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BUSINESS
December 16, 2013 | By Ricardo Lopez
The U.S. Food and Drug Administration on Monday proposed a new rule that would force companies that make antibacterial soaps to prove that their products are effective and safe. Federal regulators said that the two most common active ingredients in antibacterial soaps - triclosan and triclocarban - are no more effective at preventing the spread of illnesses than washing with plain soap and water. Furthermore, the FDA said that regular use of these soap products may contribute to bacterial resistance to antibiotics and may also have unanticipated hormonal effects.
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BUSINESS
December 15, 2013 | MICHAEL HILTZIK
Cutting-edge companies often walk a tightrope between regulators trying to keep their technologies under control and marketers trying to push them out to consumers as fast as possible. That's where a Silicon Valley company named 23andMe is today. The Mountain View, Calif., firm has been hawking genetic tests for you to take at home. You spit into a receptacle and ship your saliva back to the company so it can analyze your DNA for a mere $99. Eventually you get a readout detailing your genetic susceptibility to hundreds of diseases.
NEWS
December 13, 2013 | By Peter Lehner
Almost 40 years ago, the Food and Drug Administration found that the practice of routinely feeding antibiotics to livestock that are not sick posed a risk to human health. This week, after decades of delay, the FDA issued a weak, partial and voluntary guidance plan to address this problem. The industrial farms that produce most of the meat we eat use antibiotics to speed up growth or to compensate for the filthy, crowded environments in which animals are kept. The medical community and public health groups have been warning for years that this practice encourages the spread of antibiotic-resistant bacteria.
BUSINESS
December 6, 2013 | By Chris O'Brien
23andMe, the Google-backed personal genetics company, said it would no longer offer health-related results from its genetic tests to customers after a recent warning from federal regulators. The move comes about two weeks after the Mountain View, Calif., start-up received a letter from the U.S. Food and Drug Administration. The agency warned 23andMe to stop marketing its genetic tests because the company didn't have regulatory approval from the FDA. Founded in 2006, 23andMe sells a personal genetics test for $99. Customers submit a saliva sample and receive a slew of personal information based on their DNA, such as ancesty composition and risks for certain diseases.
BUSINESS
November 25, 2013 | By Chris O'Brien
Government regulators have ordered a Silicon Valley genetic-testing startup funded by Google to halt sales of its product to consumers. In a letter published on Monday, the Food and Drug Administration said 23andMe was selling its "Saliva Collection Kit and Personal Genome Service" in violation of federal law. "FDA is concerned about the public health consequences of inaccurate results from the PGS device," the agency said today. "The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work.
NEWS
November 25, 2013 | By Paul Whitefield
OK, FDA guys, when it comes to that 23andMe genetic test I recently took, I just want to make one thing absolutely clear: My wife made me do it! It's a story as old as Genesis, really. My little Eve offered me - well, not an apple but a simple saliva test. “Here,” she purred, “aren't you curious. Who knows what it will show?” Meanwhile, I noticed later that my insurance papers were missing from the family safe. Oh Lord, where art thou? Not that I am trying to blame her, mind you. She is a wonderful woman who has only my best interests at heart.
SCIENCE
November 13, 2013 | By Melissa Healy, This post has been corrected. See note below.
Less than five months after a pair of biotech companies submitted a candidate cancer drug to the Food & Drug Administration, the FDA has approved the drug ibrutinib as a "breakthrough therapy" for a rare and deadly form of the cancer, mantle cell lymphoma. The new medication, to be marketed under the commercial name Imbruvica, becomes a new option for patients who are diagnosed with this malignancy of the immune system's B-cells and who have received at least one prior therapy. The medication is the first product developed by Sunnyvale, Calif., biotech firm Pharmacyclics, where its promise as a treatment for B-cell malignancies such as lymphoma became evident in 2009.
SCIENCE
November 8, 2013 | By Melissa Healy
Responding to the Food and Drug Administration's move to banish trans fats from the nation's diet, some public health advocates grumped Thursday that the agency was playing catch-up to a trend already well underway nationwide. Still, many of the same experts expressed hope that the FDA's move will open the way to a new era in the agency's regulation of food additives. By setting several new precedents, the FDA's decision on trans fats may bring some of our most beloved ingredients -- salt and sugar -- under new scrutiny by the agency, they predicted.
BUSINESS
November 7, 2013 | By David Pierson, Tiffany Hsu and Monte Morin
The long war on trans fats may be drawing to a close. The government proposed new rules Thursday that would all but ban the artery-clogging fats, a move that will force makers of margarine, frozen pizza and other processed foods to reformulate their products. Under the new rules, the Food and Drug Administration has declared that partially hydrogenated oils, the source of trans fats, are a food additive no longer "generally recognized as safe. " That would require companies wishing to use the ingredient to first seek approval from the FDA, which is unlikely to grant permission given the volume of research linking trans fats to heart disease.
BUSINESS
November 1, 2013 | Stuart Pfeifer
The appearance-obsessed can get Botox injections to erase wrinkles, Rogaine to reseed fading hair lines and the prescription medicine Latisse to fill out flimsy eyelashes. Soon, they may be able to get a shot to kill fat. A Southern California company has invested millions of dollars on an injectable, fat-destroying drug that it says will do away with double chins. Kythera Biopharmaceuticals Inc. said the drug, which for now is known by the code name ATX-101, has proved effective at diminishing double chins during trials on more than 1,000 volunteers in the United States and Canada.
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