Genzyme's Pompe disease treatment Myozyme (alglucosidase alfa) has a revised user fee date of April 28 following FDA's 90-day extension. The extension is to provide time to review additional agency-requested information, Genzyme says. The company submitted the BLA July 28 (1Pharmaceutical Approvals Monthly August 2005, In Brief); the enzyme replacement therapy is receiving a priority review...

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.