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

Chelsea Vows To Resolve Latest Regulatory Woes With Northera Quickly

This article was originally published in The Pink Sheet Daily

Executive Summary

Technical deficiencies foil the resubmission of Chelsea Therapeutics’ Northera. The company thinks it can resolve the problems quickly and some analysts expect a relatively short delay of one or two months to the user fee date.

You may also be interested in...



Genzyme Lemtrada’s Momentum Halts With FDA “Refuse-To File” Letter

The company says a data formatting issue was the reason FDA declined to accept the supplemental application for alemtuzumab for relapsing multiple sclerosis.

Northera Ongoing Trial May Satisfy FDA Request For More Efficacy Data, Chelsea Says

In a “complete response” letter to Chelsea for use of droxidopa in treating neurogenic orthostatic hypotension, FDA requests data from an additional trial showing efficacy and durability of effect. Chelsea believes ongoing Study 306, which has had its own efficacy challenges, could fill the bill and enable an NDA resubmission as early as the first quarter of 2013.

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143249

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