In Vivo 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


Pfizer's Exubera: Breathing New Life Into Inhaled Insulin

Executive Summary

Dragging a host of safety concerns, Exubera hardly inspired confidence when it went before an FDA advisory committee. But Pfizer proposed an aggressive risk management scheme that won it a dramatic "yes" vote. How one company addressed a drug's safety concerns head-on to win the confidence of FDA's advisors.

You may also be interested in...

Insulin Delivery: Still Waiting to Exhale

After the commercial failure of Exubera, is inhaled insulin dead? Not at all. Exubera failed for very specific reasons: a cumbersome device, non-standard dosing, and no real clinical utility. The Exubera snafu has eroded the commercial value of inhaled insulin, but Nektar may be the best-positioned company currently competing in the inhaled insulin space. Nektar can afford to re-partner its version for less, because Pfizer has already paid for the bulk of the drug development work.

Pyramid Schemes and Pipeline Dreams: Adapting to a Tiered Regulatory System for New Drugs

FDA's new drug safety authorities suggest that the focus of drug development and lifecycle management strategies need to change. It is no longer a question of what it takes to get approval from FDA, but rather what kind of approval you can get.

The Death of Arcoxia: Drug Regulation in a "Whistleblower" Climate

There may not be a worse time to push a new drug through FDA-especially a "me-too" product with a questionable benefit-risk profile. Until Congress releases its grasp on the approval process, FDA isn't taking any chances. Unfortunately for industry, a few drugs are getting caught in the crossfire. Merck seemed unprepared for the new climate with Arcoxia; will other sponsors learn the lesson?

Related Content


Related Companies

Related Deals

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