Developers look for rules to govern name game

John Carroll — Mon, 09 Jun 2008 11:59:11 -0400

The RPM Report focuses on a new effort to revise and improve the way the FDA approves proposed proprietary drug names. The agency kicks back about 40 percent of the brand names suggested by sponsors, creating a great deal of frustration with the process. The industry wants more predictability and more insight into what it needs to do to get an approval. But a new pilot program aimed at improving the process is instead raising fears that the name-game will only grow more complex.

- read the story from RPM Report

Spin-off may signal new era for Big Pharma R&D

Thu, 14 Feb 2008 06:59:58 -0500

The Wall Street Journal notes the "dis-integration" of the traditional Big Pharma model following yesterday's announcement that AstraZeneca is spinning off its Swedish R&D facility for gastrointestinal therapies. The shop, which developed Nexium, is being spun off into Albireo Pharma, with AstraZeneca as a minority shareholder. David Chiswell, the former CEO of Cambridge Antibody Technology--bought by AstraZeneca and integrated with MedImmune--has been tapped to run the new company. Chiswell says that Albireo has several pre-clinical compounds in the hopper along with a clinical stage program he declined to name. With typical hyperbole, the Journal's health bloggers says the day may come when AstraZeneca may restrict itself to late-stage trials and drug marketing.

- see the release on Albrieo's creation
- check out the report from the Wall Street Journal

ALSO: Albireo will start off with an A round expected to top out at $40 million. Report

Related Articles:
AstraZeneca may shake up R&D with spin-off. Report
AstraZeneca drops the axe in global R&D shakeup. Report
AZ touts biologics pipeline. Report