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


Industry Should Develop Narrower Indications First To Secure Market Access, AstraZeneca Exec Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Demonstrating superiority to standard of care or placebo in narrower indications will win over regulators, AstraZeneca Exec-VP John Patterson says at R&D conference in Geneva, Switzerland. Millennium followed a similar strategy to develop Velcade.

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.

Natrecor Use Should Be Limited, Independent Panel Convened By J&J Says

The cardiologist panel calls for use of the congestive heart failure therapy to be "strictly limited" to patients that present with symptoms in the hospital setting. The expert panel also recommends that Scios "immediately undertake" a professional educational campaign about Natrecor's appropriate uses.

CMS Has “Very Robust” Number Of Medicare Part D Bids, McClellan Says

Following the June 6 bid submission deadline, CMS expects to have multiple drug plans in every region. Administrator McClellan declines to provide exact number of Part D bids.





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