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


Grassley investigating EPO marketing

Executive Summary

Senator Charles Grassley, R-Iowa, continues oversight of erythropoiesis-stimulating agents with a request for information about Johnson & Johnson's marketing of Procrit. The May 30 letter follows a similar request for a briefing and documents related to Amgen's EPO products (1"The Pink Sheet" May 28, 2007, In Brief)...

You may also be interested in...

Amgen marketing documents sought by N.Y. Attorney General

New York State Attorney General's Office subpoenas "documents related to Amgen's promotional activities, sales and marketing activities, medical education, clinical studies, pricing and contracting, license and distribution agreements and corporate communications," company discloses in a May 22 SEC filing. It is unclear whether the documents are related to a specific product, although the likely suspects are erythropoiesis-stimulating agentsAranesp (darbepoetin alfa) and Epogen (epoetin alfa). The firm also recently has come under scrutiny from Sen. Charles Grassley, R-Iowa, who is looking into Amgen's marketing practices for its EPO products, and how well it is providing drug safety information to FDA...

QUOTED. 19 April 2021. Jeff Shuren & William Maisel

Two top officials in the US FDA’s device center are warning of delays in the agency’s review of submissions for new products that aren’t directly tied to the coronavirus pandemic.

Breakthrough Therapy Designations At US FDA Stay Sluggish In 2021

With 12 new BTDs announced so far this year, 2021 is on pace to match the COVID-19-depressed total number of designations in 2020. Here’s a breakdown of the candidates that have received the designation.




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