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Since the FDA's 2005 preliminary concept paper on drug/diagnostic co-development, genomic advances have marched on, requiring the agency to revisit its now outdated guidance. A new white paper from the Personalized Medicine Coalition points out the areas requiring additional regulatory and evidentiary clarity from the agency.

According to one of the world's largest professional services firms, the trend toward tailoring drugs based on clinical factors and genomic variation will create opportunities and challenges for the pharmaceutical and biotech industries. PricewaterhouseCoopers estimates that the market for "a more personalized approach to health and wellness will grow to as much as $452 billion by 2015."

Decode's shares sank to a few pennies after the firm filed for bankruptcy protection. Meanwhile, Sequenom rose as it attempts rebound from a major setback in its Down syndrome test development program.

At a meeting hosted by the Partners HealthCare Center for Personalized Genetic Medicine last month, the events leading up to the re-labeling for colorectal cancer drugs Vectibix and Erbitux sparked discussion among participants about what Amgen and Bristol-Myers Squibb/ImClone knew about the drugs and when.

Nasdaq informed DeCode that it will suspend trading in the company’s common stock as of November 30, 2009.

The court approved Decode to continue operations under Chapter 11 bankruptcy protection, as well as its debtor-in-possession financing agreement with Saga.

Under the partnership, OptumHealth Allies' 15 million members will now have access to Pathway Genomics' health and ancestry gene scans at a 20 percent discount, which brings Pathway's $348 full health and ancestry gene scan package down to $278. Meanwhile, 23andMe's is raising the price of its health and ancestry gene scan package by an additional $100, to $499.

In addition to the filing for bankruptcy protection, Decode also has entered into an agreement to sell certain assets to Saga Investments.

The Mountain View, Calif.-based direct-to-consumer genomics firm has had a round of layoffs that it said were necessary to remain in business in a difficult economic climate. Competing DTC genomics firms have had cutbacks or are proceeding cautiously.

Decode has 30 days to make the interest payment or it will be in default.

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A South African university has told the Wellcome Sanger Institute to return DNA samples it has from indigenous African communities, The Times reports.

The University of California, Berkeley's Rasmus Nielsen and Xinzhu Wei have retracted their CCR5 gene paper due to a technical artifact.

 

University of Virginia researchers are exploring a genetic risk test to gauge type 1 diabetes risk, NPR reports.

In PNAS this week: researchers compare two high-grade neuroendocrine lung cancers, height among ancient Europeans, and more.