FDA OKs J&J prostate cancer drug for pre-chemo use

(Reuters) – U.S. health regulators on Monday expanded the approval of Johnson & Johnson‘s drug Zytiga for advanced prostate cancer to allow its use prior to treatment with chemotherapy.

The widely-expected, expanded Food and Drug Administration approval, which came after the company demonstrated that Zytiga could extend survival if used prior to chemotherapy, is likely to significantly boost sales of the new medicine.

Wells Fargo Securities analyst Larry Biegelsen, in a research note earlier this year, forecast peak Zytiga sales of $ 2.3 billion in 2016, with about 70 percent coming from pre-chemo use.

Zytiga was originally approved in April 2011 for use in combination with the steroid prednisone to treat men whose prostate cancer had progressed following treatment with the chemotherapy drug docetaxel.

The pill, which works by decreasing production of the hormone testosterone that fuels cancer growth, had sales of about $ 800 million in its first year of availability, capturing some 60 percent of the post-chemotherapy market.

That market share is likely to shrink due to new competition in the post-chemotherapy setting from Xtandi, which is sold by Medivation Inc and Astellas Pharma Inc, analysts said. Xtandi is still undergoing late stage trials in patients who have not yet received chemotherapy treatment and the drug could be a year or two away from a similar expanded approval.

However, Sanford Bernstein analyst Geoffrey Porges said Xtandi was likely to gain some “off label” use in pre-chemo patients. The term refers to doctors prescribing drugs for none-approved uses.

“Ultimately we are convinced that Xtandi will get a comparable or better label expansion by mid 2014,” he said.

Meanwhile, Zytiga patients starts will get “an immediate boost,” Porges added.

In late stage clinical trials of more than 1,000 patients with advanced prostate cancer who had not been treated with chemotherapy, those who received Zytiga on average lived more than five months longer than those who received a placebo.

“Today’s approval demonstrates the benefit of further evaluating a drug in an earlier disease setting and provides patients and health care providers the option of using Zytiga earlier in the course of treatment,” Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.

The American Cancer Society estimated that more than 28,000 U.S. men will die from prostate cancer in 2012, making it the second leading cause of cancer death behind lung cancer.

J&J shares closed up 15 cents at $ 70.60 on the New York Stock Exchange.

(Reporting by Bill Berkrot and Ransdell Pierson; Editing by Gerald E. McCormick, Nick Zieminski and Andrew Hay)

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Massive HP conference draws 10,000 attendees to ogle products, speakers, presentations

By Suzy Hansen

More than 10,000 customers, partners and attendees flocked to the Hewlett-Packard Discover conference in Frankfurt, Germany, this week to learn about HP’s latest products, exchange ideas, swap business cards and basically examine whether HP can improve the way their companies are run. The event was held at Messe Frankfurt, one of the world’s largest trade exhibition sites.

CEO Meg Whitman acknowledged in her speech on Tuesday that HP has gone through some rough times this past year. HP’s stock price has been nearly halved during her tenure. Whitman, however, pointed out that HP has $ 120 billion in revenue and is the 10th-largest company in the United States. In Q4, HP has generated $ 4.1 billion in cash flow.

“We are the No. 1 or No. 2 provider in almost every market,” Whitman told the crowd in Frankfurt.

Whitman emphasized  executives’ increasing concerns about security and said that it will be addressed by “a new approach”: HP’s security portfolio, with Autonomy and Vertica, which helps “analyze and understand the context of these events.” Executive Vice President of Enterprise Dave Donatelli spoke about converged infrastructure, or bringing together server, network and storage; their software-defined data centers; and their new servers, which “change the way servers have been defined.” George Kadifa, executive vice president of software, said 94 of the top 100 companies use HP software. HP is the sixth-largest software company in the world, with 16,000 employees in 70 countries, Kadifa added.

Also at the conference was Jeffrey Katzenberg, CEO of DreamWorks and an old friend of Whitman’s from their Disney days, who roused the crowd with a fun speech about his long relationship with HP. Katzenberg showed an old video of himself onstage with a lion, which nearly mauled him. This time, he appeared onstage with a guy in a lion suit. The lesson was to learn from past mistakes and move on.

“If I am smart enough to say ‘scalable multicorps processing,’ I am smart enough to not put myself onstage with a real lion again,” he joked.

The Discover conference is a key vehicle for HP to show off products it’s offering in the coming year. Among them were the latest ProLiant and Integrity servers, the 3PAR StoreServ 7000 and the StoreAll and StoreOnce storage systems. At the HP Labs section of the conference, attendees could learn about the cloud infrastructure or test HP’s new ElitePad 900.

Throughout the three-day event, which saw attendance grow by 30 percent this year, attendees wandered the enormous halls, milling around displays, watching videos, listening to speeches and participating in workshops. People gathered on clustered couches and chatted with new acquaintances, frequently stopping to plug in their various devices and recharge themselves with coffee. With people coming from all over the world, you could hear many languages spoken, from Arabic to French to the most bewildering of them all: the language of technology. Despite the large crowds, it was hard not to notice there were very few women among the thousands in attendance. In fact, when asked about this phenomenon, one female HP employee said, “Trust me, you aren’t the first person who has come up to me asking about this.”

Indeed, the Discover conference was like a forest of men in suits. The few women stood out like rays of sunlight. 

Regardless of their presence at this conference, women are making big strides in information technology. Among the leaders are HP CEO Whitman, who also led eBay; Carly Fiorina, who ran HP before Whitman; Yahoo! CEO Marissa Mayer; and Facebook COO Sheryl Sandberg. Were the women at the Discover conference surprised by the low female turnout?

“No, for IT this is standard,” said Stefanie, a 30-year-old product manager from Germany. “Many are afraid of all the technical stuff, and you have to prove that you are capable of it. You get more women in retail and distribution but not in high-tech areas, at least not in Europe. In America there are more women in management positions and in general.”

Americans might assume that Europe, with its generous social programs that include free daycare, enables more women to ascend the corporate ladder. But that still doesn’t mean that a woman trying to balance a high-tech career and a family is always accepted in European society.

“There is still a lot of emphasis on the family,” Stefanie said. “It’s easier to move up in the U.S., where there is a culture of ‘having it all.’ It’s quite a fight to get there here.”

Still, the IT industry might seem inhospitable to women. Could this male-dominated profession be male-dominant because women have a hard time breaking in?

Stefanie disagreed. “No, they actually like working with women,” she said. “They want to.”

One male conference attendee, who asked not to be named, was less certain.

“There’s a lot of ego and testosterone,” he said. “It can’t be easy” for women.

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EU leaders in Norway to pick up Nobel Peace Prize

OSLO, Norway (AP) — European Union leaders on Sunday hailed the achievements of the 27-nation bloc, but acknowledged they need more integration and authority to solve problems, including its worst financial crisis, as they arrived in Norway to pick up this year’s Nobel Peace Prize.

Conceding that the EU lacked sufficient powers to stop the devastating 1992-95 Bosnia war, European Commission President Jose Manuel Barroso said that the absence of such authority at the time is “one of the most powerful arguments for a stronger European Union.”

Barroso spoke to reporters with EU Council President Herman Van Rompuy and the president of the EU Parliament, Martin Schulz, in Oslo, where the three leaders were to receive this year’s award, granted to the European Union for fostering peace on a continent ravaged by war.

Nobel committee chairman Thorbjoern Jagland will present the prize, worth $ 1.2 million, at a ceremony in Oslo City Hall, followed by a banquet at the Grand Hotel, against a backdrop of demonstrations in this EU-skeptic country that has twice rejected joining the union.

About 20 European government leaders, including German Chancellor Angela Merkel, French President Francois Hollande and British Deputy Prime Minister Nick Clegg, will be joining the ceremonies. They will be celebrating far away from the EU’s financial woes in a prosperous, oil-rich nation of 5 million on the outskirts of Europe that voted in 1972 and 1994 in referendums to stay out of the union.

The decision to award the prize to the EU has sparked harsh criticism, including from three peace laureates — South African Archbishop Desmond Tutu, Mairead Maguire of Northern Ireland and Adolfo Perez Esquivel from Argentina — who have demanded the prize money not be paid out this year. They say the bloc contradicts the values associated with the prize because it relies on military force to ensure security.

The leader of Britain’s Independence Party, Nigel Farage, in a statement described rewarding the EU as “a ridiculous act which blows the reputation of the Nobel prize committee to smithereens.”

Hundreds of people demonstrated against this year’s prize winners in a peaceful torch-lit protest that meandered through the dark city streets to Parliament, including Tomas Magnusson from the International Peace Bureau, the 1910 prize winner.

“This is totally against the idea of Alfred Nobel who wanted disarmament,” he said, accusing the Nobel committee of being “too close to the power” elite.

Dimitris Kodelas, a Greek lawmaker from the main opposition Radical Left party, or Syriza, said a humanitarian crisis in his country and EU policies could cause major rifts in Europe. He thought it was a joke when he heard the peace prize was awarded to the EU. “It challenges even our logic and it is also insulting,” he said.

The EU is being granted the prize as it grapples with a debt crisis that has stirred deep tensions between north and south, caused soaring unemployment and sent hundreds of thousands into the streets to protest austerity measures.

It is also threatening the euro — the common currency used by 17 of its members — and even the structure of the union itself, and is fuelling extremist movements such as Golden Dawn in Greece, which opponents brand as neo-Nazi.

Barroso acknowledged that the current crisis showed the union was “not fully equipped to deal with a crisis of this magnitude.”

“We do not have all the instruments for a true and genuine economic union … so we need to complete our economic and monetary union,” he said, adding that the new measures, including on a banking and fiscal union, would be agreed on in coming weeks.

He stressed that despite the crisis all steps taken had been toward “more, not less integration.”

Van Rompuy was optimistic saying that EU would come out of the crisis stronger than before. “We want Europe to become again a symbol of hope,” he said.

The EU says it will donate the prize money to projects that help children in conflict zones and will double it with EU funds.

The European Union grew from the conviction that ever-closer economic ties would ensure century-old enemies like Germany and France never turned on each other again, starting with the creation in 1951 of the European Coal and Steel Community, declared as “a first step in the federation of Europe.”

In 60 years it has grown into a 27-nation bloc with a population of 500 million, with other nations eagerly waiting to join, even as its unity is being threatened by the financial woes.

While there have never been wars inside EU territory, the confederation has not been able to prevent European wars outside its borders. When the deadly Balkans wars erupted in the 1990s, the EU was unable by itself to stop them. It was only with the help of the United States and after over 100,000 lives were lost in Bosnia was peace eventually restored there, and several years later, to Kosovo.

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Obama meets with Boehner to discuss 'fiscal cliff'

WASHINGTON (Reuters) - President Barack Obama met with Republican Speaker of the House of Representatives John Boehner on Sunday at the White House to negotiate ways to avoid the "fiscal cliff," according to White House officials and a congressional aide.

The two sides declined to provide further details about the unannounced meeting. Obama and Boehner aides used the same language to describe it.

"This afternoon, the president and Speaker Boehner met at the White House to discuss efforts to resolve the fiscal cliff," White House spokesman Josh Earnest said.

"We're not reading out details of the conversation, but the lines of communication remain open," he said.

An aide to Boehner emailed an identical quote.

The two sides are trying to reach an agreement that would stop automatic spending cuts and tax increases from going into effect at the beginning of the year. Analysts say if that so-called "fiscal cliff" occurs, the U.S. economy could swing back into a recession.

Obama has made clear he will not accept a deal unless tax rates for the wealthiest Americans rise. Boehner and many of his fellow Republicans say any tax increases would hurt a still fragile economy.

Last week Boehner and Obama spoke by phone, a conversation that the Republican leader described as pleasant but unproductive.

The common language used by both men's aides suggests an agreement to keep details about their discussions private, which could help both of them sell less politically palatable aspects of an eventual deal to lawmakers in their respective parties.

(additional reporting by Rachelle Younglai; editing by Stacey Joyce)

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Obama met Boehner on Sunday over fiscal cliff: aides

WASHINGTON (Reuters) – President Barack Obama met with Republican Speaker of the House of Representatives John Boehner on Sunday at the White House to negotiate ways to avoid the “fiscal cliff,” according to White House officials and a congressional aide.

The two sides declined to provide further details about the unannounced meeting. Obama and Boehner aides used the same language to describe it.

“This afternoon, the president and Speaker Boehner met at the White House to discuss efforts to resolve the fiscal cliff,” White House spokesman Josh Earnest said.

“We’re not reading out details of the conversation, but the lines of communication remain open,” he said.

An aide to Boehner emailed an identical quote.

The two sides are trying to reach an agreement that would stop automatic spending cuts and tax increases from going into effect at the beginning of the year. Analysts say if that so-called “fiscal cliff” occurs, the U.S. economy could swing back into a recession.

Obama has made clear he will not accept a deal unless tax rates for the wealthiest Americans rise. Boehner and many of his fellow Republicans say any tax increases would hurt a still fragile economy.

Last week Boehner and Obama spoke by phone, a conversation that the Republican leader described as pleasant but unproductive.

The common language used by both men’s aides suggests an agreement to keep details about their discussions private, which could help both of them sell less politically palatable aspects of an eventual deal to lawmakers in their respective parties.

(additional reporting by Rachelle Younglai; editing by Stacey Joyce)

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Ghana’s Mahama wins election – electoral body’s Facebook page

ACCRA (Reuters) – Ghana incumbent President John Dramani Mahama was elected to a new term with 50.7 percent of votes cast, according to results posted on the Electoral Commission‘s Facebook page on Sunday.

It was not immediately possible to verify the results with an Electoral Commission official.

Mahama, who became president in July after the death of ex-leader John Atta Mills, was facing top rival Nana Akufo-Addo – who took 47.4 percent of the vote, according to the Electoral Commission’s Facebook page. http://www.facebook.com/ECGOVGH

(Writing by Richard Valdmanis; Editing by Myra MacDonald)

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North Korea considers delaying rocket launch

SEOUL, South Korea (AP) — North Korea may postpone the controversial launch of a long-range rocket that had been slated for liftoff as early as this week, state media said Sunday, as international pressure on Pyongyang to cancel the provocative move intensified.

Scientists have been pushing forward with final preparations for the launch from a west coast site, slated to take place as early as Monday, but are considering "readjusting" the timing, an unidentified spokesman for the Korean Committee for Space Technology told North Korea's state-run Korean Central News Agency.

It was unclear whether diplomatic intervention or technical glitches were behind the delay. A brief KCNA dispatch said scientists and technicians were discussing whether to set new launch dates but did not elaborate.

Word of a possible delay comes just days after satellite photos indicated that snow may have slowed launch preparations, and as officials in Washington, Seoul, Tokyo, Moscow and elsewhere urged North Korea to cancel a liftoff widely seen as a violation of bans against missile activity.

Commercial satellite imagery taken by GeoEye on Dec. 4 and shared Friday with The Associated Press by the 38 North and North Korea Tech websites showed the Sohae site northwest of Pyongyang covered with snow. The road from the main assembly building to the launch pad showed no fresh tracks, indicating that the snowfall may have stalled the preparations.

However, analysts believed rocket preparations would have been completed on time for liftoff as early as Monday.

In Seoul, officials at the Defense Ministry, Joint Chiefs of Staff and the Foreign Ministry said Sunday they were looking into what might be behind the possible delay.

North Korea announced earlier this month that it would launch a three-stage rocket mounted with a satellite from its Sohae station southeast of Sinuiju sometime between Dec. 10 and Dec. 22. Pyongyang calls it a peaceful bid to send an observational satellite into space, its second attempt this year.

The launch announcement captured global headlines because of its timing: South Korea and Japan hold key elections this month, President Barack Obama begins his second term next month and China has just formed a new leadership.

The United States, Japan, South Korea and others have urged North Korea to refrain from carrying out the launch, calling it a violation of U.N. Security Council resolutions on nuclear activity because the rocket shares the same technology used for firing a long-range missile.

China, the North's main ally and aid provider, noted its "concern." It acknowledged North Korea's right to develop its space program but said that had to be harmonized with restrictions including those set by the U.N. Security Council.

Past launches have earned North Korea international condemnation and a host of sanctions.

South Korean analysts said North Korea's announcement of a possible delay suggests the country wants to resume talks with the U.S. on receiving much-needed aid, or has yielded to diplomatic pressure by China.

North Korea may not fire the rocket if the U.S. actively engages in talks with Pyongyang and promises to ship stalled food assistance to the country, said Koh Yu-hwan, a professor of North Korean studies at Seoul's Dongguk University.

In February, the U.S. agreed to provide 240,000 metric tons of food aid to North Korea in exchange for a freeze in nuclear and missile activities. The deal collapsed after North Korea launched a long-range rocket in April.

Analyst Baek Seung-joo of the South Korean state-run Korea Institute for Defense Analyses in Seoul said China must have sent a "very strong" message calling for the North to cancel the launch plans.

"North Korea won't say it would delay the launch due to foreign pressure so that's why they say scientists and technicians are considering delaying it," he said.

The unexpected launch announcement was issued Dec. 1 as North Koreans began mourning late leader Kim Jong Il, who died on Dec. 17, 2011.

An April launch from the same new launch pad was held on April 13, two days before the centennial of the birth of his father, North Korea founder Kim Il Sung. That rocket broke up just seconds after liftoff.

The U.S. and other nations see the launches as covers for illicit tests of missile technology. North Korea has unveiled missiles designed to target U.S. soil, and has tested two atomic bombs in recent years, but has not shown yet that it has mastered the technology for mounting a nuclear warhead to a long-range missile.

Six-nation negotiations to offer North Korea much-needed aid in exchange for nuclear disarmament have been stalled since 2009.

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Lupus forces singer Toni Braxton into LA hospital

LOS ANGELES (AP) — Singer Toni Braxton has been hospitalized in Los Angeles.

The R&B performer says in a Tweet on Friday that she’s been hospitalized because of “minor health issues” related to Lupus. A spokeswoman confirmed the hospitalization but had no other details. “But no worries!,” Braxton wrote to fans. “I will be out any day now.”

The 45-year-old singer of “Un-break My Heart” revealed two years ago she has Lupus, a potentially deadly autoimmune disease that killed Braxton’s uncle. She also suffers from a narrowing of the blood vessels in her heart.

Braxton said in a recent “20/20″ interview that doctors told her the Lupus diagnosis meant her performing career would likely be diminished and the disease helped push her into a recent bankruptcy.

___

Online:

http://tonibraxton.com

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Venezuela’s Chavez to have another cancer operation

CARACAS (Reuters) – Venezuelan President Hugo Chavez said on Saturday he would undergo another cancer operation in the coming days after doctors in Cuba found a third recurrence of malignant cells in his pelvic area.

The news is a big blow for his supporters in South America’s biggest oil exporter, who elected him in October to a new six-year term in power. Chavez has twice said he was cured, and then had to return to Cuba for more surgery.

In a televised broadcast flanked by ministers at the Miraflores presidential palace, Chavez said that if anything happened to him and a new vote had to be held, his supporters should vote for Vice President Nicolas Maduro – the first time the socialist leader has named a successor.

Chavez returned to Venezuela on Friday from having medical treatment in Cuba, ending a three-week absence from public view.

“Unfortunately, during these exhaustive exams they found some malignant cells in the same area … . It is absolutely necessary, absolutely essential, that I have to undergo a new surgical intervention,” the 58-year-old said, looking resolute.

“With God’s will, like on the previous occasions, we will come out of this victorious.”

The president has already had three cancer operations in Cuba since the middle of last year. News of more surgery will likely raise new doubts about his future and the fate of his self-styled “revolution” in the OPEC nation.

Chavez, who has dominated Venezuelan politics since taking power 14 years ago, said he would return to Havana on Sunday.

Under Venezuela’s constitution, an election would have to be held within 30 days if Chavez were to leave office within the first four years of his next term, due to begin on January 10.

The president has been receiving treatment at the Cimeq hospital in Havana as a guest of his friend and political mentor, former Cuban leader Fidel Castro.

(Additional reporting by Eyanir Chinea and Diego Ore; Editing by Xavier Briand)

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Twitter to Start War on Instagram In Time for Christmas

Holidays seem to be Instagram‘s bread and butter, so it makes sense that Twitter would fire their first shot in the war on Instagram when the app is at its most vulnerable. 

RELATED: Why You Can’t See Instagram Photos on Twitter Anymore

If we learned anything from Thanksgiving, it’s that people love to Instagram their holidays. Turkeys, stuffing, table settings: you Amaro’d it all. It was the service’s best day ever. There were 10 million pictures Instagrammed on Thanksgiving. So it’s not a logistical stretch to imagine the holiday season – Hanukkah starts tonight! —  will be big business for Instagram, too. Christmas day will probably be especially big since it combines dinner, like Thanksgiving, and presents. (Also: check your Instagram feed right now and you’re sure to see at least 3 Christmas trees.)

RELATED: Meet the Parade of Greedy Crybabies Who Didn’t Get iPhones for Christmas

And so comes a report from AllThingsD’s Mike Isaac saying Twitter will launch its own photo filters on time for Christmas, likely to try and capitalize on that rush of OMG I got a cool thing! photo-sharing. Instagram stopped their photos from being shown on Twitter, because they want people on their site. The move makes enough sense, because Instagram is owned by Facebook and not Twitter, but it still sucks for the rest of us. The two companies are now in a budding rivalry over photo-sharing, so this is it, it’s war, we guess. 

RELATED: How to Get Over the Twitter-Instagram War on Photos

If you’re having trouble watching these two former friends fight, please read The Atlantic Wire’s Rebecca Greenfield’s guide to getting over it. The holidays is no place for rivalries. Didn’t Jingle All The Way teach you people anything? 

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