FDA NEWS DIGEST -- JANUARY 7, 2002

Imfinzi’s application is supported by Phase III trial data showing improved pathologic complete response in early-stage gastric cancer.

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.

The licensing agreement between the two companies gives Pfizer the rights to develop, manufacture, and commercialize 3SBio’s bispecific antibody, SSGJ-707, which is in clinical trials for the treatment of a variety of cancers.

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.

Mirvetuximab soravtansine, brand name Elahere, is the first licensed treatment for women with platinum-resistant ovarian cancer in the UK in more than 10 years.

Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on supply security, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.