First World Fitness Business Owners Summit (WFBOS) Launches August 1, 2012 - A Global Online-Virtual Conference

Share: Tweet25
Jul
2012Ken Baldwin, Executive Director of National Posture Institute, is pleased to announce his selection as a partner in the World Fitness Business Owners Summit (WFBOS). It is a global online-virtual conference starting Aug. 1 with free registration.

(1888PressRelease) July 25, 2012 - Ken Baldwin, Executive Director of the National Posture Institute, is pleased to announce his selection as a partner in the first annual World Fitness Business Owners Summit (WFBOS). It is structured as a global online-virtual conference for fitness business owners around the world, featuring the top 25 luminaries and thought leaders in the health and fitness industry. The Pre-Summit series, August 1-31, 2012, offers a FREE opportunity to sample the sessions of the full Summit before registering. The Main Summit runs September 14-29, 2012 (Early Bird: $197.00, until August 31, 2012 & Full Price: $497.00). The National Posture Institute provides all WFBOS attendees with a 20% discount to NPI Certificate Programs. Click here to learn more and register: http://www.npionline.org/workshops/WFBOS

These presenters will present their best practices and most valuable insights to thousands of health and fitness professionals worldwide who desire to learn from the finest minds and most successful leaders in the profession. Among the skills, topics and proven strategies attendees can expect to learn about include highly effective coaching, sales, niche leadership, creation of complimentary products and multiple income streams, client retention, intellectual property, social media, networking and much more.

A predicted 7000 health and fitness professionals from 129 countries are set to participate in the first WFBOS conference held via easy-to-use webinar technology. The draw, says WFBOS Presidents Rana Saini and Selina Scoble, is the highest caliber of health and fitness experts can deliver sales-pitch-free, rich content to live audiences that can interact with them in one virtual place, therefore connecting the global fitness community for the first time ever. For more details visit: http://www.npionline.org/workshops/WFBOS

"I'm extremely honored to have been selected to present at the First-Ever World Fitness Business Owners Summit (WFBOS)," stated Kenneth Baldwin, Executive Director of the National Posture Institute.

During the Summit, attendees can ask questions of presenters real-time and interact with other attendees. Members' forums encourage networking while shared Google docs enable collaboration. The full Summit will feature one to three live sessions per day that are all recorded and can be accessed for six months afterwards. Three live satellite events will be held in Europe, Asia Pacific and the Americas.

To register for the Pre-Summit or the Full Summit, please visit http://www.npionline.org/workshops/WFBOS

About the National Posture Institute (NPI)
The National Posture Institute (NPI) is an educational and member-driven organization, providing health and fitness educational programs, public outreach, corporate wellness, and professional certificate programs for allied health/medical/fitness professionals as well as posture education programs for the general public. NPI is dedicated to delivering education through innovative educational resources, teaching solutions, and courses.

For More Information Contact:
Kenneth Baldwin, Executive Director, NPI
Email: ken (

View the Original article

First Canadian P.F. Chang's Restaurant to Open at Shops at Don Mills

Share: Tweet24
Jul
2012P.F. Chang's opens it's first restaurant in Canada at Shops at Don Mills.

(1888PressRelease) July 24, 2012 - P.F. Chang's China Bistro will be opening their very first Canadian location at the prestigious Shops at Don Mills on July 27, 2012 at 5:00 PM. Their unique brand of Chinese-inspired cuisine promises to delight the culinary taste buds and refined palettes of Torontonians visiting the city's newest dining hotspot.

The atmosphere of P.F. Chang's China Bistro echoes that of its sister locations, with stylish d

View the Original article

World's first dengue vaccine beats three virus strains

"mod_id":"mediasocialchromepromos","facepile":1,"property":"news","learnmore_path":"/activity-learn-more/","moduleConf":YAHOO.Media.Facebook.ModuleConf

View the Original article

FDA approves first pill to help prevent HIV

The Food and Drug Administration on Monday approved the first drug shown to reduce the risk of HIV infection, the latest milestone in the 30-year battle against the virus that causes AIDS.

The agency approved Gilead Sciences' pill Truvada as a preventive measure for healthy people who are at high risk of acquiring HIV through sexual activity, such as those who have HIV-infected partners. The decision comes less than two weeks after the agency approved another landmark product: the first over-the-counter HIV test that Americans can use in the privacy of their homes.

The two developments are seen as the biggest steps in years toward curbing the spread of HIV in the U.S., which has held steady at about 50,000 new infections per year for the last 15 years. An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. And it's estimated that one-fifth, or about 240,000 people, are unaware that they are infected.

"I think the combination of self-testing and a medicine that you can take at home to prevent infection could mean a whole new approach to HIV prevention that is a bit more realistic," said Dr. Demetre Daskalakis of New York University's Langone Medical Center, who served on the FDA panel that recommended approving Truvada. While a positive step forward, Daskalakis added that Truvada would likely be unavailable for many people without health insurance, who often face the greatest risk of acquiring HIV.

Researchers had long sought to create a pill that could help stem the epidemic. Public health advocates said Monday that Truvada represents a major breakthrough, both as a medical therapy and as a means of expanding other preventive measures. Patients who get a prescription for Truvada will be expected to take part in a comprehensive HIV prevention plan, which experts say will enhance the drug's impact.

"It really marks a new era in HIV prevention because in adding Truvada as a prevention strategy, what comes with it is expanded access to HIV testing, condoms and preventive counseling and support," said James Loduca, vice president of the San Francisco AIDS Foundation.

But HIV experts have raised concerns that patients might not use the drug correctly. Dr. Tom Giordano of Baylor College of Medicine said Monday the drug must be taken every day to be effective, and would be most effective for a relatively small group of people.

"It's been most effective in people who are at very high risk and are able to take the drug on a regular basis," said Giordano, who served on the FDA panel that recommended approving the drug. "When you really boil it down that's going to be a relatively focused population, but it's an important population to treat."

The drug's label carries a warning that people should be tested to make sure they don't have HIV before starting Truvada. Patients who already have the virus could develop resistance to the drug, making their disease more difficult to treat. The label also warns of side effects, including kidney and liver problems.

Gilead Sciences Inc. has marketed Truvada since 2004 as a treatment for people who are already infected with the virus. The once-a-day pill is a combination of two older HIV drugs, Emtriva and Viread.

Starting in 2010, studies showed that the drug could prevent people from contracting HIV when used as a precautionary measure. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling. Last year, another study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was infected with HIV and the other was not.

Because Truvada is on the market to manage HIV, some doctors already prescribe it as a preventive measure. FDA approval will allow Gilead Sciences to formally market the drug for that use, which could dramatically increase prescriptions.

Truvada's groundbreaking preventive ability has exposed disagreements about managing the disease among those in the HIV community. Groups including the AIDS Healthcare Foundation asked the FDA to reject the new indication, saying it could give patients a false sense of security and reduce the use of condoms, the most reliable preventive measure against HIV.

But FDA scientists said Monday said there was no indication from clinical trials that Truvada users were more likely to engage in risky sexual behavior.

"What we found was that condom use increased over time and sexually transmitted infections either remained at baseline levels or decreased," said Dr. Debra Birnkrant, FDA's director of antiviral products. "So in essence, we don't have any strong evidence that condoms were not used or there was a decrease in condom use."

Gilead Sciences said Monday that it would keep the pill at its current price, nearly $14,000 per year. Even at that price, HIV physicians said the drug could be cost effective if it prevents people from contracting the virus.

"It is expensive, but on the other hand it's far cheaper than a lifetime of HIV treatment," said Dr. Joel Gallant of Johns Hopkins University School of Medicine. "So if there are people who will not use condoms but are willing to use this, then for those people it's cost effective."

The lifetime cost of treating one person diagnosed with the AIDS virus has been estimated at more than $600,000.

The decision by the FDA on Truvada follows its approval of the OraQuick test earlier this month. The test, which detects the presence of HIV in saliva collected using a mouth swab and returns a result within 40 minutes, is aimed at people who might not otherwise be tested. The FDA has said the test is not 100 percent accurate.

View the Original article

FDA Approves Truvada as First HIV Prevention Drug

in addition, patients must also practice safe sex, go through risk reduction counseling and undergo regular HIV testing.

Because of the stringent guidelines the FDA is strengthening the box warnings that patients must be confirmed that they’re HIV negative and must be tested for the virus every three months while they’re on the medication.

View the Original article

Gilead wins first approval of drug to prevent HIV

Reuters – 21 hrs ago (Reuters) - Health regulators for the first time approved using an HIV drug to prevent infection in people who are at high risk of contracting the virus that causes AIDS.

Gilead Sciences Inc's Truvada was approved for people who are not yet infected but may engage in sexual activity with HIV-infected partners, a concept known as pre-exposure prophylaxis (PrEP).

Truvada, which combines two anti-HIV drugs in one pill, is already approved in combination with other antiretroviral agents to treat patients 12 years of age and older who are infected with the virus.

Under the new Food and Drug Administration approval Truvada taken daily, is to be used along with safer sex practices, risk reduction counseling and regular HIV testing to reduce the risk of sexually acquired HIV infection in adults deemed to be at high risk.

"Today's approval marks an important milestone in our fight against HIV," FDA Commissioner Margaret Hamburg said in a statement.

Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, Hamburg said. "New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."

A landmark study published in 2010 found that giving a daily dose of Truvada to men who have sex with other men could reduce HIV infection rates by 44 percent.

The use of combination therapies for people already infected with HIV has turned the virus that was once a sure death sentence into a condition people can live with for many years.

Meanwhile, researchers have been working for decades to come up with a vaccine that would prevent the virus from infecting people only to be disappointed time and again. A 2009 clinical trial in Thailand was the first to show it was possible to prevent HIV infection in humans, and more powerful vaccines using HIV-fighting antibodies are being studied amid renewed optimism that a vaccine may be within reach.

Debra Birnkrant, director of the Division of Antiviral Products at the FDA, said the federal government has a goal of a 25 percent decrease in HIV infections in the United States by 2015, and added that responsible use of Truvada for prevention could help achieve it.

In a conference call with reporters, Birnkrant was asked if the drug might give people a false sense of security that could tempt them to stop using condoms or otherwise engage in unsafe sex.

"We are concerned about risk-taking behavior, however, the (clinical) trials did not bear that out," she said. In one U.S. trial involving 400 men who have sex with other men, she said there was not an increase in unsafe sex.

"The hope is the right messages will get out and Truvada will be used properly," she said.

As part of the approval, the FDA is strengthening the warning label on the drug to make sure physicians screen individuals to ensure they are not infected with the HIV virus before prescribing the medication as a preventive measure, and at least every three months during use.

The approval comes with a risk mitigation program that includes training and education to assist prescribers in counseling people considering Truvada as a prophylaxis.

As a condition for approval, Gilead is required to collect samples from individuals who acquire HIV while taking Truvada and to evaluate them for potential resistance to the drug. It is also required to collect data on pregnancy outcomes for women who become pregnant while taking Truvada as prophylactic.

Gilead's shares closed up 1.5 percent at $51.94 on Nasdaq.

(Reporting by Toni Clarke in Boston and Ransdell Pierson and Bill Berkrot in New York; Editing by Maureen Bavdek, Bernard Orr)

View the Original article

First Drug Approved to Lower Risk of Acquiring HIV

HealthDay – 2 hrs 2 mins ago TUESDAY, July 17 (HealthDay News) -- Truvada (emtricitabine/tenofovir disoproxil fumarate) is the first drug to be approved by the U.S. Food and Drug Administration to reduce the risk of contracting HIV among adults at higher risk of acquiring the AIDS-causing virus.

In a statement, the agency said Truvada was meant to be taken daily to reduce the chances of becoming HIV-infected among adults exposed to the virus. The agency previously approved Truvada in combination with other anti-viral drugs to treat HIV-infected people 12 years and older.

The FDA said it would strengthen the drug's label to warn that people who take the drug as a preventive should confirm they are not already HIV infected.

Truvada's safety and effectiveness were clinically evaluated among 2,499 HIV-negative gay men and transgender women "with evidence of high risk behavior for HIV infection," the agency said. Results showed the drug reduced HIV infection by 42 percent, compared with those who took a placebo.

A second study involved 4,758 heterosexual couples where one partner was infected, while the other was not. Truvada reduced the risk of transmitting infection by 75 percent, compared to those who took a placebo, the FDA said.

The most common side effects reported were diarrhea, nausea, abdominal pain, headache and weight loss. Most serious but less common adverse reactions included kidney or bone toxicity.

Drugmaker Gilead Sciences, based in Foster City, Calif., is required to conduct follow-up studies to evaluate long-term HIV resistance, and the drug's effects among pregnant women, the FDA said.

More information

To learn more about this disease, visit AIDS.gov.

View the Original article

First Drug Approved to Lower Risk of Acquiring HIV

HealthDay – 2 hrs 1 min ago TUESDAY, July 17 (HealthDay News) -- Truvada (emtricitabine/tenofovir disoproxil fumarate) is the first drug to be approved by the U.S. Food and Drug Administration to reduce the risk of contracting HIV among adults at higher risk of acquiring the AIDS-causing virus.

In a statement, the agency said Truvada was meant to be taken daily to reduce the chances of becoming HIV-infected among adults exposed to the virus. The agency previously approved Truvada in combination with other anti-viral drugs to treat HIV-infected people 12 years and older.

The FDA said it would strengthen the drug's label to warn that people who take the drug as a preventive should confirm they are not already HIV infected.

Truvada's safety and effectiveness were clinically evaluated among 2,499 HIV-negative gay men and transgender women "with evidence of high risk behavior for HIV infection," the agency said. Results showed the drug reduced HIV infection by 42 percent, compared with those who took a placebo.

A second study involved 4,758 heterosexual couples where one partner was infected, while the other was not. Truvada reduced the risk of transmitting infection by 75 percent, compared to those who took a placebo, the FDA said.

The most common side effects reported were diarrhea, nausea, abdominal pain, headache and weight loss. Most serious but less common adverse reactions included kidney or bone toxicity.

Drugmaker Gilead Sciences, based in Foster City, Calif., is required to conduct follow-up studies to evaluate long-term HIV resistance, and the drug's effects among pregnant women, the FDA said.

More information

To learn more about this disease, visit AIDS.gov.

View the Original article

FDA approves first at-home HIV test from OraSure

Reuters – Tue, Jul 3, 2012 (Reuters) - U.S. health regulators on Tuesday said they approved OraSure Technologies Inc's in-home test for HIV, making it the first over-the-counter, self-administered test for the virus that causes AIDS.

The Food and Drug Administration gave its green light to the OraQuick In-Home HIV Test, which within 20 to 40 minutes provides results from an oral fluid sample taken by swabbing the upper and lower gums inside the mouth.

Shares of the company, which were halted pending the FDA announcement, closed up 5.2 percent at $12.10 on Nasdaq.

The company said the test -- already approved for use by trained technicians -- will be available starting in October at more than 30,000 retailers and online. The price will be set closer to the launch date, it said.

OraSure, on a conference call with reporters, said it expects the retail price will be slightly higher than the $17.50 it charges for professional use to account for costs associated with packaging, labeling and other support expenses.

"We expect all the major retail outlets to carry this product," Douglas Michels, OraSure's chief executive, said.

Once the product is launched, he said, the company is planning a "pretty massive effort to communicate with consumers." A direct to consumer campaign will include television, print, radio and social media advertising.

Michaels declined to provide any revenue projections for the at home version of its HIV test kit, but said it will be a significant future contributor to OraSure's top and bottom line.

He said he believes the U.S. market for in home HIV testing to be in excess of $500 million.

The FDA cautioned that a positive result from the OraQuick test does not mean an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the result.

About 1.2 million people in the United States are living with HIV infection, but one in five are not aware of it, according to estimates from the Centers for Disease Control and Prevention. About 50,000 new people are infected with HIV each year, often from people who may not know they have the virus, the FDA said.

"Knowing your status is an important factor in the effort to prevent the spread of HIV," said Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."

An FDA advisory committee of outside experts voted unanimously in favor of the test in May, saying its ability to prevent new HIV infections and link people to medical care and social services outweighed the risk of false results.

Clinical trials for the test showed it was accurate 92 percent of the time in diagnosing people who had HIV -- meaning one out of every 12 test results would be a false negative.

False negatives are of particular concern because they could lead HIV-positive individuals to take fewer precautions, raising the danger that they will engage in unprotected sex.

The test accurately gave a negative result for those without HIV in 99.98 percent of cases, meaning there would be only one false positive result out of every 5,000 tests.

"We set out with a clear purpose - to dramatically impact the number of people getting tested for HIV nationwide," Michels said. "Today's FDA approval of OraQuick brings us much closer to accomplishing that goal."

The company hopes to eventually expand the availability of its home HIV test to other countries, the CEO said.

(Reporting by Bill Berkrot in New York and Anna Yukhananov in Washington; Editing by Maureen Bavdek, Jim Marshall, John Wallace and Bernard Orr)

View the Original article

FDA approves first rapid, take-home HIV test

"background-image:url('http://l3.yimg.com/bt/api/res/1.2/UznQqD5l0k1VLmKGYQ9apw--/YXBwaWQ9eW5ld3M7Y2g9MTMyMjtjcj0xO2N3PTIwMDA7ZHg9MDtkeT0wO2ZpPXVsY3JvcDtoPTEyNjtxPTg1O3c9MTkw/http://media.zenfs.com/en_us/News/ap_webfeeds/bff112789fea5412140f6a706700eb4d.jpg');" width

View the Original article

FDA Approves First At-Home HIV Test

HealthDay – Tue, Jul 3, 2012 TUESDAY, July 3 (HealthDay News) -- The U.S. Food and Drug Administration on Tuesday approved the first do-it-yourself HIV test that would give people their results in the privacy of their own home.

The test, called OraQuick(R) In-Home HIV Test, involves swabbing the gums, placing the swab into a vial, and then seeing the results within 20 minutes, the agency said in a statement.

The test kit's approval could herald a new era in HIV prevention, experts say. According to the CDC, more than 1.2 million Americans carry the virus that causes AIDS, but about one in five are unaware that they are infected and can pass HIV on to others.

"Knowing your status is an important factor in the effort to prevent the spread of HIV," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in the statement. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."

The move comes two months after a 17-member FDA advisory panel voted unanimously that the benefits of the test were greater than any possible risks.

OraSure Technologies Inc., which makes the over-the-counter test, already sells a version of it to doctors and other health professionals. Studies have shown the test was less accurate when used by consumers, but the FDA advisory panel agreed that the benefits of expanding HIV testing still outweighed a small drop in test accuracy.

Dr. Nitika Pant Pai, an assistant professor of medicine at Montreal's McGill University, said that "by making self tests available over the counter, a stigmatized HIV diagnosis will be normalized to some extent."

She added that, "individuals are not averse to the test, but to the process of testing. With an oral test that is convenient, noninvasive and highly accurate in the hands of a trained user and fairly accurate in the hands of an untrained user, individuals will be motivated to seek testing." Pai co-authored an analysis of the effectiveness of an at-home HIV test earlier this year.

The test, which looks for signs of HIV in oral fluid, is already used at hospitals and doctors' offices where medical professionals administer it. The FDA first approved that use in 2004.

To take the OraQuick test, people swab their outer gums and put the swab into a vial. After about 20 minutes, the test device will reveal two reddish-purple lines in a small window if there are signs that the body's immune system has geared up to battle HIV.

The test uses oral fluid, which is not the same as saliva. Its results are considered preliminary, and should be confirmed by a blood test.

OraSure had nearly 5,700 people take the at-home version of the test. The tests found that 114 thought they were HIV-positive; 106 of them actually were. That means that positive results were accurate 93 percent of the time. Negative results were accurate 99.98 percent of the time, the company said.

Pant Pai said the oral test's overall accuracy is similar to that of a blood test, although it's slightly less accurate. The oral test, in particular, may miss HIV infection in its early stage. "Self test will be a first step -- you will always need confirmation of a preliminary HIV diagnosis," she said.

Also, "the sensitivity of the test appears lower when administered in the home setting rather than a medical setting, so some of the people who are HIV-positive will get a test result that they are negative," Jane Rotheram-Borus, director of the Center for HIV Identification Prevention & Treatment Services at the University of California, Los Angeles, said in May. "However, if they would otherwise not have gotten the test at all, they may also have believed they were negative."

Experts have expressed concern for people who learn at home, possibly alone, that they are probably infected with the virus that causes AIDS.

"The arguments against the at-home test focus on the absence of a counselor who could provide support and link the newly identified HIV-positive individual to medical care," said Rotheram-Borus, who supports over-the-counter sales of the OraQuick test.

She pointed out that "over-the-counter pregnancy tests are widely used, and pregnant women do find their way into prenatal care."

In a news release issued Tuesday, Orasure said it expects that the OraQuick test will become available in October at more than 30,000 retail outlets nationwide, as well as online. Orasure has also said that it will offer a 24-hour, toll-free number that people can call to get support regarding their test results.

More information

For more on HIV and AIDS, try the U.S. National Library of Medicine.

View the Original article

FDA approves first rapid, take-home HIV test

"background-image:url('http://l3.yimg.com/bt/api/res/1.2/UznQqD5l0k1VLmKGYQ9apw--/YXBwaWQ9eW5ld3M7Y2g9MTMyMjtjcj0xO2N3PTIwMDA7ZHg9MDtkeT0wO2ZpPXVsY3JvcDtoPTEyNjtxPTg1O3c9MTkw/http://media.zenfs.com/en_us/News/ap_webfeeds/bff112789fea5412140f6a706700eb4d.jpg');" width

View the Original article

FDA approves Arena obesity drug; first in 13 years

background:url(http://l.yimg.com/a/p/us/news/editorial/a/5b/a5ba32682eb601fb573b57542c19b9c1.png);width:115px;height:25px;margin-left:50px;margin-top:7px

View the Original article

FDA approves first new weight-loss pill in decade

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 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.

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 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 says 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 $3.03, or 34 percent, to $11.88 in trading Wednesday afternoon.

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.

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 unpleasant digestive side effects and modest weight loss.

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.

View the Original article

FDA delays decision on first drug to prevent HIV

Federal health regulators have delayed a decision on whether to approve the first pill shown to prevent HIV infection, the drug's manufacturer says.

Gilead Sciences disclosed Friday that the Food and Drug Administration will take three more months to review its application for Truvada, after the company submitted additional materials to the agency earlier this month.

In May, a panel of experts recommended approval of the daily pill for healthy people who are at high risk of contracting HIV, including gay and bisexual men. The vote was nonbinding, though the FDA often follows the group's advice.

Gilead said it submitted updated information on its planned safety materials for patients and doctors using the drug. The FDA typically extends its reviews after receiving such information.

The FDA is now expected to rule by Sept. 14, the company said in a statement.

Gilead Sciences Inc., based in Foster City, Calif., has marketed Truvada since 2004 as a treatment for people who are infected with the virus. The medication is a combination of two older HIV drugs, Emtriva and Viread.

Truvada made headlines in 2010, when government researchers showed it could actually prevent people from contracting HIV when used as a precautionary measure. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling. Last year another study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was infected with HIV and the other was not.

An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. AIDS causes the body's immune system to break down, leading to infections which are eventually fatal. Gay and bisexual men account for the majority of cases

View the Original article

FDA reviews first rapid, take-home test for HIV

The Food and Drug Administration is considering approval of the first over-the-counter HIV test that would allow consumers to quickly test themselves for the virus at home, without medical supervision.

FDA reviewers said Friday the OraQuick In-Home HIV test could play a significant role in slowing the spread of HIV, according to briefing documents posted online. But they also raised concerns about the accuracy of the test, a mouth swab that returns results in about 20 minutes.

The review comes one day after an FDA advisory panel endorsed the HIV pill Truvada for preventive use. If FDA follows the group's advice, the daily medication would become the first drug approved to prevent healthy people from becoming infected with the virus that causes AIDS.

Public health experts estimate one-fifth, or about 240,000 people, of the 1.2 million HIV carriers in the U.S. are not aware they are infected. Testing is one of the chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.

In a trial conducted by the company OraSure Technologies Inc., the test correctly detected HIV in those carrying the virus 93 percent of the time. That rate is below the FDA-recommended 95 percent threshold for accuracy.

The FDA estimates the test would miss about 3,800 HIV-positive people per year, if approved for U.S. consumers.

The test was more accurate at correctly clearing patients who do not have the disease. In company studies, OraQuick correctly identified HIV-negative users 99 percent of the time.

In their briefing documents, FDA scientists noted both the benefits and risks of expanding HIV testing with the take-home diagnostic kit.

"There is considerable personal and public health value in informing infected, but otherwise untested, persons of their true positive HIV status," the reviewers state. "However, this benefit is offset in some measure by HIV-positive individuals who receive an incorrect message that they are not infected."

The lukewarm endorsement apparently spooked investors. OraSure's stock tumbled $1.32, or 11.8 percent, to close at $9.85 in trading Friday.

On Tuesday, the FDA will ask a panel of outside experts whether the test should be approved for over-the-counter sales in U.S. The agency is not required to follow the group's advice, though it usually does.

Based in Bethlehem, Pa., OraSure has marketed a version of OraQuick to doctors, nurses and other health care practitioners since 2004. The test sells for $17.50, though OraSure declined to discuss how it would price the consumer version. When used by professionals, the test is shown to accurately identify both carriers and non-carriers 99 percent of the time.

While it's not clear why the test was less accurate in consumer trials, CEO Doug Michels said company researchers anticipated that its "performance in the hands of a consumer would be different from that observed in hands of a professional."

OraSure tried the new version of the test in a study of 5,800 people of various sexual orientation, race and income levels. The trial identified about 100 HIV carriers who were previously undiagnosed.

The FDA has already approved HIV test kits that people take home. However, those kits, which require a blood sample, must be sent to a laboratory for development. But OraSure argues that a test that can be done at home will appeal to a much broader group of people.

According to the company's study, 41 percent of people who discovered they were HIV-positive using OraQuick had never been tested previously. In its own briefing documents, the company estimates that 9,000 new HIV carriers would be identified for every 1 million people who use the test.

View the Original article

FDA reviews first rapid, take-home test for HIV

The Food and Drug Administration is considering approval of the first over-the-counter HIV test that would allow consumers to quickly test themselves for the virus at home, without medical supervision.

FDA reviewers said Friday the OraQuick In-Home HIV test could play a significant role in slowing the spread of HIV, according to briefing documents posted online. But they also raised concerns about the accuracy of the test, a mouth swab that returns results in about 20 minutes.

The review comes one day after an FDA advisory panel endorsed the HIV pill Truvada for preventive use. If FDA follows the group's advice, the daily medication would become the first drug approved to prevent healthy people from becoming infected with the virus that causes AIDS.

Public health experts estimate one-fifth, or about 240,000 people, of the 1.2 million HIV carriers in the U.S. are not aware they are infected. Testing is one of the chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.

In a trial conducted by the company OraSure Technologies Inc., the test correctly detected HIV in those carrying the virus 93 percent of the time. That rate is below the FDA-recommended 95 percent threshold for accuracy.

The FDA estimates the test would miss about 3,800 HIV-positive people per year, if approved for U.S. consumers.

The test was more accurate at correctly clearing patients who do not have the disease. In company studies, OraQuick correctly identified HIV-negative users 99 percent of the time.

In their briefing documents, FDA scientists noted both the benefits and risks of expanding HIV testing with the take-home diagnostic kit.

"There is considerable personal and public health value in informing infected, but otherwise untested, persons of their true positive HIV status," the reviewers state. "However, this benefit is offset in some measure by HIV-positive individuals who receive an incorrect message that they are not infected."

The lukewarm endorsement apparently spooked investors. OraSure's stock tumbled $1.32, or 11.8 percent, to close at $9.85 in trading Friday.

On Tuesday, the FDA will ask a panel of outside experts whether the test should be approved for over-the-counter sales in U.S. The agency is not required to follow the group's advice, though it usually does.

Based in Bethlehem, Pa., OraSure has marketed a version of OraQuick to doctors, nurses and other health care practitioners since 2004. The test sells for $17.50, though OraSure declined to discuss how it would price the consumer version. When used by professionals, the test is shown to accurately identify both carriers and non-carriers 99 percent of the time.

While it's not clear why the test was less accurate in consumer trials, CEO Doug Michels said company researchers anticipated that its "performance in the hands of a consumer would be different from that observed in hands of a professional."

OraSure tried the new version of the test in a study of 5,800 people of various sexual orientation, race and income levels. The trial identified about 100 HIV carriers who were previously undiagnosed.

The FDA has already approved HIV test kits that people take home. However, those kits, which require a blood sample, must be sent to a laboratory for development. But OraSure argues that a test that can be done at home will appeal to a much broader group of people.

According to the company's study, 41 percent of people who discovered they were HIV-positive using OraQuick had never been tested previously. In its own briefing documents, the company estimates that 9,000 new HIV carriers would be identified for every 1 million people who use the test.

View the Original article

FDA favors first drug for HIV prevention

"background-image:url('http://l2.yimg.com/bt/api/res/1.2/VJ6EKWFsMCaDftWtcKPZCw--/YXBwaWQ9eW5ld3M7Y2g9MTUwMDtjcj0xO2N3PTIxMDA7ZHg9MDtkeT0wO2ZpPXVsY3JvcDtoPTEzNjtxPTg1O3c9MTkw/http://media.zenfs.com/en_us/News/ap_webfeeds/017ec95dfd67110c0f0f6a70670012c5.jpg');" width

View the Original article

FDA review favors first drug for HIV prevention

"background-image:url('http://l2.yimg.com/bt/api/res/1.2/VJ6EKWFsMCaDftWtcKPZCw--/YXBwaWQ9eW5ld3M7Y2g9MTUwMDtjcj0xO2N3PTIxMDA7ZHg9MDtkeT0wO2ZpPXVsY3JvcDtoPTEzNjtxPTg1O3c9MTkw/http://media.zenfs.com/en_us/News/ap_webfeeds/017ec95dfd67110c0f0f6a70670012c5.jpg');" width

View the Original article

FDA favors first drug for HIV prevention

"background-image:url('http://l2.yimg.com/bt/api/res/1.2/VJ6EKWFsMCaDftWtcKPZCw--/YXBwaWQ9eW5ld3M7Y2g9MTUwMDtjcj0xO2N3PTIxMDA7ZHg9MDtkeT0wO2ZpPXVsY3JvcDtoPTEzNjtxPTg1O3c9MTkw/http://media.zenfs.com/en_us/News/ap_webfeeds/017ec95dfd67110c0f0f6a70670012c5.jpg');" width

View the Original article