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Fast Money Opportunity but Only if You're Nimble

Posted: February 23, 2012 at 1:35 pm

On Thursday, the Fast Money traders are expecting a big move from this stock. Is it on your radar?

Specifically, the pros are watching Vivus

[VVUS  Loading...      ()   ] after the company received a favorable ruling on its weight loss drug Qnexa. Back in 2010, the FDA rejected Qnexa because of safety concerns.

As bullish as that catalyst is – pro trader Guy Adami sees another reason for the stock to surge.

“There’s something like 20% short interest in Vivus,” he explains. “Expect the shorts to get squeezed. As a result the jump in this stock may be larger than anticipated."

And that’s where the trading opportunity comes in – but you have to be nimble. The Fast traders thinks the stock could overshoot to the upside.

“The stock could over pop early and then have a really big pullback,” says Pete Najarian. In other words if there's an extreme move trade accordingly.

Qnexa, which combines the appetite suppressant phentermine and anti-seizure drug topiramate, helped patients lose at least 10 percent of their weight after a year of treatment, the company said.

The FDA has not approved a new obesity drug since 1999.

Current DateTime: 04:40:11 23 Feb 2012
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Current DateTime: 04:40:11 23 Feb 2012
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Trader disclosure: On Feb 22, 2012, the following stocks and commodities mentioned or intended to be mentioned on CNBC’s "Fast Money" were owned by the "Fast Money" traders; Najarian is long AAPL; Najarian is long C; Najarian is long YHOO; Najarian is long HPQ; Najarian is long MOS; Najarian is long SCCO; Najarian is long COP; Najarian is long PFE; Najarian is long MRK; Adami is long C; Adami is long GS; Adami is long INTC; Adami is long MSFT; Adami is long NUE; Adami is long BTU; Adami is long AGU

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Kass is short SPY common and calls
Kass is short QQQ
Kass is short IWM
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Fast Money Opportunity but Only if You're Nimble

The New 'Old' Idea on Looking Young and Sexy

Posted: February 22, 2012 at 11:12 pm

SAN JOSE, Calif., Feb. 22, 2012 /PRNewswire/ -- From various diets and exercise routines to complicated medical procedures such as Botox and liposuction - people go to great lengths to look better, younger and sexier. Alex Guberman, the owner of the new upscale hair salon Exclussif in San Jose, California, has a different, much simpler and more affordable idea: new hairstyle! It's a much easier and faster solution to transfer yourself into a new, sexier and younger you.

"I don't think people realize how much their hair and makeup can affect their look," says Guberman. "You can make your nose appear smaller, your eyes look larger, your skin more glowing, your cheeks perkier and your smile shinier simply by changing the style, cut and color of your hair."

Guberman opened his new salon last year by partnering up with award-winning stylist Michael Yocum, a former Joico platform artist and a recipient of multiple hair color, styling and cutting awards over the last three decades. Yocum enjoys his work and it shows. "When a customer leaves my chair," says Yocum, "I give them more than just a hair style - I give them confidence, youth and character."

In only a few months of its grand opening, Salon Exclussif is already one of the top-rated salons on Yelp with a growing number of five-star reviews. Salon customers rave about the salon stylists' abilities to perform top-quality work on different types of hair, transforming their customers' images and looks. Services range from deep conditioning, blow dry and style items, all the way to keratin treatments, color and highlights, facial waxing, makeup, and many other services. All new clients receive a free consultation where they work with salon stylists on designing their new look and a plan on its proper maintenance.

Salon Exclussif is an exclusive Joico salon that not only carries a full Joico retail line but uses the Joico products on all of the clients.

Salon Exclussif, a member of Silicon Valley Chamber of Commerce, is also giving back. Five percent of all service revenues are automatically donated to a charity of each customer's choice. The choices of charities for Salon Exclussif customers include Silicon Valley Humane Society, Red Cross - Bay Area Chapter, as well as American Cancer Society and Our City Forest. Salon Exclussif is also a place where customers can donate their hair to Locks of Love - a non-profit organization that provides hairpieces to financially disadvantaged children suffering from long-term medical hair loss.

Visit http://www.exclussif.com for more information, featured video and Yelp reviews, or call 408-377-0100. Salon is located at 2039 Woodard Rd., in the Cambrian area of San Jose, CA.

Contact:

Alex Guberman
Salon Exclussif
408-377-0100

 

This press release was issued through eReleases(R).  For more information, visit eReleases Press Release Distribution at http://www.ereleases.com.

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The New 'Old' Idea on Looking Young and Sexy

Darfur patrol returns home safely after rebel blockade

Posted: February 22, 2012 at 11:12 pm

Home > News > world-news

Al-Fashir, Darfur, Feb 22 : A 55-person patrol of the United Nations-African Union peacekeeping force in Darfur returned to its home base on Tuesday after the team had been blockaded for nearly two days by armed rebels in the northwest of the troubled Sudanese region.

The mission (UNAMID) said ?a show of force and round-the-clock negotiations? resolved the incident after members of the rebel Justice and Equality Movement (JEM) blocked the patrol and later held two UNAMID language assistants and a police adviser.

?Our officers and their troops demonstrated true resolve, courage and compassion,? said Ibrahim Gambari, the head of UNAMID and the Joint Special Representative of the UN and AU in Darfur, which has been beset by fighting and large-scale displacement since 2003.

?Our troops held their ground; they called in reinforcements and they refused to leave the area without all personnel back on the patrol, including the Yemeni police adviser and two Sudanese language assistants. This afternoon everyone has returned, without injury and without any conditionality.?

The incident began on Sunday when the contingent ? comprising 50 Senegalese troops, three police advisers and two language assistants ? was blocked by more than 100 JEM members in the village of Shegeg Tova as it was carrying out a long-range patrol from its team site in Umm Baru.

The UNAMID troops then refused to leave until the two language assistants and the police adviser were released.

The stand-off ended after ?substantial peacekeeping reinforcements? were sent by the mission, which also made repeated contact with the leadership of JEM.

?Our peacekeepers criss-cross Darfur every day to help bring security to civilians who continue to suffer the effects of conflict,? Gambari said.

?We have a mandate to execute in all parts of Darfur. At the same time we are supporting an ongoing and inclusive peace process, including implementation of the Doha Document for Peace in Darfur. This deplorable action taken by JEM contradicts the spirit of this peace process, which most people in Darfur are welcoming.? (IBNS)

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Darfur patrol returns home safely after rebel blockade

Diet Drug Qnexa Gets Thumbs-Up From FDA Panel

Posted: February 22, 2012 at 11:12 pm

Luis Pedrosa/iStockphoto.com

A new weight-loss pill could be coming to the menu.

A key federal panel Wednesday recommended the Food and Drug Administration approve the first new weight-loss drug in more than a decade.

At the conclusion of a day-long hearing, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 to endorse a request from Vivus to approve the drug Qnexa. The same panel gave a thumbs-down to Qnexa in 2010.

Qnexa is a combination of two generic drugs that are already on the market:

phentermine, a stimulant used for short periods to help control weight, and topiramate, typically used for migraines and seizures.

The FDA doesn't have to follow the advice of the panel, but the agency usually does.

 

The FDA rejected Qnexa in 2010 because of concerns about side effects, especially possible heart problems and birth defects such as cleft lips and cleft palates. The rejection came amid a series of rejections and withdrawals of weight-loss drugs, which put a spotlight on the FDA's handling of obesity medications.

Despite the obesity epidemic, the FDA hasn't approved a new weight-loss drug since 1999. In 2011, the the diet drug Meridia was pulled from the market at the request of the FDA because of concerns about heart problems. Only one weight-loss drug, Xenical, remains on the market for long-term use, but it is only marginally effective and causes diarrhea and other unpleasant side effects.

Some advocates have urged the FDA to consider allowing some drugs to be on the market even if they have risks, given the serious health problems caused by obesity.

During Wednesday's hearing, Vivus gave a series of presentations designed to show show that the benefits of the drug outweigh the risks. The risk of birth defects, one concern, was relatively low. And obesity itself can increase the danger that women will give birth to babies with birth defects, according to one presentation.

In addition, Qnexa appears to have other health benefits beyond weight loss, such as lowering blood pressure, that could outweigh any risks posed by an increase in the heart rate seen in some patients, according to another presentation.

Vivus also outlined a plan to reduce the risk that pregnant women might take Qnexa, including regular pregnancy testing of women taking the drug.

For its part, the FDA presented concerns it had highlighted in new analyses posted on its website Friday, especially the increased risks for birth defects and the elevated heart rate. The federal Centers for Disease Control and Prevention also presented data on the birth defect risk from topiramate.

During the public comment part of the hearing, several obesity experts urged the panel to recommend approval, saying diet and exercise simply do not work for many people.

Kelly Close, who described herself as an advocate for people with obesity and diabetes, urged the panel to endorse the drug. She noted few drugs were in the pipeline for obesity. "The panel and the FDA has a chance to today to do something historic for obesity," Close said.

Joe Nadglowski of the Obesity Action Coalition, agreed. He noted that only one member of the committee had any experience with treating obesity.

"There is a significant treatment gap from Weight Watchers to bariatric surgery," Nadglowski. "There is a consequence of remaining obese."

Several health advocates, however, appealed to the panel to recommend against the drug, saying the risks outweighed the benefits.

"Qnexa doesn't give women what they need," said Kate Ryan of the National Women's Health Network, noting that many people regain whatever weight they lose while taking Qnexa once they stop taking the drug.

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Diet Drug Qnexa Gets Thumbs-Up From FDA Panel

FDA Advisers Recommend New Diet Drug

Posted: February 22, 2012 at 11:12 pm

Food and Drug Administration advisers voted against the pleas of consumer advocates on Wednesday to recommend approval of what would be the first new diet drug to hit the US market in 13 years. Called Qnexa, the pill is a combination of two older drugs – one itself a diet pill called phentermine, and an anti-seizure drug that appears to help suppress appetite as part of the combination.

Such a new drug is desperately needed, with two-thirds of Americans overweight or obese. Current weight-loss products are limited and have only modest effects. But the field has been littered with failures, as many drugs have often deadly side effects – such as the heart valve damage caused by the once popular combination of phentermine and fenfluramine—Fen-Phen for short.

Two other companies have diet drugs up for approval too, and the FDA advisers recommended extra studies on the heart effects of all the drugs.

“Of all the obesity drugs, this one has the highest efficacy in terms of weight loss, so that shifts the balance in terms of requiring a post-approval study rather than a pre- approval study,” Sanjay Kaul, a cardiologist at UCLA, said at the FDA panel meeting.

Public Citizen objected.

“Public health cannot tolerate yet another drug approval for a diet drug not accurately assessed for cardiovascular risks, especially in light of suggestive findings of such risks with Qnexa,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The danger of another approved diet drug hitting something vital – the cardiovascular system – is no longer acceptable when it could be prevented by a large clinical trial powered to evaluate such risk prior to approval.”

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FDA Advisers Recommend New Diet Drug

Diet drug Qnexa should be approved, panel says

Posted: February 22, 2012 at 11:12 pm

The diet drug Qnexa has cleared a major hurdle toward eventual Food and Drug Administration approval. An independent panel of medical experts who advise the agency voted Wednesday that Qnexa's significant weight-loss benefit outweighed its potential risks.

The hearing was held in Silver Spring, Md. The surprisingly positive 20-2 vote in favor of approval moves the decision on Qnexa into the hands of the FDA, which will issue a final ruling later this year.

The agency typically follows the recommendations of an advisory committee but is not bound by it. If approved, as is now expected, Qnexa would be the first prescription diet drug to reach the market since 1999. The drug, made by Vivus Inc.of Mountain View, Calif., is a combination of the anticonvulsant topiramate and the appetite suppressant phentermine.

Studies show the medications produced an average of about 10% loss of body weight in the first two years of use. "The benefits of that degree of weight loss have been clear and unambiguous," said Dr. Stephen Smith, scientific director at the Translational Research Institute in Orlando, Fla., who was not involved in the vote. "We fully understand the topiramate risk, and the phentermine risk we have a pretty good handle on as well." The committee's vote, he said, "recognizes that doing nothing in obesity has it consequences."

More than 35% of American adults are obese and another third are overweight. Only one prescription diet drug is available in the United States. However, both topirimate and phentermine have side effects. Last year, the FDA reclassified topiramate as a class D drug, meaning it carries risks to a fetus but may still be acceptable for use in pregnant women despite the risks.

Clinical trials on Qnexa also showed an increased risk of birth defects -- typically cleft lip -- in women who became pregnant on the drug. The study also found that users have an increase in heart rate. These side effects led to a thumbs-down vote when Qnexa came before the FDA advisory committee in 2010. The FDA subsequently denied approval in October 2010, citing potential safety problems.

But officials for Vivus Inc. have proposed a tightly controlled system for prescribing Qnexa to prevent birth defects, including healthcare provider training, monthly pregnancy testing, a patient medication guide and limits on which pharmacies can dispense the medication, such as registered mail-order pharmacies.

"We will know who the prescribers are. We will know who has been trained," said Dr. Barbara Troupin, senior director of global medical affairs for Vivus. "We are confident the Qnexa [risk management program] balances the safeguards while allowing access for appropriate patients." Moreover, the panel strongly encouraged that Vivus conduct a post-marketing study to better understand the potential cardiovascular side effects of Qnexa.

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Diet drug Qnexa should be approved, panel says

WEIGHT LOSS TRANSFORMATIONS: WHY HIGH CARB LOW FAT WORKS – Video

Posted: February 22, 2012 at 11:12 pm

10-02-2012 23:15 WEIGHT LOSS TRANSFORMATIONS: WHY HIGH CARB LOW FAT WORKS Dietary thermogensis is the reason why 1000% of LONGTERM high carb low fat munchers are slim beans. Low carb HIGH FAT = High body fat and bad arteries. Hence why the majority of paleo, primal diet, low carb diet promoters have excess weight issues unless they are using steroids like is common in that scene unfortunately. Raw food diet vegan high carb low fat style based on fruit keeps you slim naturally. How to get a flat stomach, how to lose weight fast, how to lose weight with raw foods.how to start a raw food diet? all these questions and more answered by Durianrider and Freelee on our channels. Thanks for watching! 🙂 Durianrider on Facebook http://www.facebook.com To Donate to Durianrider: http://www.paypal.com Durianriders 2$ audio mp3 and blog links below. ?www.30bananasaday.com Blog ?www.durianrider.org? TAGS goal weight dream goal weight loss journey losing the fat weight watchers watch me shrink weight loss losing weight slim down baby fat shrinking calorie burning exercise calorie counting health and fitness diet and exercise diet and fitness diet bathing suit swimsuit before and after vegetarian raw food vegan durianrider freelea freelee

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WEIGHT LOSS TRANSFORMATIONS: WHY HIGH CARB LOW FAT WORKS - Video

TayTay’s 100lb Weight Loss Journey weigh in 20

Posted: February 22, 2012 at 11:12 pm

16-02-2012 16:28 TayTay's 100lb Weight Loss Journey weigh in 20 and 21.

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TayTay's 100lb Weight Loss Journey weigh in 20

FDA panel backs weight loss drug Qnexa

Posted: February 22, 2012 at 11:11 pm

SILVER SPRING, Md. — A panel of advisers to the Food and Drug Administration overwhelmingly backed approval for a highly anticipated anti-obesity pill called Qnexa, a drug which the FDA previously rejected due to safety concerns.

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The FDA panel of outside physicians voted 20-2 Wednesday in favor of the weight loss drug from Vivus Inc., setting the stage for a potential comeback for a drug that has been plagued by safety questions since it was first submitted to the agency in 2010.

A majority of panelists ultimately backed the drug due to its impressive weight loss results, with most patients losing nearly 10 percent of their overall weight after a year on the drug. But the group stressed that the drugmaker must be required to conduct a large, follow-up study of the pill's effects on the heart. Studies of Qnexa show it raises heart rate and causes heart palpitations, a longtime concern with diet pills over the years. The group of experts said it is still unclear if those side effects lead to heart attack and more serious cardiovascular problems.
"The potential benefits of this medication seem to trump the side effects, but in truth, only time will tell," said Dr. Kenneth Burman of the Washington Hospital Center.

The FDA is not required to follow the advice of its panels, though it often does. A final decision on the drug is expected in April.

In a key question, the physicians said Vivus could conduct its study after FDA approval. Conducting the study ahead of market approval would cost the company millions of dollars and take at least three more years.

"There is an urgent need for better pharmacologic options for individual patients with obesity," said Dr. Elaine Morrato, of the University of Colorado. "I believe Qnexa demonstrated a meaningful efficacy benefit and that there are consequences to not treating obesity."

Vivus, based in Mountain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.

The FDA rejected the diet pill Qnexa in October 2010, citing numerous side effects including raised heart rate, psychiatric problems and birth defects. Vivus has resubmitted the drug with additional follow-up information on safety, hoping for a more favorable ruling.

Vivus President Peter Tam said the overwhelming panel vote Wednesday underscores the need for effective weight loss drugs.

"I think they see the medical need," Tam said. "Right now there aren't any good treatments out there besides dieting and bariatric surgery, clearly there's a huge gap."

With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. Analysts expect a new weight loss pill to garner at least 10 million users within a few years.

Qnexa is a combination of two older drugs: the amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an antiseizure and antimigraine drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.

Along with heart safety, panelists raised concerns about potential birth defects in women who become pregnant while taking Qnexa. One of the two ingredients in the combination pill, topiramate, is known to more than double the risk of birth defects.

There were 34 pregnancies among 3,386 women enrolled in Vivus' studies of Qnexa, despite precautions to make sure women used contraception. An FDA expert on birth defects estimated there would be five babies born with a cleft lip defect for every 1,000 women who became pregnant while taking Qnexa.

If approved, FDA scientists said they would require Vivus to train prescribers in the pregnancy risks of Qnexa and distribute warning pamphlets to patients. The drug would only be available from 10 mail-order pharmacies. An experimental obesity drug from Vivus Inc won a U.S. panel's support on Wednesday, raising hopes regulators would approve a weight-loss pill for the first time in 13 years.

A panel of outside experts to the Food and Drug Administration voted 20-2 to recommend approval of Qnexa, meant to treat obesity and its accompanying health problems.

The FDA usually follows panel recommendations, although it is not required to, and a final decision is expected by April 17.

© 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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FDA panel backs weight loss drug Qnexa

Vivus Weight-Loss Pill Qnexa Wins Backing of FDA Advisory Panel

Posted: February 22, 2012 at 11:11 pm

By Anna Edney - Wed Feb 22 22:13:35 GMT 2012

Vivus Inc. (VVUS)’s weight-loss pill Qnexa won the backing of a U.S. advisory panel as the company seeks to gain approval for the first new obesity drug in 13 years.

Advisers to the Food and Drug Administration voted 20-2 today that Qnexa’s benefits outweigh its risks at a meeting at agency headquarters in Silver Spring, Maryland. The FDA isn’t required to follow the panel’s recommendation. The agency is scheduled to make a decision on the drug, which it rejected in 2010, by April 17.

Qnexa is one of three medications vying for the first U.S. approval of a prescription weight-loss treatment since Swiss drugmaker Roche Holding AG (ROG)’s Xenical in 1999. The FDA plans to have advisers discuss in March the possibility of requiring heart-risk studies for all weight-loss drugs. Panel members discussed whether Vivus should conduct such a study before or after approval.

“Of all the obesity drugs, this one has the highest efficacy in terms of weight loss, so that shifts the balance in terms of requiring a post-approval study rather than a pre- approval study,” said Sanjay Kaul, a cardiology professor in the David Geffen School of Medicine at UCLA Cedar Sinai Medical Center and a panel member.

Regulators raised concerns that Qnexa may contribute to a greater risk of heart ailments and birth defects. The medicine combines the appetite suppressant phentermine with topiramate, an antiseizure and migraine drug. The Mountain View, California- based company has proposed a post-approval trial to assess Qnexa in reducing major heart complications in obese, at-risk patients. The trial would involve 11,300 patients and take four and a-half years.

Sales Potential

Analysts say the drug, if approved, may generate $448 million in sales in 2015.

Topiramate is the active ingredient in Johnson & Johnson (JNJ)’s Topamax. The anticonvulsant is also associated with confusion, difficulty with concentration and memory loss.

Vivus’ analysis of heart risks for Qnexa was “somewhat reassuring,” though the significance of an observed increase in heart rate was “uncertain,” FDA staff said Feb. 17 in a report.

More than one-third of U.S. adults are obese, and another third are overweight, according to the Centers for Disease Control and Prevention. The obesity rate among adults has more than doubled since 1980 to 72 million people.

Obesity Risks

Obesity raises the risks of diabetes, heart attacks and stroke, and costs the U.S. economy an estimated $147 billion a year in medical expenses and lost productivity, according to the Atlanta-based CDC.

Orexigen Therapeutics Inc. (OREX), based in La Jolla, California, and San Diego-based Arena Pharmaceuticals Inc. (ARNA) also are seeking approval for their obesity medicines, which the FDA refused to approve without more data on safety risks.

Vivus examined medical claims data and found five oral clefts in a group of 1,740 children whose mothers had taken topiramate alone in the first trimester of pregnancy, for a prevalence rate of 0.29 percent, the company said Dec. 21 in a statement. That compared with a rate of 0.16 percent in the group whose mothers had taken antiseizure drugs, including topiramate, before pregnancy.

Vivus plans to finish the results in the third quarter of this year, after the April 17 deadline for the FDA to decide whether to approve the drug. The risk of oral clefts hasn’t been fully answered by the interim data, FDA staff said.

Topiramate Effects

The FDA asked Vivus in January to remove wording from Qnexa’s proposed prescribing label advising women with the potential to become pregnant against taking it. The FDA staff said in the Feb. 17 report severely restricting Qnexa isn’t practical because topiramate also treats other serious conditions.

Panel members suggested the FDA should consider restricting topiramate used for seizures and migraines for women of childbearing age.

“I just can’t get my mind around why it would be different,” said Lamont Weide, chief of diabetes and endocrinology at the Truman Medical Centers Diabetes Center in Kansas City and a member of the panel.

Russell Katz, director of FDA’s neurology products division, said the agency hasn’t considered restricting the drug because there aren’t many options for migraine prevention.

Vivus has suggested restricting distribution of Qnexa to less than 10 large mail-order pharmacies with pharmacists trained in dispensing the drug, Barbara Troupin, senior director of global medical affairs at the company, said.

In addition to Roche’s Xenical, London-based GlaxoSmithKline Plc (GSK)’s Alli, a half-dose version of Xenical’s active ingredient, won FDA clearance in 2007 as the first diet drug available without a prescription.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net

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Vivus Weight-Loss Pill Qnexa Wins Backing of FDA Advisory Panel


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