Celgene’s Abraxane improved pancreatic cancer survival in trial

(Reuters) – Celgene Corp said on Friday that a clinical trial of Abraxane, its drug to treat breast and lung cancer, improved survival in patients with pancreatic cancer.

The company did not give details of the extent of the improvement, saying it would do so at a medical meeting in January, but said the results were statistically significant.

Patients were given either Abraxane plus the chemotherapy, gemcitabine, or gemcitabine alone. Those in the Abraxane group on average survived longer.

Patients with advanced forms of pancreatic cancer, such as those tested in the Celgene trial, typically live 5.6 to 6.8 months following diagnosis, according to Dr. Daniel Von Hoff, a professor of medicine at the Mayo Clinic and lead investigator on the trial.

In the United States, about 46,000 patients are diagnosed with late-stage pancreatic cancer each year, he said, and 40,000 die. Only 5.5 percent of all pancreatic cancer patients live for five years.

The side effects seen in the trial were similar to those seen in earlier trials, Von Hoff said, and included a decrease in white blood cells, which can increase the chance of infection, numbness and tingling in the fingers, and nausea.

Analysts welcomed the news.

“This positive result comes somewhat earlier than we had expected, and will come as a surprise to many investors and analysts,” said Geoff Porges, an analyst at Sanford Bernstein, in a research note. “It has become almost axiomatic in the oncology world that “nothing works in pancreatic cancer” and this trial has certainly proven an exception to that rule.”

The company expects to release detailed data from the trial at a medical meeting in January and plans to file an application with regulators to market the drug to treat pancreatic cancer, as well as breast and lung cancer.

Porges estimates the potential revenue for Abraxane in pancreatic cancer alone could be as much as $ 1 billion worldwide.

(Reporting By Toni Clarke in Boston. Editing by Andre Grenon)

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Citigroup’s Pandit receives $15m

9 November 2012 Last updated at 18:51 ET

Former Citigroup chief executive Vikram Pandit, who stood down last month, will get more than $ 15m (£9.4m) as part of a settlement with the banking giant.

John Havens, the chief operating officer who resigned at the same time, will receive a similar amount.

The payments were disclosed in filings to the Securities and Exchange Commission late on Friday.

At the time of the resignations there were reports of disagreements with investors over Citi’s strategy.

Mr Pandit’s payments include $ 6.65m for incentive pay for work in 2012 and deferred stock and cash incentive awards valued at $ 8.83m.

Mr Havens’ payments include $ 6.79m for 2012 and $ 8.73m worth of deferred stock and cash incentive awards for work in 2011 and 2008.

“Vikram and John made significant contributions to Citi during their five years of service,” Citigroup chairman Michael O’Neill said in statement included in the filing.

Mr Pandit resigned on 15 October, a day after Citi reported an 88% drop in quarterly profits to $ 468m.

In a conference call at the time, Citi chairman Michael O’Neill said Mr Pandit’s departure was not due to any “strategic, regulatory or operating issue”.

He added: “Vikram offered his resignation and the board accepted it.”

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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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The Navy SEALs who shared secrets with video-game makers

After consulting on the new Medal of Honor game, the team of SEALs famous for killing Osama bin Laden finds itself in hot water for divulging military information

The covert operatives who make up Navy SEAL Team 6 may have captured the nation’s imagination when they took down Osama bin Laden, but now a handful of them are getting a pay cut. According to CBS News, seven members of the team, including one directly involved in the mission that killed the al Qaeda mastermind, have been punished for consulting on the new video-game Medal of Honor: Warfighter from Electronic Arts. Four others are still under investigation. What kind of secrets did they divulge, and what kind of blow back are they facing? Here, a brief guide to the controversy:

What is this video game?
Medal of Honor is a long-running, first-person, shooting-game franchise. The first title, released in 1999, featured military narratives set in World War II, but more recent titles have focused on modern warfare. Medal of Honor: Warfighter, released in October, stars a fictional team of Navy SEALS tackling missions inspired by recent news headlines.

What role did the real-life Navy SEALS play?
The seven SEAL Team Six members, all of whom are still on active duty, allegedly worked for Electronic Arts as paid consultants this spring and summer. While Warfighter does not explicitly recreate the bin Laden raid, it realistically depicts similar missions, such as an attack on a pirates’ den in Somalia, says David Martin at CBS News. According to the Associated Press, the implicated SEALS two main offenses were their failure to secure permission to participate in the project and their decision to share specially designed combat equipment with the game’s producers. All of the charges are non-judicial. (Read a full statement from the Department of Defense here.)

How are they being punished?
Each SEAL received a punitive letter barring him from future promotions in the ranks, and will forfeit half his salary for a two-month period. “We do not tolerate deviations from the policies that govern who we are and what we do as sailors in the United States Navy,” said Rear Adm. Garry Bonelli, deputy commoner of the Naval Special Warfare Command. This punishment is intended to “send a clear message throughout our force that we are and will be held to a high standard of accountability.”

Did they get off too easy?
Commentators don’t think so. The punishment shouldn’t come as a surprise, says Jason Lomberg at VentureBeat, even if the military “routinely lends technical assistance to Hollywood productions.” (See: Blackhawk Down, Zero Dark Thirty.) These SEALs’ mistake was failing to follow typical clearance procedures, and now they’re paying the price. Frankly, “it about time the Navy tried to restore some discipline to the SEALs’ ranks,” says Mark Thompson at TIME. SEAL Team 6 members — including Matt Bissonnette, who recounted the bin Laden mission in his book, No Easy Day — have been inappropriately visible in the media ever since the historic raid. “Why should other U.S. military special operators keep their mouths shut if the only thing that accrues to the once-secret SEALs for blabbing are best-selling books and cash to spill the beans… ?”

Sources: Associated Press, CBS News, TIME, VentureBeat, The Verge

 

SEE MORE: The Army’s eight-wheeled laser truck that zaps enemy missiles

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Frankfurt gears up for Gangnam Style at MTV awards

FRANKFURT (Reuters) – The MTV Europe Music Awards will rock Frankfurt’s Festhalle concert venue on Sunday, with Barbadian R&B singer Rihanna leading the nominations and all eyes on Korean dance sensation Psy.

Psy‘s hit “Gangnam Style“, which is up for the Best Video award, has been viewed more than 670 million times and received a record-breaking 4.9 million “likes” on Facebook since being released in mid-July.

The satirical video featuring Psy‘s horse riding-inspired dance has sparked a wave of copycat versions from Eton schoolboys to Californian lifeguards and has even caught the attention of United Nations chief Ban Ki-moon.

Psy will become the first South Korean artist to perform at the annual awards, one of the pop industry’s biggest nights outside the United States, when he takes the stage on Sunday.

German model and presenter Heidi Klum, who this year filed for divorce from singer husband Seal, will host the awards and said she had been practicing her Gangnam moves in case she gets called on to dance.

“My kids are obsessed with the song, even though it’s Korean and they have no idea what he’s talking about,” she told reporters ahead of the event.

Klum, who comes from the town of Bergisch Gladbach just two hours away from the 2012 host city, is also looking forward to some home comforts.

“I’ll be eating a lot of German food,” she said, adding jokingly that she would probably eat too much schnitzel and “gain a few pounds.”

Despite being billed as the Europe Music Awards, the vast majority of nominees are traditionally North American, and 2012 is no exception.

Alongside Psy, acts due to take the stage at the show include country singer Taylor Swift, 14-time Grammy winner Alicia Keys, the Killers and Carly Rae Jepsen.

“OLD WAYS” STILL COUNT

In a world where careers are so often launched by social media websites like YouTube, some young artists said there was still a role for more established platforms such as MTV and mainstream television.

American indie-pop band fun., who are up for three awards, hit the big time after the song “We Are Young” was featured in an advert for Chevrolet during the U.S. Superbowl.

“I don’t think that you can ever replace the impact that music videos have,” the band’s guitarist Jack Antonoff told Reuters when asked about the importance of MTV against social media channels.

“I think the more that social media takes over, the more importance you put upon the old ways.”

MTV said this week that it had become the first company to reach one million followers on Instagram, the fast-growing photo-sharing application developer.

Heading the nominations is party-loving Rihanna, with nods in six categories, including Best Song and Best Video for “We Found Love”.

Following close behind with five nominations is country star Swift, and other top nominees include Justin Bieber and Katy Perry, with four each, while Lady Gaga, who cleaned up last year with four prizes, is in the running for three awards.

Rihanna is favorite for Best Song and Best Female, according to odds offered by British bookmakers William Hill, while Gangnam Style is tipped to win Best Video.

The EMA awards were last held in Frankfurt in 2001. Last year’s awards in Belfast attracted 23 million viewers on all platforms and 158 million votes worldwide.

Following are the main nominations in 2012:

BEST SONG: Carly Rae Jepsen/Call Me Maybe; Rihanna feat. Calvin Harris/We Found Love; Gotye/Somebody That I Used To Know; Pitbull feat. Chris Brown/International Love; fun. feat. Janelle Monáe/We Are Young

BEST NEW: Rita Ora; fun.; One Direction; Lana Del Rey; Carly Rae Jepsen

BEST FEMALE: Rihanna; Katy Perry; P!nk; Taylor Swift; Nicki Minaj

BEST MALE: Justin Bieber; Kanye West; Flo Rida; Pitbull; Jay-Z

BEST POP: Justin Bieber; No Doubt; Katy Perry; Taylor Swift; Rihanna

BEST LIVE: Taylor Swift; Lady Gaga; Jay-Z & Kanye West; Green Day; Muse

BEST HIP HOP: Jay-Z & Kanye West; Nas; Rick Ross; Drake; Nicki Minaj

BEST ROCK: Linkin Park; Green Day; Muse; The Killers; Coldplay

BEST ELECTRONIC: David Guetta; Swedish House Mafia; Avicii; Skrillex; Calvin Harris

BEST ALTERNATIVE: Jack White; The Black Keys; Arctic Monkeys; Florence + The Machine; Lana Del Rey

BEST VIDEO: M.I.A./Bad Girls; Lady Gaga/Marry The Night; Katy Perry/Wide Awake; Rihanna feat. Calvin Harris/We Found Love; PSY/Gangnam Style.

(Reporting by Victoria Bryan and Maria Sheahan; editing by Mike Collett-White)

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FDA panel recommends approval of Novo degludec insulin

(Reuters) – An advisory panel to the U.S. Food and Drug Administration on Thursday voted to recommend approval of Danish drugmaker Novo Nordisk‘s new ultra-long-acting insulin degludec, despite signals of possible cardiovascular risk.

The panel of outside medical experts unanimously recommended that the company undertake a large study, possibly after the basal insulin is approved, to verify heart safety of the once-daily drug.

Panel members said during an all-day meeting that they were concerned about a trend toward higher incidence of cardiovascular events with degludec than other drugs in 16 large clinical trials, even though the difference was not statistically significant.

But they expressed enthusiasm for degludec’s 24-hour duration of action, saying it was perhaps unmatched by other drugs and would allow patients to take the insulin at a different time of the day if they missed taking it at their usual time.

“Currently available basal insulins are imperfect and don’t last 24 hours,” said Dr. David Cooke, a panel member who is an associate professor of pediatrics at Johns Hopkins University School of Medicine.

“A true basal that gives constant coverage for 24 hours would make a difference,” Cooke said.

Dr. Kenneth Burman, chief of endocrinology at Washington Hospital Center in Washington, D.C., said the drug’s duration of action “seems unique. Instead of a 12-hour half life, it’s probably 24 hours.”

But Sanford Bernstein analyst Tim Anderson said degludec’s sales potential was “meaningfully impaired” by the panel’s concern about the drug’s cardiovascular risks and the likelihood they will show up in its package insert label.

“An approved label in the United States is highly likely to call out the unknowns about the cadiovascular signal seen,” Anderson said in a research note.

The panel began weighing the benefits and risks of the medicine two days after FDA staff members said combined data from the 16 studies suggest degludec may increase the risk of cardiovascular death, non-fatal heart attacks and strokes and unstable angina, compared to standard insulins.

Moreover, FDA staff reviewers had suggested degludec may offer no strong advantage over other drugs in avoiding hypoglycemia — dangerously low blood sugar levels that are a common side effect of insulin. Some members of the FDA advisory panel echoed those concerns on Thursday.

But the panel voted 8 to 4 to recommend degludec’s approval, despite concerns about heart safety, saying its benefits appear to outweigh its risks. The FDA usually follows the recommendations of its advisory panels.

The stakes are high for Novo, the world’s largest insulin maker, because Wall Street deems the medicine capable of generating annual sales of $ 1.5 billion by 2016 if it is approved in the United States.

It would compete with Lantus, Sanofi’s dominant long-acting insulin, which had sales last year of about $ 5 billion. U.S. drugmaker Eli Lilly is developing a similar medicine that is a few years behind in development.

The company’s many completed studies of degludec did not enroll enough patients, or last long enough, to ascertain heart risks. A large trial with thousands of patients could reliably assess its safety, but could take a number of years to complete.

The panel did not vote on whether the trial should be conducted before, or after, degludec is approved.

Novo officials on Thursday, speaking at the advisory-panel meeting in Silver Spring, Maryland, said they were committed to working with the FDA on a post-approval cardiovascular outcomes trial.

The negative commentary from FDA staff members on Tuesday sent shares of the Danish drugmaker sharply lower. It plans to sell degludec under the brand name Tresiba.

The European Medicines Agency last month recommended degludec’s approval, and it has already been approved in Japan.

(Reporting By Ransdell Pierson; editing by Jim Marshall)

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AMR avoids investigation into $2.26 billion debt deals

NEW YORK (Reuters) – Hedge fund Marathon Asset Management has withdrawn a request for an independent investigator to examine the books of American Airlines, a unit of bankrupt AMR Corp, lawyers for the companies said at a hearing on Thursday.

The move came after AMR agreed to preserve potential clawback claims relating to debt deals, struck between Marathon and AMR, that left American Airlines with $ 2.26 billion of debt.

AMR entered bankruptcy last November, and is considering its options for emerging either as a standalone firm or to merge with smaller competitor US Airways Group, which is making an aggressive takeover push.

Marathon, which has said it holds “well over” $ 100 million of AMR debt, last month sought an examiner to probe intercompany transactions consummated in the weeks before AMR’s Chapter 11 filing. The deals transferred about $ 2.26 billion of debt from AMR’s American Eagle unit to American Airlines.

Marathon said in court papers it was concerned that potential legal claims to claw the money back would be barred under the language of a separate settlement, under which AMR refinanced about 200 of its aircraft.

AMR dismissed that argument in court filings as an “obvious litigation tactic.” But on Thursday, it agreed to expressly preserve such claims in exchange for Marathon dropping its request for an examiner, AMR attorney Richard Hahn said at the hearing in federal bankruptcy court in White Plains, N.Y..

The resolution also allows AMR to move forward with the underlying aircraft refinancing deal, which it says will save about $ 670 million on planes manufactured by Embraer.

Marathon has been taking a more vocal role in AMR’s bankruptcy, adding another layer of complexity to the already multi-faceted case.

The examiner request was Marathon’s second attempt to flex its muscles as a significant creditor, coming days after it sent a letter to AMR Chief Executive Tom Horton demanding more transparency about the airline’s restructuring efforts.

It remains unclear whether Marathon supports a standalone restructuring or a US Airways merger, or whether Marathon would be in a position to finance an independent exit from bankruptcy for AMR. But as a large debtholder, the hedge fund could be in a position to influence either scenario by objecting to plans it does not support.

US Airways would like to acquire AMR out of bankruptcy, while a group of debtholders including JPMorgan Chase & Co has expressed interest in financing a standalone exit.

AMR received court permission at Thursday’s hearing to extend for 30 days, through January 28, its unilateral control of its bankruptcy exit plan. That means US Airways cannot propose its own takeover plan until that date, and that any merger plan before that date would have to be a cooperative effort with AMR.

Labor issues will also affect AMR’s ability to emerge from bankruptcy independently.

High labor costs were a driving force in the company’s bankruptcy filing, and while the airline has reached new collective bargaining deals with its flight attendants’ and ground workers’ unions, it remains at odds with its pilots.

That could spook investors assessing the company’s stability going forward, and AMR’s creditors’ committee has said labor peace with pilots is a top priority.

While AMR and its pilots continue to negotiate, the pilots have said they support a merger with US Airways. They have also said they already have a tentative labor deal in place with US Airways.

The case is In re AMR Corp et al, U.S. Bankruptcy Court, Southern District of New York, No. 11-15463.

(Editing by Bernadette Baum)

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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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“Dancing” co-host Brooke Burke has thyroid cancer

LOS ANGELES (Reuters) – “Dancing with the Stars” co-host Brooke Burke said on Thursday that she has been diagnosed with thyroid cancer and will need surgery.

The television presenter and model said in a three-minute video posted on the website Modernmom.com that she will need her thyroid removed.

“I need to have thyroid surgery and a thyroidectomy, which means I’m going to have a nice, big scar right here on neck,” Burke said, drawing a finger across her throat.

Burke, a former winner of ABC’s celebrity ballroom dancing competition, said she had a biopsy in July, but it had taken her months to go public with the results.

“I’m ready to deal with it, and I’m going to be fine,” she said.

There was no word on when the surgery would take place, but Burke’s publicist said her work schedule for “Dancing with the Stars” would not be affected.

Burke, 47, said in July that her doctor suggested she undergo a thyroid ultrasound after he felt a lump in her neck during a routine physical.

The thyroid is a gland in the neck that produces hormones that regulate vital body functions, such as heart rate and blood pressure.

Burke’s co-host Tom Bergeron said on Thursday during an appearance on the CBS chat show “The Talk” that he had known about her condition for several months. “We are all there with her,” he said.

“I’ve known about this for a few months … I have had experience with this in my family. You never want to hear the word cancer. But thyroid cancer is one of the most treatable cancers. It has an incredibly high success rate,” he said.

(Reporting By Eric Kelsey; Editing by Jill Serjeant)

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