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

MannKind’s Long, Winding Development Road Ends In Approval Of Afrezza Inhaled Insulin

This article was originally published in The Pink Sheet Daily

Executive Summary

Firm now faces the commercial gauntlet of establishing an inhaled insulin in the crowded diabetes market.

You may also be interested in...



Afrezza Approval Comes With Post-Marketing Trial On Lung Cancer, CV Risk

FDA’s unusually specific request suggests continued worries about safety of MannKind’s inhalable insulin; large trial (8,000-10,000 type 2 diabetics) has a variety of goals.

Ghosts of Exubera Haunt Afrezza As Lung Function, Cancer Concerns Weigh Heavily

FDA advisory committee review of MannKind’s inhaled insulin revisits safety issues that troubled Pfizer’s first-of-its-kind product, including a potential lung cancer risk and declines in pulmonary function.

Does MannKind Finally Have What It Takes To Get Afrezza Inhaled Insulin Cleared By FDA?

Among other things, new FDA review will test whether the company has proven that data with an old device can be applied to the new inhaler the company plans to market. MannKind is not expecting an advisory committee meeting.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS077378

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