FDA staff says Zogenix painkiller has abuse risks












(Reuters) – Drug reviewers said a painkiller developed by Zogenix Inc could possibly be abused more than currently available hydrocodone combination products.


Zogenix’s painkiller Zohydro is a single-entity product containing hydrocodone — a narcotic painkiller. Hydrocodone and oxycodone are often-abused drugs.












Combination hydrocodone drugs usually also contain acetaminophen, the active ingredient in common pain products such as Tylenol.


However, since an overdose of acetaminophen can cause liver damage, especially in patients on other acetaminophen medications, there is a requirement for painkillers without acetaminophen.


The reviewers said the expected higher levels of abuse with Zohydro were based on what has been observed for oxycodone products, according to briefing documents released by the U.S. Food and Drug Administration on Wednesday. (http://link.reuters.com/hux44t)


“The abuse ratio for oxycodone combination products was 24 emergency department visits per million tablets dispensed, compared with 85 visits for oxycodone single-entity ER products,” the FDA reviewers said in the documents.


An independent panel of experts will advise the FDA and vote on the drug’s safety, efficacy and approval on Friday.


Zogenix shares were down 6 percent at $ 2.39 in early trade on Wednesday on the Nasdaq.


(Reporting by Esha Dey in Bangalore; Editing by Roshni Menon)


Medications/Drugs News Headlines – Yahoo! News


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Hugh Hefner heads to altar again, with “runaway bride”












LOS ANGELES (Reuters) – Playboy founder Hugh Hefner is headed to the altar again – with the blonde Playmate who ditched him five days before their planned wedding in 2011.


Hefner, 86, and his former “runaway brideCrystal Harris, 26, obtained a marriage license in Beverly Hills on Tuesday, Los Angeles County Recorder spokeswoman Elizabeth Knox said.












Celebrity website TMZ.com said the couple, who reunited earlier this year, are planning a New Year’s Eve wedding.


Harris was Playboy magazine‘s Miss December 2009 and appeared on the July 2011 cover of the adult magazine with a “runaway bride” sticker covering her bottom half.


In what was described at the time only as a “change of heart,” Harris dumped the magazine mogul and left his Playboy Mansion five days before a lavish June 2011 wedding before 300 guests.


This time around, the couple are playing it low-key, staying mum on their busy Twitter accounts with Hefner’s spokeswoman declining to confirm or deny their plans.


Hefner, founder of the Playboy adult entertainment empire, has been married twice before. He and his second wife Kimberley Conrad, also a former Playmate, divorced in 2010 after a lengthy separation. His first marriage to Mildred Williams ended in divorce in 1959. He has two children from each marriage.


(Reporting By Jill Serjeant)


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More than 200 dead in Philippine typhoon


NEW BATAAN, Philippines (AP) — The death toll from a powerful typhoon in the southern Philippines climbed to more than 200 people Wednesday and officials feared many more bodies could be found as rescuers reach hard-hit areas that had been isolated by landslides, floods and downed communications.


At least 151 people have died in the worst-hit province of Compostela Valley since Typhoon Bopha began lashing the region early Tuesday, including 66 villagers and soldiers who perished in a flash flood that swamped two emergency shelters and a military camp in New Bataan town, provincial spokeswoman Fe Maestre told The Associated Press.


About 80 people survived the deluge in New Bataan with injuries, but an unspecified number of villagers remain missing. On Wednesday, the farming town of 45,000 people was a muddy wasteland of collapsed houses and columns of coconut and banana trees felled by Bopha's ferocious winds.


Army Maj. Gen. Ariel Bernardo said 51 people died and 98 others are missing in nearby Davao Oriental province.


Disaster-response agencies reported seven other typhoon-related deaths elsewhere.


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WestJet embraces tech to woo business travelers












TORONTO (Reuters) – WestJet Airlines Ltd will use technological innovation, including a new Internet ticket booking system, to help it transform from a no-frills carrier to a lower-cost full-service airline courting lucrative corporate travelers, its chief executive said on Monday.


Canada’s second-biggest airline plans to launch a series of technology systems, most notably the new online booking engine, which will sell three tiers of tickets, in the next two months.












“Companies evolve or they die,” Chief Executive Gregg Saretsky told Reuters in a phone interview from the company’s Calgary head office.


“We’re 16 and going on 17 years old and we can’t stay just as we were 17 years ago. The world has changed. And we are changing to be more relevant for a broader segment of guests.”


The new Internet booking system, which WestJet hopes to launch in late January, will sell economy, mid-tier and premium tickets. That is a major shift from its current system, which sells only the lowest-priced ticket available.


Economy tickets under the new system will continue to sell the lowest available fare, but the cancellation fee for them will jump to C$ 75 ($ 75.48) from C$ 50. Mid-tier tickets will have a C$ 50 cancellation fee.


Premium tickets, unavailable until late March when WestJet finishes reconfiguring its 100 Boeing 737 planes to allow more leg room, will include priority screening and boarding, free cancellations and flexibility on ticket changes.


Pricing for those tickets, which may include free meals and drinks and an extra baggage allowance, has not yet been determined. Fares will be well below half the price for business class at WestJet’s bigger competitor, Air Canada, Saretsky said.


“It’s time for us to be more serious with respect to going after business travelers because frankly, they’re the ones who are booking last-minute and are happy to pay for the conveniences,” Saretsky said.


WestJet will launch its premium economy service with 24 seats per plane, but will consider expansion if it proves “wildly successful,” he added.


POISED FOR CHANGE


WestJet, which has spent about C$ 40 million over the past two years on technology projects, is poised for major changes in 2013 as it readies to launch a new regional airline, Encore.


Saretsky hopes that WestJet’s switch in coming weeks to a new Internet phone system will allow ticket reservation agents to work from home and help make room for Encore staff.


Some 750 reservation agents work at WestJet’s Calgary offices, which house about 2,400 staff. Space will be needed for Encore employees over the next 18 months while their office, hangars and maintenance stores are constructed at the WestJet campus.


Encore will be launch in the second half of 2013, “probably closer to July than December,” Saretsky said, with seven Bombardier Q400 planes.


While WestJet won’t announce Encore’s schedule until Jan 21, the carrier will initially serve only “a handful” of new cities, with ticket prices up to 50 percent below Air Canada’s, he added.


Over the next two months, WestJet will also roll out a guest notification system that alerts travelers via email about their flights, allowing them to check in remotely.


Such self-service technology will be critical as WestJet faces increasing labor costs, Saretsky said.


Wage and benefit costs, which represent about a third of operating costs, have climbed 50 percent since WestJet was founded in 1996.


“You can see that creates a little bit of drag on earnings,” Saretsky said. “We’ve got to find ways of reducing our component costs.”


If WestJet can increase self service options for travelers, that could limit the need for new employees, Saretsky said. Management also wants to improve attendance management, so that fewer employees book off sick around long weekends, and more quickly clean and process planes between flights, he said.


(Reporting By Susan Taylor; Editing by Peter Galloway)


(This story was corrected to show that WestJet is replacing its Internet booking engine, not entire reservation system, in the first and second paragraphs)


Canada News Headlines – Yahoo! News


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Amazon launches Kindle content service for kids












NEW YORK (AP) — Amazon is launching a subscription service for children’s games, videos and books aimed at getting more kids to use its Kindle Fire tablet devices.


Amazon.com Inc. plans to announce Wednesday that the Kindle FreeTime Unlimited service will be available in the next few weeks as part of an automatic software update.












Amazon said subscribers will have access to “thousands” of pieces of content, though the company did not give a specific number. Kids will be able to watch, play and read any of the content available to them as many times as they want. Parents can set time limits, however.


The service, aimed at kids aged 3 to 8, will cost $ 4.99 per month for one child. It’ll cost $ 2.99 per child for members of Amazon Prime, the company’s premium shipping service. Amazon Prime costs $ 79 per year for free shipping of merchandise purchased in the company’s online store.


Family plans for up to six kids will cost $ 9.99 per month and $ 6.99 for Prime members.


The Kindle already allows for parental controls through its FreeTime service. Parents can set up profiles for up to six children and add time limits to control how long kids can spend reading, watching videos or using the Kindle altogether. With the content subscription service, kids can browse age-appropriate videos, games and books and pick what they want to see. They won’t be shown ads and will be prevented from accessing the Web or social media. Kids also won’t be able to make payments within applications.


Amazon is launching the service as competition heats up in the tablet market among Apple, Barnes & Noble, Microsoft and Samsung. Amazon’s strategy is to offer the Kindle at a relatively low price and make money selling the content.


Offering a subscription service aimed at kids helps set the Kindle apart from its many competitors.


“We hope that our devices are really, really attractive for families,” said Peter Larsen, vice president of Amazon’s Kindle business.


Gadgets News Headlines – Yahoo! News


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Casting Light on Astronaut Insomnia: ISS to Get Sleep-Promoting Lightbulbs












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Matt Damon, Alec Baldwin, Don Cheadle Sign on for James Cameron’s Climate-Change Doc












LOS ANGELES (TheWrap.com) – James Cameron‘s climate-change documentary “Years of Living Dangerously” has lined up some high-level talent to get its message across. Matt Damon, Alec Baldwin and Don Cheadle have signed on to narrate the documentary, Showtime – which will air the project over multiple episodes next year – said Monday.


Actor Edward Norton is also expected to come aboard, Showtime said, with additional talent to be announced.












As previously reported exclusively by TheWrap, Cameron is teaming with producer and noted philanthropist Jerry Weintraub on the project, which will report on first-person accounts of people who’ve been affected by global warming. Cameron and Weintraub will executive “Years of Living Dangerously,” along with Arnold Schwarzenegger.la


“60 Minutes” producers Joel Bach and David Gelber are also executive-producing, along with climate expert Daniel Abbasi.


“The recent devastation on the East Coast is a tragic reminder of the direct link between our daily lives and climate change,” Showtime Networks’ president of entertainment David Nevins said. “This series presents a unique opportunity to combine the large-scale filmmaking styles of James Cameron, Jerry Weintraub and Arnold Schwarzenegger – arguably some of Hollywood’s biggest movie makers – with the hard-hitting, intimate journalism of ’60 Minutes’ veterans Joel Bach and David Gelber. I believe this combination will make for a thought-provoking television event.”


“We’ll make it exciting,” added Cameron. “We’ll make it investigative. We’ll bring people the truth. And people are always hungry for the truth.”


In addition to the narrators, “Years of Living Dangerously” will use reporting from the field, with New York Times journalists Thomas Friedman and Nicholas Kristof, columnist Mark Bittman and MSNBC host Chris Hayes.


“Years of Living Dangerously” will air over six to eight one-hour episodes, Showtime said.


Movies News Headlines – Yahoo! News


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U.S., allies weighing military options if Syria uses WMD

WASHINGTON (AP) — The White House and its allies are weighing military options to secure Syria's chemical and biological weapons, after U.S. intelligence reports show the Syrian regime may be readying those weapons and may be desperate enough to use them, U.S. officials said Monday.

President Barack Obama, in a speech at the National Defense University on Monday, pointedly warned Syrian President Bashar Assad not to use his arsenal.

"Today I want to make it absolutely clear to Assad and those under his command: The world is watching," Obama said. "The use of chemical weapons is and would be totally unacceptable. And if you make the tragic mistake of using these weapons, there will be consequences and you will be held accountable."

Secretary of State Hillary Rodham Clinton, in Prague for meetings with Czech officials, said she wouldn't outline any specifics.

"But suffice it to say, we are certainly planning to take action if that eventuality were to occur," Clinton said.

Options now being considered range from aerial strikes to limited raids by regional forces to secure the stockpiles, according to one current U.S. official, and one former U.S. official, briefed on the matter. The officials spoke on condition of anonymity because they were not authorized to discuss the issue publicly.

The administration remains reluctant to dispatch U.S. forces into Syria, but a U.S. special operations training team is in neighboring Jordan, teaching troops there how to safely secure such sites together with other troops from the region, the officials said.

The warnings to Syria come after U.S. intelligence detected signs the Syrian regime was moving the chemical weapons components around within several of Syria's chemical weapons sites in recent days, according to a senior U.S. defense official and two U.S. officials speaking on Monday. The activities involved movement within the sites, rather than the transfer of components in or out of various sites, two of the officials said.

But they were activities they had not seen before, that bear further scrutiny, one said.

Another senior U.S. official described it as "indications of preparations" for a possible use of the chemical weapons. The U.S. still doesn't know whether the regime is planning to use them, but the official says there is greater concern because there is the sense that the Assad regime is under greater pressure now.

The officials spoke on condition of anonymity because they were not authorized to speak publicly about intelligence matters.

U.S. intelligence officials also intercepted one communication within the last six months they believe was between Iran's infamous Quds Force, urging Syrian regime members to use its supplies of toxic Sarin gas against rebels and the civilians supporting them in the besieged city of Homs, a former U.S. official said. That report was not matched by other intelligence agencies, and other intelligence officials have said Iran also does not want the Syrians to use their chemical weapons.

The Assad regime insists it would not use such weapons against Syrians, though it carefully does not admit to having them. The Ministry of Foreign Affairs said the government "would not use chemical weapons — if there are any — against its own people under any circumstances." The regime is party to the 1925 Geneva Protocol banning chemical weapons in war.

The Syrian assurances did not placate the White House.

"We are concerned that in an increasingly beleaguered regime, having found its escalation of violence through conventional means inadequate, might be considering the use of chemical weapons against the Syrian people," said White House press secretary Jay Carney.

"Assad has killed so many of his people, I just wouldn't be surprised if he turned these weapons on them," added Maryland Rep. Dutch Ruppersberger, the top Democrat on the House Intelligence Committee, after intelligence briefings Monday.

An administration official said the trigger for U.S. action of some kind is the use of chemical weapons, or movement with the intent to use them, or the intent to provide them to a terrorist group like Hezbollah. The U.S. is trying to determine whether the recent movement detected in Syria falls into any of those categories, the official said. The administration official was speaking on condition of anonymity because this person was not authorized to speak publicly about the issue.

Israeli officials have repeatedly expressed concerns that Syrian chemical weapons could slip into the hands of Hezbollah or other anti-Israel groups, or even be fired toward Israel in an act of desperation by Syria.

Syria has some 75 sites where weapons are stored, but U.S. officials aren't sure they have tracked down all the locations, and fear some stockpiles may have already been moved. Syria is believed to have several hundred ballistic surface-to-surface missiles capable of carrying chemical warheads, plus several tons of material stored in either large drums, or in artillery shells, which become deadly once fired.

"In Syria, they have everything from mustard agent, Sarin nerve gas, and some variant of the nerve agent VX," according to James Quinlivan, a Rand Corp. analyst who specializes in the elimination of weapons of mass destruction.

A primary argument against sending in U.S. ground troops is that whoever takes possession of the chemical weapons will be responsible for destroying them, as part of the 1997 Chemical Weapons Convention. Destroying Syria's stockpiles could cost hundreds of millions of dollars, and take more than a decade, Quinlivan said.

Syria's arsenal is a particular threat to the American allies, Turkey and Israel, and Obama singled out the threat posed by the unconventional weapons earlier this year as a potential cause for deeper U.S. involvement in Syria's civil war. Up to now, the United States has opposed military intervention or providing arms support to Syria's rebels for fear of further militarizing a conflict that activists say has killed more than 40,000 people since March 2011.

Activity has been detected at Syrian weapons sites before.

Defense Secretary Leon Panetta said in late September the intelligence suggested the Syrian government had moved some of its chemical weapons in order to protect them. He said the U.S. believed that the main sites remained secure.

Asked Monday if they were still considered secure, Pentagon press secretary George Little declined to comment about any intelligence related to the weapons.

Senior lawmakers were notified last week that U.S. intelligence agencies had detected activity related to Syria's chemical and biological weapons, said a U.S. intelligence official, speaking on condition of anonymity to discuss the closed-door meetings. All congressional committees with an interest in Syria, from the intelligence to the armed services committees, are now being kept informed.

"I can't comment on these reports, but I have been very concerned for some time now about Syria's stockpiles of chemical weapons and its stocks of advanced conventional weapons like shoulder-launched anti-aircraft missiles," said House intelligence committee Chairman Mike Rogers, R-Mich.

"We are not doing enough to prepare for the collapse of the Assad regime, and the dangerous vacuum it will create. Use of chemical weapons by the Assad regime would be an extremely serious escalation that would demand decisive action from the rest of the world," he added.

The U.S. and Jordan share the same concern about Syria's chemical and biological weapons — that they could fall into the wrong hands should the regime in Syria collapse and lose control of them.

___

Associated Press writers Bradley Klapper in Prague, Josef Federman in Jerusalem, Albert Aji in Damascus and Matthew Lee, Lolita C. Baldor and Julie Pace in Washington contributed to this report.

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Official: Syria moving chemical weapons components












WASHINGTON (AP) — U.S. and allied intelligence have detected Syrian movement of chemical weapons components in recent days, a senior U.S. defense official said Monday, as the Obama administration strongly warned the Assad regime against using them.


A senior defense official said intelligence officials have detected activity around more than one of Syria‘s chemical weapons sites in the last week. The defense official spoke on condition of anonymity because he was not authorized to speak publicly about intelligence matters.












Secretary of State Hillary Rodham Clinton, in Prague for meetings with Czech officials, reiterated President Barack Obama‘s declaration that Syrian action on chemical weapons was a “red line” for the United States that would prompt action.


“We have made our views very clear: This is a red line for the United States,” Clinton told reporters. “I’m not going to telegraph in any specifics what we would do in the event of credible evidence that the Assad regime has resorted to using chemical weapons against their own people. But suffice it to say, we are certainly planning to take action if that eventuality were to occur.”


Syria said Monday it would not use chemical weapons against its own people. The Ministry of Foreign Affairs said Syria “would not use chemical weapons — if there are any — against its own people under any circumstances.”


Syria has been careful never to confirm that it has any chemical weapons.


The use of chemical weapons would be a major escalation in Assad’s crackdown on his foes and would draw international condemnation. In addition to causing mass deaths and horrific injuries to survivors, the regime’s willingness to use them would alarm much of the region, particularly neighboring states, including Israel.


At the White House, press secretary Jay Carney said, “We are concerned that in an increasingly beleaguered regime, having found its escalation of violence through conventional means inadequate, might be considering the use of chemical weapons against the Syrian people. And as the president has said, any use or proliferation of chemical weapons by the Syrian regime would cross a red line for the United States. “


Administration officials would not detail what that response might be.


Although Syria is one of only seven nations that have not signed the Chemical Weapons Treaty, it is a party to the 1925 Geneva Protocol that bans the use of chemical weapons in war. That treaty was signed in the aftermath of World War I, when the effects of the use of mustard gas and other chemical agents outraged much of the world.


Clinton didn’t address the issue of the fresh activity at Syrian chemical weapons depots, but insisted that Washington would address any threat that arises.


An administration official said the trigger for U.S. action of some kind is the use of chemical weapons or movement with the intent to use or provide them to a terrorist group like Hezbollah. The U.S. is trying to determine whether the recent movement detected in Syria falls into any of those categories, the official said. The administration official was speaking on condition of anonymity this person was not authorized to speak publicly about the issue.


The senior defense official said the U.S. does not believe that any Syrian action beyond the movement of components is imminent.


An Israeli official said if there is real movement on chemical weapons, it would require a response. He didn’t say what that might be and spoke on condition of anonymity pending a formal government response to the reports of the latest activities.


Israeli officials have repeatedly expressed concerns that Syrian chemical weapons could slip into the hands of Hezbollah or other anti-Israel groups, or even be fired toward Israel in an act of desperation by Syria.


Syria is believed to have several hundred ballistic surface-to-surface missiles capable of carrying chemical warheads.


Its arsenal is a particular threat to the American allies, Turkey and Israel, and Obama singled out the threat posed by the unconventional weapons earlier this year as a potential cause for deeper U.S. involvement in Syria’s civil war. Up to now, the United States has opposed military intervention or providing arms support to Syria’s rebels for fear of further militarizing a conflict that activists say has killed more than 40,000 people since March 2011.


Clinton said that while the actions of President Bashar Assad‘s government have been deplorable, chemical weapons would bring them to a new level.


“We once again issue a very strong warning to the Assad regime that their behavior is reprehensible, their actions against their own people have been tragic,” she said. “But there is no doubt that there’s a line between even the horrors that they’ve already inflicted on the Syrian people and moving to what would be an internationally condemned step of utilizing their chemical weapons.”


Activity has been detected before at Syrian weapons sites, believed to number several dozen.


Defense Secretary Leon Panetta said in late September the intelligence suggested the Syrian government had moved some of its chemical weapons in order to protect them. He said the U.S. believed that the main sites remained secure.


Asked Monday if they were still considered secure, Pentagon press secretary George Little declined to comment about any intelligence related to the weapons.


Senior lawmakers were notified last week that U.S. intelligence agencies had detected activity related to Syria’s chemical and biological weapons, said a U.S. intelligence official, speaking on condition of anonymity to discuss the closed-door meetings. All congressional committees with an interest in Syria, from the intelligence to the armed services committees, are now being kept informed.


“I can’t comment on these reports but I have been very concerned for some time now about Syria’s stockpiles of chemical weapons and its stocks of advanced conventional weapons like shoulder-launched anti-aircraft missiles,” said House intelligence committee Chairman Mike Rogers, R-Mich. “We are not doing enough to prepare for the collapse of the Assad regime, and the dangerous vacuum it will create. Use of chemical weapons by the Assad regime would be an extremely serious escalation that would demand decisive action from the rest of the world,” he added.


Syria is believed to have one of the world’s largest chemical weapons programs, and the Assad regime has said it might use the weapons against external threats, though not against Syrians. The U.S. and Jordan share the same concern about Syria’s chemical and biological weapons — that they could fall into the wrong hands should the regime in Syria collapse and lose control of them.


___


Klapper reported from Prague. Associated Press writers Josef Federman in Jerusalem, Albert Aji in Damascus and Matthew Lee, Kimberly Dozier, and Julie Pace in Washington contributed to this report.


Europe News Headlines – Yahoo! News


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Judge gives initial OK to revised Facebook privacy settlement












(Reuters) – A U.S. judge on Monday gave his preliminary approval to a second attempt by Facebook Inc to settle a class action lawsuit which charges the social networking company with violating privacy rights.


U.S. District Judge Richard Seeborg in California rejected a settlement in August over Facebook‘s ‘Sponsored Stories’ advertising feature, questioning why it did not award money to Facebook members for using their personal information.












But in a ruling handed down Monday, Seeborg said a revised settlement “falls within the range of possible approval as fair, reasonable and adequate.”


In a revised proposal, Facebook and plaintiff lawyers said users now could claim a cash payment of up to $ 10 each to be paid from a $ 20 million total settlement fund. Any money remaining would then go to charity.


The company also said it would engineer a new tool to enable users to view content that might have been displayed in Sponsored Stories and opt out if they desire, a court document said.


If it receives final approval, the proposed settlement would resolve a 2011 lawsuit originally filed by five Facebook Inc members.


The lawsuit alleged the Sponsored Stories feature violated California law by publicizing users’ “likes” of certain advertisers without paying them or giving them a way to opt out. The case involved over 100 million potential class members.


A spokesman for Facebook said the company was “pleased that the court has granted preliminary approval of the proposed settlement.” Lawyers for the plaintiffs weren’t immediately available for comment Monday evening.


Outside groups and class members will have a chance to object to the latest settlement before Seeborg decides whether to grant final approval. A hearing on the fairness of the deal has been set for June 28, 2013. The case in U.S. District Court, Northern District of California is Angel Fraley et al., individually and on behalf of all others similarly situated vs. Facebook Inc, 11-cv-1726.


(Reporting by Jessica Dye; Editing by Michael Perry)


Tech News Headlines – Yahoo! News


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