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

Northera Survives Questions About Benefit Of Dizziness Endpoint At Advisory Panel

This article was originally published in The Pink Sheet Daily

Executive Summary

The Cardiovascular and Renal Drugs Advisory Committee Jan. 14 supported approval of the drug for symptomatic neurogenic orthostatic hypotension on a vote of 16-1.

You may also be interested in...



Chelsea’s Northera Plan: Expand Ongoing Study While Assuring Integrity Of Older Data

Chelsea said it will address FDA’s “complete response” letter by modifying and enlarging an ongoing droxidopa clinical trial and submitting all patient source documentation from an ex-U.S. study site in the completed pivotal trial that the agency has called into question.

Northera Review Shows Regulatory Challenges In Difficult Therapeutic Space

Chelsea Therapeutics’ development program for droxidopa in neurogenic orthostatic hypotension led to discussion at a recent advisory committee meeting about the role of Special Protocol Assessments and appropriate validation of patient-reported outcome instruments.

Rx Misbranding Penalties Should Be Stronger To Stop Counterfeiting, FDA Says

Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS076375

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