In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Flying Through FDA: Test Runs For Pilot 1

Executive Summary

FDA's Pilot 1 rolling review process has led to accelerated approvals for cutting edge therapies. In addition to smaller biotechs, some of the largest pharmaceutical companies in the world are using it - and having success. FDA's top drug reviewer tells you how to maximize the value of the temporary program.

You may also be interested in...



Pilot 1 Fails to Fly

FDA is unlikely to make permanent its rolling review, fast-track Pilot 1 program. The agency says logistics are the key reason for the program's termination.

OSI Buys Eyetech, Market Rubs Eyes

Not the most obvious of biotech-biotech combinations. OSI thinks it can make money from Eyetech's lone product pegaptanib (Macugen), a breakthrough new treatment for age-related macular degeneration. The market has reacted poorly to the deal, worried that Macugen will be made obsolete by Genentech's Lucentis, due to be launched in late 2006.

Hurry Up and Wait: The Slowdown in Accelerated Approvals

Accelerated approvals are decelerating. Sponsors argue the FDA is so caught up in the current emphasis on safety that they're raising the AA efficacy standards. The FDA contends that the companies who have been rejected aren't meeting the efficacy standards or performing the promised follow-up trials. Is the FDA changing the rules-or are companies themselves bending them? A look at several recent cases of AA therapies reveals that both are true.

Related Content

Topics

Related Companies

Related Deals

UsernamePublicRestriction

Register

LL1128165

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