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

UsernamePublicRestriction

Intracranial Hemorrhage The Culprit In Merck's Vorapaxar Trial

This article was originally published in The Pink Sheet Daily

Executive Summary

Merck &Co. remains unsure about regulatory filing plans for the compound, while still waiting to see clinical trial data.

You may also be interested in...



Merck’s Zontivity Label Isn’t Weighed Down With Safety Language

FDA approves antiplatelet inhibitor with a label that makes little mention of the safety concerns seen in lightweight patients, despite a vibrant FDA and advisory panel discussion on how to present the unfavorable data, but the company still has a big marketing challenge ahead.

FDA Reviewers Say Vorapaxar Approvable, But Question Study Changes

As the platelet inhibitor heads to an advisory committee, agency reviewers raise issues about safety-based changes to its Phase III trials.

FDA Panel Will Have To Resolve Bleeding Risk With Merck’s Vorapaxar

Novel antiplatelet product has suffered from excess bleeding rates in clinical trials and is searching for an appropriate patient population, after initial hopes of being a blockbuster.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS071718

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