FDA NEWS DIGEST -- December 17, 2001

Lilly expands into genetic medicines with Verve's in vivo gene-editing therapies, aiming to replace chronic cardiovascular treatments with single-dose care.

Imagine 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.

With more than 100 next-generation biologics set to lose patent exclusivity in the next 15 years, there is widespread agreement that developing biosimilars for these therapies will benefit society as a whole.

In 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.

First-in-class therapy targets iron deficiency and phosphate imbalance in CKD, offering earlier intervention and simplified treatment for European patients.

The collaboration will focus on identifying pre-clinical candidates for high-priority targets, including a small molecule oral therapy for immunological diseases.