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

Spectrum’s Zevalin Still Living In Rituxan’s Shadow, FDA Advertising Letter Shows

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA citations of Rituxan comparisons in a promotion for Zevalin throw added salt on old wounds for drug that has taken backseat to Rituxan’s blockbuster story.

You may also be interested in...



Promotions For Black-Box Drugs Aren’t Specific Enforcement Targets, FDA Says

FDA advertising enforcement does not preference black-box drugs despite risk-based approach prioritizing products with significant risks; nor are drugs with small patient populations exempt from risk-based approach.

Cancer Drug Zevalin May Finally Thrive Under Spectrum

The small oncology company may be able to succeed with the non-Hodgkin lymphoma drug where others have failed.

Sliding Scale: Bar For COVID Therapeutics EUAs ‘Can Be Somewhat Variable’ – FDA’s Peter Marks

Marks appeared to use the variable EUA bar to justify what many viewed as early mistakes by FDA during COVID-19, and to emphasize the importance of physician awareness of the strength of evidence used to authorize a drug.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS076188

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