Science and Enterprise

Tag: FDA

  • St. Jude Medical Acquires Leadless Pacemaker Developer

    St. Jude Medical, a medical device company in St. Paul, Minnesota, is acquiring Nanostim Inc., a developer of self-contained leadless heart pacemakers in Sunnyvale, California. Shareholders in the privately owned Nanostim can receive up to $188.5 million in upfront cash and milestone payments as a result of the purchase. St. Jude Medical has a relationship…

  • Clinical Trial of ALS Stem Cell Therapy Begins Treatments

    The first two of up to 15 patients received their first injections of stem cells to treat amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, in an intermediate-stage clinical trial at University of Michigan in Ann Arbor and Emory University in Atlanta. The study is testing stem cell treatments made by Neuralstem, a biotechnology company…

  • FDA Approves Artificial Pancreas System with Glucose Sensor

    The medical device manufacturer Medtronic Inc. in Minneapolis says the U.S. Food and Drug Administration on Friday approved a wearable artificial pancreas system that combines an insulin pump and sensor to detect glucose levels for people with diabetes. The company also revealed it received a warning letter on 19 September from FDA about its factory…

  • FDA to Limit Oversight to Medical Device Mobile Apps

    The U.S. Food and Drug Administration will focus its regulation of mobile health apps on those that act as traditional medical devices, according to final guidance released yesterday. The guidance, to be published tomorrow in the Federal Register for public comment, says FDA will not enforce regulations on the majority of health-related smartphone and tablet…

  • Biotech Financing Up, Licensing Down in First Half of 2013

    The biotechnology industry experienced healthy growth in venture financing and valuations in the first half of 2013, but licensing deals — a prime source of biotech revenue — were flat during the period, pointing to limits on the industry’s growth potential. This accounting of biotech industry financial activity is described in a report from Evaluate…

  • Cleveland Clinic Spin-Off Developing Breast Cancer Vaccine

    Shield Biotech, a spin-off company from the Cleveland Clinic in Ohio, is creating a vaccine to prevent breast cancer based on research conducted at the clinic’s research institute. Vincent Tuohy, a Cleveland Clinic immunologist, founded the company with the clinic’s commercialization division, and serves as its chief scientist. Tuohy’s research seeks to find a method for protecting…

  • Menthol Cigarette Smoking Rising Among Teens, Young Adults

    Public health researchers from University at Buffalo in New York found smoking of mentholated cigarettes is increasing among teenagers and young adults in the U.S., while smoking of non-menthol cigarettes declined in this age group. The findings of the team led by Buffalo’s Gary Giovino — with colleagues from Johns Hopkins and Georgetown universities,  Biostatistics…

  • FDA Grants Muscle-Wasting Disease Drug Breakthrough Status

    The global pharmaceutical company Novartis says the Food and Drug Administration granted its therapy candidate bimagrumab breakthrough status to treat a rare muscle-wasting condition for which there are currently no approved treatments. FDA designates new drugs for serious or life-threatening conditions as breakthroughs to expedite their review in the agency. The disorder is known as…

  • Data Review Indicates Drug Improves Brain Cancer Survival

    Researchers at the Mayo Clinic in Minnesota found patients who took the drug bevacizumab for the brain cancer glioblastoma lived somewhat longer than patients with the disease before the drug’s FDA approval in 2009.  The team of neurologists Derek Johnson, Heather Leeper, and Joon Uhm describe their findings in a recent issue of the journal…

  • FDA Clears Enhanced Capsule Camera for GI Disorders

    The Food and Drug Administration cleared for sale in the U.S. a new version of a tiny camera in a capsule, made by Given Imaging Ltd. in Yoqneam, Israel, and swallowed by patients to diagnose gastrointestinal (GI) conditions. The company expects its PillCam SB3 to be available in the U.S. in the last quarter of…