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


FDAer Eyes Improvements In Anticoagulant Trial Design

This article was originally published in Pharmaceutical Approvals Monthly

You may also be interested in...

Novel Anticoagulants Need Blood Level Monitoring Measures, FDA’s Temple Says

Although coagulation level monitoring would negate the newer drugs’ convenience advantage over warfarin, FDA reviews of Daiichi’s Savaysa suggest a tailored dosing approach is needed to optimize antithrombotic benefits against bleeding risks.

Edoxaban Review Spurs FDA Call For Changes In Anticoagulant Trials

Agency staff recommend separate assessment of ischemic and hemorrhagic strokes, and exposure-targeting of therapeutic blood levels; cardio-renal panel endorses Daiichi Sankyo’s Factor Xa inhibitor for atrial fibrillation, but concerns about reduced efficacy in normal renal function patients may result in a competitively disadvantaged label.

Regulatory Round-Up: Drug Review Profiles From 2012

Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile. If you do not have access, contact customer care at 1-800-332-2181 for a free copy of any of these articles.

Related Content


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