Acquisition - July 3, 2015
Novo to End Tresiba in Germany
Novo Nordisk will stop distribution of its once-daily insulin drug Tresiba after price negotiations with Germany’s health insurance fund trade group broke down, according to BioSpace.com. Company officials indicated they could not come to an agreement on price with GKV-Spitzenverband, which wanted to set the price level equal to that of human insulin. The company […]
Drug Development Pharma - April 9, 2015
FDA Accepts Novo Resubmission
The US Food and Drug Administration (FDA) has accepted for review Novo Nordisk’s Class II Resubmissions for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart). To preserve the integrity of the ongoing DEVOTE trial, only a small team within Novo Nordisk has access to the data, according to the company. This team has prepared the interim analysis […]
Clinical Trials - March 27, 2015
Novo to Resubmit Drugs to FDA
Novo Nordisk has decided to resubmit the prespecified interim analysis of DEVOTE as part of a Class II Resubmission of the New Drug Applications (NDAs) of Tresiba® and Ryzodeg® to the US Food and Drug Administration (FDA). The resubmission is expected to take place within the next month, according to the company. The cardiovascular outcomes trial for […]
Clinical Trials - December 22, 2014
Diabetes Drug Use Expanding
Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for expanded use of Tresiba®(insulin degludec) in children and adolescents aged 1-17 years with diabetes. Once the European Commission approves the label expansion, physicians in the European Union will be able to prescribe Tresiba® to children with type […]
