Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Novo Nordisk Dismayed By “Complete Response” Letter For Insulin Degludec

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA is requesting data from a dedicated cardiovascular outcomes trial before approving the ultra-long-acting insulins Tresiba and Ryzodeg. News of the regulatory setback caused a 13% drop in the company’s stock price on Feb. 11.

You may also be interested in...

Novo Nordisk Plans Q1 Launch Of Long-Acting Insulin Tresiba

After initial rejection and resubmission, FDA approves ultra-long-acting insulin Tresiba, and also Ryzodeg, which combines Tresiba and the company’s meal-time insulin NovoLog.

Cost-Effectiveness Of Upcoming Diabetes And Asthma Drugs To Get ICER Reviews

ICER is likely to consider whether Novo Nordisk's Tresiba can be differentiated from other long-acting insulins and the potential size of the patient population for GlaxoSmithKline's asthma drug, Nucala.

Novo Will Seek Tresiba Anti-Hypoglycemia Claim In 2016, Firm Says

Firm is aiming to make Tresiba the first basal insulin to carry a claim for reduced risk of hypoglycemia.

Related Content


Related Companies

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts