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

GSK’s Breo Ellipta Gets “Snowquestered” As FDA Delays Advisory Cmte

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA missed its deadline to post the advisory committee briefing materials then postponed the meeting as a winter storm headed towards Washington.

You may also be interested in...



GSK R&D President Patrick Vallance On Increasing R&D Productivity: An Interview With PharmAsia News (Part 2 of 2)

An R&D model aimed at bringing the pressure and promise of startups to life within GlaxoSmithKline PLC continues to be tweaked, according to Patrick Vallance, president of pharmaceuticals R&D. He sat down with PharmAsia News during a recent visit to Singapore to give an overview of the company’s strategy.

New COPD Candidates Could Get Hung Up On Safety Concerns

FDA is facing several novel candidates for chronic obstructive pulmonary disease in 2013; those products should expect close scrutiny due to past issues with class safety and new signals in clinical trials.

Hurricane Sandy Rains On User Fee Dates, Advisory Committees

FDA will extend user fee goal dates as needed to account for the loss of two days in review cycles resulting from the government office shutdown. The extreme weather conditions led to cancellation of three advisory committees during the week of Oct. 29.

Topics

Related Companies

UsernamePublicRestriction

Register

PS075479

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