The Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) completed its meeting regarding the New Drug Applications (NDA) for Novo Nordisk’s insulin degludec (to be marketed under the name Tresiba) and insulin degludec/insulin aspart. Read more
A homerun for Novo Nordisk, but a strike-out for Jessica Apple. I spent the weekend in Copenhagen taking part in Novo Nordisk’s DAWN2 Global Results Meeting. Before I say anything else, I want to note that I was honored … Read more
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted positive opinions, recommending marketing authorizations, for Novo Nordisk’s new insulin Tresiba and insulin Ryzodeg for the treatment of diabetes mellitus in adults.
Tresiba , the intended brand name for insulin degludec, is a new generation of once-daily basal insulin. In “treat-to-target? studies supporting the new drug application, where Tresiba was compared to insulin glargine, Read more
According to the GAPP2™ (Global Attitudes of Patients and Physicians) survey, funded by Novo Nordisk and presented today at the Annual Meeting of the European Association for the Study of Diabetes (EASD), four out of five (80%) people with type 2 diabetes have experienced self-treated hypoglycemia… Read more
Data from two new studies shows patients with type 2 diabetes starting insulin therapy had a 43% lower rate of night-time hypoglycemia when using degludec, Novo Nordisk’s ultra-long-acting insulin, compared with those using insulin glargine (Lantus).
The Japanese Ministry of Health, Labour and Welfare has approved Novo Nordisk’s ultra-long acting insulin, insulin degludec, for treatment of diabetes.
Insulin degludec, marketed globally under the name Tresiba, is a new generation of once-daily basal insulin, which has been discovered and developed by Novo Nordisk. Read more
Semaglutide successfully completed phase 2 development in 2010. At that time, it was decided to compare semaglutide with a once-weekly formulation of liraglutide being studied in phase 1 trials before selecting a candidate for phase 3 development. Liraglutide is the … Read more
JDRF and Novo Nordisk have announced that they are partnering in an attempt to discover and develop novel immunotherapies to prevent, treat, and help cure type 1 diabetes. The collaboration between JDRF and Novo Nordisk will focus on research originating from … Read more
New data from observational studies in the UK shows that patients with type 2 diabetes experience greater reduction of HbA1c levels when using Victoza compared to Byetta (exenatide) and DPP-4 inhibitors. Victoza… Read more
The U.S. FDA has informed Novo Nordisk that a three-month extension period was required in order to complete its regulatory review of the new drug applications (NDA) for the ultra-long-acting insulins degludec and insulin degludec/insulin aspart… Read more