Category: Regulations
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St. Jude Medical Invests in Pain Therapy Device Developer
Medical device manufacturer St. Jude Medical in St. Paul, Minnesota is investing $40 million in pain therapy systems developer Spinal Modulation Inc. in Menlo Park, California. The equity investment deal, says St. Jude Medical, includes an option for the outright purchase of the privately-owned Spinal Modulation. Under the agreement, St. Jude Medical becomes the exclusive…
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Health Organizations Form Genetics Data Standards Alliance
Some 70 health care organizations worldwide are forming an alliance to develop common standards for collecting and sharing genetic data. The organizations — representing health care providers, government agencies, academic and research institutes, foundations, and advocacy groups — seeks to create a common interoperable framework, with associated regulatory and practical guidelines, for the interchange of…
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FDA Approves Robotic Device for Stroke Rehabilitation
Oregon Health and Science University in Portland reports that the Food and Drug Administration approved for marketing in the U.S. a robotics device that helps stroke patients move limbs and improve muscle function during their rehabilitation. The device was developed by Paul Cordo, a biomedical engineering professor at Oregon Health and AMES Technology, a spin-off…
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Analysis Shows Life-Cycle Impacts of Lithium-Ion Batteries
A cradle-to-grave analysis of lithium-ion batteries, like those used in electric vehicles, shows the batteries have potential adverse impacts on the environment and public health beyond the benefits from their day-to-day use. The study, by consulting firm Abt Associates in Bethesda, Maryland, was conducted for the U.S. Environmental Protection Agency, with researchers from battery manufacturers,…
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Clinical Trial Shows Antibody Effective with Severe Asthma
A clinical trial testing a new asthma drug by the pharmaceutical companies Sanofi in Paris and Regeneron Pharmaceuticals in Tarrytown, New York shows the drug sharply cut the rate of asthma exacerbations or attacks compared to a placebo in patients with moderate to severe forms of the disease. The findings were reported yesterday in the…
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IV Catheters Linked to Blood Clot Risk in Sickest Patients
Medical researchers at University of Michigan in Ann Arbor found a widely used catheter for intravenous (IV) drug delivery is linked to a higher risk of deep vein blood clots, particularly among critically ill patients or those with cancer. The findings of the team led by internal medicine professor Vineet Chopra, which show associations and…
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Clinical Trial Underway to Test MicroRNA Cancer Therapy
Mirna Therapeutics Inc., a biotechnology company in Austin, Texas, recently began a clinical trial to test its lead candidate, MRX34 that simulates the tumor-suppression action of microRNA, as a therapy for cancer. The trial is an early-stage study mainly of MRX34’s safety with patients suffering from cancer of the liver or advanced or metastatic cancer…
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Simplified Medicare Could Save Money, Improve Senior Health
Public health researchers found combining into one program Medicare’s separate hospital, doctor, and drug plans with supplemental insurance could save $180 billion over a decade while improving care for older Americans. The study, led by Johns Hopkins School of Public Health professor Karen Davis and conducted for the Commonwealth Fund, appears in the May 2013 issue…
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New Hepatitis C Treatment Given FDA Breakthrough Status
A new anti-viral combination treatment for hepatitis C developed by the biopharmaceutical company AbbVie received a breakthrough therapy designation by the U.S. Food and Drug Administration. AbbVie, in North Chicago, Illinois was spun-off from Abbott Laboratories as a separate company on 1 January 2013. Hepatitis C is an infection that attacks the liver and usually…
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Emergency Care Costs Likely Higher than Current Estimates
An analysis of emergency care costs in the U.S. suggests the actual price tag for visiting hospital emergency rooms may be more than earlier thought. A study by economist turned emergency room physician Michael Lee at Brown University, with colleagues from Brown and Harvard Medical School, appears online in Friday’s issue of the journal Annals…