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FDA clears first new weight-loss pill in 13 years

This photo provided by Food and Drug Administration shows Arena Pharmaceutical's anti-obesity pill Belviq. The Food and Drug Administration has approved Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade. The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. (AP Photo/Food and Drug Administration)

This photo provided by Food and Drug Administration shows Arena Pharmaceutical's anti-obesity pill Belviq. The Food and Drug Administration has approved Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade. The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. (AP Photo/Food and Drug Administration)

(AP) ? The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.

Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.

The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. The drug should be used in combination with a healthy diet and exercise.

Obesity Society President Patrick O'Neil said he's encouraged by the drug's approval because it underscores the notion that lifestyle changes alone are not enough to treat obesity.

"This is good news because it tells us that the FDA is indeed treating obesity seriously," said O'Neil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq. "On the other hand, it's not the answer to the problem ? or even a big part of the answer."

Even if the effects of Belviq are subtle, experts say it could be an important first step in developing new treatments that attack the underlying causes of obesity.

"The way these things tend to work is you have some people who do extremely well and other people don't lose any weight at all. But if we had 10 medicines that were all different and worked like this, we would have a real field," said Dr. Louis Aronne, director of the weight loss program at Weill-Cornell Medical College.

The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.

Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.

With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.

But a long line of prescription weight loss offerings have been associated with safety problems, most notably the fen-phen combination, which was linked to heart valve damage in 1997. The cocktail of phentermine and fenfluramine was a popular weight loss combination prescribed by doctors, though it was never approved by the FDA.

In a rare move, the FDA explicitly stated in a press release that Belviq "does not appear to activate" a chemical pathway that was linked to the heart problems seen with fen-phen.

The FDA said the drug acts on a different chemical pathway in the brain, which is believed to reduce appetite by boosting feelings of satiety and fullness.

Belviq is one of three experimental weight-loss drugs whose developers have been trying for a second time to win approval, after the FDA shot them all down in 2010 or early 2011 because of serious potential side effects.

Vivus Inc.'s Qnexa is thought to be the most promising of the drugs, achieving the most weight loss. But the FDA has delayed a decision on that pill until July.

Shares of San Diego-based Arena Pharmaceuticals Inc. jumped $2.54, or 28.7 percent, to close at $11.39. Shares of Mountain View, Calif.-based Vivus rose $1.94, or 7.4 percent, to $28.33. Shares of Orexigen Therapeutics Inc., the third drugmaker with an obesity pill before the FDA, rose 20 percent to close at $4.92.

Arena's studies showed that patients taking Belviq, known generically as lorcaserin, had modest weight loss. On average patients lost just 3 to 3.7 percent of their starting body weight over a year. About 47 percent of patients without diabetes lost at least 5 percent of their weight or more, which was enough to meet FDA standards for effectiveness. By comparison, average weight loss with Qnexa is 11 percent, with more than 83 percent of patients losing 5 percent of their weight or more.

The FDA said patients should stop taking Belviq after three months if they fail to lose 5 percent of their body weight. Patients are unlikely to see any significant weight loss by staying with the drug.

Side effects with the drug include depression, migraine and memory lapses.

In May a panel of expert advisers to the FDA voted 18-4 to recommend approval of Arena's drug, concluding that its benefits "outweigh the potential risks when used long term" in overweight and obese people.

Experts say the challenge of weight loss drug development lies in safely turning off one of the body's fundamental directives: to eat enough food to maintain its current weight.

While several drugs are available for short-term weight loss, until Wednesday there was only one FDA-approved prescription drug for long-term weight loss: Xenical from Roche, which is seldom prescribed because of unpleasant digestive side effects and modest weight loss. Belviq is the first new prescription drug approved to treat obesity since Xenical's approval 13 years ago.

Other safety failures for diet pills have continued to pile up in recent years.

Four years ago Sanofi-Aventis SA discontinued studies of its highly anticipated pill Acomplia due to psychiatric side effects, including depression and suicidal thoughts. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased heart attack and stroke.

Associated Press

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Huawei Ascend D Quad delayed?

Android Central

The Verge are reporting that the Huawei Ascend D Quad, that we first got hands on with at MWC back in February, is suffering a delayed release due to its powerful chipset.

Posting on the Chinese microblogging site Weibo yesterday, Yu Chengdong revealed that Huawei was experiencing "technical problems" with its ambitious K3V2 system-on-chip. But he noted that the company's R&D division was "stepping up efforts" to get it ready.

This news certainly will not do Huawei any favors with the likes of the HTC One X and Samsung Galaxy S III already being on sale. The Ascend D Quad is on par with the forementioned handsets specs wise and will be Huawei's flagship device this year.

The 4.5 inch 720P high definition touchscreen 'beast' is powered by Huawei's K3V2 quad-core 1.2GHz/1.5GHz processor so is set to give the other big players a run for their money.

Fingers crossed Huawei can iron out any problems sooner rather than later.

Source: The Verge

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Care for babies with food allergies lagging: study

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Freitag F60 Joan ? Cycling Carryall

Here’s a bag for all those cyclists out there who need to carry some gadgets but don’t like backpacks, messengers, or saddlebags. The F60 Joan?from Frietag?measures?in at 350 X 120 X 180mm (8.13 X 4.7 X 7.1 inches) and has a?4 litre capacity. Using hideable Velcro straps, it converts quickly and easily from a large [...]

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Colorado State University - Pueblo appoints faculty to Honors Program, Graduate Dean

Colorado State University - Pueblo appoints faculty to Honors Program, Graduate Dean

PUEBLO ?? Colorado State University-Pueblo Provost Dr. Rick Kreminski has announced the appointment of a new Honor?s Program Director and an Interim Dean of Graduate Studies and Research.?

Kreminski announced this week the appointment of Dr. Marc Pratarelli, professor of psychology, as Director of the University Honors Program and Dr. Kristy Proctor, professor of chemistry, as Interim Dean of Graduate Studies and Research.

Pratarelli replaces Dr. David Malet, assistant professor of political science, who has taken a position with the University of Melbourne in Australia.? Pratarelli has extensive experience working with students.

?Earlier this month, he attended an international conference (Human Behavior & Evolution Society, hosted by the University of New Mexico), where he accompanied four top psychology undergraduates who gave presentations,? Kreminski said.??

He has made more than 60 professional presentations with graduate and undergraduate students, and nearly 20 percent of his publications have been co-authored by students or former students. Pratarelli earned a bachelor?s degree from University of California, San Diego, and master?s and doctoral degrees from the University of California, Los Angeles. He has been on the CSU-Pueblo faculty since 1999.
?
Effective July 1, Dr. Kristy Proctor (Chemistry) will serve as Interim Dean of Graduate Studies and Research.? Proctor has extensive administrative experience, having served as department chair of Chemistry from 1994 to 2001; Assistant Provost 2001-2002; and Dean of the College of Science and Mathematics from 2002-2007. Proctor earned her bachelor?s degree in chemistry from CSU-Pueblo and a doctoral degree from CSU-Fort Collins.?

?She is passionate about graduate education, research, and grant-related projects, and looks forward to working with a wide variety of constituencies across campus,? Kreminski said.

Proctor, who has been at the University since 1989, replaces Dr. Mel Druelinger, who served for more than 10 years as Director of Research and Sponsored Programs and four years as Graduate Dean. He will leave full-time administration to return to his academic roots as full-time faculty member in the Department of Chemistry. Dr. Druelinger will assist with the transition to ensure a seamless transfer of duties.????????????????????????
The University will conduct a national search for the permanent dean position.

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Jerry Sandusky on suicide watch, undergoing evaluations

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92% Headhunters

Do you ever tire of hearing that a Hollywood remake is in the pipeline, when the ink has hardly dried on the original script? Like "The Girl With The Dragon Tattoo", "Cell 211" and "Let The Right One In" before it, this is another that has had the green light for an English language version. It's easy to see why there would be interest in this as it's an exceptionally good thriller. I just don't see why it's necessary to have it redone. Roger Brown (Aksel Hennie) is a high-flying businessman who works as a headhunter. He scouts potential applicants for executive jobs. While interviewing them, he learns very useful information that leads him to his second source of income: a sideline in executing valuable art robberies. His extravagant and expensive lifestyle can't be funded by his headhunting job alone. One particular interviewee is Clas Greve (Nicolaj Coster-Waldau). He has all the credentials for a post that Brown needs to fill but he also has just inherited a piece of art that will cure all of Brown's financial woes - if he can just get his hands on it. As it turns out though, this art theft is not as simple as his previous ones and Greve is not as buttoned up as he makes out. As this film opens we are introduced to unlikely leading actor Aksel Hennie who has an appearance that resembles the love child of Christopher Walken and Steve Buscemi. He's not your average leading man and his character is not that appealing either. He's a self-centred weasel of a man that seems to lack any morals but you know that things are, not entirely, going to go to plan for this scheming, double-crossing thief and that's exactly what captures your attention and provides the hook in this adaptation of Norwegian writer Jo Nesbo's novel. Director Morten Tyldum is wise enough to play his cards when he needs them and wrings out the suspense, masterfully, at every turn. He mounts the tension slowly before staging one gripping scene after another. The unpredictability of the spiralling plot delivers genuine excitement, helped immeasurably by natural characters and performers. Hennie in particular, is absolutely brilliant and will no doubt become a household name after this (apparently he already is, in his native Norway). Kudos to screenwriters Lars Gudmstead and Ulf Ryberg. It's their tight, deliberately paced and unpredictable script that keeps you guessing and shows a good level of intelligence. Admittedly, I haven't read the novel but if I were author Jo Nesbo, I'd be very proud of the job that has been done here. When the headhunter becomes the headhunted, this film grips like a vice and refuses to let go. I've seen quite a few film's from Scandinavia over recent years and have been very impressed with the high standard they are delivering. This is no exception and a thriller that will definitely compete with the best of the year.

June 12, 2012

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