> The day after Repros Therapeutics announced it was suspending dosing patients in clinical trials of proellex, the FDA put a clinical hold on the program. Researchers halted dosing after seeing a significant increase in liver enzymes--a red flag for any clinical trial. Repros shares were hammered on the news and the developer says it needs to raise new funds in order to stay in business. Release
> La Jolla's Genomics Institute of the Novartis Research Foundation has struck a research deal with the Juvenile Diabetes Research Foundation to speed up development of new therapies for Type 1 diabetes. The four-year program will aim at launching four or five new drug development programs. Report
> Athersys CEO Gil Van Bokkelen told analysts that even though the company has enough cash to continue operations through 2011, he'd like to go ahead and find some partners on the stem cell and drug programs it has in development. "We believe that the optimal way to advance our MultiStem program is to find a significant commercial partner," Van Bokkelen said. Report
> Amgen says that a new clinical trial of Vectibix demonstrates that the drug is more effective than chemotherapy alone in treating colon cancer. Approved as a third-line treatment, Amgen is making a case that the drug works as a first-line drug. Story
> Entegrion has won two contracts with the U.S. Navy for improving the safety and availability of blood-derived products to treat battle injuries. The base contracts total about $4 million, with an additional $2 million for expanded research. Release
> OncoMed Pharmaceuticals announced the publication in Cell Stem Cell of data demonstrating anti-cancer activity in colon and breast cancer models for OMP-21M18, which is currently in Phase I clinical testing. Release
> Aurora Health Care, Wisconsin's largest health care provider, and Celera Corporation will collaborate on the integration of genetic testing aimed at optimizing heart care for Aurora patients. Release
> San Marino, CA-based Viral Genetics had formed a subsidiary called MetaCytoLytics to advance a technology developed by University of Colorado Professor M. Karen Newell called "metabolic disruption technology." The technology blocks a tumor cell's ability to generate energy from glucose or from fatty acids, triggering cell death and enhancing the effectiveness of chemotherapy and radiation therapy. Dr. Richard J. Trauger, Ph. D., will be chief executive officer of the new company. He will focus on bringing this concept forward into clinic trials and expanding the indications provided by the technology platform. Release
Pharma News
> No more stalling, your FDA commissioner says. Dr. Margaret Hamburg vowed yesterday to crack the FDA whip more quickly and aggressively, with procedural changes designed to speed up safety enforcement. No more long, drawn-out internal debate. No more long-drawn out negotiations with companies. It's action time. FDA Report
> Biogen says it's "reviewing its legal options" after Tysabri partner Elan slapped it with a lawsuit yesterday. Indeed. The companies are now in a pitched battle over the rights to the MS drug, never mind a recent spate of cases of PML, the potentially fatal brain infection that temporarily sent it to pasture in 2006. Report
And Finally... Amgen is building up its case for broader use of Vectibix. Ironically, it's doing so by narrowing its focus on a subset of patients. Report