Tag: FDA
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Engineered HIV/AIDS Vaccine Approved for Clinical Trials
A vaccine designed to prevent HIV infection based on a genetically engineered virus has received approval by the U.S. Food and Drug Administration to start clinical trials. The vaccine is a product of a joint venture between Universiy of Western Onatrio in London and the Canadian subsidiary of Korean pharmaceutical venture company Sumagen. Chil-Yong Kang…
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FDA Approves Cardiac Device for Children Awaiting Transplant
The U.S. Food and Drug Administration (FDA) on Friday approved the Excor Pediatric System, a device to support children with heart failure until a donor for a heart transplant can be found. The device is made by Berlin Heart GmbH in Germany and The Woodlands, Texas. The Excor Pediatric System is an external heart pump…
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FDA, Ohio Consortium to Partner on Biomaterials Regulations
The U.S. Food and Drug Administration (FDA) and Austen BioInnovation Institute in Akron (ABIA) are collaborating on the development of regulations affecting biomaterials in medical devices. The consortium of Akron, Ohio area hospitals, universities, and foundations signed the partnership agreement with FDA yesterday. The FDA and ABIA established the partnership to develop the research protocols…
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GSK, University of Dundee Partner on Huntington’s Disease
University of Dundee in Scotland and the pharmaceutical company GlaxoSmithKline (GSK) will collaborate in research to tackle Huntington’s disease, an inherited brain disorder. The joint project is valued at more than £1 million ($US 1.6 million). Dundee medical professor Susann Schweiger, who has discovered a mechanism that controls production of the disease-causing protein involved in…
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PhRMA: 88 HIV/AIDS Meds in Development at U.S. Companies
A report by Pharmaceutical Research and Manufacturers of America (PhRMA) says U.S. biopharmaceutical companies are testing 88 medicines and vaccines to treat or prevent HIV/AIDS and related conditions. The report, issued on World AIDS Day (1 December 2011), also lists 36 currently approved medications for HIV infection and AIDS. According to PhRMA’s report, more than…
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Commentary: Manufacturing the Health Care Venture Crisis
Rahm Emanuel, the current mayor Chicago and former chief of staff to President Obama, once famously said, “You never want a serious crisis to go to waste.” The National Venture Capital Association (NVCA) has gone Emanuel one better, using highly selected bits and pieces from an industry survey to predict an imminent retreat by investors…
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FDA Approves Age-Related Macular Degeneration Drug
The Food and Drug Administration approved the drug Eylea (aflibercept) to treat patients with neovascular age-related macular degeneration (AMD), also known as “wet” AMD. Regeneron Pharmaceuticals Inc. in Tarrytown, New York developed Eylea, in partnership with Bayer HealthCare in Germany. Wet AMD is a leading cause of vision loss and blindness in Americans ages 60…
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Treatment for Rare Bone Marrow Disease Gains FDA Approval
The Food and Drug Administration today approved the drug ruxolitinib, to treat the bone marrow disease myelofibrosis, for marketing in the U.S. Ruxolitinib is marketed under the brand name Jakafi by Incyte Corporation, a biotechnology company in Wilmington, Delaware. Jakafi is a pill taken two times a day to inhibit enzymes called Janus Associated Kinase…
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FDA Approves Touch-Screen Insulin Pump System
Tandem Diabetes Care Inc. in San Diego says the Food and Drug Administration has cleared the company’s insulin pump system for marketing in the U.S. The t:slim Insulin Delivery System, as it’s called, is one of the first insulin pumps to be cleared under the FDA’s new Infusion Pump Improvement Initiative, according to the company.…
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Geron Halts Embryonic Stem Cell Research, Clinical Trial
Geron Corporation, a biotechnology company in Menlo Park, California, says it has discontinued its development of therapies based on human embryonic stem cells to focus on cancer drugs. The immediate results of its decision are to end a clinical trial of its stem cell drug on patients with spinal cord injuries — the first clinical…