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

UsernamePublicRestriction

Novartis Resubmits Onbrez To FDA; Touts Comparative Trial Against Spiriva

This article was originally published in The Pink Sheet Daily

Executive Summary

The once-daily COPD treatment, already approved in Europe with ho-hum sales, is a lynchpin of Novartis' plan to establish a respiratory franchise.

You may also be interested in...



Novartis Finally Wins Arcapta Approval, Having Lost Battle On Desired Dose

Bronchodilator is approved for COPD at a 75 mcg dose, compared to 150 mcg and 300 mcg in Europe. Label nods to quality-of-life data.

Novartis Finally Wins Arcapta Approval, Having Lost Battle On Desired Dose

Bronchodilator is approved for COPD at a 75 mcg dose, compared to 150 mcg and 300 mcg in Europe. Label nods to quality-of-life data.

COPD Drug Dose Selection May Face Greater Scrutiny In Arcapta’s Wake

FDA’s lingering concerns about the appropriate dose for Novartis’ chronic obstructive pulmonary disease therapy Arcapta Neohaler (indacaterol) suggest the agency will take a harder line on dosing data requirements for new COPD treatments, particularly when they have not first been approved in asthma.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS071514

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

Cancel