Pink Sheet 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


J&J/Medivir’s Simeprevir Review Makes For Back-To-Back Hep C Advisory Committees

This article was originally published in The Pink Sheet Daily

Executive Summary

Like Merck’s boceprevir and Vertex’s telaprevir in 2011, simeprevir and Gilead’s sofosbuvir both have been accepted as priority review candidates for hepatitis C therapy, and will be reviewed by FDA’s Antiviral Drugs Advisory Committee on consecutive days. A positive tone is anticipated at both panel meetings.

You may also be interested in...

Sweden’s Medivir Prepares For Simeprevir And Profitability

Swedish hepatitis specialist Medivir aims to start Nordic marketing of its oral therapy simeprevir in 2014 and start anew as a profitable biotech with expansion prospects.

Merck’s ‘COVID Pill’ Shows Promise, But Mortality Benefits Will Be Hard To Prove

Early results from its novel antiviral are encouraging, but demonstrating life-saving qualities in a short window of time will be tricky.

ROI For US With FDA's Emergency Use Approval Of Cue Health's OTC At-Home COVID-19 Test

After federal agencies invested almost $5600m to ensure Cue Health could scale up production, FDA announces the self-administered test will be available OTC. it's the agency's first emergency use authorization for an at-home molecular diagnostic test available nonprescription.


Related Companies




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