Seven of the world's biggest drug makers are banding together to create a research consortium that will develop genetic tests that can identify patients vulnerable to dangerous adverse events. Under prodding from the FDA, Pfizer, Roche and others will back a research program that will develop tests for serious liver toxicity [1] as well as Stevens-Johnson syndrome. Their work will go into the public domain, available to anyone wishing to develop a genetic test on that data. The development of pharmacogenetics is considered crucial to a new generation of biotech drugs, which are intended to produce higher efficacy rates among smaller groups of patients.
- check out this release [2]Â for details on the program
- read the article [3] from The New York Times
Related Articles:
House overhauls, passes PDUFA. Report [4]
Bickering may stall trial database. Report [5]
PDUFA debate highlights drug safety issues. Report [6]
Senate toughens drug safety supervision in PDUFA bill. Report [7]
Links:
[1] http://www.fiercebioresearcher.com/story/breakthrough-mice-produce-human-liver-cells/2007-08-14
[2] http://www.fiercebiotech.com/press-releases/press-release-fda-leading-pharma-companies-launch-global-collaboration-research-genet
[3] http://www.nytimes.com/2007/09/27/health/research/27effect.html?ref=health
[4] http://www.fiercepharma.com/story/house-overhauls-passes-pdufa/2007-09-20
[5] http://www.fiercepharma.com/story/bickering-may-stall-trial-database/2007-09-17?utm_medium=nl&utm_source=internal
[6] http://www.fiercebiotech.com/story/pdufa-debate-highlights-drug-safety-issues/2007-07-05?utm_source=related&utm_medium=internal
[7] http://www.fiercebiotech.com/story/senate-toughens-drug-safety-supervision-in-pdufa-bill/2007-05-10