Zai Lab and Pfizer Inc. are teaming up in China to fight the deadly carbapenem-resistant Acinetobacter baumannii (CRAB) infection with novel antibacterial drug Xacduro (sulbactam-durlobactam). Through the collaboration, Zai Lab will leverage Pfizer’s commercial infrastructure in the anti-infective space to widen access to Xacduro in mainland China. Terms of the deal were not released. Read More
The Ministry of Food and Drug Safety (MFDS) approved South Korea’s first denosumab (Prolia/Xgeva) biosimilars, developed by Celltrion Inc. under the brand names of Stoboclo/Osenvelt (CT-P41) for respective indications, a move the company hopes will help secure first-mover advantage for the drugs, currently under review in the U.S. and Europe. Read More
Former U.S. FDA Commissioner Margaret Hamburg has added her voice to concerns that the incoming Trump administration’s pledge to slim down federal agencies will damage public health. “These are certainly challenging times,” Hamburg told delegates at the World Science Forum, Budapest, Hungary, meeting to discuss issues dominating the interface between science and policy. Read More
The U.S. FDA approved 15 drugs in October, marking a decline from 24 in September and 22 in August. Despite the drop, the 2024 monthly average stands at about 19 approvals, exceeding last year’s average of 16, 2022’s 12.5, and the 17-per-month averages recorded in both 2021 and 2020. Read More
Many studies have linked the presence of specific bacteria to various diseases. But a general overgrowth of gut bacteria can be a symptom of different conditions, including colorectal cancer and inflammatory bowel disease. Read More
It’s difficult to fathom that the health of half the world’s population is underserved. But it’s a hard truth. Women’s health has traditionally focused on what Seema Kumar, the CEO of Cure, coined as the “bikini zone.” However, reproduction and breast health are a drop in the bucket when it comes to women’s health. In this multipart, in-depth series, BioWorld provides insight into the oft-overlooked space of women’s health, exposing the disparities in research and funding while looking toward future opportunities for bridging the gender gap in health care. Read More
Karen Carey, BioWorld’s managing editor and chief analyst, and Anette Breindl, managing editor of Bioworld Science, join this episode of the BioWorld Insider podcast to talk about the business and the science of women’s health. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alloy, Ayrmid, Biolinerx, Gamida, Pep2tango, Primefour, Takeda, Transposon. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Inxmed, Jazz, Nurix. Read More
