Pfizer's Vaccine for C. Difficile Receives FDA Fast Track Designation
Pfizer announced that its investigational vaccine candidate for the treatment of Clostridium difficile has been granted the Fast Track designation from FDA.
Pfizer Inc. announced on Aug. 28 that FDA has granted Fast Track designation to the company’s investigational Clostridium difficile (C. difficile) vaccine candidate. Currently in Phase II clinical development, the vaccine candidate is designed to prevent C. difficile-associated disease, which can include life-threatening diarrhea and pseudomembranous colitis.
The FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.
Source: Pfizer
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.
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.
Pfizer Obtains Exclusive Rights to 3SBio’s Bispecific Antibody Targeting PD-1 and VEGF
July 25th 2025The 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.
