeks to expedite local registration of its six-monthly anti-HIV injection in South Africa, offering it at no-profit prices to 18 countries, including SA. Generic versions will be available in 2027 for 120 high-HIV-rate countries. Lenacapavir, the drug in the injection, has shown 100% protection for HIV-negative women and 96% reduction in HIV infection risk for other groups. SAHPRA, though understaffed, aims to expedite reviews using EU-M4All, potentially reducing review times from over a year to seven months. The National Department of Health considers publishing a request for information before SAHPRA approval to save time. Price negotiations and market demand will be crucial for the drug's affordability and accessibility.

A team of philanthropists, including Gary Michelson, plans to establish the California Institute for Immunology and Immunotherapy by 2027, focusing on rapid vaccine development and the human microbiome. Michelson's $120 million commitment aims to support early-career scientists and interdisciplinary collaboration, with the institute expected to be one of the largest in the field. The project is part of a broader effort to translate scientific discoveries into real-world therapeutics, addressing diseases from cancer to COVID.

Gilead Sciences withdrew FDA accelerated approval of Trodelvy for locally advanced or metastatic urothelial carcinoma, based on TROPiCS-04 study not meeting primary endpoint of overall survival. This withdrawal does not affect other Trodelvy indications.

Gilead Sciences and MSD's antiretroviral combination, islatravir and Sunlenca, maintained HIV suppression with a single weekly oral dose in a phase 2 trial, advancing to phase 3. The regimen showed non-inferior efficacy compared to daily Biktarvy, potentially improving adherence and reducing stigma.

Gilead Sciences plans to withdraw U.S. accelerated approval for sacituzumab govitecan (Trodelvy) in metastatic urothelial cancer, after TROPiCS-04 study failed to meet primary endpoint of overall survival. Decision made in consultation with FDA; other approved indications unaffected.

The AI in Biotechnology Market is projected to grow from USD 2.10 Bn in 2024 to USD 7.11 Bn by 2031, at a CAGR of 19%. Key opportunities include increased diagnostic accuracy, personalized therapies, revolutionized drug discovery, advanced genomic analytics, and integrated healthcare systems. Major players analyzed include AstraZeneca, Bristol-Myers Squibb, and Gilead Sciences Inc.

Gilead and Merck announce Phase 2 data on islatravir and lenacapavir, showing 94.2% viral suppression at 48 weeks, advancing to Phase 3 for potential weekly oral HIV treatment.

Gilead and Merck presented Week 48 results from a phase 2 study evaluating a once-weekly oral combination of islatravir and lenacapavir for HIV-suppressed patients, showing comparable viral suppression rates to daily Biktarvy. The combination, not yet approved, will advance to phase 3 trials.

Gilead Sciences and Merck presented Phase 2 study results at IDWeek 2024 showing islatravir and lenacapavir maintained high viral suppression in virologically suppressed adults at 48 weeks. No participants had a viral load ≥50 copies/mL. The study supports further development of this once-weekly oral combination for HIV treatment.