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FDA approves weight-management drug Qsymia

 shopping  No Responses »
Jul 172012
 
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For Immediate Release: July 17, 2012
Media Inquiries: Morgan Liscinsky, 301-796-0397; morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves weight-management drug Qsymia

The U.S. Food and Drug Administration today approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and exercise for chronic weight management.

The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).

BMI, which measures body fat based on an individual’s weight and height, is used to define the obesity and overweight categories. According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.

“Obesity threatens the overall well being of patients and is a major public health concern,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition.”

Qsymia is a combination of two FDA-approved drugs, phentermine and topiramate, in an extended-release formulation. Phentermine is indicated for short-term weight loss in overweight or obese adults who are exercising and eating a reduced calorie diet. Topiramate is indicated to treat certain types of seizures in people who have epilepsy and to prevent migraine headaches.

Qsymia must not be used during pregnancy because it can cause harm to a fetus. Data show that a fetus exposed to topiramate, a component of Qsymia, in the first trimester of pregnancy has an increased risk of oral clefts (cleft lip with or without cleft palate). Females of reproductive potential must not be pregnant when starting Qsymia therapy or become pregnant while taking Qsymia. Females of reproductive potential should have a negative pregnancy test before starting Qsymia and every month while using the drug and should use effective contraception consistently while taking Qsymia.

The safety and efficacy of Qsymia were evaluated in two randomized, placebo-controlled trials that included approximately 3,700 obese and overweight patients with and without significant weight-related conditions treated for one year. All patients received lifestyle modification that consisted of a reduced calorie diet and regular physical activity.

The recommended daily dose of Qsymia contains 7.5 milligrams of phentermine and 46 mg of topiramate extended-release. Qsymia is also available at a higher dose (15 mg phentermine and 92 mg of topiramate extended-release) for select patients.

Results from the two trials show that after one year of treatment with the recommended and highest daily dose of Qsymia, patients had an average weight loss of 6.7 percent and 8.9 percent, respectively, over treatment with placebo. Approximately 62 percent and 69 percent of patients lost at least five percent of their body weight with the recommended dose and highest dose of Qsymia, respectively, compared with about 20 percent of patients treated with placebo.

Patients who did not lose at least three percent of their body weight by week 12 of treatment with Qsymia were unlikely to achieve and sustain weight loss with continued treatment at this dose. Therefore, response to therapy with the recommended daily dose of Qsymia should be evaluated by 12 weeks to determine, based on the amount of weight loss, whether to discontinue Qsymia or increase to the higher dose.  If after 12 weeks on the higher dose of Qsymia, a patient does not lose at least five percent of body weight, then Qsymia should be discontinued, as these patients are unlikely to achieve clinically meaningful weight loss with continued treatment.

Qsymia must not be used in patients with glaucoma or hyperthyroidism. Qsymia can increase heart rate; this drug’s effect on heart rate in patients at high risk for heart attack or stroke is not known. Therefore, the use of Qsymia in patients with recent (within the last six months) or unstable heart disease or stroke is not recommended. Regular monitoring of heart rate is recommended for all patients taking Qsymia, especially when starting Qsymia or increasing the dose.

The FDA approved Qsymia with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a Medication Guide advising patients about important safety information and elements to assure safe use that include prescriber training and pharmacy certification. The purpose of the REMS is to educate prescribers and their patients about the increased risk of birth defects associated with first trimester exposure to Qsymia, the need for pregnancy prevention, and the need to discontinue therapy if pregnancy occurs. Qsymia will only be dispensed through specially certified pharmacies.

Vivus Inc. will be required to conduct 10 postmarketing requirements, including a long-term cardiovascular outcomes trial to assess the effect of Qsymia on the risk for major adverse cardiac events such as heart attack and stroke.

The most common side effects of Qsymia are tingling of hands and feet (paresthesia), dizziness, altered taste sensation, insomnia, constipation, and dry mouth.

Qsymia is marketed by Vivus Inc. in Mountain View, Calif.

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Where is Zune is the new Microsoft Nokia partnership?

 Zune  No Responses »
Feb 132011
 
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Theories about as to what will happen with Zune now that Microsoft and Nokia are set to link up with the embattled handset maker using the venerable software makers latest mobile operating system as their next generation devices. Zune is mysteriously missing from any of the graphics depicting the mesh, or should I say mess, they intend on making. Either they didn’t have room or they are planning on scaling back the Zune name and focusing more on the Windows Phone brand which is strategically more important than Zune. If they had any substantial plans for Zune it would have earned a little square somewhere in that horizontal stack of little squares, instead not even the Zune name appears anywhere in the official announcements of the partnership.

Whatever the case we can be certain that the Zune brand will be taking a a back seat to Windows Phone name which so desperately needs to catch on with consumers if Microsoft intends on being relevant in the future. Without a strong prescience in the mobile market Microsoft may as well start working on an exit strategy because regardless of how much cash Windows or Office are making now it is obvious that those days will soon end.

Open source software is about to trounce Microsoft as the default choice for a majority of the world. I predict in 5 years we’ll be calling for an end to the traditional Windows default installation business model. The personal computer is dying and a larger variety of devices with different OS choices are hitting the market on a daily basis. Operating systems will all be mobile in the future with integrated communications and small form as the standard. Flip style pocket devices will rule as we all go mobile with our computing and learn to type and scroll on the go. Those images of idiots walking into public fountains in the mall or falling off the train tracks because of their mobile devices will become common place and websites will spring up just to showcase the idiots who kill themselves texting or even sexting.

I wish this laptop was smaller and more mobile. My next one sure will be.

Nokia / Microsoft: Where’s Zune? | LiveSide.net

However one brand is conspicuously missing from the equation: Zune. It doesn’t appear anywhere on the slide, nor anywhere else in the Nokia/Microsoft announcements. Paul Thurrott, in his Window Supersite post analyzing the announcements, noted that neither Nokia CEO Stephen Elop or Microsoft CEO Steve Ballmer mentioned Zune. Thurrott quotes Elop and gives his opinion:

Microsoft, meanwhile, has a “great software platform” in Windows Phone, and the brands that mobile consumers want, “like Bing, Xbox LIVE, and Office.” (Side-note: Zune was conspicuously absent from this list. It is my opinion and guess that Microsoft is currently phasing out the Zune brand and will simply roll the various Zune services into Windows Live.)

And again, when Steve Ballmer took the stage Friday morning, he didn’t mention Zune either, as noted by Thurrott:

He said that Windows Phone was not just a single product but was instead the combination of many products from across Microsoft, “not only Windows, but Office, Bing, Hotmail, and Xbox.” (Note, again, how Zune was conspicuously left out of this equation.)

While this can’t be the greatest news for Zune or Zune fans, we think there are some explanations that fall somewhere south of “ZOMG, Zune is Dead!!”.

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All about MS

 Community  No Responses »
Sep 282010
 
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What is Multiple Sclerosis? Multiple Sclerosis, or MS as it is commonly known, is a debilitating disease that affects the central nervous system and causes nerve degeneration in the brain and spinal cord. MS causes impaired or involuntary muscle movements and manifests in ticks or twitches.

AllAboutMS.com is a guide for MS that provides information on the disease including news and useful articles on living with MS and available treatments and procedures to minimize damage and manage life with MS. The MS Discussion Board offers news on MS treatment and advice on what to do if you are diagnosed with MS.

Many patients seek an MS diet to help curd the effects of this disease and websites like AllAboutMS.com are vital in sharing valuable data on MS treatments and services.

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KIN Phones show us what Microsoft has planned for our future

 Microsoft  No Responses »
Jun 132010
 
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The article below may be one of the first to tie notice how cool the KIN phones really are regardless of their limited success and also shows us just what Microsoft has planned for our future. As I have stated before the KIN Studio services are awesome and a truly visionary feature that all mobile devices will employ in the future. I can’t give credit to MS for Studio because they basically bought it from Sidekick when they assimilated the pioneering handset maker.

Sadly it may have taken them too long to integrate the features into WinMo 7 and so it’s a bit unfinished at this point but anyone with a brain can see just how wicked cool the future of mobile is going to be. I can see a day when I can walk the streets of my home town and shoot a video of some newsworthy scene and upload it to my Studio and within seconds have distributed said video to the entire digital stream. My video will sync across all of my devices including my home gaming console and every web connected device I own. I’ll be able to share it over all social networks with my friends and even send it to major publishers like CNN or my local news station without ever having to upload or transcode a thing.

Within minutes I can share this video with the entire world and I would not have had to make a single change in my day or activity. For parents like me, KIN Studio would be a great way to shared the fun and excitement of children with all our friends and family without the trouble of taking the content from one device and moving it to another device or service. How cool will that be?

How a silly phone for teens reveals Microsoft’s plan for us all – Wireless- msnbc.com

Despite its mobile prowess, Apple sucks at the Internet.

But surprisingly it’s Microsoft — not Google—that’s best positioned for Our Future in the Cloud. Here’s why. (MSNBC is a Microsoft – NBC joint venture.)

It’s common for writers to trot out the Google/Apple binary. It’s not entirely invalid: Yes, following spectacular success with the iPhone and the App Store, Apple has let its online ambitions — Mobile Me and the like — whither. And Google, inexperienced in hardware and consumer software as it may be, is an Internet company, so you’d expect it to be ahead of the curve when it comes to, well, using the internet. But consider Microsoft, the lumbering giant, the sprawling monster. This is a company with more experience online than the other two companies combined; which could, if it wanted to, bring the lives of people — their media, their documents, their photos, their everything — online in a way that its competitors only dream of.

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Microsoft fails to learn iPhone lessons | THINQ.co.uk

 Microsoft  No Responses »
Mar 172010
 
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Microsoft fails to learn iPhone lessons | THINQ.co.uk

Microsoft has ignored the weight of public opinion when it comes to mobile phones and announced that the first version of its new mobile operating system will be lacking in two vital areas.

When Apple launched the iPhone way back when, two of the most common short-fallings complained about by Apple naysayers were the device’s lack of multitasking for third party applications, and its inability to copy and paste chunks of text.

Apple has long since fixed the text manipulation issue, and the company is widely expected to introduce multitasking in the next refresh of the hardware and OS predicted to be coming in June.

But it looks like Microsoft engineers have been looking the other way as the company has announced that neither copy and paste or multitasking will be included in the first iteration of the Windows Phone Series 7 operating system.

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Feb 282010
 
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With the fast paced lives many of us lead we find the need for mobile devices such as cell phones and laptops to be an ever increasing part of our life. Many of us now carry at least a mobile phone if not a portable computer and even separate media devices like the Zune media players.

The trouble is that those fast paced lives can lead to a few mistakes on occasion and common liabilities like losing your phone or even having a laptop stolen because you were on the phone are happening more often. The need for insurance on these products may exist for those lacking a comprehensive plan and Laptop Insurance and even iPhone Insurance policies now exist.

For under $8 you can have a iPhone Insurance with a 50 dollar deductible that not only overs theft and accidental damage but even includes liquid damage which seems so common with portable devices. the best part is that it there is no requirement for a new phone to qualify for coverage and there is waiting period to file a claim for reimbursement.

Prices start at $55 for 8GB iPhone and up to $79 for the 32GB iPhone 3GS. Check out there online product comparison and find out about iPhone Insurance now.

Get iPhone Insurance with Worth Ave Group

  • Accidental Damage (optional)*
  • Liquid Damage and Drops (optional)*
  • Theft
  • Fire
  • Vandalism
  • Natural disasters (floods, hurricanes, earthquakes, tornadoes, water damage, and power surge due to lightning)
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Windows Mobile to feature Xbox Live Integration

 windows mobiles  3 Responses »
Dec 302009
 
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job listings seem to point to better integration between Windows Mobile devices and Xbox Live as a future goal for Microsoft. Funny thing to me is that it seems that maybe they should already have had someoen working on this. I hope this job position is actually a replacement for the guy who has been dragging his feet with mobile gaming at Microsoft.

Microsoft to integrate Windows Mobile, Xbox Live | Electronista

Microsoft has committed itself to developing Windows Mobile as a more substantial gaming platform, according to a pair of freshly discovered job listings. A post for a Principal Program Manager is the most significant and would task the recruit with bringing “Xbox Live enabled games” to Windows Mobile phones. The move wouldn’t result in Xbox-quality games but instead linking them to the social aspects of the service, including avatars, social elements and “multi-screen experiences.”

Simultaneously, a Software Test Engineer position is less specific about Xbox Live integration but does seek help creating the mobile gaming experience at Microsoft and puts a focus on a phone’s “always connected Internet” as a cornerstone of the platform.

The moves would not just address a common complaint of Microsoft’s various platforms being isolated from each other but a significant deficit in gaming for Windows Mobile. Despite having full 3D support and even getting help from companies like NVIDIA in receiving gaming-friendly hardware, the mobile OS has trailed platforms like iPhone and Android not just in the number of games available but also relative quality, as most commercial-level games aren’t developed for Windows Mobile. Microsoft’s strongest commitment to mobile gaming has been the launch of Zune HD games that themselves are only carefully hand-picked titles.

Windows

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Press Pass Access for Sumfest 2008

 Concerts  No Responses »
Jul 122008
 
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Reggae Sumfest

I went to the Reggae Sumfest 2007 last July and I got the idea to ask for a press pass this year and yesterday I got an email requesting a photograph for my pass which has been approved. I did not expect that I would be able to do so because I got a late start and actually made my request after the official accreditation process had been closed. I think I was able to sweet talk a very special young lady in SumFest administration who facilitated my special request and was able to help me out.

I was only planning on going for just one day, Thursday evening is Dancehall night and my good friend Ras Slick wants to go that night. The King of Dancehall Beenie Man headlines with Bounty Killer, Elephant Man and Mavado for what should be an explosive evening of hardcore Jamaican musicians. Now that I have backstage and artist access I suppose I’ll have to go for the 3 main evenings and my plans are now to catch Friday and Saturday nights shows as well. I’m not very prepared but I think it should be a fun experience.


Friday nights line-up
features Lil Wayne, Keyshia Coles, John Courtney and Jah Cure who happens to be smoking hot here in Jamaica right now. This guy has a huge fan base here in Jamaica and is set to remain so for quite some time it seems. I’d like to interview him just to ask him some questions about wa gwan here in Jamaica. He seems to be a powerful influence on Jamaican youth and I’d like to hear his views on things in his home country. Jamaican musicians have incredible impact in the development of young Jamaicans and it’s not uncommon to hear 5-7 year old kids singing the latest hardcore hits word for word. I know a few 5 year olds who swear to be “Gangsta for Life” as the “Gully Creep” for me.

Saturday nights show features T-Pain as the main act with Reggae legend Beres Hammond and rising star Tarrus Riley backing up a mixed line-up of international stars. John Holt, Etana and Rootz Underground are also on the bill and should make fora great days music. I’m looking forward to my week. Anyone else in Jamaica for Sumfest with their Zune?

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