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

FDA Puts Several Drugs On Its “Nice” List; EMA Decides One Is “Naughty”

Executive Summary

NPS Pharmaceuticals, GSK, Roche and Cangene receive early holiday gifts as FDA goes on an approval spree. But EMA bears more bad news for Merck’s Tredaptive.

You may also be interested in...



FDA Advisory Cmte. Loosens Statistical Significance Standard, Waves GSK’s Anthrax Drug Through

An additional animal study that Human Genome Sciences did after receiving a “complete response” letter from FDA showed clinical benefit for raxibacumab, but with a p-value higher than the standard maximum value of 0.05.

Gattex Review Shows FDA Approach On MedGuides Outside REMS

FDA said a Medication Guide need not be encompassed within NPS Pharma’s proposed Risk Evaluation and Mitigation Strategy for teduglutide due to the extensive interactions between short bowel syndrome patients and their health care providers and the inclusion of other patient-directed materials.

European Pharmacovigilance Update Still Causing Concern

The European pharma industry understands the need to tighten EU pharmacovigilance rules, but increased powers for a new advisory and assessment body could signal trouble ahead.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS054994

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