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October 7, 2008
Database Finds 150K Patients
In Silico Studies By i3 Innovus
The health outcomes division of the i3 brand discusses trials that are professionally designed and run on the computer.
IND Ethics Loophole
Circare: Academic Patient Advocate
University of Maryland physicist Adil Shamoo, founder of CIRCARE, says there are gaps in existing law that leave patients exposed.
Shark Repellent
Empirica From Phase Forward
A new name for the safety products from Phase Forward, plus insights into faster responses to safety crises.
A-List Of Speakers At Harvard
Post-Approval? Or Pre-Apocalypse?
With Mark McClellan and Janet Woodcock on the agenda, the Outcome meeting will be another illuminating event this year.
Strategies from Wyeth, Actelion & Pfizer
CTC 2008: Proactive Risk Abatement
A report from the Clinical Trials Congress about risk. One message: start a regulatory conversation early. And consult your preclinical team.
Johnson & Johnson has informed the FDA that its Evra birth control patch may double the risk of blood clots. The patch contains a higher dose of estrogen than is found in the pill form of the same product. The FDA had expressed its concerns about the patch last year,… more...
Phase Forward announced that the Medicines and Healthcare products Regulatory Agency (MHRA), the U.K.’s regulatory agency, has implemented the company’s Lincoln Technologies pharmacovigilance signal detection and signal management software, WebVDME. The software will be used by MHRA clinicians, pharmacists and scientists to examine reports of suspected drug side effects from… more...
Biotech Halts Trial
February 17, 2006
A large, late scale clinical trial of Avastin in colon cancer has been stopped by Genentech and Roche. Two thousand patients had already been recruited, with another 1,500 sought. While they evaluate the data, the sponsors have temporarily suspended patient enrollment after several unexpected deaths were reported during one of… more...
The Archives of Internal Medicine is reporting that doctors ignore “black box” warnings. The warnings are an increasingly common way for the FDA to let a drug remain on the market despite worrisome but inconclusive evidence of a drug’s dangers to the public. After looking at the records of 324,548… more...
