Science and Enterprise

Tag: FDA

  • Prostate Cancer Compound Granted U.S. Patent

    Adamis Pharmaceuticals Corp. in San Diego, California says the technology behind its cancer drug candidate has received a patent from the U.S. Patent and Trademark Office. Claims in patent 7863324 “Chroman-Derived Compounds for the Treatment of Cancer” include methods for inhibiting the growth of prostate cancer cells, delaying the progression of prostate cancer, and  preventing…

  • FDA Approves Blood Thinning Drug for Heart Disease

    The Food and Drug Administration approved the blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). Brilinta is a product of AstraZeneca in Wilmington, Delaware. Brilinta helps prevent the formation of new blood clots, thus maintaining blood flow in the body to help reduce the risk…

  • FDA Issues Draft Guidance on Mobile Medical Phone Apps

    The U.S. Food and Drug Administration today issued a draft of guidance to industry on oversight of mobile medical applications (apps) designed for smartphones and other mobile computing devices. Interested parties have 90 days to comment on the proposed regulations. The industry market analysts Research2Guidance expect as many as 500 million smartphone users worldwide will…

  • Council Recommends Steps for Home Medical Devices, Health IT

    The National Research Council has recommended a series of actions to meet the likely increased demand for home use of medical devices and health information technology. The study was sponsored by the Agency for Healthcare Research and Quality (AHRQ), a division of the Department of Health and Human Services. The 11 recommendations for other agencies…

  • FDA Issues Draft Guidance on Diagnostic/Therapy Companions

    The U.S. Food and Drug Administration (FDA) issued a draft of guidance to encourage the development and review of diagnostics tests to help health care professionals determine if a patient should receive a particular drug therapy or its dosage. The agency is seeking public input on the draft guidance for 60 days. The draft document…

  • Anti-Smoking Drug Raises Risk of Heart Problems

    Researchers at Johns Hopkins University, Wake Forest University, and University of East Anglia in the U.K. found healthy tobacco users that take a leading smoking cessation drug face a notably greater chance of hospitalization from heart problems, compared to those taking a placebo. The findings appear in the current issue of the Canadian Medical Association…

  • Neuromuscular Drug Gets Fast-Track, Orphan Approval

    Repligen Corp. in Waltham, Massachusetts says its drug candidate for spinal muscular atrophy received fast-track and orphan drug status from U.S. and European regulators. The U.S. Food and Drug Administration (FDA) granted fast-track status to Repligen’s RG3039, while the European Medicines Agency gave the drug its orphan medicinal product designation. Spinal muscular atrophy (SMA) is…

  • University Start Up Commercializes Feeding Tube Research

    A start up company founded by a University of Utah medical researcher is developing a feeding tube for patients that reduces the risks and casualties from misplacement. The company, Veritract Inc. in Salt Lake City, was started by John Fang, clinical director of the university’s gastroenterology division. The privately held Veritract is developing what they…

  • Pain Killer with Built-in Abuse Deterrence Gets FDA Clearance

    A prescription pain killing drug developed by Pfizer Inc. in New York and Acura Pharmaceuticals Inc. in Palatine, Illinois has received marketing approval from the U.S. Food and Drug Administration. Oxecta, an opioid analgesic tablet made from oxycodone hydrochloride (HCl), contains ingredients developed by Acura Pharmaceuticals to deter tampering that leads to misuse or abuse…

  • FDA Approves Genetic Test for Breast Cancer Treatment

    The Food and Drug Administration (FDA) approved a new genetic test that will help health care professionals determine if women with breast cancer are candidates for Herceptin (trastuzumab), a commonly used breast cancer treatment. The Inform Dual ISH test is made by Ventana Medical Systems, a division of the Roche Group, in Tucson, Arizona. The…