The US Food and Drug Administration’s complete response letter for Novo Nordisk A/S’s once-weekly insulin icodec for patients with type 1 and type 2 diabetes leaves open a window for Eli Lilly and Company’s competing once-weekly insulin, efsitora alfa, to make it to market first.
Novo Nordisk’s Weekly Insulin Trips Just Before Finish Line
The drug maker said the US FDA issued a complete response letter for insulin icodec that included requests related to manufacturing process and the type 1 diabetes indication.
More from New Products
• By
The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
• By
The German group is paying $3.9bn to get hold of the US firm and its two approved products.
• By
Akeso’s penpulimab will be the second to hit the US market for nasopharyngeal carcinoma, but the first to win FDA approval for the indication based on clinical findings in US patients.
More from Scrip
• By
While CAR-NKs have pivoted towards autoimmune disease, the Norwegian biotech believes its unique platform can deliver in oncology
• By
The triple therapy improves lung function in the Phase III KALOS and LOGOS studies
• By
As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.