Diabetes Combination Studies Leave Market Challenges Unresolved
Novo Nordisk and Sanofi's trials were intended to satisfy FDA's combination product rule, but sponsors have not addressed some important clinical questions around use of the basal insulin/GLP-1 agonist products.
You may also be interested in...
US FDA approves Xultophy and Soliqua, both fixed-ratio combinations of a basal insulin and a GLP-1 agonist, on the same day even though Sanofi redeemed a priority review voucher that earned Soliqua an earlier user fee goal date.
FDA request for more information on pen injector forces three-month review extension, offsetting advantage from priority review voucher redemption.
COVID-19 Vaccines: ACIP’s Allocation Proposal Prioritizes Long-Term Care Residents, Essential Workers
First group to receive vaccine would comprise health care personnel and residents of long-term care facilities; next in line are non-health care essential workers, who would take priority over adults with high-risk medical conditions and those ages 65 years and older, according to the CDC advisory committee’s proposed allocation framework.