Acambis Gets Positive Recommendations for Smallpox Vaccine
Acambis plc (Cambridge, UK, www.acambis.com) has announced that the Vaccines and Related Biological Products Advisory Committee of the US Food and Drug Administration has voted unanimously that Acambis' ACAM2000 is both safe and efficacious.
Acambis plc (Cambridge, UK, www.acambis.com) has announced that the Vaccines and Related Biological Products Advisory Committee of the US Food and Drug Administration has voted unanimously that Acambis’ ACAM2000 is both safe and efficacious. The Advisory Committee was asked to review whether the clinical data demonstrated that ACAM2000 was safe and effective for use in persons at high risk of exposure to smallpox virus. It voted 11–0 in favor on both the safety and efficacy of ACAM2000. The FDA has identified August 31, 2007, as the target date for its response to Acambis’ ACAM2000 license application under the Prescription Drug User Fee Act.
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.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
