FYCOMPA is the First and Only FDA-Approved Non-Competitive AMPA Glutamate Receptor Antagonist FYCOMPA offers patients and their physicians a new adjunctive treatment option, said Lonnel Coats, President and Chief Executive Officer, Eisai Inc. This is important because far too many patients with partial onset seizures continue to have seizures even while on medication. FYCOMPA was approved by the FDA in October 2012, primarily based on three Phase III studies (304, 305 and 306). These multi-center, randomized, double-blind, placebo-controlled, parallel group studies evaluated the efficacy and safety of FYCOMPA compared to placebo given as adjunctive therapy in patients age 12 and older with partial-onset seizures. The studies demonstrated that FYCOMPA significantly reduced seizure frequency in patients with partial-onset seizures with or without secondarily generalized seizures. In the three clinical studies, the most common adverse events (greater than or equal to 4 percent and greater than placebo) in patients treated with FYCOMPA 8 or 12 mg were dizziness, sleepiness, tiredness, irritability, falls, nausea, problems with muscle coordination, problems walking normally, vertigo and weight gain. Serious or life-threatening psychiatric (mental) and behavioral problems were also seen more frequently in patients treated with FYCOMPA. These reactions are described in the Boxed WARNING bolded below … Continue reading →

Among the many stents, surgical clamps, pumps and other medical devices that have recently come before the Food and Drug Administration for clearance, none has excited the widespread hopes of physicians and researchers like a machine called the Illumina MiSeqDx. This compact DNA sequencer has the potential to change the way doctors care for patients by making personalized medicine a reality, experts say. "It's about time," said Michael Snyder, director of the Stanford Center for Genomics and Personalized Medicine. Physicians who rely on genetic tests to guide their patients' treatment have had to order scans that reveal only small parts of a patient's genome, as if peeking through a keyhole, Snyder said: "Why would you study just a few genes when you can see the whole thing?" Back in 2000, when the Human Genome Project completed its first draft of the 3 billion base pairs that make up a person's DNA, the effort took a full decade and cost close to $100 million. The Illumina MiSeqDx can pull off the same feat in about a day for less than $5,000 and the results will be more accurate, two of the nation's top physicians gushed in the New England Journal of … Continue reading →

Regenocyte Adult Stem Cell Therapy - Ron O'Leary By: RegenocyteStemCells … Continue reading →