Regulators question HGS drug; Gilead gets panel review date;

> In anticipation of an upcoming FDA panel review, regulators questioned the efficacy of Human Genome Science's anthrax drug and asked if it truly works better than existing therapies. Story

> Gilead Sciences says that aztreonam for inhalation solution, an investigational product for the treatment of infections due to Pseudomonas aeruginosa in patients with cystic fibrosis, is scheduled to be reviewed by the FDA's Anti-Infective Drugs Advisory Committee on December 10. Release

> Jan Öhrström, the former chief medical officer of Seattle-based ZymoGenetics, has jumped to the COO's job at the rival ProFibrix. He talks to Xconomy about the developer's plans in the field of excess bleeding. Story

Pharma News

> Years ago, Japanese car manufacturers turned to management gurus to make their plants more efficient. Now, AstraZeneca is hiring automotive gurus to apply their efficiencies to drug production, the Financial Times reports. AZ story

> GAO: The FDA doesn't act on post-marketing data. Article

> Hear the shouts of joy from Shire? The FDA has validated five years of market exclusivity for Shire's attention-deficit drug Vyvanse. Report

> European regulators are taking a hard look at the multiple sclerosis wonder drug Tysabri. Article

IT News

> Finally, some detail on the far-more-hyped-than-tried adaptive clinical trial. Two trials show that adaptive techniques have their place. Report

> Phase Forward continues its clinical trial software announcement blitz with two in the last week: an enhanced trial supply management system and a free tool to catch medidata errors. Article

> The Quintiles ClinicalResearch.com Internet site, which aids prospective subjects in their search for clinical trials, is intended as more than a simple directory, says Dave Coman, senior VP for patient recruitment at the contract research giant. "Our role is making sure that patients understand the role of clinical trials. That's the uber-issue--patient awareness, understanding, participation." Report

> Advanced pattern detection, treatment comparison, and functional analysis of genomic expression data are among the objectives of Biomarker Discovery 2.0 software from Integromics for the TIBCO Spotfire business intelligence platform. Improved methods of data access and normalization are additional objectives. Report

And Finally..Futurist Paul Saffo says that advancements in biotechnology and robotics will make it possible for the rick to develop into a new species. In Saffo's future, replacement body parts will function better than the original. Article

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