Generics Bulletin 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

Hyloris Gets Head Start On Maxigesic IV In US

FDA Sets Earlier Than Expected PDUFA Date For Value-Added Intravenous Analgesic

Executive Summary

The US FDA has set a PDUFA date for Hyloris’ Maxigesic IV 505(b)(2) NDA that is earlier than expected, following two positive Phase III trials, spurring hopes that the product could also see earlier commercialization and registration than previously anticipated.

You may also be interested in...



Finance Watch: VC Mega-Rounds Surge Again, Led By Acelyrin’s $300m Series C

Private Company Edition: Acelyrin will use its latest funding for Phase III development of izokibep in inflammatory diseases. Also, ArsenalBio raised $220m to take its programmable cell therapies into the clinic and RayzeBio’s $160m series D round will fund clinical trials for its radiopharmaceuticals. 

FDA Asks Hyloris For More Data On Maxigesic IV

Hyloris has received a complete response letter from the US FDA asking for more information on its 505(b)(2) hybrid application for its Maxigesic IV intravenous analgesic for treating post-operative pain.

Hyloris Outlines Ambitious Growth Strategy During Full-Year Results

Hyloris expects to expand its portfolio to around 30 candidates by 2024, bolstered by €50m in cash and cash equivalents as of the end of 2021.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

GB151416

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