Sanofi's Admelog, a Humalog Follow-On, Approved In US As 'Black Hole' For Insulins Looms
Short-acting insulin approved under 505(b)(2) pathway appears poised to receive three years of Hatch-Waxman exclusivity but would lose nine months of this protection under FDA's current interpretation of the 'transition provisions' for certain protein products that take effect in March 2020.
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Performance of Dupixent, which just picked up a new indication, was a third quarter highlight and bodes well for future growth, but sales of the blockbuster insulin glargine Lantus are crumbling.
Keeping Track: Mylan Wins First US FDA Approval For Neulasta Biosimilar, But Lands A CRL For Insulin Glargine; Genentech Nabs Broad Full Approval For Venclexta, PV Indication For Rituxan
The latest drug development news and highlights from our US FDA Performance Tracker.
HHS endorsement of company-sponsored discount programs for cash-paying customers with Medicare would be preferable to lowering list pricing.