Shire’s ADHD amphetamine wins British backing

LONDON (Reuters) – Shire‘s hyperactivity treatment Vyvanse will be available in Europe within months after Britain’s drugs regulator backed the amphetamine-based stimulant used to treat millions of U.S. students.

The drug, lisdexamfetamine dimesylate, has a slow-release action that activates the amphetamine ingredient over the course of a day, helping levels of alertness and concentration in children with ADHD (attention deficit hyperactivity disorder).

It was assessed under the European Union‘s decentralized approvals procedure, led by Britain’s medicines watchdog. The application was supported by two European studies and clinical data from the United States.

Seven other EU countries – Denmark, Finland, Germany, Ireland, Norway, Spain and Sweden – participated, and they have agreed product labels. They will now issue their own national approvals, a process that takes up to three months, Shire said.

Chief executive Angus Russell said: “As all ADHD patients are different and will vary in their responses to the available treatments, we believe introducing Elvanse will provide physicians with a broader range of options to help patients with ADHD manage their individual needs effectively”.

Shire has established a leading position in treating hyperactivity in the United States with its stimulants Adderall XR and Vyvanse. The latter saw sales rise 24 percent to $ 247 million in the three months to September.

Shore Capital analyst Brian White said while he had modest sales expectations in the short term for the drug in Europe, where it will be the first amphetamine to be approved for ADHD, the decision was significant because the condition was becoming better known in Europe.

“Shire has been very successful in the U.S. with its ADHD franchise and one would expect them to use that experience to do a similar job in Europe, although that will take a lot longer just given the much lower awareness,” he said.

“They have another product coming along later (Intuniv) which is a non-stimulant, and that could be more appropriate for the European market than a stimulant.”

Vyvanse, which Shire said was the top-selling branded prescribed ADHD medicine in the United States, has been indicated in Europe for ADHD in children aged six years and over when treatment with methylphenidate, better known as Ritalin, was not successful.

(Editing by Dan Lalor)

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Syrian rebels take control of Damascus Palestinian camp

BEIRUT (Reuters) – Syrian rebels took full control of the Yarmouk Palestinian refugee camp on Monday after fighting raged for days in the district on the southern edge of President Bashar al-Assad‘s Damascus powerbase, rebel and Palestinian sources said.

The battle had pitted rebels, backed by some Palestinians, against Palestinian fighters of the pro-Assad Popular Front for the Liberation of Palestine-General Command (PFLP-GC). Many PFLP-GC fighters defected to the rebel side and their leader Ahmed Jibril left the camp two days ago, rebel sources said.

“All of the camp is under the control of the (rebel) Free Syrian Army,” said a Palestinian activist in Yarmouk. He said clashes had stopped and the remaining PFLP fighters retreated to join Assad‘s forces massed on the northern edge of the camp.

The battle in Yarmouk is one of a series of conflicts on the southern fringes of Assad’s capital, as rebels try to choke the power of the 47-year-old leader after a 21-month-old uprising in which 40,000 people have been killed.

Government forces have used jets and artillery to try to dislodge the fighters but the violence has crept into the heart of the city and activists say rebels overran three army stations in a new offensive in the central province of Hama on Monday.

On the border with Lebanon, hundreds of Palestinian families fled across the frontier following the weekend violence in Yarmouk, a Reuters witness said.

Syria hosts half a million Palestinian refugees, most living in Yarmouk, descendants of those admitted after the creation of Israel in 1948, and has always cast itself as a champion of the Palestinian struggle, sponsoring several guerrilla factions.

Both Assad’s government and the mainly Sunni Muslim Syrian rebels have enlisted and armed divided Palestinian factions as the uprising has developed into a civil war.

“NEITHER SIDE CAN WIN”

Syrian Vice President Farouq al-Sharaa said in a newspaper interview published on Monday that neither Assad’s forces nor rebels seeking to overthrow him can win the war.

Sharaa, a Sunni Muslim in a power structure dominated by Assad’s Alawite minority, has rarely been seen since the revolt erupted in March 2011 and is not part of the president’s inner circle directing the fight against Sunni rebels. But he is the most prominent figure to say in public that Assad will not win.

Sharaa said the situation in Syria was deteriorating and a “historic settlement” was needed to end the conflict, involving regional powers and the U.N. Security Council and the formation of a national unity government “with broad powers”.

“With every passing day the political and military solutions are becoming more distant. We should be in a position defending the existence of Syria. We are not in a battle for an individual or a regime,” Sharaa was quoted as telling Al-Akhbar newspaper.

“The opposition cannot decisively settle the battle and what the security forces and army units are doing will not achieve a decisive settlement,” he said, adding that insurgents fighting to topple Syria’s leadership could plunge it into “anarchy and an unending spiral of violence”.

Sources close to the Syrian government say Sharaa had pushed for dialogue with the opposition and objected to the military response to an uprising that began peacefully.

In a veiled criticism of the crackdown, he said there was a difference between the state’s duty to provide security to its citizens, and “pursuing a security solution to the crisis”.

He said even Assad could not be certain where events in Syria were leading, but that anyone who met him would hear that “this is a long struggle…and he does not hide his desire to settle matters militarily to reach a final solution.”

In Hama province, rebels and the army clashed in a new campaign launched on Sunday by rebels to block off the country’s north, activists said.

The Syrian Observatory for Human Rights, an opposition-linked violence monitor, said fighting raged through the provincial towns of Karnaz, Kafar Weeta, Halfayeh and Mahardeh.

It said there were no clashes reported in Hama city, which lies on the main north-south highway connecting the capital with Aleppo, Syria’s second city.

Qassem Saadeddine, a member of the newly established rebel military command, said on Sunday fighters had been ordered to surround and attack army positions across the province. He said Assad’s forces were given 48 hours to surrender or be killed.

In 1982 Hafez al-Assad, father of the current ruler, crushed an uprising in Hama city, killing up to 30,000 civilians.

Qatiba al-Naasan, a rebel from Hama, said the offensive would bring retaliatory air strikes from the government but that the situation is “already getting miserable”.

(Additional reporting by Oliver Holmes, Erika Solomon and Dominic Evans in Beirut, Afif Diab at Masnaa, Lebanon; editing by Philippa Fletcher)

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Xbox SmartGlass updated with second-screen ESPN and NBA Game Time app experiences

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First of eight funerals begins at Newtown church

NEWTOWN, Conn. (AP) — Family members have gathered for the first of eight funerals for school shooting victims to be held at a Catholic church in Newtown, Conn.

A motorcade of dozens of vehicles led by police motorcycles accompanied the family of 6-year-old James Mattioli to St. Rose of Lima on Tuesday. His funeral comes a day after two other 6-year-old boys were laid in the first of a long, almost unbearable procession of funerals.

Margarita Rosniak and her 10-year-old daughter, Charlotte, watched from the sidewalk as people entered the church. They had traveled from California for a Christmas vacation in New York and came to Newtown to join the residents in their grief.

Clutching her daughter close, Margarita Rosniak spoke of sympathizing with the parents. Her daughter says she plans to do a school project on the massacre. She asks, "What was the point of it? They're just little kids."

Gunman Adam Lanza shot his mother Friday, then headed to Sandy Hook Elementary where he killed 20 children and six adults, and himself.

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Florida man sentenced to 10 years in “hackerazzi” case

LOS ANGELES (Reuters) – A Florida man who pleaded guilty to hacking into the email accounts of celebrities to gain access to nude photos and private information was sentenced to 10 years in prison by a federal judge in Los Angeles on Monday.

Former office clerk Christopher Chaney, 36, said before the trial that he hacked into the accounts of film star Scarlett Johansson and other celebrities because he was addicted to spying on their personal lives.

Prosecutors said Chaney illegally gained access to email accounts of more than 50 people in the entertainment industry, including Johansson, actress Mila Kunis, and singers Christina Aguilera and Renee Olstead from November 2010 to October 2011.

Chaney, who was initially charged with 28 counts related to hacking, struck a plea deal with prosecutors in March to nine felony counts, including wiretapping and unauthorized access to protected computers.

“I don’t know what else to say except I’m sorry,” Chaney said during his sentencing. “This will never happen again.”

Chaney was ordered to pay $ 66,179 in restitution to victims.

Prosecutors recommended a 71-month prison for Chaney, who faced a maximum sentence of 60 years.

TEARFUL JOHANSSON

Prosecutors said Chaney leaked some of the private photos to two celebrity gossip websites and a hacker.

Johansson said the photos, which show her topless, were taken for her then-husband, actor Ryan Reynolds.

In a video statement shown in U.S. District Court in Los Angeles, a tearful Johansson said she was “truly humiliated and embarrassed” when the photos appeared online, asking Judge S. James Otero to come down hard on Chaney.

Prosecutors said Chaney also stalked two unnamed Florida women online, one since 1999 when she was 13 years old.

Chaney, a native of Jacksonville, Florida, was arrested in October 2011 after an 11-month FBI investigation dubbed “Operation Hackerazzi” and he continued hacking after investigators initially seized his personal computers.

Shortly after his arrest, Chaney told a Florida television station that his hacking of celebrity email accounts started as curiosity and later he became “addicted.”

“I was almost relieved months ago when they came in and took my computer … because I didn’t know how to stop,” he said.

(Reporting by Eric Kelsey; Editing by Jill Serjeant and Andrew Hay)

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Pediatricians call to keep thimerosal in vaccines

(Reuters Health) – A mercury-containing preservative rarely used in the United States should not be banned as an ingredient in vaccines, U.S. pediatricians said Monday, in a move that may be controversial.

In its statement, the American Academy of Pediatrics (AAP) endorsed calls from a World Health Organization (WHO) committee that the preservative, thimerosal, should not be considered a hazardous source of mercury that could be banned by the United Nations.

The AAP in 1999 asked for its removal from vaccines in the United States because of a concern that youngsters receiving multiple shots containing thimerosal might get too much mercury – and develop autism or other neurodevelopmental problems, despite the lack of hard evidence at the time.

“It was absolutely a matter of precaution because of the absence of more information,” said Dr. Louis Cooper, from Columbia University in New York, who was on the organization’s board of directors at the time.

“Subsequently an awful lot of effort has been put into trying to sort out whether thimerosal causes any harm to kids, and the bottom line is basically, it doesn’t look as if it does,” he said.

In a 2004 safety review, for example, the independent U.S. Institute of Medicine concluded there was no evidence thimerosal-containing vaccines could cause autism. A study by the Centers for Disease Control and Prevention came to the same conclusion in 2010.

With the exception of some types of flu shots, the compound is not used in vaccines in the United States, which are distributed in single-dose vials.

And nobody is arguing that should change, according to Dr. Walter Orenstein, a member of the AAP Committee on Infectious Diseases and a researcher at the Emory Vaccine Center in Atlanta.

But in countries with fewer resources – where many children still die of vaccine-preventable diseases – it is cheaper and easier to use multi-dose vials of vaccines against diphtheria and tetanus, for example.

Thimerosal prevents the rest of a multi-dose vial from getting contaminated with bacteria or fungi each time a dose is used.

Researchers estimated it could cost anywhere from two to five times as much to manufacture vaccines for developing countries without thimerosal, and both transporting vaccines and keeping them refrigerated would also be much harder.

“We’re having a hard time completing the task of getting every kid immunized now. That would add a tremendous burden,” Cooper said, adding that more children would probably die as a result.

Children who can now be protected from these life-threatening diseases could become vulnerable, Orenstein told Reuters Health.

The new statement is published in the AAP’s journal Pediatrics.

Thimerosal contains a type of mercury called ethyl mercury. Toxic effects have been tied to its cousin, methyl mercury, which stays in the body for much longer.

Earlier this year, the WHO said replacing thimerosal with an alternative preservative could affect vaccine safety and might cause some vaccines to become unavailable.

Mercury, however, is still on the list of global health hazards to be banned in a draft treaty from the United Nations Environment Program – which would mean a ban on thimerosal.

Reducing mercury exposure “is a wonderful thing,” Orenstein said.

However, “We need this exception because thimerosal is so vital for protecting children.”

For the Pediatrics document, please see: bit.ly/cxXOG

(Editing by Christine Soares, Nick Zieminski)

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Iran media: Son of ex-president released on bail

TEHRAN, Iran (AP) — Iranian media say the son of influential former President Akbar Hashemi Rafsanjani has been released on bail.

Several papers, including the pro-reform Etemad daily, say Mahdi Hashemi was released late Sunday and immediately went to his father’s home.

Authorities arrested the younger Hashemi in late September, a day after he returned to Iran from Britain.

He is held on charges of fomenting unrest in the aftermath of Iran’s disputed 2009 presidential election that brought President Mahmoud Ahmadinejad a second term in office. Hashemi also faced corruption charges.

His arrest came days after his sister, Faezeh, was taken into custody to serve a six-month sentence on charges of making propaganda against Iran’s ruling system.

Since Rafsanjani backed Ahmadinejad’s reformist challenger in 2009, his family has come under pressure from hardliners.

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Clearwire accepts slightly sweeter bid from Sprint

(Reuters) – Clearwire Corp agreed to sell roughly half of the company for $ 2.2 billion to majority shareholder Sprint Nextel Corp, which would then have full ownership of spectrum that will help it offer high-speed wireless services.

The $ 2.97-per-share deal is only 7 cents per share higher than a bid many minority shareholders said was too low days before. Clearwire shares tumbled 12.2 percent to $ 2.96 in morning trading on Monday.

Sprint already owns slightly more than half of Clearwire. The company said owners of 13 percent of Clearwire shares – Comcast Corp, Intel Corp and Bright House Networks LLC – had agreed to vote for the deal.

But it was not immediately clear whether Sprint, the No. 3 U.S. wireless carrier, could win the backing of a majority of Clearwire’s minority shareholders, which it needs to take control.

“This is not going to be popular with the minority shareholders,” said Davidson & Co analyst Donna Jaegers.

But Clearwire’s top executive told analysts on a Monday call that the company had little alternative.

“Despite our efforts we have been unable to secure new partnerships,” said Clearwire Chief Executive Officer Erik Prusch. “Our existing governance agreements prevented us from offering third parties the governance rights they desired in a partnership.”

Shareholders with more than 13 percent of Clearwire shares said last week that they were not happy with the $ 2.90-per-share offer, and some have said Sprint should offer as much as $ 5 per share.

Crest Financial, which owns more than 3 percent of Clearwire, recently filed a lawsuit to stop the company from selling itself to Sprint.

After the deal was announced on Monday, Crest said it had amended the lawsuit to make it a class action.

Another shareholder, Mount Kellett, said last week that the $ 2.90-a-share deal “grossly” undervalued Clearwire.

Clearwire, which also counts Sprint as its biggest customer, has been seeking financing for a high-speed wireless network upgrade and to keep itself afloat.

While some analysts and shareholders said Clearwire did not need to rush into a sale to Sprint, others have said that move would be its best hope for survival.

Sprint, whose shares rose 1 percent to $ 5.61 on Monday, needs Clearwire’s substantial spectrum to better arm itself against larger rivals Verizon Wireless and AT&T Inc.

Reuters reported last week that Japan’s Softbank Corp, which recently struck a deal to buy 70 percent of Sprint, would not consent to a bid of more than $ 2.97 per share.

Softbank said on Monday that it supported the deal.

(Reporting by Sinead Carew in New York and Sayantani Ghosh in Bangalore; Editing by Rodney Joyce, Sriraj Kalluvila and Lisa Von Ahn)

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Funerals begin for Newtown shooting victims

NEWTOWN, Connecticut (Reuters) - Mourners in Newtown, Connecticut, headed for the first two of 20 funerals of schoolchildren massacred in their classroom as the rest of the nation anxiously sent children back to school on Monday with tightened security.

Within hours of the school day starting, lockdowns were declared in nearby Connecticut and New York towns. In New Jersey, one high school's morning announcements included an added warning not to let strangers into the building.

Newtown's schools remained closed on Monday, the first academic day since the 20-year-old gunman claimed 28 lives, including his mother's and his own.

Tiny caskets marked the first wave of funerals for the 20 children and six adults killed in the shooting rampage at Sandy Hook Elementary School on Friday. Noah Pozner and Jack Pinto, both 6 years old, will be laid to rest on Monday afternoon.

Their funerals come a day after President Barack Obama visited Newtown to comfort the families. Obama's remarks were heralded on Monday morning by relatives of teacher Victoria Soto, 27, who was killed as she tried to protect her first-grade students.

"He really made us feel like she really was a hero and that everyone should know it," her brother, Carlos Soto, told CBS "This Morning."

All the dead children were 6 or 7 years old. The school principal of Sandy Hook Elementary, the school psychologist and four teachers were also gunned down.

Noah was the youngest victim of rampage and his twin sister, Arielle, escaped unhurt. The family's rabbi has said he encouraged Noah's mother to focus on her other four children amid the grief.

Jack was a wrestler who loved sports. The New York Giants receiver Victor Cruz played Sunday's football game with the boy's name written all over his cleats and gloves.

At Sunday night's memorial, Obama offered words of hope and promises of action to stop future tragedies.

"We bear responsibility for every child ... This is our first task, caring for our children. It's our first job. If we don't get that right, we don't get anything right," he said.

The president kept his emotions in tighter check than he did on Friday, when he cried openly while addressing the shooting. But tears ran freely among mourners in the packed high school auditorium, who wailed when he read the names of the adults and children killed.

Schools remained closed in Newtown as faculty members met to decide when they would open again. To keep children occupied on a drizzling Monday, youth sports groups set up an indoor field day with athletics, board games and arts and crafts. By early morning, more than 100 children joined in the activities.

The community will have to make a decision about what to do with the bullet-ridden Sandy Hook Elementary School, whose students will for now attend classes in an empty school in a neighboring town.

"I think we have to go back into that building at some point. That's how you heal. It doesn't have to be immediately but I sure wouldn't want to give up on it," said local resident Tim Northrop.

A more detailed picture of Adam Lanza's stunning attack emerged on Sunday.

After killing his mother, Nancy Lanza, at home, Adam Lanza shot his way into the school. He had attended Sandy Hook as a child, according to former classmates.

Police said Lanza was armed with hundreds of bullets in high-capacity magazines of about 30 rounds each for the Bushmaster AR 15 rifle and two handguns he carried into the school, and had a fourth weapon, a shotgun, in his car outside. He killed himself in the school.

In Washington, a pro-gun lawmaker called on Congress and the gun industry to come together on a "sensible, reasonable approach" to curbing high-powered, assault weapons like those used in Newtown.

"Never before have we seen our babies slaughtered. This never happened in America, that I can recall, ever seeing this kind of carnage," said Senator Joe Manchin, a West Virginia Democrat who has earned top marks from the gun industry. "This has changed where we go from here."

(Additional reporting by Jeff Mason, Edith Honan, Martinne Geller, David Ingram, Colleen Jenkins and Chris Francescani; Susan Heavey and Doina Chiacu in Washington; Writing by Barbara Goldberg; Editing by Mohammad Zargham and Doina Chiacu)

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Jason Mraz tops Myanmar anti-trafficking concert

YANGON, Myanmar (AP) — American singer-songwriter Jason Mraz mixed entertainment with education to become the first world-class entertainer in decades to perform in Myanmar, with a concert to raise awareness of human trafficking.

Mraz’s 2008 hit “I’m Yours” was the finale for Sunday night’s concert before a crowd of about 50,000 people at the base of the famous hilltop Shwedagon Pagoda in Yangon, the country’s biggest city.

Local artists, including a hip-hop singer, also played at the event organized by the anti-trafficking media group MTV EXIT — for “End Exploitation and Trafficking” —in cooperation with U.S. and Australian government aid agencies and the anti-slavery organization Walk Free.

Myanmar is emerging from decades of isolation under a reformist elected government that took office last year after almost five decades of military rule. It has been one of the region’s poorest countries, and its bad human rights record made it the target of political and economic sanctions by Western nations.

But democratic reforms initiated by President Thein Sein have led to the lifting of most sanctions, and the country is hopeful of a political and economic revival. Nobel Peace Prize laureate Aung San Suu Kyi, the pro-democracy opposition leader, was released from house arrest in late 2010 and won a seat in parliament last April.

Mraz called his top-billed appearance at the concert a “tremendous honor.”

“I think the country is, at this time, downloading lots of new information from all around the world,” he said. “I’ve always wanted my music to be here, (for) hope and celebration, peace, love and happiness. And so I’m delighted that my music can be a part of this big download that Myanmar is experiencing right now.”

Organizers said Mraz was the first international artist to perform at an open-air, mass public concert in Myanmar. Jazz artists Count Basie, Duke Ellington and Charlie Byrd visited the country under U.S. government sponsorship in the 1970s, when it was still called Burma, but played at much smaller venues.

Many in the crowd queued for two hours before being admitted to the concert site. Yangon native Sann Oo, 31, wearing a white T-shirt with a sketch of Mraz, said he was pleased that Mraz had come and that there would be a broadcast of the event.

“His visit can promote the image of Myanmar, because people outside have been seeing the country as an insecure place, and poor,” he said. “Now they can see how we look like from the concert. It also opens the potential for more concerts by foreign artists.”

Mraz has a history of involvement with human rights and other social causes.

But there was some criticism of his visit by campaigners for Myanmar‘s Muslim Rohingya community, which has been the target of ethnic-based violence this year that has forced tens of thousands of people from their homes into makeshift refugee camps. They feel Myanmar’s government has been complicit in the discrimination, and that Mraz’s visit provides it cover with the image of being a defender of human rights.

Mraz said he was aware of the issue, but that if he didn’t come to do the concert because someone else had asked him to protest another problem, then that would not help tackle the exploitation and human trafficking issue.

“I understand that there is a lot of wrongdoing in this world,” he said. “Today I’m here for this.”

Walk Free used the occasion of Sunday’s concert to launch a campaign calling on the world’s major corporations “to work together to end modern slavery by identifying, eradicating and preventing forced labor in their operations and supply chains.” They are seeking to have the companies make a “zero tolerance for slavery pledge” by the end of March next year.

“While many think of slavery as a relic of history, experts estimate that there are currently 20.9 million people living under threat of violence, abuse and harsh penalties,” the Australia-based group said in a statement. “Within this massive number, the majority of people – more than 14.2 million – are in a forced labor situation, used to source raw materials, and create products in sectors such as agriculture, construction, manufacturing and domestic work.”

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