Pink Sheet is part of the Business Intelligence Division 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

'Clean Label' For Intercept's Ocaliva In PBC Bodes Well For NASH Claim

Executive Summary

By determining a safe dosing regimen for Child-Pugh B and C patients, FDA was able to provide a label almost completely without contraindications despite safety concerns about liver-related adverse reactions.

Advertisement

Related Content

Genfit May Be Gaining An Edge In NASH Race
Intercept's Ocaliva Seems Headed For Black Box On Liver Injury Risk
FDA Warning On Ocaliva Puts Intercept's NASH Opportunity In Jeopardy
Intercept's Revised NASH Trial Improves Prospects
Genfit Says Safety/Tolerability Will Give Elafibranor An Edge In NASH
Intercept Seeks Long-Term Data To Build Ocaliva Market In PBC
Galectin Hopes To Set Surrogate Endpoints For NASH Cirrhosis, Despite Trial Failure
Ocaliva In NASH Manageable With Indication-Based Pricing, ICER Roundtable Suggests

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS057684

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