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Amgen said a jury in the U.S. Federal District Court in Boston ruled that Roche's anemia drug Mircera infringes 11 Amgen patent claims for its recombinant erythropoietin (EPO). The Thousand Oaks, California-based biotech giant said it was pleased with the jury's verdict and will now seek an injunction to prevent Roche from commercializing Micera in the United States. The injunction hearing is scheduled for November 15. Amgen generates nearly $6.6 billion a year through sales of its erythropoietin products, about half its total revenue. Roche said it is exploring its legal options and might appeal the decision. The drugs are recombinant forms a hormone that stimulates the production of red blood cells. It is used to treat anemia in cancer and kidney patients.

 

The Autism Consortium, a group of researchers, clinicians, and families seeking to accelerating research and enhancing clinical care for autism, said it has completed the first genome scan for autism spectrum disorders (ASD) through its Autism Gene Discovery Project. It has released the reference data set to a database that autism researchers around the world can use. The scan on genetic data from more than 3,000 children with ASD and their families was conducted using new, high resolution technology developed by Santa Clara, California-based Affymetrix. The pre-publication release of such a significant trove of data is a dramatic departure from the traditionally less open culture of research science. The number of individuals diagnosed with ASD has significantly increased in recent years. Although there is some uncertainty about the role played by better diagnosis, greater recognition of the disorders, and biological and environmental factors, there is growing agreement in the research community that genes have a significant role in autism spectrum disorders. The release of the data from this screen is a significant step toward identifying which genes are involved. 

 

SRI International said it has been awarded a $7.9-million contract by the National Cancer Institute to conduct analytical chemistry evaluations of anti-cancer drugs and dosage formulations. The Menlo Park, California-based independent nonprofit research and development organization said the new contract, which the NCI's Pharmaceutical Resources Branch awarded as part of its Developmental Therapeutics Program, aims to further the development of promising compounds by providing resources to investigators developing new therapies. Fundamental to the drug development process, analytical chemistry helps identify and quantify a drug, specifically determining its identity, strength, quality, and stability. This chemical data provides a clear definition of the drug substance or dosage formulation, leading to safer and more effective therapies.

 

Without sleep, the emotional centers of the brain dramatically overreact to negative experiences, reveals a new brain imaging study in the journal Current Biology. The reason for that hyperactive emotional response in sleep-deprived people stems from a shutdown of the prefrontal lobe—a region that normally keeps emotions under control. The new study from Harvard Medical School and the University of California at Berkeley is the first to explain, at the neural level, why sleep loss leads to emotionally irrational behavior. In the study, researchers assigned 26 healthy people to either a sleep-deprivation group—in which participants were kept awake for about 35 hours—or a normal sleep group. On the following day, the study subjects’ viewed 100 images while researchers scanned their brains with functional magnetic resonance imaging, which measures brain activity on the basis of blood flow. The images were at first emotionally neutral, but became increasingly aversive over time. The emotional centers of the brain were more than 60 percent more reactive under conditions of sleep deprivation than in subjects who had obtained a normal night of sleep. The findings might also offer some insight into the clinical connection between sleep disruptions and psychiatric disorders.

 

San Diego-based Orexigen Therapeutics presented the results of a pre-clinical study that further supports its understanding of an aspect of the mechanism of action of Contrave, a  late-stage obesity drug candidates that is a combination of bupropion and naltrexone. The findings showed the combination resulted in a 94 percent reduction of food intake in obese mice, greater than either drug alone. The study showed the drugs act in a part of the brain where food reward pathways are located. It also showed the combination directly increased firing of neurons associated with reduction in food intake and satiety. The data were disseminated in a poster presentation at The Obesity Society’s Annual Scientific Meeting in New Orleans.

 

More than half of all drugs given to patients work by targeting a particular type of receptor, found on cells in the body to steer the cell's machinery toward healing an illness. Researchers from Stanford University School of Medicine and the Scripps Research Institute have determined what one of those receptors looks like at the molecular level, giving them the keys to greater control of the process. A scientific feat, identifying the structure of these docking stations—called G protein-coupled receptors—can direct the future design of drugs that will precisely bind to specific receptors. Precise binding by a drug can stimulate or block that particular receptor's normal activity, leading to more powerful treatment while minimizing bothersome side effects. The researchers said that the majority of hormones and neurotransmitters work through one of these receptors and that determining the specific structure of one advances efforts to determine the structure of others. The findings are published in two Science Express articles.

 

Fremont, California-based Vermillion said it completed clinical trial enrollment for its ovarian cancer triage test. The prospective clinical trial was designed to demonstrate that the ovarian triage test is a useful adjunct for distinguishing benign from malignant ovarian tumors. A total of 550 patients were enrolled at 27 clinical trial sites. The company said it is now compiling the clinical data for submission to the U.S. Food and Drug Administration for in vitro diagnostic clearance and expects to report top-line results in December. Studies show that women with ovarian cancer who are initially operated on by a gynecologic oncologist or at specialist medical centers survive longer and have a better chance of being cured, compared to those whose surgeries are performed by a non-specialist, the company said. The ovarian tumor triage test is designed to assist physicians in determining whether patients should be referred to specialists prior to their initial surgery.

 

La Jolla, California-based TorreyPines Therapeutics said that its drug candidate tezampanel met the primary endpoint in a mid-stage clinical trial for the treatment of a single, acute migraine attack. In the study, which evaluated tezampanel administered subcutaneously, the 40 mg dose demonstrated statistically significant improvement on headache pain response at two hours post-dose compared to a placebo, and the response was sustained through 24 hours post-dose. There were no serious or medically important adverse events reported. The company intends to submit the data from this trial to the U.S. Food and Drug Administration in order to initiate a late-stage program in acute migraine in the second half of 2008.