Number of new drugs picks up in Europe and U.S.

LONDON (Reuters) – The number of new medicines approved or pending approval is on the rise on both sides of the Atlantic, painting an encouraging picture for the global drugs industry as it emerges from a wave of patent expiries.

European regulators said on Tuesday that they expect an increase in new drug applications to about 54 in 2013. In the United States, a total of 34 new drugs have been approved for sale so far in 2012 – the highest level in eight years.

The sector badly needs a pick-up in productivity as companies try to refill their medicine chests after a wave of patient expiries that have peaked this year, depriving leading U.S. and European drug companies of more than $ 30 billion of revenue.

“It bodes well,” said Standard & Poor’s (S&P) analyst Olaf Toelke, who predicts that strong pipelines will allow most large drugmakers to emerge unscathed from the spike in sales losses.

“It shows that companies are addressing the need to find new drugs to replace those facing patent expiration. They have done their homework and it looks as if the industry will be at least stable in future and not fall off the threatened patent cliff.”

The U.S. Food and Drug Administration (FDA), gatekeeper to the world’s biggest pharmaceuticals market, still has just over a week to add more approvals to this year’s tally – and there are signs that the number will increase further.

Three new products for leukemia, anthrax and Cushing’s disease from Ariad Pharmaceuticals, GlaxoSmithKline and Novartis were approved last Friday alone, and the FDA is scheduled to hand down decisions on a further four drugs before the end of the month.

FEWER GENERICS

A green light for all these would take the 2012 tally of new molecular entities (NMEs) approved by the agency’s Center for Drug Evaluation and Research to 38 – two more than the 2004 total of 36.

The European Medicines Agency painted a different picture of improving productivity by announcing that its work program for the year ahead included a forecast for 54 new drug applications, up from 52 in 2012, 48 in 2011 and 34 in 2010. These figures exclude medicines designated for “orphan”, or rare, diseases.

Significantly, the London-based agency is also expecting a sharp drop in the number of applications from companies to sell generic versions of drugs, to 20 in 2013 from 39 in 2012, given the slowdown in patent expiries next year.

Major U.S. drug companies will lose a total of about $ 21 billion in revenue this year from lucrative medicines coming off patent, while the hit for European businesses is about $ 10 billion, according to S&P.

This year’s expiries have included Sanofi and Bristol-Myers Squibb’s heart drug Plavix and AstraZeneca’s antipsychotic Seroquel.

Winning approval from regulators, however, is only part of the battle for drugmakers.

Investors will also be watching closely to see how the new drugs perform commercially once they reach the market, since securing payment for innovative medicines is an increasingly tough fight – especially in austerity-hit Europe.

An analysis by Deloitte and Thomson Reuters this month found that while new drug approvals were increasing, this was offset by lower expected revenues from many individual products.

(Editing by David Goodman)

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Rush to boost safety sparks flurry of ideas

(Reuters) - They began calling on Friday morning, even before confirmation of the death toll at Sandy Hook Elementary. Principals, district administrators, school police chiefs all asked the same pleading questions: What can we do? How do we stop this? How can we keep our children safe?

Michael Dorn, phone to his ear until 2 a.m., gave them all the same advice: Slow down.

Every horrific school shooting sets off a rush to bolster security, and Dorn, a widely respected school safety consultant, says he has seen hundreds of millions of dollars wasted in the frenzy to upgrade.

Principals spend lavishly on emergency response software, not realizing how impractical it is to fumble with a log-in during a crisis. Districts buy pricey metal detectors, only to switch them off because they cannot afford to deploy staff to do pat-downs and search book bags.

"People are frightened. They're trying so hard," said Dorn, a former schools police chief who runs the nonprofit consulting network Safe Havens International in Macon, Georgia. "But you want to build something that will last decades. Focus on making quality improvements rather than doing it quickly."

The horrific toll in Newtown has prompted administrators across the U.S. to reassess their safety protocols. Some have found obvious deficiencies that will take money to fix, such as classroom doors that don't lock. Bu t in many cases, security experts say districts can strengthen safety on campus without big spending.

In a survey conducted by the American Association of School Administrators in 2009 -- the 10th anniversary of the Columbine High School shootings -- fully a third of educators admitted they sometimes propped open doors to their schools, potentially giving intruders easy access. And almost 40 percent acknowledged they weren't training staff adequately in emergency response.

School safety consultants said such lapses remained common until the Newtown tragedy snapped administrators out of their complacency. "We tend to let our guard down as memories fade," said Paul Timm, president of RETA Security Inc, a consulting firm in Lemont, Illinois.

He and others said schools could greatly improve safety with a series of inexpensive measures: Keep all exterior doors shut and locked. Equip recess monitors with walkie-talkies to report signs of trouble. Regularly review emergency plans and practice for a variety of scenarios, not just an active shooter. Train all adults on campus to recognize behavior patterns that could indicate that a student is planning mischief or malice.

Hundreds of school districts and colleges across the U.S. have also adopted a more controversial approach to safety: teaching staff -- and students -- to fight back in the face of danger.

The ALICE protocol, developed a decade ago by a former police officer in response to a series of school shootings, rejects as inadequate the traditional response to an armed intruder, which prompts teachers and students to lock themselves in their classroom, turn out the lights and hide as best they can.

Greg Crane, the retired police officer who developed ALICE, says rather than fall back on that response, students and teachers must develop the confidence that allows them to think on their feet.

If they can escape the building quickly, through a window perhaps, why huddle in a darkened classroom? And if an intruder enters the classroom, why remain passive; why not run around, scream, throw books and desks at the gunman, even try to tackle him, Crane asks.

"If a predator tried to snatch a child off the street, what part of our advice is for him to remain quiet, static, passive?" Crane asked. "We want you throwing things, yelling, trying to get out of there," he said. The same should hold in a classroom, he said, arguing that even 5- and 6-year-olds can cause enough distraction to confuse a gunman and perhaps buy a few minutes for escape.

"Chaos is not a bad thing," Crane said. "We want to see chaos. That makes it very difficult for the shooter to operate."

The ALICE program -- it stands for Alert, Lockdown, Inform, Counter, Evacuate -- has sparked concern in some communities, with parents protesting that terrified children can't be asked to confront crazed gunmen or make snap decisions about escape routes.

But Crane said his company, Response Options, which is based in Burleson, Texas, has been flooded with calls since Friday from officials eager to sign up for his $400 training workshop, which prepares participants to teach ALICE to students and teachers in their communities.

While the tragedy at Sandy Hook focused attention on the danger of armed intruders, safety consultants cautioned that schools must also remain vigilant about internal threats from students who may feel alienated or may be struggling with mental illness.

"The ultimate in safety is caring about one another and kids trusting you with information," said Bill Bond, a security consultant with the National Association of Secondary School Principals.

Bond was the principal at Heath High School in West Paducah, Kentucky, in 1997, when a student opened fire on a morning prayer circle, killing three girls. He advocates programs that connect children with adult mentors.

Such connections are harder to maintain in an era of tight budgets, however. There is just one school counselor for every 471 students in the U.S.; a few years ago, the ratio was 1 to 457, according to the American School Counselor Association. Faced with tight budgets, some districts have asked every adult connected with the school, including bus drivers, custodians and cafeteria workers, to pitch in with mentoring and monitoring kids.

"People want to be able to say, if we just do X, Y and Z in every school in America, we'll stop these," said Dorn, the security consultant in Georgia. There is no such solution, he said. Each school, and each threat, is too different.

But Dorn said he understands why the school officials who call him up are so eager to do something, anything, at once. "I have a 4-year-old. I took him to school this morning," Dorn said. "I understand the fear." (Reporting By Stephanie Simon. Editing by Douglas Royalty)

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N. Korea displays Kim Jong Il a year after death

PYONGYANG, North Korea (AP) — North Korea unveiled the embalmed body of Kim Jong Il, still in his trademark khaki jumpsuit, on the anniversary of his death Monday as mourning mixed with pride over a recent satellite launch that was a long-held goal of the late authoritarian leader.

Kim lies in state a few floors below his father, national founder Kim Il Sung, in the Kumsusan mausoleum, the cavernous former presidential palace. Kim Jong Il is presented lying beneath a red blanket, a spotlight shining on his face in a room suffused in red.

Wails echoed through the chilly hall as a group of North Korean women sobbed into the sashes of their traditional Korean dresses as they bowed before his body. The hall bearing the glass coffin was opened to select visitors — including The Associated Press — for the first time since his death.

North Korea also unveiled Kim’s yacht and his armored train carriage, where he is said to have died. Among the personal belongings featured in the mausoleum are the parka, sunglasses and pointy platform shoes he famously wore in the last decades of his life. A MacBook Pro lay open on his desk.

North Koreans paid homage to Kim and basked in the success of last week’s launch of a long-range rocket that sent a satellite named after him to space.

The launch, condemned in many other capitals as a violation of bans against developing its missile technology, was portrayed not only as a gift to Kim Jong Il but also as proof that his young son, Kim Jong Un, has the strength and vision to lead the country.

The elder Kim died last Dec. 17 from a heart attack while traveling on his train. His death was followed by scenes of North Koreans dramatically wailing in the streets of Pyongyang, and of the 20-something son leading ranks of uniformed and gray-haired officials through funeral and mourning rites.

The mood in the capital was decidedly more upbeat a year later, with some of the euphoria carrying over from last Wednesday’s launch. The satellite bears one of Kim Jong Il’s nicknames, Kwangmyongsong, or “Lode Star,” a moniker given to him at birth according to the official lore.

Cameras were not allowed inside the mausoleum, and state media did not release any images of Kim Jong Il’s body.

With the death anniversary came a hint that Kim Jong Un himself might soon be a father.

His wife, Ri Sol Ju, was seen on state TV with what appeared to be a baby bump as she walked slowly next to her husband at the mausoleum, where they bowed to statues of Kim’s father and grandfather.

There is no official word from Pyongyang about a pregnancy. In addition, Ri is shown wearing a billowing traditional Korean dress in black that makes it difficult to know for sure.

North Koreans are reluctant to discuss details of the Kim family that have not been released by the state. Still there are rumors even in Pyongyang about whether the country’s first couple is expecting.

To honor Kim’s father, North Koreans stopped in their tracks at midday and bowed their heads as the national flag fluttered at half-staff along streets and from buildings.

Pyongyang construction workers took off their yellow hard hats and bowed at the waist as sirens wailed across the city for three minutes.

Tens of thousands of North Koreans gathered in the frigid plaza outside, newly transformed into a public park with lawns and pergolas. Geese flew past snow-tinged firs and swans dallied in the partly frozen moat that rings the vast complex in Pyongyang’s outskirts.

“Just when we were thinking how best to uphold our general, he passed away,” Kim Jong Ran said at the plaza. “But we upheld leader Kim Jong Un. … We regained our strength and we are filled with determination to work harder for our country.”

Speaking outside the mausoleum, renamed the Kumsusan Palace of the Sun, the military’s top political officer, Choe Ryong Hae, said North Korea should be proud of the satellite, calling it “a political event with great significance in the history of Korea and humanity.”

Much of the rest of the world, however, was swift in condemning the launch, which was seen by the United States and other nations as a thinly disguised cover for testing missile technology that could someday be used for a nuclear warhead.

The test, which the U.N. Security Council said violated a ban on launches using ballistic missile technology, underlined Kim Jong Un’s determination to continue carrying out his father’s hardline policies even if they draw international condemnation.

Washington said Monday it has no option but to seek to isolate Pyongyang further.

“What’s left to us is to continue to increase pressure on the North Korean regime and we are looking at how to best to do that, both bilaterally and with our partners going forward until they (North Korea) get the message. We are going to further isolate this regime,” U.S. State Department spokeswoman Victoria Nuland said.

Some outside experts worry that Pyongyang’s next move will be to press ahead with a nuclear test in the coming weeks, a step toward building a warhead small enough to be carried by a long-range missile.

Despite inviting further isolation for his impoverished nation and the threat of stiffer sanctions, Kim Jong Un won national prestige and clout by going ahead with the rocket launch.

At a memorial service on Sunday, North Korea’s top leadership not only eulogized Kim Jong Il, but also praised his son. Kim Yong Nam, president of the Presidium of North Korea’s parliament, called the launch a “shining victory” and an emblem of the promise that lies ahead with Kim Jong Un in power.

The rocket’s success also fits neatly into the narrative of Kim Jong Il’s death. Even before he died, the father had laid the groundwork for his son to inherit a government focused on science, technology and improving the economy. And his pursuit of nuclear weapons and the policy of putting the military ahead of all other national concerns have also carried into Kim Jong Un’s reign.

In a sign of the rocket launch’s importance, Kim Jong Un invited the scientists in charge of it to attend the mourning rites in Pyongyang, according to state media.

The reopening of the mausoleum on the anniversary of the leader’s death follows tradition. Kumsusan, the palace where his father, Kim Il Sung, served as president, was reopened as a mausoleum on the anniversary of his death in 1994.

___

Associated Press writers Hyung-jin Kim in Seoul, South Korea, and Matthew Pennington in Washington contributed to this report. Follow Jean Lee, AP’s bureau chief for Pyongyang and Seoul, at www.twitter.com/newsjean.

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Amazon adds episodes of alt-comedy show “UnCabaret”

LOS ANGELES (TheWrap.com) – Amazon Instant Video has added four exclusive episodes of “UnCabaret,” an alt-comedy showcase for the likes of Margaret Cho and Andy Dick, to its Prime Instant Video service.

The show was created and hosted by comedian and entertainer Beth Lapides and features performances by such comedy stars as Sandra Bernhard, Garfunkle and Oates, Greg Fitzsimmons and Rob Delaney. Instead of punch-line driven sets, performers are encouraged to show off story-based stream-of-consciousness acts.

Amazon Prime members will get free access to the titles. The episodes will be available for rental or purchase for Amazon Instant Video customers on an a la carte basis.

Amazon Prime costs $ 79 annually and gives members free two-day shipping as well as streaming access to movies and shows from the likes of Paramount and Disney-ABC. The catalog of titles grew a little larger Monday. In addition to “UnCabaret,” Amazon announced an exclusive content licensing agreement with Turner Broadcasting System and Warner Bros. TV to add two TNT shows, “Falling Skies” and “The Closer” to its service.

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Inherited colon cancer risk tied to certain foods

NEW YORK (Reuters Health) – Among people who have a genetic susceptibility to colon cancer, those whose diets are heavy in junk food have an even higher risk, according to a new study.

“These patients have this very high risk because of this (genetic) mutation they have, but it might be that they could reduce the number of (tumors) by having a more healthy lifestyle,” said Akke Botma, the lead author of the study.

Botma’s study is just the first to find a link between certain foods and a higher colon cancer risk in this group, and it can’t prove that the diet is to blame.

All of the people in the study had Lynch syndrome, a genetic disorder that predisposes people to cancer at younger ages and that affects up to one in 660 people.

In Western countries, colorectal and endometrial cancers are the dominant cancers to turn up in people with the syndrome, while in Asia it’s mostly stomach cancer, Botma said.

Up to 70 percent of people with Lynch syndrome will develop colon cancer. Among people without Lynch syndrome, such cancers are thought to be influenced by diet, particularly alcohol and red and processed meat, the authors note in their study, published in the journal Cancer.

Botma and her colleagues at Wageningen University in the Netherlands contacted 486 people with Lynch syndrome from a national database of families with inherited risks for cancer.

At the beginning of the study they surveyed the participants about what they ate, and they ranked each person on whether he ate low, medium or high amounts of foods within four dietary categories.

The food groups included one that was dominated by fruits, vegetables and whole grains; another that was high in meat and coffee; a third dietary group that resembled a Mediterranean diet – fish, leafy greens, pasta, sauces and wine; and a fourth group that was heavy on fried snacks, fast food and diet soda.

Botma and her colleagues found that, over 20 months of follow up, 56 of the participants — or 12 percent — screened positive for tumors in the colon, a precursor to cancer.

Of the four dietary groupings, only the junk food category showed any link with a different risk for developing colon tumors.

Of the 160 people who scored low on the junk food diet, 17 developed tumors, while 18 out of the 160 people who ate the most junk food developed tumors.

The numbers initially seemed similar, but after taking into account smoking and other risk factors, the researchers determined that those in the high junk food group were twice as likely to develop colon tumors.

HOW TO MANAGE RISKS?

“It’s hard to say why” junk food is linked with a greater risk for these tumors, said Dr. Mala Pande, an instructor at the University of Texas MD Anderson Cancer Center in Houston who was not involved in the research.

She said some researchers have suggested that high fat might have something to do with it, but it’s impossible to conclude that from this study.

Although the findings are too preliminary to be used in making dietary recommendations to people with Lynch Syndrome, the study was valuable in launching research into the possible role of certain foods on cancer risk, said Christopher Amos, a professor at the Geisel School of Medicine at Dartmouth College.

“People with Lynch Syndrome are at higher risk, and we’d really like to know how to manage their risks better,” Amos, who was not part of the study, told Reuters Health.

Certain foods have been shown to be linked with different types of cancer, but many of those studies contradict each other and sow confusion (see Reuters Health report of December 5, 2012 here: http://reut.rs/YPuDcs).

Amos said the new study is a good start, but “it would be nice to confirm (it) with additional findings.”

SOURCE: http://bit.ly/SG85JD Cancer, online December 17, 2012.

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Fate of massacre site can help healing

AURORA, Colo. (AP) — As Newtown, Conn., grieves the deadly mass shooting at Sandy Hook Elementary School, victims' families and residents will eventually have to decide what to do with the building and how to memorialize the fallen.

Will they decide to demolish the school where authorities say Adam Lanza killed 20 children and six adults before killing himself? Or just the parts where he opened fire? Will there be a memorial on school grounds, or in town? Or both?

Whatever they choose, it will give them a measure of control over a situation in which they have had very little, said Dr. Louis Kraus, chief of child and adolescent psychiatry at Rush University Medical Center in Chicago.

"To be able to have some control and say in that process I think is going to be very important" to the healing process, he said.

Here's a look at what communities that have faced deadly mass shootings have done:

— After a white supremacist opened fire in a Sikh temple in Oak Creek, Wis., in August, killing six people and injuring four, temple officials held a purifying ceremony and removed bloodstained carpeting, repaired shattered windows and painted over gunfire-scarred walls.

But they left one reminder of the violence — a dime-size bullet hole in the door jamb leading to the prayer room. The hole is now marked with a small gold plate engraved with "We Are One. 8-5-12."

"It frames the wound," Pardeep Kaleka, son of former temple president Satwant Singh Kaleka, who died in the massacre, said recently. "The wound of our community, the wound of our family, the wound of our society."

— After a gunman killed 12 people at a midnight showing of the Batman movie in Aurora, Colo., more than 70 percent of the 6,300 people who responded to an online survey wanted the theater reopened.

A memorial that sprang up near the theater is gone but a new sign offers sympathy to those suffering from the nation's latest mass shooting —"Newtown, CT We feel your pain."

— In Norway, extensive remodeling is planned on the small island of Utoya, where 69 people, more than half of them teenagers attending summer camp, were killed by a far-right gunman in 2011.

Utoya's main building, a cafeteria where 13 of the victims were shot to death, will be torn down and replaced by a cluster of new buildings surrounding a square, creating the feel of a "small village," project manager Joergen Frydnes said.

The idea is to bring back the positive atmosphere that characterized Utoya before the tragedy, he said. There was no summer camp this year and it's unclear when the left-wing youth group will be back at Utoya for what used to be its annual highlight.

Frydnes said it will happen, eventually.

— At Virginia Tech, the scene of the worst mass shooting in modern U.S. history, a classroom building where a student gunman killed 30 people in April 2007 is now home to the Center for Peace Studies and Violence Prevention.

A dormitory where the two other students were killed has been turned into a residential college. The gunman killed himself.

As at many other scenes of mass shootings, a memorial was created on the campus' main lawn recreating the 32 stones — one for each person killed — placed there in the hours after tragedy.

— In Pennsylvania, an Amish community quickly decided that removing a schoolhouse where five girls were killed and five others were wounded in October 2006 by a gunman would be the best way to help bring resolution, mainly out of sensitivity to their children.

Ten days after the shooting, heavy machinery moved in before dawn to demolish the West Nickel Mines Amish School, making the site indistinguishable from the surrounding pasture.

New Hope Amish School, its replacement with added security features, was built a few hundred yards away and opened April 2, 2007 — six months to the day after the massacre.

— After a man killed 16 children and a teacher at a primary school gymnasium in Dunblane, Scotland, before turning the gun on himself, authorities demolished the gym.

The site of the gym is now a small garden that includes a plaque with the names of all the victims, most of whom were aged 5. A new gym was built on the school grounds.

Two miles from the school, on the outskirts of the town, is a community center built after a vote on how to spend the money donated from well-wishers around the world.

On the night of the Newtown shooting, some people came to the center and lit candles, said Stewart Prodger, a trustee of the charity that runs the center.

— After two students went on a deadly rampage at Columbine High School in Littleton, Colo., in April 1999, students finished the year at another school. Columbine reopened in time for the following school year after extensive repairs.

"The intent of the school district is to put this back as a high school," Jack Swanzy, lead architect on the refurbishing project, said at the time. "We don't want to make it a shrine to the tragedy."

School district officials originally considered remodeling and reopening the second-floor library, where most of the students were killed, but parents objected and asked that it be demolished and replaced.

The district eventually agreed and the old library, which sat above the school cafeteria, was removed and the space converted into an atrium.

A memorial to those killed — 12 students and a teacher — opened years later on a hill above the school. The broad oval sunken into the rolling terrain still attracts people.

On Friday, after the Newtown shooting, Amber Essman, 24, made her first visit. She was in grade school at the time of the shooting and had been hesitant to visit before because of the emotions it would bring up.

She wanted to pay belated respects to those killed at Columbine and provide some comfort to their families. "They need comfort and peace today in addition to the families in Connecticut that have been affected," she said.

___

Associated Press writers Karl Ritter in Stockholm, Dinesh Ramde in Milwaukee, Michael Felberbaum in Richmond, Va., Mark Scolforo in Harrisburg, Pa., and Ben McConville in Edinburgh, Scotland, contributed to this report.

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Egyptians hand Islamists narrow win in constitution vote

CAIRO (Reuters) – Egyptians voted in favor of a constitution shaped by Islamists but opposed by other groups who fear it will divide the Arab world’s biggest nation, officials in rival camps said on Sunday after the first round of a two-stage referendum.

Next week’s second round is likely to give another “yes” vote as it includes districts seen as more sympathetic towards Islamists, analysts say, meaning the constitution would be approved.

But the narrow win so far gives Islamist President Mohamed Mursi only limited grounds for celebration by showing the wide rifts in a country where he needs to build a consensus for tough economic reforms.

The Muslim Brotherhood‘s party, which propelled Mursi to office in a June election, said 56.5 percent backed the text. Official results are not expected until after the next round.

While an opposition official conceded the “yes” camp appeared to have won the first round, the opposition National Salvation Front said in a statement that voting abuses meant a rerun was needed – although it did not explicitly challenge the Brotherhood‘s vote tally.

Rights groups reported abuses such as polling stations opening late, officials telling people how to vote and bribery. They also criticized widespread religious campaigning which portrayed “no” voters as heretics.

A joint statement by seven human rights groups urged the referendum’s organizers “to avoid these mistakes in the second stage of the referendum and to restage the first phase again”.

Mursi and his backers say the constitution is vital to move Egypt’s democratic transition forward. Opponents say the basic law is too Islamist and tramples on minority rights, including those of Christians who make up 10 percent of the population.

The build-up to Saturday’s vote was marred by deadly protests. Demonstrations erupted when Mursi awarded himself extra powers on November 22 and then fast-tracked the constitution through an assembly dominated by his Islamist allies.

However, the vote passed off calmly with long queues in Cairo and several other places, though unofficial tallies indicated turnout was around a third of the 26 million people eligible to vote this time. The vote was staggered because many judges needed to oversee polling staged a boycott in protest.

The opposition had said the vote should not have been held given the violent protests. Foreign governments are watching closely how the Islamists, long viewed warily in the West, handle themselves in power.

“It’s wrong to have a vote or referendum with the country in the state it is – blood and killings, and no security,” said Emad Sobhy, a voter who lives in Cairo. “Holding a referendum with the country as it is cannot give you a proper result.”

INCREASINGLY DIVIDED

As polls closed, Islamists attacked the offices of the newspaper of the liberal Wafd party, part of the opposition National Salvation Front coalition that pushed for a “no” vote.

“The referendum was 56.5 percent for the ‘yes’ vote,” a senior official in the Brotherhood’s Freedom and Justice Party operations room set up to monitor voting told Reuters.

The Brotherhood and its party had representatives at polling stations across the 10 areas, including Cairo, in this round. The official, who asked not to be identified, said the tally was based on counts from more than 99 percent of polling stations.

“The nation is increasingly divided and the pillars of state are swaying,” opposition politician Mohamed ElBaradei wrote on Twitter. “Poverty and illiteracy are fertile grounds for trading with religion. The level of awareness is rising fast.”

One opposition official also told Reuters the vote appeared to have gone in favor of Islamists who backed the constitution.

The opposition initially said its exit polls indicated the “no” camp would win comfortably, but officials changed tack during the night. One opposition official said in the early hours of Sunday that it would be “very close”.

A narrow loss could still hearten leftists, socialists, Christians and more liberal-minded Muslims who make up the disparate opposition, which has been beaten in two elections since Hosni Mubarak was overthrown last year.

They were drawn together to oppose what they saw as a power grab by Mursi as he pushed through the constitution. The National Salvation Front includes prominent figures such as ElBaradei, former Arab League chief Amr Moussa and firebrand leftist Hamdeen Sabahy.

If the constitution is approved, a parliamentary election will follow early next year.

DEADLY VIOLENCE

Analysts question whether the opposition group will keep together until the parliamentary election. The Islamist-dominated lower house of parliament elected earlier this year was dissolved based on a court order in June.

Violence in Cairo and other cities has plagued the run-up to the referendum. At least eight people were killed when rival camps clashed during demonstrations outside the presidential palace earlier this month.

In order to pass, the constitution must be approved by more than 50 percent of those casting ballots. There are 51 million eligible voters in the nation of 83 million.

Islamists have been counting on their disciplined ranks of supporters and on Egyptians desperate for an end to turmoil that has hammered the economy and sent Egypt’s pound to eight-year lows against the dollar.

The army deployed about 120,000 troops and 6,000 tanks and armored vehicles to protect polling stations and other government buildings. While the military backed Mubarak and his predecessors, it has not intervened in the present crisis.

(Additional reporting Yasmin Saleh and Marwa Awad; Writing by Edmund Blair and Giles Elgood; Editing by Tom Pfeiffer)

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‘Hobbit’ bests ‘Rings’ with $84.8 million opening

NEW YORK (AP) — Peter Jackson‘s “The Hobbit” led the box office with a haul of $ 84.8 million, a record-setting opening better than the three previous “Lord of the Rings” films.

The Warner Bros. Middle Earth epic was the biggest December opening ever, surpassing Will Smith’s “I Am Legend,” which opened with $ 77.2 million in 2007, according to studio estimates Sunday. “The Hobbit: An Unexpected Journey” also passed the December opening of “Avatar,” which opened with $ 77 million. Internationally, “The Hobbit” also added $ 138.2 million, for an impressive global debut of $ 223 million.

Despite weak reviews, the 3-D adaptation of J. R. R. Tolkien‘s first novel in the fantasy series was an even bigger draw than the last “Lord of the Rings” movie, “The Return of the King.” That film opened with $ 72.6 million. “The Hobbit” is the first of another planned trilogy, with two more films to be squeezed out of Tolkien’s book.

While Jackson’s “Rings” movies drew many accolades — “The Return of the King” won best picture from the Academy Awards — the path for “The Hobbit” has been rockier. It received no Golden Globes nominations on Thursday, though all three “Rings” films were nominated by the Hollywood Foreign Press Association for best picture.

Particularly criticized has been the film’s 48-frames-per-second (double the usual rate), a hyper-detailed look that some have found jarring. Most moviegoers didn’t see “The Hobbit” in that version, though, as the new technology was rolled out in only 461 of the 4,045 theaters playing the film.

Regardless of any misgivings over “The Hobbit,” the film was a hit with audiences. They graded the film with an “A” CinemaScore.

“What’s really important, what makes this special is the CinemaScore,” said Dan Fellman, president of domestic distribution for Warner Bros. “All these things point to a great word of mouth. We haven’t even made it to the Christmas holidays yet. Kids are still in school this week.”

The strong opening culminated a long journey for “The Hobbit,” which was initially delayed when a lawsuit dragged on between Jackson and “Rings” producer New Line Cinema over merchandizing revenue. At one point, Guillermo del Toro was to direct the film with Jackson producing. But eventually the filmmaker opted to direct the movie himself, originally envisioning two “Hobbit” films. The production also went through the bankruptcy of distribution partner MGM and a labor dispute in New Zealand, where the film was shot.

The long delay for “The Hobbit,” nearly a decade after the last “Lord of the Rings” film, made it “one of those movies that had everyone scratching their heads as to how it would open,” said Paul Dergarabedian, an analyst for box-office tracker Hollywood.com.

“It’s been a decade since the ‘Lord of the Rings‘ trilogy concluded,” said Dergarabedian. “There’s been so much anticipation for this film and having Peter Jackson back at the helm just made it irresistible both to fans and the non-initiated alike.”

“The Hobbit” was far and away the biggest draw in theaters, with no other new wide release. Paramount’s “Rise of the Guardians” continued to draw the family crowd, with $ 7.4 million, bringing its cumulative total to $ 71.4 million. The Oscar contender “Lincoln” from Walt Disney crossed the $ 100 million mark, adding another $ 7.2 million to bring its six-week total to $ 107.9 million. And Sony‘s James Bond film “Skyfall,” with another $ 7 million domestically, drew closer to a global take of $ 1 billion.

The box office continued to be on the upswing and with anticipated releases like “Les Miserables,” ”Django Unchained” and “The Guilt Trip” approaching in the holiday moviegoing season. Dergarabedian expects the year to break the 2009 record of $ 10.6 billion. With some $ 10.2 billion in revenue thus far, he said, “We’re on track to be in that realm.”

Estimated ticket sales for Friday through Sunday at U.S. and Canadian theaters, according to Hollywood.com. Where available, latest international numbers are also included. Final domestic figures will be released Monday.

1. “The Hobbit: An Unexpected Journey,” $ 84.8 million ($ 138.2 million international).

2. “Rise of the Guardians,” $ 7.4 million ($ 20.1 million international).

3. “Lincoln,” $ 7.2 million.

4. “Skyfall,” $ 7 million ($ 12.2 million international).

5. “Life of Pi,” $ 5.4 million ($ 11.5 million international).

6. “The Twilight Saga: Breaking Dawn, Part 2,” $ 5.2 million ($ 13 million international).

7. “Wreck-It Ralph,” $ 3.3million ($ 4.7 million international).

8. “Playing for Keeps,” $ 3.2 million ($ 1.4 million international).

9. “Red Dawn,” $ 2.4 million.

10. “Silver Linings Playbook,” $ 2 million ($ 370,000 international).

___

Estimated weekend ticket sales at international theaters (excluding the U.S. and Canada) for films distributed overseas by Hollywood studios, according to Rentrak:

1. “The Hobbit: An Unexpected Journey,” $ 138.2 million.

2. “Rise of the Guardians,” $ 20. 1 million.

3. “The Twilight Saga: Breaking Dawn, Part 2,” $ 13 million.

4. “Skyfall,” $ 12.2 million.

5. “Life of Pi,” $ 11.5 million.

6. “Wreck-It Ralph,” $ 4.7 million.

7. “26 Years,” $ 3.5 million.

8. “Whatcha Wearin’? (My P.S. Partner),” $ 3 million.

9. “Tutto Tutto Niente Niente,” $ 2.4 million.

10. “Pitch Perfect,” $ 2.3 million.

___

Universal and Focus are owned by NBC Universal, a unit of Comcast Corp.; Sony, Columbia, Sony Screen Gems and Sony Pictures Classics are units of Sony Corp.; Paramount is owned by Viacom Inc.; Disney, Pixar and Marvel are owned by The Walt Disney Co.; Miramax is owned by Filmyard Holdings LLC; 20th Century Fox and Fox Searchlight are owned by News Corp.; Warner Bros. and New Line are units of Time Warner Inc.; MGM is owned by a group of former creditors including Highland Capital, Anchorage Advisors and Carl Icahn; Lionsgate is owned by Lions Gate Entertainment Corp.; IFC is owned by AMC Networks Inc.; Rogue is owned by Relativity Media LLC.

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Boehner opens door to tax hikes, shifts U.S. fiscal cliff talks

WASHINGTON (Reuters) – U.S. House of Representatives Speaker John Boehner‘s offer to accept a tax rate increase for the wealthiest Americans knocks down a key Republican road block to a deal resolving the year-end “fiscal cliff.”

The question now boils down to what President Barack Obama offers in return. Such major questions, still unanswered so close to the end of the year suggest, however, that no spending and tax agreement is imminent.

A source familiar with the Obama-Boehner talks confirmed that Boehner proposed extending low tax rates for everyone who has less than $ 1 million in net annual income, meaning tax rates would rise on all above that line.

Under current law, the 35 percent top tax rate is scheduled to expire on January 1, and would automatically go to 39.6 percent. Boehner’s proposal would allow that rate to rise as scheduled at a threshold of $ 1 million – putting it back to where it was during the Clinton administration.

The White House has not accepted the proposal and the source could not confirm any additional talks were held on Sunday between Obama and Boehner.

With just over two weeks before the fiscal cliff’s $ 600 billion in automatic tax hikes and spending cuts are triggered, threatening a new recession, there is little time to craft a comprehensive deal that will satisfy both Democrats and Republicans.

Until the latest Republican offer, made on Friday, Boehner had insisted on extending all of the Bush era’s lower tax rates, resisting Obama’s demand to let the marginal rates rise on income above $ 250,000. A rising chorus of business executives also had urged Republicans to agree to this.

Some lawmakers and congressional aides had predicted that Republicans, once serious negotiations began, might try to raise the $ 250,000 threshold, say to $ 500,000 or $ 1 million. They also speculated that Republicans, if forced into a tax rate hike on the upper-income groups, might seek a smaller increase, say to around 37 percent.

Although the White House has not accepted Boehner’s gambit, it could push negotiations away from entrenched, ideological positions.

“Boehner has now accepted the premise of higher rates. So now we’re just arguing over details. I think it’s a significant step,” said Greg Valliere, chief political strategist at Potomac Research Group.

A framework deal spelling out tax revenue and spending cut targets to be finalized in the new year could be possible, Valliere said.

“Boehner’s offer to allow tax rates to go up for taxpayers earning over $ 1 million fundamentally transforms fiscal cliff negotiations,” added Sean West, U.S. policy analyst at Eurasia Group, a political risk consultancy.

In a note to clients, West wrote that it signals, significantly, that Boehner ultimately believes a deal to avoid the cliff is still possible.

“The political burden is now shifted back to the president, who must be willing to take on his party in order to get a deal Boehner can ultimately pass. We do not think the president will overreach: Obama will work with Boehner to get to a deal.”

There are still several critical elements to a deal besides a tax rate increase on the wealthy, including Republican demands to cut spending on social programs.

Changes to the expensive Medicare and Medicaid health care programs for the elderly and the poor could be central to any deal, which must also include an increase in the federal debt limit needed by the end of February.

DEMANDS SOCIAL PROGRAM CUTS

Boehner conditioned his tax rate increase offer on Obama’s agreement to cuts in social program spending, often called entitlements.

Many Republican lawmakers want to raise the eligibility age for Medicare to 67 from 65. They also want to link Medicare to the income of recipients, making wealthier retirees pay more for their care.

Currently, Medicare does have some means testing, charging higher premiums for coverage of doctors visits and prescription drugs to individuals earning more than $ 85,000 and married couples earning more than $ 170,000. Only about 5 percent of recipients pay these higher premiums.

Thus far, Obama has offered only about $ 400 billion in 10-year entitlement savings, mostly through small adjustments in reining in health care costs – not fundamental changes such as raising the eligibility age.

And just as Boehner faces opposition in his own party to raising any tax rates, Obama faces opposition to cuts to Medicare, Medicaid and Social Security from Democrats, who pledged in election campaigns they would protect these programs.

A major bloc of congressional Democrats has already signaled they will not accept major cutbacks in Medicare as part of any fiscal cliff deal.

House Minority Leader Nancy Pelosi of California and Maryland Representative Chris Van Hollen of Maryland are among the high ranking Democrats in the House who have come out forcefully in recent days against raising the age for eligibility for Medicare to 67 years of age.

“Given the level of savings that is being talked about from Medicare, you can’t get it all from providers and drug makers,” said Paul Heldman, an analyst at Potomac Research, which tracks Washington policy for investors.

“So opponents of raising the eligibility age have reason to believe beneficiaries will take some sort of hit if a mega-deal is cut,” he said.

If Republicans are not successful in securing entitlement program cuts in exchange for a tax-rate increase on the wealthy, they are adamant about using a debt-limit increase as leverage to overhaul Social Security and Medicare.

The U.S. Treasury expects to reach its $ 16.4 trillion statutory debt cap by year-end, and will exhaust its remaining borrowing capacity around mid-February, risking a potential default.

Louisiana Republican Representative John Fleming, a member of the conservative Tea Party caucus who has never voted to increase the debt ceiling, said he would support a debt limit hike if it were part of a deal to make Medicare and Social Security sustainable.

The pace of activity could pick up the coming week.

House Republicans were told to prepare for a possible weekend session next week, potentially interrupting travel plans for the long Christmas holiday weekend.

House Majority Leader Eric Cantor scheduled “possible legislation related to expiring provisions of law,” a reference to the expiring tax cuts, for the end of the week, portending a weekend session. Cantor has said the House would meet through the Christmas holidays and beyond.

(This story was fixed to correct current top tax rate to 35 percent from 36 percent)

(Additional reporting by Thomas Ferraro, Richard Cowan and Kim Dixon; Editing by Fred Barbash, Todd Eastham and Jackie Frank)

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Obama offers 'love, prayers of nation' to Newtown

NEWTOWN, Conn. (AP) — He spoke for a nation in sorrow, but the slaughter of all those little boys and girls left President Barack Obama, like so many others, reaching for words. Alone on a spare stage after the worst single day of his presidency, the commander in chief was a parent in grief.

"I am very mindful that mere words cannot match the depth of your sorrow, nor can they heal your wounded hearts," Obama said at an evening vigil in the grieving community of Newtown, Conn. "I can only hope that it helps for you to know that you are not alone in your grief."

The massacre of 26 children and adults at Sandy Hook Elementary on Friday elicited horror around the world, soul-searching in the United States, fresh political debate about gun control and questions about the incomprehensible — what drove the suspect to act.

It also left a newly re-elected president openly grappling for bigger answers. Obama said that in the coming weeks, he would use "whatever power this office holds" to engage with law enforcement, mental health professionals, parents and educators in an effort to prevent more tragedies like Newtown.

"Can say that we're truly doing enough to give all the children of this country the chance they deserve to live out their lives in happiness and with purpose? I've been reflecting on this the last few days," Obama said, somber and steady as some in the audience wept.

"If we're honest without ourselves, the answer is no. And we will have to change."

He promised to lead a national effort, but left unclear was what it would be, and how much it would address the explosive issue of gun control.

"What choice do we have?" Obama said. "Are we really prepared to say that we're powerless in the face of such carnage, that the politics are too hard?"

As Obama read some of the names of victims early in his remarks, several people broke down, their sobs heard throughout the hall.

He closed his remarks by slowly reading the first names of each of the 26 victims.

"God has called them all home. For those of us who remain, let us find the strength to carry on and make our country worthy of their memory," he said.

For Obama, ending his fourth year in office, it was another sorrowful visit to another community in disbelief. It is the job of the president to be there, to listen and console, to offer help even when the only thing within his grasp is a hug.

All the victims were killed up close by multiple rifle shots.

The toll: six adults. Twenty boys and girls, all of whom were just 6 or 7 years old.

Inside the vigil children held stuffed teddy bears and dogs. The smallest kids sat on their parents' laps.

There were tears and hugs, but also smiles and squeezed arms. Mixed with disbelief was a sense of a community reacquainting itself all at once. One man said it was less mournful, more familial. Some kids chatted easily with their friends. The adults embraced each other in support.

The president first met privately with families of the victims and with the emergency personnel who responded to the shootings. That meeting happened at Newtown High School, the site of Sunday night's interfaith vigil, about a mile and a half from where the shootings took place.

"We're halfway between grief and hope," said Curt Brantl, whose fourth-grade daughter was in the library of the elementary school when the shootings occurred. She was not harmed.

Police and firefighters got hugs and standing ovations when they entered. So did Obama.

"We needed this," said the Rev. Matt Crebbin, senior minister of the Newtown Congregational Church. "We need to be together here in this room. ... We needed to be together to show that we are together and united."

The shootings have restarted a debate in Washington about what politicians can to do help — gun control or otherwise. Obama on Friday called for leaders to agree on "meaningful action" to prevent killings.

Police say the gunman, Adam Lanza, was carrying an arsenal of ammunition big enough to kill just about every student in the school if given enough time. He shot himself in the head just as he heard police drawing near, authorities said.

A Connecticut official said the gunman's mother was found dead in her pajamas in bed, shot four times in the head with a.22-caliber rifle. The killer then went to the school with guns he took from his mother and began blasting his way through the building.

The tragedy plunged the picturesque New England town of 27,000 people into mourning.

"I know that Newtown will prevail, that we will not fall to acts of violence," said First Selectwoman Patricia Llodra. "It is a defining moment for our town, but it does not define us."

A White House official said Obama mainly wrote the speech himself. He worked with presidential speechwriter Cody Keenan, who helped Obama write his speech last year after shootings in Tucson, Ariz., left six dead and 13 wounded, including Rep. Gabby Giffords.

Just this past summer, Obama went to Aurora, Colo., to visit victims and families after a shooting spree at a movie theater in the Denver suburb left 12 dead.

In November 2009, Obama traveled to Fort Hood, Texas, to speak at the memorial service for 13 service members who were killed on the post by another soldier.

After the Colorado shooting in July, the White House made clear that Obama would not propose new gun restrictions in an election year and said he favored better enforcement of existing laws.

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