Search Results for Shire

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Industry Supports FDA Proposal to Create New Office of Patient Affairs By Zachary Brennan - Published 13 June 2017

Industry groups BIO and TransCelerate, as well as companies GlaxoSmithKline and Shire, have offered their support for the creation of a new office at the US Food and Drug Administration (FDA) focused on patient affairs.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Drugs, Project management, Regulatory intelligence, Regulatory strategy

Tags: BIO, GSK, TransCelerate, Shire, Office of Patient Affairs, FDA patient engagement

FTC: Shire ViroPharma Abused FDA Citizen Petition Process, Delaying Generics By Zachary Brennan - Published 07 February 2017

The US Federal Trade Commission (FTC) on Tuesday filed a complaint against Shire ViroPharma for blocking and delaying the marketing of generic versions of its antibiotic Vancocin (vancomycin), which was first approved by FDA in 1986.

Categories: News, US, FTC, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Vancocin, c. difficile, Eli Lilly, Shire, citizen petitions

Are the Days of FDA Approving 'Basically Everything' Falling by the Wayside? By Zachary Brennan - Published 21 October 2015

In the not-too-distant past (ie. August), the US Food and Drug Administration (FDA) was vilified by some and praised by others for the steep increase in the number of new molecular entities (NMEs) it was approving, though that supposed leniency may have begun to shift in just the past week.

Categories: News, US, FDA, Business Skills, Drugs, Government affairs, Project management, Quality, Regulatory intelligence, Regulatory strategy

Tags: FDA, approval, NME, Ostroff, Pfizer, AstraZeneca, Shire

Germany’s IQWiG Declines to Recommend Shire’s Elvanse for ADHD By Louise Zornoza, RegLink - Published 05 September 2013

Tags: IQWiG, Germany, Shire

Shire Pulls BLA Submission After FDA Demands More Clinical Trials By Alexander Gaffney - Published 16 March 2012

Tags: Withdrew, Agalsidase Alfa, Replagal, Fabry, Shire, FDA< BLA, Withdraw, application, Latest News, disease