
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 […]