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


Novartis’ TOBI Podhaler: Can Patient Satisfaction Overcome FDA’s Clinical Concerns?

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA seems to find the data from the pivotal trials of the inhalation powder drug-device combination for the management of cystic fibrosis patients with Pseudomonas aeruginosa something less than persuasive.

You may also be interested in...

Novartis’ Tobramycin Inhalation Powder May Face Questions Over Study Endpoint

Novartis’ inhalation powder version of the antibiotic tobramycin appears to be much more convenient in treating Pseudomonas aeruginosa infections in cystic fibrosis patients than the currently marketed nebulized solution (Tobi), but the appropriateness of the FEV1 endpoint is likely to be a matter of dispute during advisory committee review.

Janssen’s Sirturo Needs Minor Tweaks To Confirmatory Trial, FDA Panel Says

Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.

Ranbaxy’s Atorvastatin Recall: Will Glass Shards Nick FDA’s Reputation?

Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.


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