Biologics Are Ray Of Light In Dim Outlook For FDA’s 2008 Approval Totals
This article was originally published in The Pink Sheet Daily
Executive Summary
At the half-year mark, FDA had approved eight novel BLAs – more than in all of 2007.
You may also be interested in...
ZymoGenetics Experiences a Biotech Disconnect
It's logical to think that synthetic thrombin is safer than bovine- or plasma-derived equivalents. But ZymoGenetics is finding out it's not an easy sell, especially to Wall Street.
Turning Back the Clock: Drug Approvals Hit 25 Year Low
You have to go back to 1983 to find a year as bad as 2007 for R&D output. It was a terrible year by any measure. The key question for industry: does it need to learn to subsist on a trickle of new drugs coming to market each year, or is the current drought in fact a sign of a transition to a new, more innovative R&D model? The sparse class of 2007 does offer some glimmers of hope.
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.