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.
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.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpha, Capricor, Immunesensor, Ocugen, Pfizer, UCB.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 23andme Holding, Ampersand, Alligator, Exscientia, Flagship, Mirador, Montai, Novartis, Orion, Pfizer, Recursion, Vyriad.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amacathera, Argenx, Melt, Newamsterdam, Novo Nordisk, Painreform, Pasithea, Quralis, Sage, Uvax, Virion.
An international consortium of thousands of scientists is creating the Human Cell Atlas, a three-dimensional map of all the cells in the body. The goal is to understand all the cells that make up human tissues, organs and systems, which will enable multiple medical applications. This collection of cell maps is openly available for navigation at single-cell resolution, identified through omics analyses that reveal the tridimensional distribution of each cell.
The BioWorld Drug Developers Index (BDDI) continued its downward spiral through the fall, going from a modest 1.11% decline at the end of August to a 6.2% dip in September and an 11.3% loss by October’s close.
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