Gilead to Acquire Myogen
Gilead Sciences, of Foster City, CA (www.gilad.com), has agreed to acquire Myogen for about $2.5 billion, a move aimed at gaining ownership of Ambrisentan, a treatment for pulmonary arterial hypertension that is in late-stage clinical trials.
Gilead Sciences, of Foster City, CA (www.gilad.com), has agreed to acquire Myogen for about $2.5 billion, a move aimed at gaining ownership of Ambrisentan, a treatment for pulmonary arterial hypertension that is in late-stage clinical trials. The drug is Myogen’s lead product candidate. Myogen expects to file a new-drug application for Ambrisentan with the FDA as early as the fourth quarter. British drug maker GlaxoSmithKline holds rights to the product outside of the US.
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.
