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.