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

Roche's Pegasys Gains Hepatitis B Indication

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA clears peginterferon alfa-2a for treatment of HBeAg-positive and negative chronic hepatitis B patients; approval is based on two Phase III head-to-head trials with GlaxoSmithKline's Epivir-HBV. Roche is highlighting Pegasys' limited duration of treatment relative to other hepatitis B therapies.

You may also be interested in...



Novartis/Idenix Request Priority Review For Once-Daily Chronic Hepatitis B Treatment

Telbivudine demonstrates significantly greater viral suppression compared to lamivudine in one-year data.

Novartis/Idenix Request Priority Review For Once-Daily Chronic Hepatitis B Treatment

Telbivudine demonstrates significantly greater viral suppression compared to lamivudine in one-year data.

Roche Pegasys sBLA Filing For Hepatitis B Could Receive Priority Review

Roche announced simultaneous U.S. and European submissions July 21; six-month review would set user fee date at mid-January. Roche is likely to highlight superiority to GlaxoSmithKline’s Epivir-HBV and efficacy in HBeAg-negative patients in promotions.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS062215

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