Science and Enterprise

Tag: FDA

  • FDA Approves Viral Load Test for Organ Transplant Patients

    The U.S. Food and Drug Administration today approved the first DNA test to gauge anti-viral treatments with solid organ transplant patients in  cytomegalovirus (CMV) antiviral therapy. The COBAS AmpliPrep/COBAS TaqMan CMV Test was is marketed by Roche Molecular Systems in Pleasanton, California. CMV is a common virus that can cause severe diseases such as pneumonia…

  • FDA Approves Drug to Manage Spinal Cord Injury Pain

    Pfizer Inc. in New York says the U.S. Food and Drug Administration (FDA) has approved its drug pregabalin, marketed as Lyrica, to manage neuropathic pain associated with spinal cord injury. The drug was given a priority review by FDA. Spinal cord injuries can happen to young, healthy people as a result of trauma from car…

  • NC State, Strasbourg Institutes to Advance Biomanufacturing

    North Carolina State University in Durham and University of Strasbourg in France, along with the Alsace BioValley cluster in Europe, are forming Biomanufacturing Training and Education Center (BTEC) International, to provide educational and regulatory advisory services in the U.S. and Europe. BTEC International will initially combine the resources of NC State’s Golden LEAF Biomanufacturing Training…

  • FDA Approves Assay for Rare Cell Disorders

    The U.S. Food and Drug Administration approved a new test to help physicians diagnose a group of rare cell disorders. The test, or assay, was developed by Lawrence Schwartz (pictured right), a medical school professor at Virginia Commonwealth University in Richmond and a researcher in the field of mast cells. Mast cells are found in…

  • Study: FDA Approves Drugs Faster Than in Europe, Canada

    Researchers at the Yale University medical school have found that since 2001, the U.S. Food and Drug Administration (FDA) generally approves drug therapies faster and earlier than its counterparts in Canada and Europe. The findings of medical student Nicholas Downing and colleagues appear online in the New England Journal of Medicine. Downing’s team, under the…

  • Two Paralyzed People Use Brain-Controlled Robotic Arms

    Two stroke victims with tetraplegia — total loss of the use of limbs and torso — were able to control robotic arms with brain activity to reach, grasp, and use physical objects. The results of this study from the BrainGate project are reported today online in the journal Nature (paid subscription required). The BrainGate project…

  • U.S. Patent Awarded for Synthetic Hepatitis C Biocatalysts

    The U.S. Patent and Trademark Office awarded yesterday a patent covering biocatalysts and biocatalytic processes used to make intermediate products in the synthesis of hepatitis C drugs. Patent number 8,178,333 was awarded to 13 inventors and assigned to Codexis Inc. in Redwood City, California. Codexis is a biotechnology company that develops and markets engineered enzymes…

  • Biopharm Lands $25M Venture Funding for Phase 3 Trial

    Argos Therapeutics Inc., a biopharmaceutical company in Durham, North Carolina, says it secured $25 million in series D venture financing, the fourth funding installment after initial start-up. The funds are expected to support a planned clinical trial of Argos Therapeutics’ immunotherapy for metastatic renal cell carcinoma, a form of kidney cancer. The financing was led…

  • PhRMA Company R&D Investment Flat in 2011

    The Pharmaceutical Research and Manufacturers of America (PhRMA) released its annual industry profile today showing its 28 member companies spent $49.5 billion on research and development in 2011, down slightly from the $50.7 billion expended in 2010. The $49.5 billion spent on R&D is about 17 percent of total sales. The organization cites the latest…

  • FDA Approves Brain Imaging Agent for Alzheimer’s Diagnosis

    Eli Lilly and Company in Indianapolis says the U.S. Food and Drug Administration on Friday approved Amyvid, a radioactive diagnostic agent made by its subsidiary Avid Radiopharmaceuticals. Amyvid is designed to work with Positron Emission Tomography (PET) scans to reveal beta-amyloid plaques in patients with suspected cognitive impairment disorders such as Alzheimer’s disease. Amyvid is…