Scrip is part 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

GSK Seeks MHLW Approval For Hepsera As Single Agent Therapy

This article was originally published in PharmAsia News

Executive Summary

GlaxoSmithKline has filed for approval of Hepsera (adefovir pivoxil) as a single agent treatment with Japan's Ministry of Health, Labor and Welfare. Hepsera is currently approved in Japan in combination with Zefix to treat lamivudine-resistant chronic hepatitis B and cirrhosis hepatitis B. However, outside of Japan, Hepsera is also approved as a single agent to treat the diseases. American Association for the Study of Liver Diseases guidelines lists Hepsera as the top option for treating hepatitis B and cirrhosis hepatitis B. (Click here for more - Japanese language

You may also be interested in...



QUOTED. 26 February 2020. Mark Leahey.

In an exclusive interview with Medtech Insight, Mark Leahey, president of the Medical Device Manufacturers Association (MDMA), said the previous four Medical Device User Fee negotiations with the US FDA have set a strong foundation for the industry and the next round of negotiations should focus on tweaking past deals that are already in place. See what MDMA's president, Mark Leahey, said about it here.

The Quality Lowdown: On Redeploying Inspectors, API Suppliers Thanks To Coronavirus

US investigators fan out to non-China inspection priorities and Secretary Azar talks supply management; warning letters hit record keeping, investigations and basic GMP compliance.

Mallinckrodt's Opioid Resolution Through Generic Unit Bankruptcy May Be 'Test Case'

Mallinckrodt to pay $1.6bn and place its generics unit in bankruptcy under agreement in principle for US global settlement; six states are not on board, including New York, whose suit is still set to go to trial March 20.

UsernamePublicRestriction

Register

SC067889

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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