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

GSK/Corixa Bexxar user fee extended

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA extends the review period for GlaxoSmithKline/Corixa's Bexxar by three months, to Aug. 1, to review additional safety data. Corixa submitted safety data in early April from an additional 375 non-Hodgkin's lymphoma patients. The data was requested by FDA after the Dec. 17 Oncologic Drugs Advisory Committee review of the tositumomab BLA. "The overall safety profile of Bexxar was not altered by the inclusion of this additional data," Corixa maintains. "A majority of the steps required for approval already have been completed," the firm notes, including satisfactory pre-approval manufacturing inspections, "agreement on several elements of post approval studies," submission of secondary draft labeling, and "completion and submission of information and procedures for drug ordering, dose preparation, dosimetry methods and dose administration." The companies remain in discussion with FDA regarding labeling and postmarketing commitment

You may also be interested in...



The ICER Process: Allergan Engagement Improves Cost Effectiveness Rating For Ubrelvy

ICER president Steve Pearson is ‘cautiously optimistic’ that net pricing for acute migraine treatments will align with benefits once discounts are factored in.

US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected

Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).

Gene Therapy Approvals By US FDA Could Double In 2020

CBER is starting the year with four novel gene and cell therapy applications under review and rolling submissions underway for more.

Topics

UsernamePublicRestriction

Register

PS002244

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