Amgen pagará 762 millones por vender un medicamento para usos no autorizados






Nueva York, 19 dic (EFE).- El gigante estadounidense de la biotecnología Amgen pagará una sanción de 762 millones de dólares tras declararse culpable de introducir en el mercado un medicamento para usos no permitidos por las autoridades federales.


La compañía aceptó hoy en un tribunal federal de Brooklyn (Nueva York) un acuerdo para declararse culpable, clausurar el caso y pagar 150 millones en sanciones criminales y 612 millones para cubrir las solicitudes de compensación a programas públicos de seguro médico, como Medicare o Medicaid.






El caso se refiere al “Aranesp”, un medicamento aprobado por la Administración de Fármacos y Alimentos (FDA, por sus siglas en inglés) para favorecer la formación de glóbulos rojos en los tratamientos de anemias.


“A fin de incrementar las ventas de Aranesp y lograr más beneficios, Amgen ilegalmente vendió el medicamento con la intención de que se usara con dosis que la FDA había estudiado y rechazado, y para tratamientos que la FDA nunca aprobó”, señaló el tribunal federal en un comunicado.


El acuerdo supone la mayor sanción por fraude a una compañía de biotecnología en la historia de Estados Unidos.


El fiscal federal Marshall Miller señaló que “en lugar de trabajar para alargar y mejorar la vida humana, Amgen buscó ilegalmente los beneficios empresariales mientras ponía en peligro la seguridad de consumidores vulnerables que sufrían enfermedades”. EFE


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Bank chief house costs to be paid







Mark Carney, the next head of the Bank of England, will be paid £250,000 in housing costs in addition to his salary and pension costs.






He will receive the money on top of his annual £480,000 salary and a yearly pension allowance of £144,000.


The housing allowance will be taxed at the new top rate of tax of 45%, which will be in place by the time he takes up his post next July,


Mr Carney is currently the head of the Bank of Canada.


A housing allowance was agreed as part of the package to tempt Mr Carney, who lives with his wife and four children, from his current post in Canada, but has only just been signed off by the non-executive directors of the Bank of England.


The allowance is designed to help him maintain a similar lifestyle to his current one in Ottawa, where he has a spacious family house near the Bank of Canada’s headquarters.


Continue reading the main story

What may stir controversy is that Mr Carney’s package protects him from the kind of gyrations in the economy that it will be his role to temper”



End Quote



Mr Carney’s salary itself is well above the £305,000 paid to the current governor of the Bank of England, Sir Mervyn King.


The Bank says this reflects in part the increased role the next governor will be faced with, as the Bank is taking over most of the UK’s bank regulation from the Financial Services Authority next year.


The Chancellor, George Osborne, spent months trying to court Mr Carney to take the post as Bank chief.


Mr Carney had gone on record as saying he was not interested in the post, but was persuaded to change his mind by Mr Osborne.


Part of the deal included allowing Mr Carney to serve just five years as Bank governor, rather than the eight-year term normally served in that position.


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Worries grow in east Congo with fighter buildup






DAKAR, Senegal (AP) — Aid workers warned Wednesday that armed groups are setting up new front lines in and around the city of Goma in eastern Congo, where the U.N. said it now has documented at least 126 rape cases last month.


Thousands of fighters from the M23 rebel group withdrew several weeks ago from Goma, and the fighters have since taken steps toward negotiating with the Congolese government.






However, residents in Goma say M23 and other armed fighters are now positioning themselves in an around the city — including inside camps for people displaced by the violence.


The arrival of several thousand fighters within the last week is prompting fear among civilians, who already have experienced years of fighting and rebellions, said Tariq Riebl, Oxfam’s humanitarian coordinator there.


“They are very concerned — people are seeing this and they don’t know what it means,” he said. “I think what everyone is scared about is that it seems like people are ramping up, ramping up but for what purpose?”


Oxfam warns that more than 1 million people could come under attack if violence again flares in Goma, where more than 100,000 people already have fled from elsewhere in the region.


“Goma is typically the last refuge safe haven and now it’s being directly called into question. If Goma falls in a big battle, where are people going to go?” Riebl said.


“This is very, very disconcerting because you have a population of over 1 million people and if war were to break out, we’re looking at a horrific situation.”


The M23 rebel group, which is believed to be backed by neighboring Rwanda, is made up of hundreds of soldiers who deserted the Congolese army in April.


They took control of many villages and towns in the mineral-rich east over the last seven months, culminating in the seizure of Goma on Nov. 20. It took days of negotiations and intense international pressure, including from the U.N., for the thousands of fighters from M23 to finally withdraw from the regional capital.


The U.N. mission says it’s received allegations of serious rights violations, including killings and wounding of civilians, rape, looting, and forced recruitment of children, by elements of the M23 rebels in Goma and neighboring areas.


Congo’s armed forces are also blamed for a series of attacks as they fled Goma in retreat in late November.


The U.N. said Tuesday it now has been able to document at least 126 rapes during that period in the Minova area, about 60 kilometers (40 miles) south of Goma.


U.N. spokesman Martin Nesirky said that two Congolese soldiers so far have been arrested in connection with the rapes, while seven others had been implicated in looting in the area.


“The Congolese Armed Forces have started investigating those human rights violations,” he said. “The U.N. Mission is supporting the military justice procedure in conducting thorough investigations into these allegations to ensure that the perpetrators are identified and held accountable.”


Rape has long been used as a brutal weapon of war in eastern Congo, where both soldiers and various armed groups use sexual violence to intimidate, punish and control the population.


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EU’s Almunia sets deadline for Google antitrust plan






BRUSSELS (Reuters) – The European Union set Google an ultimatum on Tuesday, giving it a month to come up with detailed proposals to resolve a two-year investigation into complaints that it used its power to block rivals, including Microsoft.


The EU’s antitrust chief, Joaquin Almunia, delivered the deadline in a meeting with Google Executive Chairman Eric Schmidt in Brussels.






If it fails to address the complaints, the world’s most popular search engine could face a lengthy battle with what is arguably the world’s most powerful antitrust authority. If found guilty, it could mean a fine of up to 10 percent of its revenue, or $ 4 billion.


“Since our preliminary talks with Google started in July, we have substantially reduced our differences regarding possible ways to address each of the four competition concerns expressed by the Commission,” Almunia said in a statement.


“On the basis of the progress made, I now expect Google to come forward with a detailed commitment text in January 2013.”


Almunia said he would seek feedback from rivals and users once he has received Google’s proposal.


Google said it continues to work co-operatively with the Commission.


The European Commission has been examining informal settlement proposals from Google since July but has not sought feedback from the complainants, suggesting it is not convinced by what Google has put on the table so far.


The EU watchdog’s two-year investigation has centered on complaints that Google unfairly favored its services over its rivals in search results, and that it may have copied material from travel and restaurant websites without permission.


The Commission is also looking into whether Google restricted advertisers from transferring their data to rivals.


The Commission’s decision to press Google to offer more far-reaching concessions comes in sharp contrast to the case U.S. regulators have against the company.


Sources told Reuters the U.S. Federal Trade Commission could drop their investigation into Google without requiring any major change in how the company does business.


(Reporting by Foo Yun Chee; Editing by Robin Emmott, Louise Heavens and Nick Zieminski)


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Ben Stiller’s Red Hour sells two more comedies to ABC Studios






LOS ANGELES (TheWrap.com) – Ben Stiller‘s Red Hour Television is continuing to pump out comedies for ABC Studios.


Following the sale of “Complikated” in October, the production company has sold network’s production division two new series – “You’re Not Doing It Right” and “Between Two Kings” – a rep for Red Hour told TheWrap on Monday.






Comedian Michael Ian Black writes, stars and produces in the former, a half-hour single-camera comedy based on his book of the same name that explores his childhood, marriage, children and career. Set “in the wilds of Connecticut,” the show takes a hard look at what happens when you wake up, look around and don’t recognize the life you’re living as your own, Red Hour said.


“Between Two Kings” is written and executive-produced by Jeff Kahn, who has written for series like “Drawn Together” and “The Ben Stiller Show.” It follows the hardships of a divorced father raising an 11-year-old son while living in his elderly father’s home.


Both are being executive-produced by Stiller, along with Red Hour’s Debbie Liebling and Stuart Cornfeld.


Since signing an overall deal with ABC Studios at the end of 2011, Red Hour also has sold “Please Knock,” written by Kevin Napier, and “The Notorious Mollie Flowers,” written by Adam Resnick.


The sale of “You’re Not Doing It Right” and “Between Two Kings” were first reported by Deadline.


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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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S&P raises Greece’s credit rating







Ratings agency Standard and Poor’s has raised the credit rating of Greece’s sovereign debt by six levels, praising the “strong determination” of fellow eurozone countries to help it stay as a member state.






S&P has increased Greece’s rating from “selective default” to “B-minus”.


The agency also praised the continuing efforts by Greece’s government to cut its spending.


Greece is currently receiving the second of two bailouts.


Last week, Greece started to receive the latest tranche of the bailout funds from the European Union and International Monetary Fund.


They agreed to release 49.1bn euros ($ 57bn; £37bn) after continuing austerity work by Greece, and a buyback of some of its debt.


A total of 240bn euros has been earmarked for Greece from the two bailout loans.


So far, Greece has received nearly 149bn euros (£119bn; $ 191bn) from the eurozone and the International Monetary Fund, out of that 240bn euros.


Continue reading the main story

This is a significant upgrade, which the Greek government will consider a vote of confidence, but it seems to be more of a vote of confidence in the euro in general. ”



End Quote



S&P said in its statement: “The upgrade reflects our view of the strong determination of European Economic and Monetary Union (eurozone) member states to preserve Greek membership in the eurozone.


“The outlook on the long-term rating is stable, balancing our view of the government’s commitment to a fiscal and structural adjustment against the economic and political challenges of doing so.”


Greece had to seek the bailouts to meet its debt repayments after years of overspending meant it could not keep up with its debt obligations.


The negative market opinion of Greece’s situation only worsened its position, as it pushed up the yield, or level of interest, that the the country had to offer on the sale of its new government bonds, in order to attract buyers.


The BBC’s economics editor Stephanie Flanders said of S&P’s announcement: “This is a significant upgrade, which the Greek government will consider a vote of confidence, but it seems to be more of a vote of confidence in the euro in general.


“Greece is not out of the woods economically, by any stretch of the imagination. But financial markets do now think a Greek exit from the euro is less likely.


“S&P is catching up with that market optimism with this upgrade. In theory, the fact that a large part of Greek sovereign debt has already been restructured also makes future defaults a bit less likely.”


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NBC’s Engel, TV crew escape abduction in Syria






BEIRUT (AP) — NBC‘s chief foreign correspondent Richard Engel said Tuesday he and members of his network crew escaped unharmed after five days of captivity in Syria, where more than a dozen pro-regime gunmen dragged them from their car, killed one of their rebel escorts and subjected them to mock executions.


Appearing on NBC’s “Today” show, an unshaven Engel said he and his team escaped during a firefight Monday night between their captors and rebels at a checkpoint. They crossed into Turkey on Tuesday.






NBC did not say how many people were kidnapped with Engel, although two other men, producer Ghazi Balkiz and photographer John Kooistra, appeared with him on the “Today” show. It was not confirmed whether everyone was accounted for.


Engel said he believes the kidnappers were a Shiite militia group loyal to the Syrian government, which has lost control over swaths of the country’s north and is increasingly on the defensive in a civil war that has killed 40,000 people since March 2011.


“They kept us blindfolded, bound,” said the 39-year-old Engel, who speaks and reads Arabic. “We weren’t physically beaten or tortured. A lot of psychological torture, threats of being killed. They made us choose which one of us would be shot first and when we refused, there were mock shootings,” he added.


“They were talking openly about their loyalty to the government,” Engel said. He said the captors were trained by the Iranian Revolutionary Guard and allied with Hezbollah, the Lebanese Shiite militant group, but he did not elaborate.


There was no mention of the kidnapping by Syria’s state-run news agency.


Both Iran and Hezbollah are close allies of the embattled Syrian government of President Bashar Assad, who used military force to crush mostly peaceful protests against his regime. The crackdown on protests led many in Syria to take up arms against the government, and the conflict has become a civil war.


Engel said he was told the kidnappers wanted to exchange him and his crew for four Iranian and two Lebanese prisoners being held by the rebels.


“They captured us in order to carry out this exchange,” he said.


Engel and his crew entered Syria on Thursday and were driving through what they thought was rebel-controlled territory when “a group of gunmen just literally jumped out of the trees and bushes on the side of the road.”


“There were probably 15 gunmen. They were wearing ski masks. They were heavily armed. They dragged us out of the car,” he said.


He said the gunmen shot and killed at least one of their rebel escorts on the spot and took the hostages into a waiting truck nearby.


Around 11 p.m. Monday, Engel said he and the others were being moved to another location in northern Idlib province.


“And as we were moving along the road, the kidnappers came across a rebel checkpoint, something they hadn’t expected. We were in the back of what you would think of as a minivan,” he said. “The kidnappers saw this checkpoint and started a gunfight with it. Two of the kidnappers were killed. We climbed out of the vehicle and the rebels took us. We spent the night with them.”


Engel and his crew crossed back into neighboring Turkey on Tuesday.


The network said there was no claim of responsibility, no contact with the captors and no request for ransom during the time the crew was missing.


NBC sought to keep the disappearance of Engel and the crew secret for several days while it investigated what happened to them. Major media organizations, including The Associated Press, adhered to a request from the network to refrain from reporting on the issue out of concern it could make the dangers to the captives worse. News of the disappearance did begin to leak out in Turkish media and on some websites on Monday.


Syria has become a danger zone for reporters since the conflict began.


According to the Committee to Protect Journalists, Syria is by far the deadliest country for the press in 2012, with 28 journalists killed in combat or targeted for murder by government or opposition forces.


Among the journalists killed while covering Syria are award-winning French TV reporter Gilles Jacquier, photographer Remi Ochlik and Britain’s Sunday Times correspondent Marie Colvin. Also, Anthony Shadid, a correspondent for The New York Times, died after an apparent asthma attack while on assignment in Syria.


The Syrian government has barred most foreign media coverage of the civil war in Syria. Those journalists whom the regime has allowed in are tightly controlled in their movements by Information Ministry minders. Many foreign journalists sneak into Syria illegally with the help of smugglers and travel with rebel escorts or drivers.


Engel joined NBC in 2003 and was named chief foreign correspondent in 2008. He previously worked as a freelance journalist for ABC News, including during the U.S. invasion of Iraq. He has lived in the Middle East since graduating from Stanford University in 1996.


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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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