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

UsernamePublicRestriction
UsernamePublicRestriction

Bayer/J&J Will Resubmit Xarelto For Acute Indication In Second Half, Along With New Application For Chronic Use

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bayer/J&J plan to file the first chronic indication for their anticoagulant Xarelto, as well as respond to FDA on the "complete response" letter for their application for acute use in hip and knee replacement surgery, in the second half of 2010, Bayer CEO Werner Wenning announced Feb. 26 during the firm's 2009 year-end report

You may also be interested in...



Bristol/Pfizer Offer Some Good Apixaban Results, With Key Study Against Warfarin On Track To Report 2H 2011

The experimental anticoagulant's win over aspirin in patients intolerant to or unsuitable for warfarin therapy may allow a narrower indication.

Bristol/Pfizer Offer Some Good Apixaban Results, With Key Study Against Warfarin On Track To Report 2H 2011

Bristol-Myers Squibb/Pfizer got incremental good news and a nice addition to the safety database for their experimental anticoagulant apixaban when a Phase III study was ended early for efficacy at preventing stroke compared to aspirin. The next big read-out for the oral Factor Xa inhibitor, though, will be in the first half of 2011, when results of a major head-to-head contest against warfarin in that setting are due

Bristol/Pfizer Offer Some Good Apixaban Results, With Key Study Against Warfarin On Track To Report 2H 2011

Bristol-Myers Squibb/Pfizer got incremental good news and a nice addition to the safety database for their experimental anticoagulant apixaban when a Phase III study was ended early for efficacy at preventing stroke compared to aspirin. The next big read-out for the oral Factor Xa inhibitor, though, will be in the first half of 2011, when results of a major head-to-head contest against warfarin in that setting are due

Related Content

Topics

UsernamePublicRestriction

Register

LL1134044

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

Cancel