Amgen to pay $762 million, pleads guilty in marketing case

NEW YORK (Reuters) – Amgen Inc pleaded guilty in a New York federal court on Tuesday for improper marketing practices involving its once top-selling Aranesp anemia drug, and prosecutors said the company has agreed to pay $ 762 million in a civil settlement and criminal fines.

The world’s largest biotechnology company had set aside funds it expected to have to pay as a result of federal and state investigations, as well as nearly a dozen civil whistleblower lawsuits.

Federal prosecutors said in court that the company had agreed to pay $ 612 million in a civil settlement, a $ 14 million criminal forfeiture payment, and a $ 136 million criminal fine.

Amgen entered the guilty plea to one misdemeanor count. Acting U.S. attorney Marshall Miller confirmed that under the agreement Amgen will not lose any federal business or contracts. Exclusion from federal programs, such as Medicare, could have crippled its business.

As part of the deal, Amgen will enter into a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services, prosecutors said. The agreement will require Amgen’s executives and members of its board of directors to certify compliance with applicable regulations, institute new transparency measures and put corporate officers “on the hook” for compliance failures within that five-year period, prosecutors said.

The plea agreement must be approved by U.S. District Judge Sterling Johnson. He has scheduled a hearing for Wednesday morning.

Aranesp, primarily used to treat anemia in cancer patients undergoing chemotherapy, remains one of Amgen’s largest drugs with sales of $ 2.3 billion in 2011. Its sales, and that of a related older red blood cell booster Epogen, have declined significantly over the past few years amid safety concerns, stricter usage guidelines and reimbursement restrictions.

Amgen was accused of promoting Aranesp for anemia caused by cancer, for which it was not approved, rather than to combat anemia as a side effect of chemotherapy treatments. The company was also accused of pushing higher doses and more convenient treatment schedules than what was approved in the drug’s label for both cancer and chronic kidney disease patients.

The government said the illegal practices were undertaken in part to help Amgen take market share from Johnson & Johnson’s similar anemia drug Procrit.

Amgen was “pursuing profits at the risk of patients’ safety,” Miller told reporters Tuesday after the plea hearing. He added that while the company “circumvented the FDA approval process,” the investigation had not uncovered any evidence of fraudulent intent on Amgen’s part.

Federal prosecutors declined to comment further on the civil portion of the settlement, which they said is still under seal.

A spokeswoman for the company, based in Thousand Oaks, California, said that if the judge accepts the criminal plea tomorrow, “Amgen expects immediately thereafter to complete the comprehensive resolution of related civil and criminal matters,” for which it had previously recorded a $ 780 million charge in the third quarter of 2011.

In a recent regulatory filing with the U.S. Securities and Exchange Commission, Amgen said it had accrued $ 806 million related to the proposed settlement of charges arising out of the federal civil and criminal investigations.

Amgen shares were down 14 cents at $ 89.36 in late morning trading on the New York Stock Exchange.

(Additional reporting and writing by Bill Berkrot and Caroline Humer; Editing by Lisa Von Ahn, Andrew Hay and David Gregorio)

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Survivor's dad to NRA: Help make the U.S. safe for kids

Dan Gross, president of the Brady Campaign to Prevent Gun Violence, calls on Congress to address gun violence at …A teacher saved his 8-year-old son from the massacre in Newtown, and now Andrei Nikitchyuk has a message for the National Rifle Association: Help make the United States safe for kids again.

"I would offer NRA: Return this country their kids. If they can do it, I would like that very, very much," Nikitchyuk told reporters outside the Capitol after a press conference organized by the Brady Campaign to Prevent Gun Violence. The event was organized to pile pressure on lawmakers to enact new gun restrictions.

On Friday, which started like any other day at Sandy Hook Elementary School, Nikitchyuk's son, Bear, was walking with another child to turn in attendance sheets at the principal's office when the gunfire started. The boy told his father it sounded like someone slamming a door.

A teacher, Abby Clements, pulled the boys into her classroom and barricaded the door. Twenty children and six adults weren't so lucky and died in one of the worst mass shootings in U.S. history.

Nikitchyuk, who emigrated from the Soviet Union 22 years ago,  said he used to think that guns are part of American history and that "our politicians will do whatever they can do keep our children safe." After past mass shootings — Columbine and Aurora — "I would avert my eyes."

But now "we all need to speak up," Nikitchyuk said.

Relatives of Americans killed in other mass shootings stood somberly behind him, some nodding their heads or clutching photographs of their slain loved ones.

"It's not a partisan issue, it's an issue of safety of our children," he said. "Let's make it back to the country it was: Safe for kids."

"Friday changed everything," said Brady Campaign President Dan Gross. "It is a tipping point."

Gross echoed President Barack Obama's call for a national conversation about gun control. He insisted that the vast majority of Americans — including "responsible" gun owners — agree on the need for new restrictions.

"The only place that this is a contentious political debate is in that building behind us," he said, with a nod at the Capitol.

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Live chat: Newtown rebuilds after shooting

In the aftermath of Friday's Newtown school shooting, we've heard tales mostly horrifying and occasionally heroic, from surviving witnesses and mourning citizens alike, but this one lies somewhere in between, all the more unshakeable. One six-year-old Sandy Hook student played dead in her first-grade classroom, her family pastor said late Sunday, with the kind of quick thinking that ended up saving her life but now leaves her with the unshakeable memories of watching all her classmates being shot and killed. ...

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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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HBO making “Game of Thrones”-themed beer

LOS ANGELES (TheWrap.com) – Winter is coming – and so is a new line of beers based on HBO‘s fantasy drama “Game of Thrones.” Presumably, all will boast a full, robust head, perhaps resting on top of a spike.

HBO is teaming with Cooperstown, N.Y. brewery Ommegang for a line of brews centered around the series, the New York Times reports. The first beer, Iron Throne Blonde Ale, is slated to go on sale in March, in time for the March 31 premiere of the show’s third season.

It sounds like the perfect libation for watching the premiere from the comfort of your $ 30,000 Iron Throne replica.

A second “GoT”-themed beer will go on sale in fall 2013, with two more varieties expected to go on sale in conjunction with new seasons of the series.

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Merck, GE to collaborate on Alzheimer’s drug development

(Reuters) – Merck & Co and General Electric Co‘s healthcare unit have agreed to collaborate on an experimental drug for Alzheimer’s disease, the companies said on Tuesday.

GE Healthcare will supply Flutemetamol, an investigational imaging agent, to Merck for use with its experimental Alzheimer’s disease drug MK-8931.

The companies hope GE’s imaging agent will help identify patients who might benefit from a therapy such as Merck’s, which targets beta amyloid, a protein that can clump together and form plaques in the brain. Such plaques have been found in the brains of patients with Alzheimer’s disease.

MK-8931 is Merck’s lead Alzheimer’s drug candidate and is designed to modify progression of the disease as well as improve symptoms. Alzheimer’s robs patients of their memory and can cause other cognitive disturbances.

Based on promising results from an early-stage clinical trial of MK-8931, Merck plans to move forward with a larger trial, called EPOCH, at multiple sites around the world.

Flutemetamol is a positron emission tomography (PET) imaging agent that has been able, in clinical trials, to detect beta amyloid in the brain.

GE Healthcare will supply Flutemetamol to help select patients for clinical trials and evaluate the agent as a companion diagnostic tool. Financial and other terms of the agreement between the companies were not disclosed.

(Reporting By Toni Clarke; editing by John Wallace)

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Merry Christmas, America-Haters?

When TNT was preparing its annual special “Christmas in Washington” with the president of the United States, you’d think the last star musician they would consider to join the official caroling would be Psy, the South Korean rapper. What on Earth is Christmasy about this man’s invisible-horse-riding dance to his dorky disco-rap hit “Gangnam Style”? It’s not exactly the natural flip-side to “O Holy Night.” But TNT couldn’t resist this year’s YouTube sensation.

This inane publicity stunt backfired when the website Mediaite reported on Dec. 7 that Psy (real name: Park Jae-sang) had participated in a 2002 protest in which he crushed a model of an American tank with a microphone stand. But that’s nothing compared to the footage of a 2004 performance after a Korean missionary was slaughtered by Islamists in Iraq. These lyrics cannot be misunderstood.

“Kill those f—-ing Yankees who have been torturing Iraqi captives … Kill those f—-ing Yankees who ordered them to torture … Kill their daughters, mothers, daughters-in-law and fathers … Kill them all slowly and painfully.”

This isn’t just anti-American. It’s anti-human.

Guess where this story first surfaced in the American media? CNN, from the same corporate family tree as TNT. It was posted back on Oct. 6 on CNN’s iReport, an open-source online news feature that allows users to submit stories for CNN consideration.

The Korean one-hit wonder put out the usual abject careerist apology, but he weirdly said, “I’m deeply sorry for how these lyrics could be interpreted.” Those darn lyrics and those darn people who misinterpret lyrics about killing Yankees’ mothers. It is like Barack Obama expressing regret for the awful things said about Susan Rice, ignoring the awful things said by Susan Rice.

Psy is now a millionaire. As Jim Treacher wrote at the Daily Caller: “So far he’s made over $ 8 million from the song, about $ 3 million of it from the people he once wanted to kill.” Brad Schaeffer at Big Hollywood noted his own father fought for South Korea’s independence in the Korean War: “Had it not been for ‘f——-g Yankees’ like my Dad, this now-wealthy South Korean wouldn’t be ‘Oppan Gangnam Style’ so much as ‘Starving Pyongyang Style.’” (Gangnam is a posh district in the South Korean capital of Seoul.)

Despite the controversy, neither the Obama White House nor the TNT brass felt it was necessary to send Psy packing before the Dec. 9 taping. On Saturday, ABC reporter Muhammad Lila merely repeated, “the White House says the concert will go on and that President Obama will attend, saying that they have no control over who performs at that concert.”

What moral cowardice. On Monday morning, another pliant publicist, NBC correspondent Peter Alexander, calmly relayed that the White House did take control on the Psy front — on its own “We The People” website, where the people may post petitions to the president for their fellow citizens to sign. A petition asking Obama to dump Psy from the Christmas concert was itself dumped. Alexander explained: “But that petition was removed because the rules say the petitions only apply to federal actions. And, of course, the President had no say over who the private charity chose to invite.”

This is double baloney. The White House hasn’t removed silly “federal action” petitions like the one asking to “Nationalize the Twinkie Industry,” or one to “Secure resources and funding, and begin construction of a Death Star by 2016.” They removed one that they didn’t want people to sign.

As for Obama having “no say over” who appeared on the TNT show, the president could easily declare he wasn’t going to share a stage with this America-hater. Or he could have obviously placed one phone call to Time Warner CEO Jeff Bewkes (an Obama donor), and expressed the dismay of the President of the United States.

Instead, the Obamas came and honored Psy. Yes, the president honored a man who despised America enough to want its citizens slaughtered.

John Eggerton of Broadcasting and Cable magazine observed, “At the end of the taping, when the First Family customarily shakes hands and talks briefly with the performers, the First Lady gave Psy a hug, followed by a handshake from the President, who engaged Psy in a short, animated discussion — at one point Psy appeared to rock back with laughter — and patted the singer on the shoulder.”

I never thought I’d ever view a Christmas special featuring a hideous hater of America celebrated by the President of the United States.

L. Brent Bozell III is the president of the Media Research Center. To find out more about Brent Bozell III, and read features by other Creators Syndicate writers and cartoonists, visit the Creators Syndicate Web page at www.creators.com.

COPYRIGHT 2012 CREATORS.COM

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N. Korea displays Kim Jong Il a year after death

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

___

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

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Massachusetts fines Morgan Stanley over Facebook research

BOSTON (Reuters) – Morgan Stanley, the lead underwriter for Facebook Inc’s initial public offering, will pay a $ 5 million fine to Massachusetts to settle charges that its bankers improperly influenced its research analysts when the Internet company went public.

Massachusetts’ top securities regulator, William Galvin, charged that Morgan Stanley improperly helped Facebook disclose sensitive financial information selectively, perpetuating what he calls “an unlevel playing field” between Wall Street and Main Street.

Morgan Stanley has been under criticism since the social media company went public in May for having revealed revised earnings and revenue forecasts to select clients on conference calls before the media company’s $ 16 billion initial public offering. A Morgan Stanley spokeswoman did not immediately return a call seeking comment.

Galvin, who has been aggressive in policing how research is distributed on Wall Street ever since investment banks reached a global settlement in 2003, said the bank violated that settlement. He fined Citigroup $ 2 million over similar charges in late October.

Massachusetts says that a senior Morgan Stanley banker helped a Facebook executive release new information and then guided the executive on how to speak with Wall Street analysts about it. The banker, Galvin’s office said, rehearsed with Facebook’s Treasurer and wrote the bulk of the script Facebook’s Treasurer used when calling the research analysts.

The banker “was not allowed to call research analysts himself, so he did everything he could to ensure research analysts received new revenue numbers which they then provided to institutional investors,” Galvin said in a statement.

Retail investors were not given any similar information, Galvin said, saying this case illustrates how institutional investors often have an edge over retail investors.

(Reporting By Svea Herbst-Bayliss with additional reporting by Suzanne Barlyn in New York; Editing by Theodore d’Afflisio)

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TV network aimed at millennials set for summer

NEW YORK (AP) — Participant Media plans to launch a cable network aimed at viewers 18 to 34 years old with programming it describes as inspiring and thought-provoking.

The as-yet-unnamed network is set to start next summer with an initial reach of 40 million subscribers, the company announced Monday.

Targeting so-called millennials, Participant is developing a program slate with such producers as Brian Graden, Morgan Spurlock and Brian Henson of The Jim Henson Company.

Evan Shapiro, who joined Participant in May after serving as President of IFC and Sundance Channel, will head the new network.

Parent company Participant Media has produced a number of fiction and nonfiction films including “Charlie Wilson’s War,” ”An Inconvenient Truth” and Steven Spielberg’s current biopic “Lincoln.”

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