Twin explosions strike southern Syrian city

BEIRUT (AP) — Syria‘s state-run news agency says two large explosions have struck the southern city of Daraa, causing multiple casualties and heavy material damage.

SANA did not immediately give further information or say what the target of Saturday’s explosions was.

The Britain-based Syrian Observatory for Human Rights says the blasts went off near a branch of the country’s Military Intelligence in Daraa.

The Observatory, which relies on a network of activists on the ground, says the explosions were followed by clashes between regime forces and rebels fighting to topple President Bashar Assad.

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Justin Bieber and Selena Gomez have broken up, reports say

LOS ANGELES (Reuters) – Pop star Justin Bieber and his girlfriend, Selena Gomez, a Disney actress and singer, have broken up, ending a relationship that made them one of Hollywood’s most high-profile young couples, media reports said.

Bieber, 18, and Gomez, 20, disclosed their relationship in February 2011 when they appeared together at an Oscar night party after months of rumors of their dating.

E! Online late on Friday was the first to report the split, with other media outlets including US Weekly and People also saying the relationship was over. The reports cited unnamed sources close to the couple.

Representatives for Bieber and Gomez did not returns calls or emails on Saturday.

Bieber has released two No. 1 albums in just over a year – the holiday-themed “Under the Mistletoe” and his latest, “Believe.” In September, he topped Billboard’s “21 Under 21″ list of top young musical acts. It was his second year in a row with the title.

Gomez rose to fame as a teenager in the Walt Disney Co television series “Wizards of Waverly Place” and has enjoyed success as a pop singer.

(Reporting By Alex Dobuzinskis; Editing by Greg McCune and Peter Cooney)

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Boehringer Ingelheim to start late-stage hepatitis C drug trial

BOSTON (Reuters) – Boehringer Ingelheim said on Saturday it plans to initiate a late-stage clinical trial of its experimental hepatitis C treatment following promising results from earlier studies.

The company announced final data from a mid-stage trial of its treatment regimen which showed that 69 percent of patients in the study were free of the virus 12 and 24 weeks following the end of treatment.

Hepatitis C is a blood-borne infectious disease of the liver that can lead to liver failure and transplant.

Historically, hepatitis C has been treated with pegylated interferon and ribavirin, but treatment lasts as long as 48 weeks and interferon is associated with flu-like side effects.

The goal of drugmakers now, including Boehringer, Vertex Pharmaceuticals Inc, Gilead Sciences Inc and Bristol-Myers Squibb Co is to develop products that do not need to be combined with interferon. Most analysts consider Gilead to currently be at the forefront of the race.

Full results from Boehringer’s trial, known as SOUND-C2, were presented at the annual meeting of the American Association for the Study of Liver Diseases in Boston. Preliminary data were presented earlier this year.

Boehringer’s trial tested a combination of BI-201335, a protease inhibitor, BI-207127, a polymerase inhibitor, and ribivirin.

Boehringer is a privately held company headquartered in Ingelheim, Germany.

(Reporting By Toni Clarke; Editing by Marguerita Choy)

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FBI probe of Petraeus began with 'suspicious emails'

WASHINGTON (Reuters) - The FBI investigation that led to the discovery of CIA Director David Petraeus' affair with author Paula Broadwell was sparked by "suspicious emails" that initially did not contain any connection to Petraeus, U.S. law enforcement and security officials told Reuters on Saturday.

But the CIA director's name unexpectedly turned up in the course of the investigation, two officials and two other sources briefed on the matter said.

It was "an issue with two women and they stumbled across the affair with Petraeus," a U.S. government security source said.

The Washington Post reported on Saturday that the FBI probe was triggered when Broadwell sent threatening emails to an unidentified woman close to the CIA director.

The woman went to the FBI, which traced the threats to Broadwell and then uncovered explicit emails between Petraeus and Broadwell, the Post said.

Attempts by Reuters and other news media to reach Broadwell, an Army reserve offer and author of a biography of Petraeus, have not been successful.

The FBI and CIA declined comment on Saturday.

Many questions in the case remain unanswered publicly, including the identity of the second woman; the precise nature of the emails that launched the FBI investigation; and whether U.S. security was compromised in any way.

Nor is it clear why the FBI waited until Election Day to tell U.S. Director of National Intelligence James Clapper, who oversees the CIA and other intelligence agencies, about its investigation involving Petraeus.

The CIA director announced his resignation suddenly on Friday, acknowledging an extramarital affair and saying he showed "extremely poor judgment.

The developments likely ended the public career of one of the United States' most highly regarded generals, who was credited with helping pull Iraq out of civil war and led U.S. and NATO troops in Afghanistan.

Meanwhile, new details emerged on Saturday about developments in the final days leading to Petraeus' departure from atop the CIA.

Clapper was notified by the FBI on Tuesday evening about 5 p.m. - just as returns in the U.S. presidential election were about to come in - about "the situation involving Director Petraeus," a senior intelligence official said. Clapper and Petraeus then spoke that evening and the following morning.

WHITE HOUSE NOTIFIED WEDNESDAY

"Director Clapper, as a friend and a colleague and a fellow general officer, advised Director Petraeus that he should do the right thing and he should step down," the official said.

Clapper is a retired Air Force lieutenant general; Petraeus served nearly four decades in the U.S. Army.

On Wednesday, Clapper notified the National Security Council at the White House that Petraeus was considering resigning and President Barack Obama should be informed, the official said.

U.S. law enforcement and intelligence officials agreed to discuss the Petraeus matter only on condition of anonymity because of the issue's sensitivity and because it is the subject of a law enforcement investigation.

Once Petraeus' name turned up in the investigation, the importance of the FBI inquiry was immediately escalated, as investigators became concerned the CIA chief somehow might have been compromised, the law enforcement official said.

However, the official and two sources briefed on the matter said no evidence has turned up suggesting Petraeus had become vulnerable to espionage or blackmail. At this point, it appears unlikely that anyone will be charged with a crime as a result of the investigation, the official said.

The FBI investigation began fairly recently - months ago rather than years ago, when Petraeus would still have been in uniform as one of the U.S. Army's top field commanders, the official said.

Representative Peter King, Republican chairman of the House of Representatives' Homeland Security Committee, said in an interview on MSNBC the FBI was "investigating or monitoring ... the director of the CIA for four or five months."

Several officials briefed on the matter said senior officials at the Pentagon, CIA and Congress knew nothing of the FBI's investigation of Petraeus until Thursday afternoon at the earliest, and some key officials were not briefed on the details until Friday.

There is no evidence at this time that anyone at the White House had knowledge of the situation involving Petraeus prior to the U.S. presidential election on Tuesday, which saw Obama elected to a second four-year term.

Another U.S. government security source said it was not until Friday afternoon that some members of the House and Senate intelligence oversight committees were notified about Petraeus' resignation by Clapper's office.

The congressional committees were told that it was a personal issue that Petraeus had to discuss with his wife. When pressed, a representative of the Office of the Director of National Intelligence said it involved another woman.

(Writing by Warren Strobel; Additional reporting by Doug Palmer and Matt Spetalnick; Editing by Todd Eastham)

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Syria opposition bloc elects Christian as leader

DOHA, Qatar (AP) — Syria‘s main opposition group in exile has elected a Christian Paris-based former geography teacher as its new president.

George Sabra said Friday that his election as head of the Syrian National Council is a sign that the opposition is not plagued by sectarian divisions.

Sabra says the SNC‘s main demand is to receive weapons from the international community. The U.S. and some other foreign backers of rebels fighting the regime of President Bashar Assad have so far refused to send weapons for fear they can fall into the wrong hands.

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Philip Roth says he’s done writing

NEW YORK (AP) — Exit, Philip Roth? Having conceived everything from turning into a breast to a polio epidemic in his native New Jersey, Roth has apparently given his imagination a rest.

The 79-year-old novelist recently told a French publication, Les inRocks, that his 2010 release “Nemesis” would be his last. Spokeswoman Lori Glazer of Houghton Mifflin Harcourt said Friday that she had spoken with Roth and that he confirmed his remarks. Roth’s literary agent, Andrew Wylie, declined comment.

Roth certainly produced, completing more than 20 novels over half a century and often turning out one a year. He won virtually every prize short of the Nobel and wrote such classics as “American Pastoral” and “Portnoy’s Complaint.”

His name will remain on new releases, if only because the Library of America has been issuing hardcover volumes of his work. Roth also is cooperating with award-winning biographer Blake Bailey on a book about his life.

The author chose an unexpected forum to break the news, but he has been hinting at his departure for years. He has said that he no longer reads fiction and seemed to say goodbye to his fictional alterego, Nathan Zuckerman, in the 2007 novel “Exit Ghost.”

Retirement is rarely the preferred option for writers, for whom the ability to tell stories or at least set down words is often synonymous with life itself. Poor health, discouragement and even madness are the more likely ways literary careers end. Roth apparently is fit and his recent novels had been received respectfully, if not with the awe of his most celebrated work.

“I don’t believe it,” Roth’s friend and fellow writer Cynthia Ozick said upon learning the news. “A writer who stops writing while still breathing has already declared herself posthumous.”

His parting words from “Nemesis”: “He seemed to us invincible.”

Roth’s interview appeared in French and has been translated, roughly, by The Associated Press. He tells Les inRocks that “Nemesis” was “mon dernier livre” (“My last book”) and refers to “Howard’s End” author E.M. Forster, and how he quit fiction in his 40s. Roth said he doesn’t plan to write a memoir, but will instead go through his archives and help ensure that Bailey’s biography comes out in his lifetime.

Explaining why he stopped, Roth said that at age 74 he became aware his time was limited and that he started re-reading his books of the past 20-30 years, in reverse order. He decided that he agreed with what the boxer Joe Louis had said late in life, that he had done the best he could with what he had.

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Getting A Handle On Malaria in the Americas

Malaria cases and deaths from the mosquito-borne disease have both declined substantially in the Americas, according to an update by the Pan American Health Organization (PAHO).

From 200 to 2011, cases dropped 59% and deaths declined 70%, PAHO reported Thursday  at its 6th Annual Malaria Day in the Americas Forum in Washingotn.

More than 541,000 confirmed malaria cases and 72 deaths from malaria were reported in 2011 in the region, PAHO says.

While the progress is impressive, it must continue, according to Dr. Socorro Gross, assistant director of PAHO.  ”We want to have zero cases and zero deaths,” she told those attending the forum.

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Worldwide, malaria affects 250 million people each year, PAHO says. About 655,000 worldwide die of the disease annually.

The decline in the Americas (and elsewhere) is credited largely to the World Health Organization initiative known as T3.

The T3 initaitive includes testing, treating and tracking. Under it, officials in malaria-endemic countries are urged to move to universal access to both testing and treatment. They are encouraged to build stronger malaria surveillance systems.

Under T3, public health officials in countries with endemic malaria should test all suspected cases and treat confirmed cases with antimalarial drugs.

Each country is urged to have a surveillance system that will help them form policy and operations about malaria control.

At the forum, three countries were named this year’s Malaria Champions of the Americas: Brazil, Ecuador and Paraguay.

The countries were recognized for making significant strides against malaria.

Paraguay got the top honor. Its National Malaria Control Program was cited for reducing malaria burden by following the initiative.  As of 2011, the number of malaria cases reported there was down 99% compared to 2002. Paraguay last reported a malaria-related death in 1989.

The champions program was launched in 2008. It’s a joint effort of PAHO and WHO, the Pan American Health Education Foundation and the George Washington University Center for Global Health.

Despite the good news about declining cases and deaths in the Americas, officials at the forum repeatedly expressed the need for continued vigilance and control efforts.

In the Americas, more than 23 million people live in areas of malaria risk, says Dr. Don Tharpe, president of the Pan American Health Education Foundation.

It is easy to forget how malaria can ravage lives, he says. The elderly and infants are most vulnerable. The economic and educational fallout are both substantial.

Public health programs that include education, bed nets and other precautions as well as spraying can help reduce transmission, he says.

A parasite, Plasmodium, causes malaria, which is transmitted by the bites of mosquitoes infected by the parasite.

Malaria symptoms, which typically occur with in 10 to 15 days after the bite,  include headache, fever and vomiting.

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Untreated malaria can be life-threatening as it disrupts blood from getting to vital organs.

In many areas, the parasites have become resistant to many malaria medicines.

In the U.S., about 1,500 cases of malaria are diagnosed each year, according to the Centers for Disease Control and Prevention. Most of the cases area in  travelers returning from endemic areas.

The risk is greatest for travelers to sub-Saharan Africa, the CDC says. but the risk is present in any country with malaria.

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Kathleen Doheny is a Los Angeles journalist who writes about health. She doesn’t believe inmiracle cures, but continues to hope someone will discover a way for joggers to maintain their pace.

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Was Petraeus affair linked to lax Libya response?

CIA Director David Petraeus abruptly resigned Friday, citing an extramarital affair and the need to sort out the “personal and professional issues” involved.

The former commander of forces in Iraq and Afghanistan had built a stellar and nearly unassailable reputation – but mounting criticism of the Central Intelligence Agency’s response to the Benghazi, Libya, terrorist attack in September was beginning to tarnish that reputation.

Word of Mr. Petraeus’s resignation sent ripples of stunned surprise through both the intelligence and military communities, raising questions that revolved around how long the affair had been going on and how an officer known for his rigorous self-discipline – and attention to his reputation within the media — could have made such a lapse in judgment.

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In a letter of resignation accepted by the White House, Petraeus said he had been married 37 years but had exercised “very poor judgment” in choosing to enter into an extramarital affair.

Petraeus, who was widely celebrated as a military commander and even occasionally mentioned as a potential presidential candidate, was sworn in as head of the CIA in September 2011 – and had kept a low profile since. Now speculation is sure to proliferate over whether that low profile resulted from Petraeus focusing on America’s intelligence gathering or on personal matters.

In particular, members of Congress and other officials demanding answers about the Benghazi attack on the US consulate that resulted in the deaths of four Americans – including the US ambassador to Libya, Christopher Stephens, and two CIA agents – will want to know if there was any link between Petraeus’s extramarital activities and what has been increasingly criticized as the CIA’s weak performance on the night of the Benghazi attack.

More broadly, the reason for Petraeus’s departure will raise questions about any compromising of US covert operations and intelligence. The potential for blackmail of intelligence officers is always a concern about the spy corps, but the involvement of the nation’s top spy in an extramarital affair takes the concern to a new level.

The Federal Bureau of Investigation has been probing Petraeus and the potential security risks posed by his affair, CNN reported late Friday afternoon.

In the weeks since the Benghazi attack, officials have leaked information, including how Petraeus kept information on the CIA’s role in Benghazi so private that even Secretary of State Hillary Rodham Clinton was left to call Petraeus as the attack unfolded to try to get intelligence information from him.

Last week, CIA officials revealed that in fact, the intelligence agency’s operations in Benghazi dwarfed diplomatic operations at the consulate and that the CIA maintained what was described as an “annex,” about a mile from the diplomatic mission.

State Department officials have said there was an informal understanding that the annex and its agents would come to the assistance of the consulate (which had private contractors providing security) if a need arose. CIA officials insist their agents responded to the consulate’s distress calls within a half-hour.

In a statement released Friday afternoon, President Obama praised Petraeus for his “extraordinary service” to the country, adding, “By any measure, through his lifetime of service, David Petraeus has made our country safer and stronger.”

In a statement, Sen. John McCain (R) of Arizona highlighted Petraeus’s role in Iraq, saying that his “inspirational leadership and his genius were directly responsible – after years of failure – for the success of the surge in Iraq.”

But Petraeus’s success in Iraq and Afghanistan was a result to a certain extent of his focus on a counterinsurgency strategy that involved large numbers of troops fighting the enemy by incorporating nation-building into the battle. When Mr. Obama named Petraeus to head the CIA, it was widely interpreted as the president’s signal that he intended to wind down America’s wars and shift from a counterinsurgency strategy to counterterrorism.

Obama did not cite Petraeus’s reason for resigning but did say, “Going forward, my thoughts and prayers are with Dave and Holly Petraeus, who has done so much to help military families through her own work. I wish them the very best at this difficult time.”

Mrs. Petraeus is the assistant director of the Consumer Financial Protection Bureau, where she supports veterans and troops facing difficulties as a result of the financial crisis.

Obama initially tried to convince Petraeus not to resign, according to some souces. “I am told that President Obama tried to talk Petraeus out of resigning, but Petraeus took the samurai route and insisted that he had done a dishonorable thing and now had to try to balance it by doing the honorable thing and stepping down as CIA director,” Tom Ricks reports in his blog “The Best Defense.”

Such a move is in keeping with the military culture in which Petraeus rose to the rank of four-star general.

Under the Uniform Code of Military Justice, adultery is a punishable offense for soldiers if the conduct is shown to be detrimental “to good order and discipline in the armed forces or was of a nature to bring discredit upon the armed forces.”

Obama said that Michael Morell, deputy director of the CIA, would take over as acting director. Mr. Morell served briefly as acting director after Leon Panetta left the agency last year to become Defense secretary.

Petraeus was set to testify Thursday at a closed-door session of the Senate Intelligence Committee on the Benghazi attack, but it was unclear if his resignation would alter that schedule.

Sen. Dianne Feinstein (D) of California, the Intelligence Committee chair, told NBC News that Petraeus’s personal mistake should not have led to his resignation.

“I would have stood up for him,” she said. “I wanted him to continue. He was good, he loved the work, and he had a command of intelligence issues second to none.”

Obama, after winning reelection Tuesday, was already expected to make some changes in his national security team for a second term, but early speculation had been that Petraeus would stay on at the CIA. Now the job of spy chief will be added to the new-team mix.

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Myanmar says Obama to visit later this month

YANGON, Myanmar (AP) — President Barack Obama will make a groundbreaking visit later this month to Myanmar, an official said Thursday, following through with his policy of rapprochement to encourage democracy in the Southeast Asian nation.

The Myanmar official speaking from the capital, Naypyitaw, said Thursday that security for a visit on Nov. 18 or 19 had been prepared, but the schedule was not final. He asked not to be named because he was not authorized to give information to the media.

The official said Obama would meet with opposition leader Aung San Suu Kyi as well as government officials including reformist President Thein Sein.

It would be the first-ever visit to Myanmar by an American president. U.S. officials have not yet announced any plans for a visit, which would come less than two weeks after Obama’s election to a second term.

Obama’s administration has sought to encourage the recent democratic progress under Thein Sein by easing sanctions applied against Myanmar’s previous military regime.

Officials in nearby Thailand and Cambodia have already informally announced plans for visits by Obama that same week. Cambodia is hosting a summit meeting of the Association of Southeast Asian Nations, and Thailand is a longtime close U.S. ally.

The visit to Myanmar, also known as Burma, would be the culmination of a dramatic turnaround in relations with Washington as the country has shifted from five decades of ruinous military rule and shaken off the pariah status it had earned through its bloody suppression of democracy.

Obama’s ending of the long-standing U.S. isolation of Myanmar’s generals has played a part in coaxing them into political reforms that have unfolded with surprising speed in the past year. The U.S. has appointed a full ambassador and suspended sanctions to reward Myanmar for political prisoner releases and the election of Nobel laureate Suu Kyi to parliament.

From Myanmar’s point of view, the lifting of sanctions is essential for boosting a lagging economy that was hurt not only by sanctions that curbed exports and foreign investment, but also by what had been a protectionist, centralized approach. Thein Sein’s government has initiated major economic reforms in addition to political ones.

A procession of senior diplomats and world leaders have traveled to Myanmar, stopping both in the remote, opulent capital city, which was built by the former ruling junta, and at Suu Kyi’s dilapidated lakeside villa in the main city of Yangon, where she spent 15 years under house arrest. New Zealand announced Thursday that Prime Minister John Key would visit Myanmar after attending the regional meetings in Cambodia.

The most senior U.S. official to visit was Hillary Rodham Clinton, who last December became the first U.S. secretary of state to travel to Myanmar in 56 years.

The Obama administration regards the political changes in Myanmar as a marquee achievement in its foreign policy, and one that could dilute the influence of China in a country that has a strategic location between South and Southeast Asia, regions of growing economic importance.

But exiled Myanmar activists and human rights groups are likely to criticize an Obama visit as premature, rewarding Thein Sein before his political and economic reforms have truly taken root. The military — still dominant and implicated in rights abuses — has failed to prevent vicious outbreaks of communal violence in the west of the country that have left scores dead.

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Exclusive: Google Ventures beefs up fund size to $300 million a year

SAN FRANCISCO (Reuters) - Google will increase the cash it allocates to its venture-capital arm to up to $300 million a year from $200 million, catapulting Google Ventures into the top echelon of corporate venture-capital funds.

Access to that sizeable checkbook means Google Ventures will be able to invest in more later-stage financing rounds, which tend to be in the tens of millions of dollars or more per investor.

It puts the firm on the same footing as more established corporate venture funds such as Intel's Intel Capital, which typically invests $300-$500 million a year.

"It puts a lot more wood behind the arrow if we need it," said Bill Maris, managing partner of Google Ventures.

Part of the rationale behind the increase is that Google Ventures is a relatively young firm, founded in 2009. Some of the companies it backed two or three years ago are now at later stages, potentially requiring larger cash infusions to grow further.

Google Ventures has taken an eclectic approach, investing in a broad spectrum of companies ranging from medicine to clean power to coupon companies.

Every year, it typically funds 40-50 "seed-stage" deals where it invests $250,000 or less in a company, and perhaps around 15 deals where it invests up to $10 million, Maris said. It aims to complete one or two deals annually in the $20-$50 million range, Maris said.

LACKING SUPERSTARS

Some of its investments include Nest, a smart-thermostat company; Foundation Medicine, which applies genomic analysis to cancer care; Relay Rides, a carsharing service; and smart-grid company Silver Spring Networks. Last year, its portfolio company HomeAway raised $216 million in an initial public offering.

Still, Google Ventures lacks superstar companies such as microblogging service Twitter or online bulletin-board company Pinterest. The firm's recent hiring of high-profile entrepreneur Kevin Rose as a partner could help attract higher-profile deals.

Soon it could have even more cash to play around with. "Larry has repeatedly asked me: 'What do you think you could do with a billion a year?'" said Maris, referring to Google chief executive Larry Page.

(Editing by Muralikumar Anantharaman)

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VP Joe Biden guest stars as celebrity crush on “Parks and Rec”

LOS ANGELES (Reuters) – Someone has a big crush on U.S. Vice President Joe Biden – and now she is getting to meet him.

Biden will make his TV acting debut with a cameo on NBC‘s comedy “Parks and Recreation” as the celebrity crush of actress Amy Poehler‘s ditzy local councilwoman Leslie Knope, NBC said on Thursday.

Biden, 69, will play himself in the episode “Leslie vs. April,” airing November 15, where Knope, a city councilwoman for the fictional small town of Pawnee, Indiana, has a surprise meeting with the vice president in Washington D.C.

Knope has long described her ideal man as having the “brains of George Clooney and the body of Joe Biden.”

“Meeting Vice President Biden was a thrill for me and for Leslie,” Poehler said in a statement.

“He was a good sport and a great improviser. The vice president maintained his composure while I harassed him and invaded his personal space. The nation of ‘Parks and Rec’ will be forever grateful,” she added.

The scenes with Biden were shot in July in the chambers of the vice president’s ceremonial office, during the TV show’s recent trip to the nation’s capital to film scenes for this season’s storylines.

The biggest challenge of landing Biden’s cameo was keeping it a secret before Tuesday’s U.S. elections. Airing the episode prior to November 6 could have been equivalent to a campaign contribution to advertise a candidate, executive producer Michael Schur told Entertainment Weekly.

“Parks and Recreation” follows the Pawnee Parks department and its tireless deputy Knope, who puts all her efforts into improving her little hometown.

This is a big season for Poehler’s character, who is finally elected into city government, gets engaged to campaign advisor Ben Wyatt and meets her political heroes including Senators Barbara Boxer, Olympia Snow and John McCain, who were featured in September’s season premiere.

(Reporting By Piya Sinha-Roy, editing by Jill Serjeant)

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Calif. city plans to provide transgender surgeries

SAN FRANCISCO (AP) — San Francisco is preparing to become the first U.S. city to provide and cover the cost of sex reassignment surgeries for uninsured transgender residents.

The city’s Health Commission voted Tuesday to create a comprehensive program for treating transgender people experiencing mental distress because of the mismatch between their bodies and their gender identities. San Francisco already provides transgender residents with hormones, counseling and routine health services, but has stopped short of offering surgical interventions, Public Health Director Barbara Garcia said Thursday after the vote was announced.

The idea for a new program that included surgeries came out of conversations between public health officials and transgender rights advocates who wanted mastectomies, genital reconstructions and other surgeries that are recommended for some transgender people covered under San Francisco’s 5-year-old universal health care plan.

At the urging of the San Francisco Board of Supervisors and the San Francisco-based Transgender Law Center, the commission agreed this week to drop sex reassignment surgery from the list of procedures specifically excluded from the Healthy San Francisco plan.

But Garcia described the move as “a symbolic process” for now because the city currently does not have the expertise, capacity or protocols in place to provide the surgeries through its clinics and public hospital.

“The community felt the exclusion on Healthy San Francisco was discriminatory and we wanted to change that as the first step,” she said.

Instead of expanding the existing plan, the Health Commission approved the establishment of a separate program that covers all aspects of transgender health, including gender transition. Garcia hopes to have it running by late next year, but said her department first needs to study how many people it would serve, how much it would cost, who would perform the surgeries and where they would be performed.

“Sex reassignment surgery is not the end all. It’s one service that some transgender people want and some don’t,” she said. “We can probably manage this over the next three years without much of a budget increase because we already have these (other) services covered.”

San Francisco in 2001 became the first city in the country to cover sex reassignment surgeries for government employees. Last year, Portland, Ore. did the same. The number of major U.S. companies covering the cost of gender reassignment surgery for transgender workers also doubled last year, reflecting a decades-long push by transgender activists to get insurance companies to treat such surgeries as medically necessary instead of elective procedures.

Kathryn Steuerman, a member of a transgender health advocacy group in San Francisco, said the city’s latest move would help residents avoid going into debt to finance operations related to gender transition, as she did.

“I am filled with hope and gratitude that we are achieving this level of support for the well-being of the transgender community,” Steuerman said.

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Boehner: Raising tax rates 'unacceptable'

Raising tax rates is "unacceptable" to House Speaker John Boehner as he prepares to open negotiations on the looming "fiscal cliff" with the president and congressional Democrats, he told "World News" anchor Diane Sawyer today in an exclusive interview.

"Raising tax rates is unacceptable," Boehner, R-Ohio, said in his first broadcast interview since the election Tuesday.

"Frankly, it couldn't even pass the House. I'm not sure it could pass the Senate."

That stance could set up a real showdown with the White House given that the president has said he would veto any deal that does not allow tax cuts for the rich to expire. But the speaker said that Republicans would put new tax revenue on the table as leaders work toward a deal.

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"I would do that if the president was serious about solving our spending problem and trying to secure our entitlement programs," Boehner said. "If you're increasing taxes on small-business people, it's the wrong approach."

Nevertheless, Boehner added that he is at least willing to listen to the president's proposals, even if they clash with his party's principles.

"Of course, we'll talk about it. We talk about all kinds of things we may disagree on," Boehner said. "I'm the most reasonable, responsible person here in Washington. The president knows it. He knows that he and I can work together. The election's over. Now it's time to get to work."

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The fiscal cliff is a mix of tax increases and spending cuts set to take effect at the end of the year that could sink the economy back into recession. Boehner told Sawyer he imagines that negotiations on a bipartisan deal will begin soon, although he did not reveal whether any talks had already been scheduled.

Still, he said he hoped the framework of a deal could be completed by the end of the year in order to direct the next Congress to work out the details.

"The American people elected new representatives," he said. "They're the ones who ought to be the ones to do this.

"There are things that we can do in the lame duck to avert the fiscal crisis, but we want to do this the right way. We don't want to rush through this in the next two to three weeks. And what do you get? You can't rewrite the tax code in the next two or three weeks. And, so, there's a lot of possibilities in terms of how we proceed, and I'm confident that we can."

Boehner also said he welcomes back Rep. Paul Ryan, whose profile has exploded since he was chosen by Mitt Romney as the vice presidential nominee. Ryan won re-election to his House seat in Wisconsin at the same time he lost the vice presidency, but Boehner demurred when asked whether his place on the presidential ticket would increase his leadership profile.

"Because he ran for the vice presidency, is he the leader of the Republican party now?" Sawyer asked.

"Oh, I wouldn't think so. Paul Ryan's a policy wonk," Boehner said. "He's involved in the cause of trying to bring us pro-growth economic agendas for America and making sure that we're doing this in a fiscally responsible way.

"I'm glad that Paul Ryan's coming back to the Congress. I would expect he would continue as chairman of the Budget Committee," he said.

"Probably nobody in the Congress knows more about pro-growth economic policies other than Paul Ryan. I don't think there's many people in the Congress who understand the entitlement crisis that we're facing more than Paul Ryan. I think he'll be an important voice in this discussion and in this debate."

Boehner also said that once he saw that Mitt Romney would lose the race for the White House, he went to sleep at about 11:15 p.m. on election night with the realization that he would wake up to divided government, but still "slept like a baby."

"I may not like the five cards that have been dealt to me, but those are the cards I've got in my hand, and my job on behalf of the American people is to find a way to vote with my Democratic colleagues and a Democratic president to solve America's problems," he said. "If there was one mandate that came out of the election, it was find a way to work together to address our problems."

Sawyer asked the speaker whether Romney should take responsibility for those election results, but Boehner said he is proud of his campaign.

Read More..

Merkel says Germany, Britain must work together on EU

LONDON (Reuters) – Germany and Britain must cooperate to work round their differences on the European Union‘s long-term spending plans, German Chancellor Angela Merkel said on Wednesday.

“Despite differences that we have it is very important for me that the UK and Germany work together,” Merkel said through a translator before a meeting in London with Prime Minister David Cameron to discuss the EU‘s 2014-2020 budget.

“We always have to do something that will stand up to public opinion back home. Not all of the expenditure that has been earmarked has been used with great efficiency … We need to address that,” she said.

EU leaders meet in Brussels on November 22-23 to try to secure a seven-year budget for the 27-nation bloc amid signs of differences of opinion over what action should be taken.

(Reporting by Peter Griffiths; Editing by Andrew Osborn)

Europe News Headlines – Yahoo! News

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Apple slides to five-month low, uncertainty grows

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Taylor Swift reigns over Billboard 200, Meek Mill debuts high

LOS ANGELES (Reuters) – Country-pop star Taylor Swift held onto the top spot on the Billboard 200 album chart on Wednesday as her latest album “Red” kept rapper Meek Mill from the top spot.

“Red,” Swift’s fourth studio album safely took the No. 1 position after selling 344,000 copies according to figures from Nielsen SoundScan.

Last week, “Red” scored the highest first week U.S. sales in a decade after selling 1.2 million copies. The album has outsold One Direction’s “Up All Night” to become the second-biggest album of 2012, behind Adele’s juggernaut record “21,” which has sold more than 4 million copies this year.

Rapper Meek Mill entered the chart at No. 2 with his debut studio album “Dreams & Nightmares,” selling 164,000 copies. The rapper collaborated with fellow Maybach Music artists for his debut, including Trey Songz, Wale, Rick Ross and Mary J. Blige.

Ahead of the holiday season, two festive albums debuted on the chart, with veteran crooner Rod Stewart’s “Merry Christmas Baby” at No. 3 and Trans-Siberian Orchestra’s extended play record “Dreams of Fireflies (On a Christmas Night)” at No. 9.

Country singer Toby Keith landed at No. 6 with his latest album “Hope on the Rocks,” following his appearance and best music video win at the County Music Association (CMA) awards last week.

Country group Little Big Town also saw a boost from their CMA vocal group of the year win as their album “Tornado” climbed the chart to No. 10.

Canadian singer Neil Young and his band Crazy Horse scored their second top ten album this year with “Psychedelic Pill” at No. 8, following their “Americana” album in June.

Over on the Digital Songs chart, Korean rapper Psy held the top spot with his infectious dance-pop single “Gangnam Style,” while Bruno Mars’ “Locked Out of Heaven” remained at No. 2 and Ke$ ha’s “Die Young” was a non-mover at No. 3.

(Reporting by Piya Sinha-Roy, editing by Jill Serjeant)

Celebrity News Headlines – Yahoo! News

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Statins may be linked to cancer survival

NEW YORK (Reuters Health) – Danish cancer patients taking cholesterol-lowering statin drugs were 15 percent less likely to die, of cancer or any other cause, than patients who were not on the popular medications, in a new study.

The pattern held regardless of a person’s age, cancer type, tumor size or whether it had spread. Only patients who had received chemotherapy showed no apparent benefit from taking statins – the most commonly-prescribed drugs in the world.

Eric Jacobs, a researcher at the American Cancer Society who was not involved in the new work, called the findings “intriguing and exciting” but said they “do not mean that people with cancer should start using statins in the hopes of improving their progress.”

The study, published Wednesday in the New England Journal of Medicine, did not look at whether the statins, with familiar brand names such as Lipitor and Mevacor, can prevent cancer – only at what happens once cancer is diagnosed.

Using multiple registries containing data on cancer, drug use, population characteristics and deaths for the nation of Denmark, the research team analyzed the cancer cases of 18,721 people over age 40 who were diagnosed between 1995 and 2007.

All were taking statins regularly before their cancer was discovered, and the study compared them to 277,204 people who had not regularly taken the drugs before getting cancer treatments.

Overall, the cancer death rate among statin users was 15 percent lower, and so was the rate of death from any cause.

The appearance of a benefit from taking statins was strongest for 13 cancer types in particular, ranging from an 11 percent lower death rate among pancreatic cancer patients to a 36 percent lower rate among cervical cancer patients. For 14 other tumor types, the results were less clear-cut.

The study’s senior author, Dr. Stig Bojesen of the University of Copenhagen compared the difference in mortality to that seen with chemotherapy. “The benefit of receiving chemotherapy versus not receiving chemotherapy is 15 percent to 20 percent, depending on cancer type,” he told Reuters Health. “What we see (in the new study) is comparable to that. That’s really something.”

The fact that a seeming benefit from statins was not seen in people taking chemotherapy, however, doesn’t mean that people should avoid chemotherapy treatment and turn to statins instead, Bojesen stressed.

Rather, he thinks therapeutic use of statins might be considered when no good chemotherapy option is available for a particular cancer type.

And, if his team’s finding is confirmed in a larger study, statins may offer an easy, inexpensive way to reduce cancer deaths in some patients, he added.

Because the drugs are available in generic form, “The daily cost is about 10 cents or something like that. It’s extremely cheap,” Bojesen said.

An estimated one in four Americans over age 45 takes statin drugs, which work in the liver to reduce the amount of “bad” cholesterol in the bloodstream.

Bojesen speculates that the drugs may be robbing cancer cells of an important building block of cell membranes, and thereby slowing tumor growth.

“Our hypothesis is that by reducing cholesterol, you steal cholesterol from the proliferating cancer cells … improving survival,” he said.

But there is cause for skepticism. The people who took less than the recommended dose of a statin had a higher rate of survival than cancer patients who took higher doses. A positive relationship between dose and response is usually seen as evidence, at least, of cause and effect.

“The absence of a dose trend might indicate that just some statin might be enough,” Bojesen said. “But this is just an observational study, so the exact dose and the exact mechanism is something we can’t clarify with this paper.”

In an editorial accompanying the new report, Dr. Neil Caporaso of the National Cancer Institute said the study is also limited because no information on factors such as smoking were available.

So, for instance, the higher likelihood that people taking statins had heart disease and might therefore have also been targeted for smoking cessation treatment, would muddy the connection between being on statins and having lower cancer mortality.

In addition, information on treatment with chemotherapy and radiation were missing for 72 percent of the people taking statins, he noted.

“Because this study was an observational study, the slightly lower cancer death rates among cancer patients who had used statins before their cancer diagnosis could have been caused by factors other than the statin itself,” Jacobs told Reuters Health. “People using statins may have been more likely to use aspirin, which has been linked with improved cancer survival in some recent studies.”

SOURCE: http://bit.ly/TuzoQN New England Journal of Medicine, online November 7, 2012.

Diseases/Conditions News Headlines – Yahoo! News

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How did America become so polarized?

WASHINGTON (AP) — The election laid bare a dual — and dueling — nation, politically speaking, jaggedly split down the middle on the presidency and torn over much else. It seems you can please only half of the people nearly all of the time.

Americans retained the fractious balance of power in re-electing President Barack Obama, a Republican House and a Democratic Senate, altogether serving as guarantors of the gridlock that voters say they despise. Slender percentages separated winner and loser from battleground to battleground, and people in exit polls said yea and nay in roughly equal measure to some of the big issues of the day.

Democracy doesn't care if you win big, only that you win. Tuesday was a day of decision as firmly as if Obama had run away with the race. Democrats are ebullient and, after a campaign notable for its raw smackdowns, words of conciliation are coming from leaders on both sides, starting with the plea from defeated Republican rival Mitt Romney that his crestfallen supporters pray for the president.

But after the most ideologically polarized election in years, Obama's assertion Wednesday morning that America is "more than a collection of red states and blue states" was more of an aspiration than a snapshot of where the country stands.

"It's going to take a while for this thing to heal," said Ron Bella, 59, a Cincinnati lawyer who lives in Alexandria, Ky. He is relieved Obama won, but some of his co-workers are in a "sour mood" about it.

"They feel like the vast majority of the country wanted Romney, and the East and the West coasts wanted Obama," he said. "I'm not sure exactly why that is, but there just seems to be such hatred for Obama out there."

Compromise was a popular notion in the hours after Obama's victory and an unavoidable one, given the reality of divided government. But the familiar contours of partisan Washington were also in evidence, especially the notion that compromise means you do things my way.

As Democratic Rep. Steve Israel of New York put it, "If you refuse to compromise, we are going to beat you." Israel, chairman of the Democratic Congressional Campaign Committee, said the election showed "if you are an extremist tea party Republican, you are going to lose."

Senate Republican Leader Mitch McConnell of Kentucky said pointedly that Republicans will meet Obama halfway "to the extent he wants to move to the political center" and propose solutions "that actually have a chance of passing."

In New York's bustling Times Square, hope, skepticism and the usual polarities were all to be found when people talked about the president. "He may not have done a great job in my mind but I kinda trust him," said Jerry Shul. "I have faith he will get with the Republicans and get something done."

A less-flattering George Dallemand called this "a moment of truth" for the country. "I guess we have to wish for the best now, but I still think he is socialism."

In Miami, Karen Fitzgerald, 55, wore a black dress and said she was in mourning over Romney's defeat.

"It's an upsetting day," she said. But she took some comfort from her Democratic friends on Facebook, who have stopped chiding the other side in their posts. "Now they're all saying we need to work together and be united," she said. "Maybe we can."

In Springfield, Ohio, an "elated" Frank Hocker, 67, hoped Republicans would get the message to get out of Obama's way. "There was a backlash," he said. "For this obstructionist House and those tea party people, I hope they learned their lesson. I hope they learned their lesson: Don't stop the progress of this country."

In Chicago, Obama supporter Scherita Parrish, 56, predicted the president will reach out to Republicans but may not get much back.

"But the people have spoken," she said. "They need to lick their wounds, get on with it and start working with the president."

Unity is a challenge not just for Obama but for the Republicans, who won less than 30 percent of the growing Hispanic vote and not even one in 10 black voters. Obama built a strong Electoral College majority, if only a narrow advantage in the popular vote, despite losing every age group of non-Hispanic white voters.

Surveys of voters found Obama's health care law to be as divisive as ever, with just under 50 percent wanting it repealed in whole or part, and 44 percent liking it as is or wanting more of it.

But democracy doesn't care about exit polls, either, and the election almost certainly means Republicans can forget about trying to roll it back now.

In reaffirming divided government, though, Americans all but ensured colossal fights are ahead over the shape of government and Obama's agenda. He is out to break a wall of Republican opposition to tax increases on the wealthy — a move that about half the voters in exit polls thought was a good idea. And extraordinarily difficult negotiations are imminent as the president and Congress try to make a deal to avoid the "fiscal cliff" — steep spending cuts and a variety of tax increases in January.

In the end, voters split about equally on whether Obama or Romney would be better at handling the economy.

Then again, they were divided down the middle on whether Obama or his predecessor, George W. Bush, deserves most of the blame for the economy's problems.

So it goes in the 50-50 nation, give or take.

___

Associated Press writers Christine Armario in Miami, Michael Tarm in Chicago, David Martin in New York, Amanda Myers in Cincinnati and Ann Sanner in Columbus, Ohio, contributed to this report.

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Officials: New mass graves found in Ivory Coast

ABIDJAN, Ivory Coast (AP) — Up to 10 new mass graves have been discovered near the site of a July attack on a camp for displaced people, officials said Tuesday, amid allegations that initial casualty totals were downplayed to mask killings carried out by the national army.

Rights groups claim summary executions were carried out by the Republican Forces of Ivory Coast, known by its French acronym of FRCI. Last month, officials found six bodies in a well close to the former campsite in the western town of Duekoue.

Government, army and U.N. officials toured 10 more graves in the same area on Saturday, said Paul Mondouho, vice-mayor of Duekoue. He said the graves had first been identified by civilians, and that officials did not know the number of bodies they contained because they had not yet been properly exhumed.

“People were suspecting the presence of bodies in these graves because of the smell coming out of them and because of the shoes we saw nearby,” Mondouho said.

Prosecutor Noel Dje Enrike Yahau, who is based in the commercial capital of Abidjan, confirmed that multiple new graves had been discovered but could not provide details. U.N. officials and the local prosecutor in charge of investigating the suspected killings could not be reached Tuesday.

U.N. spokeswoman Sylvie van den Wildenberg confirmed that U.N. forces helped Ivorian authorities secure a perimeter around 10 wells “similar to the one in which six bodies were found,” and that “some of those wells are suspected mass graves.”

She stressed that Ivorian authorities were leading the investigation but that the U.N. was able to provide assistance.

Army spokesmen could not be reached Tuesday. The Justice Ministry has previously vowed to investigate the discovery of the initial grave.

On the morning of July 20, a mob descended on the U.N.-guarded Nahibly camp, which housed 4,500 people displaced by violence in Ivory Coast, burning most of the camp to the ground. Officials said at the time that six people were killed.

The attack was prompted by the shooting deaths of four men and one woman on the night of July 19, according to local officials and residents. In response a mob of some 300 people overran the camp on the morning of July 20 after the perpetrators of the shootings reportedly fled there.

The victims in the July 19 attack lived in a district dominated by the Malinke ethnic group, which largely supported President Alassane Ouattara in the disputed November 2010 election. The camp primarily housed members of the Guere ethnic group, which largely supported former President Laurent Gbagbo.

Gbagbo’s refusal to cede office despite losing the election to Ouattara sparked months of violence that claimed at least 3,000 lives.

Albert Koenders, the top U.N. envoy to Ivory Coast, said one week after the attack that U.N. security forces had been inside and outside the camp at the time but that no Ivorian security forces were present. He said the U.N. forces decided not to fire at a large group of people that were attacking the camp in order to avoid “a massacre.”

Several witnesses have said soldiers and traditional hunters, known as dozos, participated in the attack on the camp. Both military and dozo leaders have denied the claims, saying they had tried to protect the camp.

In a statement released Friday, the International Federation for Human Rights, known by its French acronym of FIDH, said it had information — including the preliminary results of autopsies — confirming that the six bodies found in October were men who had been summarily executed by the army.

“The disappearance of dozens of displaced persons after the attack, as well as confirmation of cases of summary and extra-judicial executions, suggest a much higher victim rate than the official figures report,” said the organization, which counts Ivorian civil society groups among its members.

Duekoue was one of the hardest-hit towns during the post-election violence. The U.N. has established that at least 505 people were killed in and around the town, including during a notorious March 2011 massacre that claimed hundreds of lives and was allegedly carried out by fighters loyal to Ouattara.

Duekoue residents belonging to ethnic groups that supported Gbagbo have long complained about abuses carried out by the FRCI, with some pointing to the direct involvement of the local commander, Kone Daouda. FIDH said in its statement that Daouda had been transferred following the discovery of the grave in October, and called for him to be interrogated over the matter.

The group also said two FRCI members were being “actively sought” after failing to return to their barracks on Oct. 16, noting that they are believed to have fled to neighboring Burkina Faso.

Africa News Headlines – Yahoo! News

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Exclusive - Amazon to win EU e-book pricing tussle with Apple

BRUSSELS (Reuters) - European Union regulators are to end an antitrust probe into e-book prices by accepting an offer by Apple and four publishers to ease price restrictions on Amazon, two sources said on Tuesday.

That decision would hand online retailer Amazon a victory in its attempt to sell e-books cheaper than rivals in the fast-growing market publishers hope will boost revenue and increase customer numbers.

"Faced with years of court battles and uncertainty I can understand why some of these guys decided to fold their cards and take the whipping," said Mark Coker, founder of Smashwords, an ebook publisher and distributor that works with Apple.

"It's certainly another win for Amazon," he added. "I have not seen the terms of the final settlement, but my initial reaction is that it places restrictions on what publishers can do, slowing them down just when they need to be more nimble."

A spokesman at the EU Commission said its investigation was not yet finished. Amazon and Apple declined to comment.

In September, Apple and the publishers offered to let retailers set prices or discounts for a period of two years, and also to suspend "most-favored nation" contracts for five years.

Such clauses bar Simon & Schuster, News Corp. unit HarperCollins, Lagardere SCA's Hachette Livre and Verlagsgruppe Georg von Holtzbrinck, the owner of German company Macmillan, from making deals with rival retailers to sell e-books more cheaply than Apple.

The agreements, which critics say prevent Amazon and other retailers from undercutting Apple's charges, sparked an investigation by the European Commission in December last year.

Pearson Plc's Penguin group, which is also under investigation, did not take part in the offer.

The EU antitrust authority, which in September asked for feedback from rivals and consumers about the proposal, has not asked for more concessions, said one of sources.

"The Commission is likely to accept the offer and announce its decision next month," the source said on Tuesday.

Antoine Colombani, spokesman for competition policy at the European Commission, said: "We have launched a market test in September and our investigation is still ongoing."

Amazon declined to comment, while Apple did not respond to an email seeking comment.

Companies found guilty of breaching EU rules could be fined up to 10 percent of their global sales, which in Apple's case could reach $15.6 billion, based on its 2012 fiscal year.

AGGREGATE PRICING

UBS analysts estimate that e-books account for about 30 percent of the U.S. book market and 20 percent of sales in Britain but are minuscule elsewhere. When Amazon launched its Kindle e-reader, it charged $9.99 per book.

Apple's agency model let publishers set prices in return for a 30 percent cut to the maker of iPhone and iPad.

The U.S. Department of Justice is investigating e-book prices. HarperCollins, Simon & Schuster and Hachette have settled, but Apple, Pengin Group and Macmillan have not.

The DOJ settlement required that retailers must at least break even selling all ebooks from a publisher's available list, according to Coker and Joe Wikert, general manager and publisher at O'Reilly Media Inc.

It was not clear if EU regulators will include a similar requirement, which would prohibit Amazon from pricing all ebooks at a loss, said Wikert, a former publishing executive.

In the United States, Amazon will likely price popular titles at a loss and try to make up the difference on a publisher's other ebooks, he said.

Coker said any such rule could be dangerous in Europe, which still has distinct markets.

"It could allow a single retailer to charge full price in a large market like the U.K., and then sell below cost or for free in multiple smaller markets as a strategy to kill regional ebook retailing upstarts before they take root," Coker said.

FROWNING ON ONLINE TRADE CURBS

Antitrust regulators tend to frown on restrictions on online trade and the case is a good example, said Mark Tricker, a partner at Brussels-based law firm Norton Rose.

"This case shows the online world continues to be a major focus for the Commission," he said.

"These markets change very quickly and if you don't stamp down on potential infringements of competition rules, you can have significant consequences."

(Additional reporting by Alistair Barr in San Francisco; Editing by Rex Merrifield, David Goodman and David Gregorio)

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Rihanna unveils Chris Brown duet “Nobodies Business”

LOS ANGELES (Reuters) – R&B star Rihanna unveiled a duet entitled “Nobodies Business” with ex-boyfriend Chris Brown on Tuesday, three years after Brown was charged with assaulting her.

The song was part of an official track list that Barbadian singer Rihanna tweeted to her followers for her upcoming album “Unapologetic,” and comes after weeks of speculation in the media that the couple have rekindled their romance being spotted together at numerous events.

While Rihanna, 24, has stayed mum on her relationship status with Brown, the “Turn Up The Music” singer attended Rihanna‘s Halloween party last week and tweeted a photograph of himself dressed in Arab robes and a rifle.

Brown, 23, is currently halfway through his five-year probation after pleading guilty to assaulting Rihanna on the eve of the Grammy awards in 2009. He was ordered to complete community service and a domestic violence program.

Brown was given permission by a Los Angeles judge to embark on his European tour at a recent hearing overseeing his progress on his probation.

The former couple have had a tumultuous relationship in the last three years, including a restraining order against Brown following the assault.

But recently the two singers have made peace, coming together on a remix of Rihanna‘s raunchy song “Birthday Cake” earlier this year.

The Barbadian singer told Oprah Winfrey in an emotional interview in August that she and Brown now had a “very close friendship,” and that she still loved him.

Other collaborations on Rihanna‘s upcoming “Unapologetic” album include rapper Eminem, newcomer singer-songwriter Mikky Ekko and rapper Future.

(Reporting By Piya Sinha-Roy, editing by Jill Serjeant)

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Novartis heart failure drug cuts death by 37 percent: study

LOS ANGELES (Reuters) – An experimental Novartis AG drug to treat hospitalized acute heart failure patients reduced deaths by 37 percent compared with a placebo and appeared to be safe, according to data from a late stage clinical trial presented on Tuesday.

The drug, serelaxin, which is a form of a human hormone that relaxes blood vessels and eases stress on the heart and other organs, is considered one of the most important medicines in the Swiss drugmaker’s developmental pipeline.

“With a meaningful mortality benefit, we believe Serelaxin could represent a $ 2.5 billion (annual) sales opportunity,” Deutsche Bank analysts said in a research note prior to release of the final data at the American Heart Association scientific meeting in Los Angeles.

Novartis said it now planned to seek approval for serelaxin. In the study of 1,161 patients, the drug cut deaths from any cause at six months by 37 percent and led to a marked reduction in worsening of heart failure during hospitalization, researchers said.

Patients who received 48 hours of continuously infused serelaxin experienced more than 45 percent fewer episodes of worsening heart failure symptoms than those who got a placebo.

Novartis had previously disclosed that serelaxin met one of the study’s two primary goals measuring relief of dyspnea, or extreme shortness of breath – a common symptom of acute heart failure – and that it reduced deaths. But the company did not say by how much. By one measure, serelaxin led to a 19 percent improvement in dyspnea, researchers said.

The drug failed to hit a secondary goal of the study that combined cardiovascular death with need for reshospitalizations, but researchers felt the life saving benefit was more important.

“We did have a startling death benefit. One of the reasons there may have been an inability to show a decrease in hospitalizations is more patients were alive to be rehospitalized,” said Dr John Teerlink, one of the trial’s co-lead researchers.

The data showed that only 29 acute heart failure patients would have to be treated with serelaxin to prevent one cardiovascular death, said Teerlink, a cardiologist and heart failure specialist at the San Francisco VA Medical Center.

Doctors say there is an enormous need for a treatment for acute heart failure, with few available options for the condition in which the heart is unable to pump enough blood.

“If it was approved we would not only use it, there would be a mandate to use it because we don’t have anything for acute decompensated heart failure,” said Dr. Milton Packer, a prominent cardiologist from the University of Texas Southwest Medical Center in Dallas, who was not involved in the study.

“If that mortality finding is real, boy are we going to get excited,” said Packer, who has been a member of FDA advisory panels for heart drugs.

There are more than one million hospitalizations in the United States each year for acute heart failure and another million in Europe. About half of all patients die within five years of diagnosis, often as a result of acute episodes that require urgent hospital care.

TREATMENT BENEFITS

The study showed the Novartis drug also reduced the duration of time spent in intensive care units by almost half a day and cut the length of hospital stay by almost a full day.

There was no difference in serious side effects between the two groups, but there was a significant increase in kidney impairment in the placebo group, as the Novartis drug appears to prevent worsening of kidney function, researchers said.

Despite missing some of the pre-set end points, or goals, of the study, Novartis said it is likely to seek approval of the drug based on the trial results.

“We believe this is a strong set of data and have started discussions with the main regulatory agencies. Our filing strategy will be determined by the outcome of these discussions,” said Ameet Nathwani, Novartis’ global business franchise head for critical care.

Dr John McMurry of the University of Glasgow, who was on a panel to critique the study, said that if there were a second serelaxin trial that also showed a mortality benefit it would be hard for health regulators to ignore.

“I think the agent was beneficial. This drug is doing something good in terms of relief,” he said.

(Reporting by Bill Berkrot and Deena Beasley. Editing by Andre Grenon and Richard Pullin)

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