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

UsernamePublicRestriction
UsernamePublicRestriction

HHS Eyed Optimal Use Of Protease Inhibitors Even Before Victrelis Approval

Executive Summary

Even before FDA’s May 13 approval of Merck’s protease inhibitor Victrelis (boceprevir) for hepatitis C, federal health officials were eyeing the best way to maximize treatment with this new class of drugs.

You may also be interested in...



Protease Inhibitors Could Get Hepatitis C Market Boost From CDC Funding Request

A series of federal public health initiatives are aligning to expand the market for the first two protease inhibitors expected to win approval for hepatitis C treatment.

US FDA To Exercise ‘Maximum Regulatory Flexibility’ For COVID-19 Plasma-Derived Therapeutics

Agency is working with manufacturers, including Takeda and Emergent BioSolutions, to accelerate development of hyperimmune globulin products, with an eye toward starting clinical testing in several months; new FDA guidelines on convalescent plasma collection for single-patient emergency IND use are helpful in understanding agency expectations around source plasma collection for manufactured products as well, Emergent SVP Laura Saward says.

US Marks Biologics Transition Day

Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.

Topics

UsernamePublicRestriction

Register

PS053422

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