Organon/Sanofi-Synthelabo Arixtra "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Fondaparinux is deemed "approvable" Aug. 15 for prevention of venous thromboembolic events after orthopedic surgery. Organon submitted the NDA Feb. 15 and received priority review. Arixtra, which will be co-marketed in the U.S. by Sanofi-Synthelabo, is in Phase III studies for treatment of venous thrombosis and pulmonary embolism and in Phase II trials for treatment of arterial thrombosis
You may also be interested in...
Cosmetics Europe Talks Microplastic: ECHA Frustrations, ‘Value Judgments’ And International Trade Uncertainty
The European Chemicals Agency's microplastic restriction proposal received committee backing in 2020 without changes sought by the cosmetics industry, which faces €15bn in projected costs and scarce alternatives at present. It may come down to EU Member States to decide whether the ECHA restriction proposal is proportionate in balancing environmental goals and socio-economic impacts.
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.