Advanced Magnetics plans to submit an NDA for its iron replacement therapy ferumoxytol for use in anemic chronic kidney disease patients, regardless of dialysis status, "during the first half of 2006," the firm says Jan. 13. Submission was previously projected by the end of 2005 (1Pharmaceutical Approvals Monthly May 1, 2004, In Brief). The company also announced initiation of a large-scale, multi-center Phase III safety study, which will be the last study in the iron therapy program. Ferumoxytol is also in "exploratory Phase II clinical studies for use as a contrast agent in magnetic resonance angiography"...

Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.

To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.