U.S. FDA Clears Japan’s Astellas To Resume Death-Halted Anemia Trial
This article was originally published in PharmAsia News
U.S. FDA says Japan's Astellas Pharma and its biotech partner FibroGen may resume Phase II trials halted when a participant died. The trials of the YM 311 drug for treating anemia in pre-dialysis patients with chronic kidney disease were stopped last May. Astellas has considered the drug one of its three priority drugs in development. The trial participant who died was aged 76 and found to be taking 10 other medicines. (Click here for more
You may also be interested in...
From enforced detention to hefty fines, China's newly passed Biosecurity Law will fundamentally change how the life science sector handles human genetic resources over years to come, legal experts say.
Comments ahead of the vaccine advisory committee ranged from public health groups opposed to emergency use authorizations, to industry requests for guidance on EUA labeling materials.
"One of the issues that COVID-19 has brought out is, how safe is the production of animal-based food products?"