The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-0, with one abstention, that the benefits of Pfizer Inc.-Biontech SE pediatric formulation of its two-dose COVID-19 vaccine outweigh its risks for children ages 5 through 11. Many of those votes came with caveats, as the VRBPAC members struggled with the unknowns of the vaccine and the fear that schools would mandate its use, even though it would still be considered experimental if the FDA grants it an emergency use authorization. Read More
When James Peyer, Cambrian Biopharma Inc.’s CEO, watched his grandfather fail every cancer treatment and eventually pass away, he came to a realization that now forms the backbone of his company. “The more I learned about cancer, the more convinced I became that we were approaching cancer as a disease in the wrong way,” Peyer told BioWorld. “We were waiting until people were sick and only then doing something about it.” Cambrian just closed on an oversubscribed series C that brought in $100 million to develop a pipeline of therapies designed to treat and prevent age-related diseases. Read More
Quanta Therapeutics Inc., a company developing therapies for RAS-driven cancers, closed $60 million in series C financing led by Surveyor Capital and Vida Ventures. The South San Francisco-based company said it would use proceeds from the financing to advance oncology-focused programs targeting RAF1 and KRAS through clinical candidate selection, IND filing and on to initial proof of concept. Read More
Mozart Therapeutics Inc. CEO Katie Fanning said the firm’s $55 million series A financing will allow the filing of an IND, probably in early 2024, for a prospect in celiac disease. Founded in July 2020, Seattle-based Mozart is based on research into the CD8 T-cell regulatory network, which has been found to play an important role in surveillance, recognition and elimination of inappropriately activated autoreactive and pathogenic immune cells. Read More
China’s Center for Drug Evaluation (CDE) released a draft guide on clinical trials of drugs for rare disease as part of an ongoing push to encourage new drug development and nudge developers to focus on biomarkers, pharmacometrics and patient-reported outcomes. Both are needed to continue moving China’s R&D capabilities up the value chain and closer to being on par with the capabilities of other countries that are at the forefront of new drug development. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Arrowhead, Avenue, Bausch, Cardiol, Clearside, Eyenovia, Merck & Co., PTC, Recce, Ridgeback. Read More
