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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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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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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House Republicans eye limited fiscal cliff bill

WASHINGTON (Reuters) – With time running short before a Dec. 31 deadline, House of Representatives Speaker John Boehner will begin work on legislation that simply would extend current low income tax rates for all families with incomes below $ 1 million a year, according to an aide.

Negotiations will continue with the White House on a broader tax and spending deal, the Boehner aide said.

Boehner is presenting the plan to rank-and-file Republicans in a closed-door session.

On January 1, income tax increases for most Americans will begin unless Congress acts.

Last July, the Democratic-controlled Senate passed a bill to extend the current low rates for all families with net incomes below $ 250,000 a year. The House Republican proposal, if passed by the House, would require agreement by the Senate or force a round of negotiations on a compromise between the two chambers.

In excerpts of remarks Boehner was delivering to his Republican members Tuesday morning, the speaker complained that “the White House just can’t seem to bring itself to agree to a ‘balanced’ approach” to deficit-reduction in negotiations. At the same time, Boehner said Republicans were “leaving the door wide open for something better” than just the limited extension of current low tax rates for most Americans.

“Current law has tax rates going up on everyone January 1. The question for us is real simple: How do we stop as many of those rate hikes as possible?” Boehner said.

For months, Democrats have been urging House Republicans to pass a bill protecting middle-class taxpayers from a January 1 rate increase.

(Reporting By Richard Cowan; Editing by Doina Chiacu)

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First of 8 funerals at Newtown church begins

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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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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Beck looks for new connection with ‘Song Reader’

NASHVILLE, Tenn. (AP) — Beck Hansen wants you to think about the way music has changed over the last century and what that means about how human beings engage each other these days.

Laboring over the intricate and ornate details of his new “Song Reader” sheet music project, he was struck by how social music used to be — something we’ve lost in the age of ear buds.

“You watch an old film and see how people would dance together in the ’20s, ’30s and ’40s. You’d go out and people would switch partners and it was a way of social interaction,” Hansen said. “It’s something that was part of what brought people together. Playing music in the home is another aspect of that that’s been lost. Again, I’m not on a campaign to get people to take up songs and play music in their home or anything. But it is interesting to me, the loss of that, what it means.”

Beck hopes the “Song Reader” inspires some of us to pick up instruments and limber our vocal cords. It includes 20 songs annotated on sheet music that’s been decorated in the style popular in the early 20th century when the songwriting industry was a thriving enterprise with billions of songs sold.

The 42-year-old singer notes in the book’s preface that Bing Crosby’s “Sweet Leilani” sold an estimated 54 million copies in 1937, meaning about 40 percent or more of the U.S. population was engaged in learning how to play that song. They were touching it directly, speeding it up, slowing it down, changing the lyrics and creating something new.

“There’s popular bands now that people know the words to their songs and can sing along, but there’s something about playing a song for yourself or for your friends and family that allows you to inhabit the song and by some sort of osmosis it becomes part of who you are in a way,” he said. “So when I think of my great-grandparents’ generations, music defined their lives in a different way than it does now.”

Beck proposed the idea to McSweeney’s Dave Eggers in 2004 and it soon blossomed into something more ambitious as the artist wrapped his mind around the challenge of not just writing a song, but presenting it in a classic way that also engages fans who might not be able to read music or play their own instruments.

They quickly agreed it would make no money, but it seemed like an idea worth exploring.

“And it seemed like only Beck would have thought of it,” Eggers said in an email to the Associated Press. “It’s a very generous project, in that he wrote a bunch of songs and just gives them to the world to interpret. That’s a very expansive kind of generosity and inclusiveness that we’re happy to be part of. On a formal level, we love projects like this, that are unprecedented, and that result in a beautiful object full of great art and great writing. And it all started with Beck. It’s a testament to his groundbreaking approach to everything he does.”

Beck hopes fans will record their own versions and upload them to the Internet so those songs grow into something more universal.

As for his own recorded music, that’s a little more complicated.

Beck’s not sure where he’s headed at the moment. He recorded an album in 2008, but set it aside to work with Charlotte Gainsbourg on “IRM,” which he wrote and produced. He’s also been writing songs for soundtracks and special projects and producing artists like Thurston Moore, Stephen Malkmus and Dwight Yoakam. All that has left him feeling creatively satisfied, but he does acknowledge it’s been a while since he released 2008′s Danger Mouse-produced “Modern Guilt.”

He says in many ways he’s reached a crossroads he’s not yet sure how to navigate.

“This last year I’ve been thinking about whether I’d finish those songs (from 2008), whether they’re relevant or worthy of releasing. I know that doesn’t sound very definitive,” he said, laughing, “but that’s the kind of place I’m in — in this kind of limbo — and, um, yeah.”

The “Song Reader” spurred Beck to think about his own work in a new light as well. Spending six months finishing off the project after working on it sporadically over the years, he was struck by how much craft went into the creation of each song and how quickly music can come into existence today.

“There is so much music out there, to me,” he said. “I don’t know if it’s just where I am in my own music making or if it’s a product of the amount of music out there, but I feel like a piece of music does have to have a certain validity to be put out there and to ask people to listen. … I feel like it’s impossible for everyone to keep up, you know, so I guess I’ve been feeling like maybe there’s something to picking what you’re going to put out, about being more particular about what you put out.”

___

Online:

http://beck.com

___

Follow AP Music Writer Chris Talbott: http://twitter.com/Chris_Talbott.

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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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