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


Sugammadex Clinical Trial Issues Still Causing Trouble For Merck

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

After FDA abruptly cancelled an advisory committee meeting on the anesthesia injection product in July to review trial site inspection results for a hypersensitivity study, it issues a “complete response” letter indicating site “operational” concerns.

You may also be interested in...

FDA Needs More Time To Review Sugammadex Inspection Report, Cancels Advisory Committee

Merck’s anesthesia reversal agent, which was deemed “not approvable” in 2008, faces another setback as FDA cancels its July 18 advisory committee meeting to allow more time to review clinical trial site inspection data.

Merck On Track To File Novel Sleep Aid Suvorexant In 2012

Merck announced its potential first-in-class dual orexin receptor antagonist suvorexant successfully completed a second Phase III trial, apparently without safety concerns that led Actelion/GlaxoSmithKline to drop their DORA almorexant a year ago on Phase III results.

Schering-Plough’s Bridion Makes Positive Impression On Advisory Panel

Advisory committee agrees sugammadex data on routine reversal of neuromuscular blockade is clinically relevant.


Related Companies




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