Science and Enterprise

Tag: FDA

  • Phase 2 Clinical Trial Planned for Depression Drug

    Rexahn Pharmaceuticals Inc., a clinical stage pharmaceutical company in Rockville, Maryland, submitted today a Phase 2b protocol to the U.S. Food and Drug Administration for the clinical study of Serdaxin, a drug that treats major depressive disorder. The company says Serdaxin may work as an enhancer of serotonin and dopamine in the brain. In Rexahn’s…

  • FDA Holding Workshop on Nanotech and Medical Devices

    The U.S. Food and Drug Administration (FDA) wants to learn more about the safety and effectiveness of medical devices made with or from nanotechnology, and has scheduled a public workshop to find out. The session is set for Wednesday, 23 September 2010 in Gaithersburg, Maryland. According to the notice of the meeting … FDA would…

  • FDA Clears Catheter Guidance System

    SonoSite Inc. of Bothell, Washington, a maker of ultrasound medical devices, says it received U.S. Food and Drug Administration clearance for its LumenVu Catheter Guidance System, designed to direct the placement of peripherally inserted central catheters (PICC). The company says LumenVu combines near-infrared technology with a fiber optic stylet, which replaces a traditional guide wire,…

  • FDA Approves New Blood Pressure Drug

    The U.S. Food and Drug Administration (FDA) approved the drug Tekamlo to treat high blood pressure, made by pharmaceutical manufacturer Novartis of East Hanover, New Jersey. Tekamlo tablets combine the renin inhibitor aliskiren with the calcium channel blocker amlodipine. FDA approved Tekamlo as an initial therapy for patients who are likely to need multiple drugs…

  • HHS Review Highlights Role of Business in Medical Countermeasures

    The Department of Health and Human Services (HHS) today released a report on the federal government’s system to produce medications, vaccines, equipment, and supplies needed to meet a health emergency. The report — Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs — reviews the process and makes…

  • FDA Grants Orphan Status for Neuromuscular Drug

    Acceleron Pharma, Inc., a biopharmaceutical company in Cambridge, Massachusetts, today said the U.S. Food and Drug Administration (FDA) granted ACE-031, its treatment for Duchenne Muscular Dystrophy (DMD), with an orphan drug designation. DMD is a debilitating and fatal genetic disorder characterized by the progressive loss of muscle strength and function. The disease affects mainly boys…

  • FDA Fast-Tracks Treatment for Hepatitis C Infection

    Pharmasset Inc., in Princeton, New Jersey, received a fast-track designation from the U.S. Food and Drug Administration (FDA) for its drug PSI-7977, developed for the treatment of chronic hepatitis C virus (HCV) infection. PSI-7977 is an oral nucleotide analog inhibitor of HCV. Pharmasset recently completed dosing in a Phase 2a trial to evaluate PSI-7977 in…

  • FDA Committee Advances Anti-Epileptic Drug

    GlaxoSmithKline in Research Triangle Park, North Carolina and Valeant Pharmaceuticals International in Aliso Viejo, California announced that a U.S. Food and Drug Administration (FDA) advisory committee voted that clinical studies offered substantial evidence of the effectiveness of the companies’ drug ezogabine as an added treatment for adults with partial-onset seizures. The FDA’s Peripheral and Central…

  • Clinical Trial Approved of Potential Treatment for Asthma, COPD

    N30 Pharmaceuticals in Boulder, Colorado, announced today approval by the U.S. Food and Drug Administration to begin a phase I clinical trial of a drug called N6022, that the company says has the potential to be a treatment for acute exacerbations of asthma, chronic obstructive pulmonary disease (COPD) and inflammatory bowel disease. The trial, involving…

  • FDA Approves Drug for Neurological Movement Disorders

    According to Merz Pharmaceuticals in Greensboro, North Carolina, the U.S. Food and Drug Administration (FDA) has approved its drug Xeomin for the treatment of adults with cervical dystonia or blepharospasm, disorders characterized by involuntary, sustained muscle contractions. Merz Pharmaceuticals says the FDA approved the drug, with the generic name incobotulinumtoxinA, based on results from two…