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

Rare Liver Disease Drug Contenders Among Latest EU Filings

MAA For Bayer’s Finerenone Also Filed

Executive Summary

Among the 13 new drug marketing applications that the European Medicines Agency has most recently accepted for review are two products that could become the first approved treatments for children with progressive familial intrahepatic cholestasis, a life-threatening disorder.

You may also be interested in...



Orphan Drugs Dominate EU Fast-Track Request Decisions In July

The European Medicines Agency decided this month whether to grant fast-track review for planned marketing authorization applications for three potential new orphan treatments.

EU Decision Time For Albireo’s Rare Liver Disease Drug

Odevixibat, which could become the first drug approved for treating progressive familial intrahepatic cholestasis in children, is up for an opinion from the European Medicines Agency.

Plenty Of Action On EU Accelerated Assessment Front

A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS143490

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