The US Food and Drug Administration?s Vaccines and Related Biological Products Advisory Committee voted that clinical data support both the efficacy and safety of Cervarix, GlaxoSmithKline?s (GSK, Middlesex, UK) candidate cervical cancer vaccine.
The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted that clinical data support both the efficacy and safety of Cervarix, GlaxoSmithKline’s (GSK, Middlesex, UK) candidate cervical cancer vaccine. The Committee’s favorable recommendation, although not binding, will be considered by the FDA in its final review of the biologics license application for the candidate vaccine. If approved, the FDA will determine final prescribing information.
GSK designed Cervarix with its ASO4 adjuvant system to deliver high and sustained levels of antibodies aimed at providing long-term protection against cancer-causing human papillomavirus (HPV) types, although the exact level of antibodies that confer protection is not known. Protection has been shown through 6.4 years and ongoing clinical studies continue to assess duration of protection. ASO4 enhances the body's immune response to the antigens contained in the vaccine. This response provides protection at the cervix, where natural antibody response to infection may not adequately protect against future infections with the same virus type.
Cervarix was shown to be effective and well tolerated in girls and young women for the prevention of cervical pre-cancers and cervical cancer related to HPV types 16 and 18, the two most common virus types that cause cervical cancer. The committee also discussed data demonstrating the efficacy of Cervarix against additional cancer-causing virus types.
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.