Pink Sheet 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

Velcade "Impressive" Efficacy Offsets Concern Over Response As Endpoint

This article was originally published in The Pink Sheet Daily

Executive Summary

Millennium’s multiple myeloma agent response rate is "better than expected," NDA review documents indicate. FDA reverses its initial request for Phase III study results to support accelerated approval after final data from Phase II are submitted.

You may also be interested in...



Millennium Velcade Supplement Seeks Full Approval, Second-Line Use

The company hopes to convert Velcade's accelerated approval for third-line use to full approval and add a second-line multiple myeloma indication based on the Phase III APEX trial, which showed a significant survival benefit.

Madrigal’s FDA Approval In MASH Ends Years Of Industry Frustration

As the first approved MASH (formerly NASH) therapy, nearly four years after initially anticipated, Madrigal gets the opportunity to establish a MASH marketplace with Rezdiffra (resmetirom).

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS058787

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