Pink Sheet 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


Quality By Design Pilot Found Unprecedented Manufacturing Quirk For Effient

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Lilly's participation in an FDA manufacturing pilot program designed to maximize efficiency and agility appears to have uncovered an unusual issue that further complicated the lengthy and overdue review of the Effient (prasugrel) NDA - but, serendipitously, may have laid the groundwork for another fortuitous comparison for Effient in its commercial battle with Plavix

You may also be interested in...

FDA Updates Plavix Label, Leaves Effient With Clear Advantage

FDA expands upon the warning that it discreetly slipped into the anti-clotting drug's labeling in May, with new data that clopidogrel is 50% less effective when given with Prilosec.

"Silent" MIs Outweigh "Scary" Bleeds, FDA Concludes In Effient Review

FDA's approval of Lilly/Daiichi Sankyo's antiplatelet agent Effient (prasugrel) reflects the review team’s willingness to look past the increased risk of bleeding – a dramatic and viscerally alarming adverse event, though understandable due to the medical setting – to see the less immediately apparent benefit of a reduction in a type of cardiac event that includes so-called "silent MIs" that have no visible clinical presentation.

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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