IN THIS ISSUE - STRATEGY

Optimizing Drug Safety: Abbott Labs’ James Summers Shares Strategies
Malorye Allison  

As safety problems continue to bedevil drug manufacturers, companies are making a huge shift in how they do things. At this week’s CHI World Pharmaceutical Congress in Philadelphia, experts bemoaned the industry’s predicament and shared insights about new tools and strategies for drug safety assessment.
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NEWS BRIEFS

The largest-ever study of the genetics behind common diseases -- The Wellcome Trust Case Control Consortium -- has reportedly found "more than ten genes that predispose to common diseases." Many of these genes are in areas of the genome not previously thought to have been related to the diseases.  Read more

Safety concerns over diabetes drug rosiglitazone (GlaxoSmithKline’s Avandia) have sparked a firestorm of debate. A study published last month in The New England Journal of Medicine (NEJM) concluded that the drug is associated with an increased risk of heart attack and death from cardiovascular causes. Weeks later, however, NEJM released early findings from a study called Record, which were inconclusive regarding such effects. The FDA will convene a meeting of outside experts on July 30 to discuss rosiglitazone and similar drugs.  Read more

QIAGEN N.V. is buying Digene Corp. for $1.6 billion. The transaction combines QIAGEN's portfolio of sample and assay technologies, including a broad panel of molecular diagnostic tests, with Digene's position in HPV targeted molecular diagnostic testing. It is anticipated that the combined company will have over $350 million of molecular diagnostics revenues and more than $800 million in revenues overall in 2008.   Read more

Molecular diagnostics firm DxS has launched a new kit for detecting K-RAS mutation status. K-RAS is a predictor of resistance to tyrosine kinase inhibitors, such as gefitinib (AstraZeneca’s Iressa) or erlotinib (Roche/OSI Pharmaceuticals’ Tarceva). The DxS K-RAS mutation detection kit can be used to identify patients whose tumors carry these mutations and in biomarker studies for drugs in development.  Read more

Nexavar (Bayer/Onyx’s sorafenib), extended survival in patients with hepatocellular carcinoma (HCC) by 44%,, compared to placebo, in a Phase III study reported at this year’s American Society of Clinical Oncology (ASCO) meeting in Chicago. Just over 700 patients were enrolled in the study, which found a median overall survival of 10.7 months in the Nexavar-treated patients compared to 7.9 months for those on the placebo.  Read more

Beyond Genome, June 20-22, San Francisco, CA
Top Ten Challenges in the Post-Genome Era

Nucleic Acid-Based Technologies, June 25-27, Baltimore, MD
Meeting the Demands

Point-of-Care Diagnostics, August 14-15, Washington DC

New Applications for MDA, August 15-17, Washington DC
Integrating Genetics with “Omics”