Rebetron adds pediatric data
Schering adds Rebetol pediatric use information to Rebetron (Rebetol/Intron A combination) labeling. FDA's June 8 approval letter notes there was an "oversight" in Rebetol labeling, which failed to reflect that patients under age five received only oral solution, not capsules, in pediatric trials. New labeling states oral solution is approved for ages three and older, capsules for ages five and older...
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.