Novo's Diabetes Combo May Find Home With General Practitioners
This article was originally published in The Pink Sheet Daily
Executive Summary
Despite FDA skepticism about fixed dosing, advisory committee says there are patients and providers who will benefit.
You may also be interested in...
Novo Nordisk, Sanofi Insulin Combo Products Clear US Regulatory Hurdles
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.
Sanofi Loses iGlarLixi Advantage Over Novo's iDegLira Amid Pen Problems
FDA request for more information on pen injector forces three-month review extension, offsetting advantage from priority review voucher redemption.
US FDA Oncology, Device Centers Developing Public Diagnostic Standards
Pilot program would get around the ‘one drug, one test’ policy, which has created intellectual property issues.