Category: Regulations
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Pharmacist/Tech Initiative Found to Cut Medication Errors
An initiative led by pharmacists, using information technology was found to reduce more prescription errors by general practitioners than simple automated feedback among patients at risk for these errors. The findings by a team led by University of Nottingham medical professor Tony Avery, himself a practicing G.P. , appear online in the journal The Lancet…
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Cell Phone User Locations Open to Hackers via Networks
Computer scientists at University of Minnesota in Minneapolis have discovered a vulnerability in cellular networks that can allow hackers to follow individual cell phone users without their knowledge. Ph.D. candidate Denis Foo Kune, with fellow student John Koelndorfer and professors Nick Hopper and Yongdae Kim presented their findings earlier this month at the Network &…
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Patent Awarded for Clinical Trial Molecular Matching System
The U.S. Patent and Trademark Office awarded a patent to the Moffitt Cancer Center at University of South Florida in Tampa on its system for matching patients to clinical trials based on molecular profiles of the patients and drugs. Patent number 8,095,389 was granted last month to inventors William Dalton, president of the Moffitt Cancer…
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FDA Approves Drug for Glaucoma, Ocular Hypertension
The pharmaceutical company Merck in Whitehouse Station, New Jersey says the Food and Drug Administration has approved its drug Zioptan to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Zioptan is the brand name for Merck’s tafluprost ophthalmic solution to reduce pressure inside the eye. Glaucoma is the second most common…
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Study: 4.5 Million Americans Had Knee Replacement Surgery
Researchers at Brigham and Women’s Hospital in Boston calculate that more than 4.5 million Americans have had a total knee replacement (TKR), becoming one of the most common conditions affecting people in the U.S. age 50 and over. The team led by Elena Losina of the hospital’s Orthopedic and Arthritis Center for Outcomes Research, presents…
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FDA Releases Draft Biosimilars Guidance
The Food and Drug Administration has issued three guidance documents in draft on biosimilar therapeutics — functional equivalents of biologic therapies — that the agency says will soon be open for public comment. Guidance documents offer insights into the current thinking of FDA on key scientific and regulatory topics, and are not binding on the…
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Gaps Found in Satellite Telephone Encryption Algorithms
Computer scientists at Ruhr-Universität in Bochum, Germany say they have cracked algorithms of European encryption standards used globally for satellite telephones in less than an hour and with simple equipment. The team from the university’s Horst Görtz Institute for IT Security (HGI) will present the findings of their proof-of-concept tests at the IEEE Symposium on…
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FDA Grants Priority Review to Breast Cancer Therapy
Genentech in South San Francisco, California, says the Food and Drug Administration has granted priority review status to its drug pertuzumab to treat human epidermal growth factor receptor 2- (HER2-) positive breast cancer. Genentech is a division of the global pharmaceutical company Roche, headquartered in Switzerland. FDA applies the priority review status in this case…
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Warfarin, Aspirin Provide Similar Stroke Prevention
In a six-year, 11-country clinical trial, researchers at Columbia University found aspirin and the anti-clotting drug warfarin to offer about equal protection against death and strokes in heart failure patients with normal heart rhythms. The findings of the study led by Columbia medical school professor Shunichi Homma were presented at the International Stroke Conference in…
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Prostate Cancer Therapy Shown Effective in Chemo Patients
A phase 3 clinical trial has shown a new drug to treat prostate cancer is effective with patients who had previously been treated with chemotherapy. The results of the study of MDV3100 — made by the biopharmaceutical company Medivation Inc. in San Francisco and Astellas Pharma Inc. in Tokyo, Japan — will be presented tomorrow…