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.

Menu

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
Menu
My View
  • Edit
  • Add your favourite topics for quick access
Meet the Team
Ask the Analyst
Partnered Content
PDF Library
RSS Feeds
Subscribe
FAQs
Advertising
Report Store
UsernamePublicRestriction
Tags:
BioPharmaceutical Ireland United States

Quick Resubmission Has Shire Seeking Third Quarter Lifitegrast OK

This article was originally published in The Pink Sheet Daily

  • News

Executive Summary

Having produced positive top-line data from a third Phase III trial within two weeks of FDA's complete response letter, Shire made quick work of its reply to the agency on the dry eye disease candidate.

You may also be interested in...



Shire's Xiidra Gets Advantageous Label Covering Signs, Symptoms Of Dry Eye Disease

By examining the "totality of the data" including a Phase II study, FDA approved drug for both measures of dry eye, despite mixed results in pivotal trials.

Keeping Track: FDA Nixes Medicure’s Aggrastat For STEMI, Approves Insys’ Syndros

The latest drug development news and highlights from our FDA Performance Tracker

New Shire CEO Has Big Ophthalmology Plans; SARcode Sets The Stage

With its third acquisition this year, Shire gains Phase III Lifitegrast in development for dry eye disease. It expects to launch the product in the U.S. in 2016.

Table

View full table

Topics

Related Companies

Tags:
BioPharmaceutical Ireland United States
UsernamePublicRestriction

Register

SC081785

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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

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