EPO orphan meeting
FDA Blood and Blood Products Advisory Committee meeting scheduled for June 29 has been put on hold, according to FDA. The committee is to consider whether Amgen's Epogen and Chugai-Upjohn's Marogen are different products for the purpose of determining the extent of Epogen orphan exclusivity.
You may also be interested in...
While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.