FDA reviews 2 promising new drugs for hepatitis C

WASHINGTON (AP) — Doctors may soon have two new drug options for patients with hepatitis C, just as the liver-destroying virus becomes a major public health concern for millions of baby boomers.

The Food and Drug Administration holds a public meeting this week to review two experimental medications from Johnson & Johnson and Gilead Sciences. The new drugs, if approved, could offer a quicker, more effective approach to eliminating hepatitis C, a blood-borne disease blamed for 15,000 deaths in the U.S. this year.

In a review posted online Tuesday, the FDA reported that J&J's drug simeprevir has a slightly higher cure rate than currently available treatments, though it also caused rashes and sunburn in some patients.

On Thursday the FDA will ask a panel of outside experts whether the drug should carry warnings about rashes and sunburn on its label. The agency is not required to follow the panel's advice, though it often does.

The meeting comes at a time when federal health officials are urging baby boomers to get tested for the virus, which can go unnoticed for decades before causing symptoms.

Between 3 million and 4 million Americans are infected with hepatitis C, and people born between 1945 and 1965 are five times more likely to have it than people of other age groups, according to the Centers for Disease Control and Prevention.

Many baby boomers contracted the virus by sharing needles or having sex with an infected person in their youth. The disease was also spread by blood transfusions before 1992, when blood banks began testing for the virus.

"If something is not done soon, all these people who were infected in the 60s and 70s are going to start experiencing the long-term consequences of liver disease," said Gaston Picchio, head of hepatitis drug development for J&J's Janssen Therapeutics unit.

Most people with hepatitis C do not even know they have the virus until after liver damage has occurred, causing abdominal pain, fatigue, itching and dark urine.

For most of the last 20 years, the standard treatment involved a grueling one-year regimen of pills and injections that caused flu-like symptoms and cured less than half of patients. Many patients failed to complete the full treatment cycle. Others delayed starting treatment at all in the hopes that more effective treatments would come along.

Two drugs approved in 2011 kicked off a new effort to treat the disease. Research shows that adding the two new drugs — Vertex Pharmaceuticals' Incivek and Merck & Co.'s Victrelis — to the older drug cocktail can boost cure rates to between 65 and 75 percent.

And the drugs the FDA is reviewing this week have the potential to push cure rates even higher.

J&J's simeprevir cured 80 percent of patients who had not previously been treated for the disease, according to the FDA's review. Additionally, the vast majority of patients were able to cut their treatment time in half to 24 weeks, compared with the usual 52 weeks. The New Brunswick, N.J., company is seeking approval to combine the daily pill with the older treatment regimen for patients with the most common form of the virus. J&J developed the drug with Swedish drugmaker Medivir.

On Friday, the same FDA panel will review another hepatitis C drug from Gilead Sciences Inc. that some analysts say will become the first-choice for treating the disease. The pill, known as sofosbuvir, has been shown to cure up to 90 percent of patients after just 12 weeks of therapy, according to one company study. Additionally, analysts believe the drug will eventually be used without interferon, the injectable medication used in the current drug cocktail that causes nausea, diarrhea and other unpleasant side effects.

Gilead is racing against other drugmakers to develop the first all-pill approach to treating hepatitis C, long viewed as the holy grail by drugmakers. Similar efforts are underway from Abbott Laboratories, Bristol-Myers Squibb Co., Vertex Pharmaceuticals and others.

Pharmaceutical industry consulting firm Decision Resources estimates the market for hepatitis C drugs will grow to more than $23 billion by 2018. Sales of the drugs are expected to decline to $17.5 billion by 2021 as more patients are cured of the virus.

• Health
• Pharmaceuticals & Drug Trials
• Gilead Sciences
• Food and Drug Administration
• hepatitis C
• baby boomers

Source: http://news.yahoo.com/fda-reviews-2-promising-drugs-hepatitis-c-155356071.html
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The new iPads: Want thrills? Look elsewhere

Credit: iStockphoto

At 10 a.m. PT today, Apple is expected to show off new iPad and iPad Mini models. In the month before the iPhone 5c and 5s were announced, there were constant rumors about what they would sport. On the whole, the rumor mill was very accurate, no doubt thanks to a little help from Apple to keep the iPhone top of mind. By contrast, there have been few rumors circulating about the new iPads.

Does that mean Apple has shocks in store -- or that there's actually not much to say about them? I'm betting on the latter. I fully expect Apple's 64-bit A7 processor, M7 motion coprocessor, and fingerprint scanner (all introduced in the iPhone 5s) to make their way on to the full-size iPad. Some or all might also find their way into the cheaper iPad Mini, but given how the iPad Mini accounts for more than half of all iPad sales at a lower profit per unit than the full-sized model, I won't be surprised if we see the iPad Mini treated like the iPhone 5c and be computationally inferior, at least in cheaper models.

[ Mobile security compared: iOS vs. stock Android vs. Samsung SAFE vs. Windows Phone 8 vs. BlackBerry 10. | See InfoWorld's recommendations for a road warrior's must-have mobile toolkit, and discover the best productivity apps for your iPad. | Keep up on key mobile developments and insights via Twitter and with the Mobile Edge blog and Mobilize newsletter. ]

We'll probably see the fifth-generation full-size iPad have the sharper lines of the iPad Mini (which I prefer), and Apple will likely add the gold color option introduced in the iPhone 5s. The iPad Mini may get the Retina display of its full-size sibling, for a modest improvement in screen clarity. I hope we don't see the iPad Mini take on the M&M colors of the iPhone 5c, but that could be the case. We may also see new Apple iPad covers, perhaps with built-in keyboard, à la Microsoft's Type Cover for its Surface Pro.

We'll certainly see new iPod models, as well as a deeper look at the new Mac Pro and its radical new design -- and, for the third time, the forthcoming OS X Mavericks, a good but not earth-shattering upgrade for Mac users. I really hope we get the significant updates promised earlier this year to the iWork suite for both iOS and OS X -- Apple needs to make Pages and Numbers much better than they now are to truly compete with Microsoft Office. Plus, I hope we'll get a better understanding of iBeacons, Apple's intriguing indoor location interaction technology.

But for most people, new iPads are what's hot. A 64-bit iPad, coupled with the 64-bit iOS 7 and apps designed for 64-bit processing (there are now extremely few), could be a powerful alternative to a lightweight laptop. It could even run complex or compute-intensive apps such as Adobe Photoshop that today need more horsepower than what a tablet delivers.

I know many people who carry only an iPad while traveling, and at the Interop networking conference a few weeks ago, I met several CIOs who expected to have sizable tablet-only user communities in a few years, particularly for sales forces and field forces. The group could even extend to desk workers who require little beyond email, the Web, and core office productivity capabilities that you can already get on an iPad and and that Google, Microsoft, and Apple are all working to deliver via the Web.

But more is needed.

Source: http://www.infoworld.com/d/mobile-technology/the-new-ipads-want-thrills-look-elsewhere-228836?source=rss_mobile_technology
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Adblock Plus' new target: Facebook 'annoyances'

October 22, 2013

Call it "walled-garden manicuring," if you will. Adblock Plus is now capable of blocking that many more of the sorts of annoyances that only Facebook provides to its readers.

Having the ad-blocking plug-in block the likes of sponsored stories, promoted posts, and so on isn't new. What is new is the ability to block things like upcoming events in your area, or "People You May Know" displays.

Twenty-one additional Facebook elements can now be blocked with the new plug-in. Most of them are attempts to glean feedback from the user about other Facebook content (e.g., "Games You May Like," or "Rate Movies You've Watched"). Even Adblock Plus' own makers admit, "[These] are not advertisements. Rather, this material is actually from Facebook, and it is served to you based upon the information Facebook receives from your profile and activities."

The privacy implications of this are never gladdening, especially if such material ends up leaking out of Facebook entirely. No surprise then that some people would prefer it was never served up at all. But being able to one-up Facebook's own customization is something that almost certainly won't sit well with Facebook.

Adblock Plus has garnered itself a mixed reputation from both content providers and end users alike. Many end users understand all too well that the vast majority of sites need ad revenue to survive, but are fed up with obnoxious, experience-killing ads that leak privacy data. But Adblock Plus' attempts to dictate the direction of Web-based advertising via its "Acceptable Ads" initiative has come off as a heavy-handed attempt to dictate how advertising on the Web should work. (Adblock Plus recently reached out to Twitter to be non-annoying right as that company was filing for its IPO.)

Until now Adblock Plus has focused most of its work on blocking ads on sites where the difference between an ad and the actual content is normally quite clear. But now it seems Adblock Plus is also attempting to change the ways end users experience sites where content, advertisement, and promotion are heavily -- sometimes inextricably -- mixed.

Source: http://podcasts.infoworld.com/t/web-browsers/adblock-plus-new-target-facebook-annoyances-229247?source=rss_applications
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First Polio Cases Since 1999 Suspected In Syria

Opposition fighters sit on the front line in the city of Deir Ezzor, Oct. 13. Ongoing violence has ravaged the city since March 2011.

AFP/AFP/Getty Images

Opposition fighters sit on the front line in the city of Deir Ezzor, Oct. 13. Ongoing violence has ravaged the city since March 2011.

AFP/AFP/Getty Images

The World Health Organization is investigating a cluster of possible polio cases in an eastern province of Syria.

If the cases are confirmed, they'd be the first ones in the war-torn nation in more than a decade. The country eliminated polio in 1999.

The suspected polio cases are in the Syrian province of Deir Ezzor (pink), which borders Iraq.

Courtesy of Map data (c) 2013 Basarsoft, Google, Mapa GISrael, ORION-ME

The suspected polio cases are in the Syrian province of Deir Ezzor (pink), which borders Iraq.

Courtesy of Map data (c) 2013 Basarsoft, Google, Mapa GISrael, ORION-ME

Syria used to have one of the highest polio vaccination rates in the region. If virus has returned, it would be a high-profile example of the ramifications of the collapse of Syria's once-vaunted public health system.

Initial tests from the Syrian national laboratory in Damascus suggested that polio has crippled two children in the east, the WHO said Saturday. Further laboratory tests related to the cases are underway at the WHO's regional offices.

"We still need final confirmation from a laboratory, but all the indicators show that this is polio," Oliver Rosenbawer, from the Global Polio Eradication Initiative told The Telegraph on Sunday.

The Syrian Ministry of Health says that it's treating the cases as part of a polio outbreak and beginning emergency vaccination campaigns in the area. The cluster of paralysis cases is in the eastern province of Deir Ezzor, which straddles the Euphrates River. That river flows east from Syria across Iraq.

Over the last two decades, the world has nearly eradicated polio.
There were only 223 cases recorded globally in 2012, and they were all from remote areas of Nigeria, Afghanistan and Pakistan.

This year, there have been 296 cases worldwide, but more than half of them have been in Somalia, which had eliminated polio in 2007.

Before the civil war broke out in Syria in 2011, the WHO estimated that 83 percent of Syrian children were fully vaccinated against polio. By 2012 that vaccination rate had fallen to 52 percent.

The WHO has issued a regional polio surveillance alert in response to the cases from Syria. It is urging neighboring countries to launch supplementary polio vaccination campaigns to keep the virus from spreading.

In September, Israel underwent an emergency immunization drive after polio appeared in sewers around the country. The campaign aimed to give polio boosters to a million children under the age of 9.

But carrying out such vaccination campaigns in Syria amid the ongoing civil war, however, could prove very difficult.

Source: http://www.npr.org/blogs/health/2013/10/21/238693328/first-polio-cases-since-1999-suspected-in-syria?ft=1&f=
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Reckitt CEO says pharma review independent of other actions

LONDON (Reuters) - Reckitt Benckiser Group is exploring options for its prescription drug business independently of any other strategic projects it may be undertaking, Chief Executive Rakesh Kapoor said on Tuesday.

Kapoor told analysts on a conference call that the review was being done on a standalone basis.

Analysts had wondered whether as one of its options, Reckitt would consider swapping the prescription drug business for some consumer health businesses, which it has shown interest in.

Another Reckitt executive stressed though that all options, including keeping the business, were on the table.

(Reporting by Martinne Geller, Editing by Patrick Lannin)

Source: http://news.yahoo.com/reckitt-ceo-says-pharma-review-independent-other-actions-085132917--sector.html
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Dick Cheney's Fear of Heart Device Hacks Justified

Dick Cheney's fear of assassination by heart device hack was justified, according to medical device security experts.

The former vice president, who relied on a pacemaker, an implantable defibrillator and a left ventricular assist device before undergoing a heart transplant in March 2012, said he worried that terrorist hackers could crash the computerized implants – a scenario depicted in the TV series Homeland.

"I found it credible," the 72-year-old said of the fictional plotline on CBS's "60 Minutes." "I was aware of the danger, if you will, that existed."

While there have been no reports of hacking attempts on medical implants in the U.S., scientists have long warned about the possibility.

"Researchers have been looking at this for decades but more seriously since about 2006 or 2007," said medical device securities expert Kevin Fu, an associate professor of electrical engineering and computer science at the University of Michigan. "But I think it's important to stress that patients are actually much safer using these devices than not."

Fu said hundreds of thousands of Americans have benefitted from implantable devices like pacemakers and pumps, and he's "not aware of single case of someone being harmed."

"[The risks] are based on theoretical, in-lab experiments as opposed to happenings in the real world, if that's at all comforting," said Fu, who has five PhD students in his lab working on improving the cybersecurity of medical devices.

But even the remote possibility of a real-world problem can be unsettling for patients who rely on devices buried deep in their bodies. In 2012, a McAfee researcher revealed that he could trigger a life-threatening release of insulin from an implantable pump 300 feet away. And studies by Fu and others suggest that a "growing list of confirmed cybersecurity vulnerabilities in medical devices pose challenging risks to patients whose privacy or disease management depends on the proper functioning of devices."

But most experts agree that the odds of living a long, healthy life with an implantable device are much higher than those of being hacked.

"Diabetes is infinitely more dangerous than the possibility of a hacker deciding to target your insulin pump," Dr. David Lubarsky, professor and chief of the University of Miami Health System, said of the McAfee experiment.

"I can't emphasize enough that patients are far safer with the devices," Fu added, explaining that for every Cheney that are "tens of thousands of lives saved" by the wirelessly-controlled machines. "And the good news is that there are good people working on approaches to mitigate the risks."

Source: http://abcnews.go.com/Health/dick-cheneys-fear-heart-device-hacks-justified-experts/story?id=20633284
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Victor Daviet: French Pow Slayer

Posted by: Evan Litsios / added: 10.21.2013 / Back to What Up

If you like pow lines, big jumps, and stylish airs, you'll love watching Victor Daviet sending it in this full part from Rip Curl. Victor has a timeless style, and appreciates big floater airs just as much as high-flying double corks. This won't be the last you'll see from this 23 year old Frenchman, so stay tuned.

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Source: http://www.frqncy.com/news/2013/10/21/victor-daviet-french-pow-slayer?utm_campaign=blog_feed&utm_medium=feed&utm_source=feed_reader
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