Scrip 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.

Menu

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
My View
Tags:

Merck seeks FDA nod for hep C combo grazoprevir/elbasvir

This article was originally published in Scrip

Executive Summary

After some back-and-forth with the FDA over the status of the breakthrough therapy designation of Merck's experimental hepatitis C virus (HCV) combination drug grazoprevir/elbasvir (100mg/50mg) – which was eventually tweaked – the company is now seeking approval of the product in the US, announcing after the markets closed on 28 May it had submitted a new drug application (NDA).

Table

View full table

Related Companies

Tags:
Latest Headlines

‘It’s Not About Me’ – AstraZeneca’s Soriot Says His Pay Rise Will Help European Pharma

Executives On The Move: Three New CEOs Among This Week's Changes

Sanofi To Pursue Smart M&A Pacts And Stick With Early-Stage Oncology R&D

Xaira Launches With $1bn-Plus And End-To-End AI Strategy

See All
UsernamePublicRestriction

Register

SC028867

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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

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