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

FDA’s Go-To Statistician: UW’s Fleming Holds Court At Xifaxan Advisory Committee Meeting

This article was originally published in RPM Report

Executive Summary

University of Washington statistician Thomas Fleming seems to be showing up more often on FDA advisory committees and is having an outsized impact on the meetings.

You may also be interested in...



FDA's Brilliant Management of Avandia Re-Review Provides Flexibility on Final Decision

Going into the Avandia re-review, FDA looked stuck between a rock and a hard place. Coming out of the FDA advisory committee meeting, the agency has a full set of options to choose from that would likely be viewed as a credible outcome by the public. But possible surprises remain.

Hyloris Partner Signs To Market Maxigesic IV In Central And Eastern Europe

Hyloris’ partner AFT has signed an exclusive licensing and distribution agreement with Salus Pharmaceuticals covering nine central and eastern European countries. Meanwhile, Hyloris has also struck an in-licensing deal for a new blood phosphorus deficiency treatment. 

Idorsia’s Clazosentan Fails Yet Another Pivotal Brain Injury Trial As Cash Runway Dwindles

Funding pressures grow as the Swiss firm’s endothelin A receptor antagonist clazosentan once again misses the mark in a Phase III brain injury trial aimed at breaking into the Western market, despite prior success in similar Japanese trials.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS080919

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