FDA panel opposes recommending painkiller, cites safety

WASHINGTON (Reuters) – A U.S. Food and Drug Administration panel of outside experts voted against recommending Zogenix Inc’s Zohydro painkiller for FDA approval on Friday, citing concerns about the danger of addiction posed by the drug class known as opioids.

But FDA officials said the regulatory agency could still approve the drug for sale in the United States by imposing restrictions to protect public safety.

In an 11-2 vote, advisory committee members said the San Diego-based pharmaceutical company had met narrow FDA targets for safety and efficacy but worried that the drug known generically as hydrocodone bitartrate could become a drug of choice for people addicted to other opioid painkillers including those based on the drug oxycodone.

“The primary thing has to be the public health,” said Dr Judith Kramer of Duke University. “And I don’t see how we can’t see this as a promised repeat performance.”

FDA officials will consider the committee’s recommendation in deciding by March 1 whether to approve Zohydro for sale in the United States for people who require a round-the-clock painkiller for an extended period of time.

Dr Bob Rappaport, director of the FDA’s division of anesthesia, analgesia and addiction products, said regulators must decide whether the panel’s decision was based on a tangible difference between Zohydro and opioid-based medications already available in the marketplace.

Otherwise, he told the panel, “you’re punishing this company and this drug because of the sins of the previous developers and their products. And from a regulatory standpoint, that’s not really something we can do.”

POSSIBLE SALES BOOST

Wall Street analysts say FDA approval could bring Zogenix up to $ 500 million in annual sales from Zohydro by 2019, or more than ten times the pharmaceutical company’s expected 2012 annual revenue of $ 45.5 million.

Trading of Zogenix shares was suspended on Friday because of the FDA hearing. The stock closed at $ 2.36 on Thursday.

Zohydro is a single-entity, extended-release product containing the narcotic painkiller hydrocodone with no other pharmaceutical ingredient such as acetaminophen, which can lead to liver damage if used too often.

“Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue. However, it is also important to remember that there is a documented patient need for an extended-release hydrocodone medicine without acetaminophen,” the company said in a statement.

“We remain confident in the measures we have proposed to support safe use of Zohydro and are committed to continuing to work with the FDA through the review process to bring this treatment option to this specific patient population,” it added.

Health officials say hydrocodone, the active ingredient in Zohydro, is already the most widely abused drug in an opioid class linked to a prescription drug abuse epidemic that has ballooned over the past 20 years.

Law enforcement officials say prescription drugs now pose a bigger public safety hazard than more traditional narcotics, including heroin and cocaine.

An estimated 7 million Americans abuse pharmaceutical drugs. Prescription drugs account for about 75 percent of all drug-related U.S. overdose deaths, according to the U.S. Centers for Disease Control and Prevention. Three of every four deaths from pills involve opioid pain relievers including oxycodone.

SHARPLY CONTRASTING TESTIMONY

Before voting, the panel heard testimony from more than a dozen public witnesses, including chronic pain sufferers who see drugs like Zohyrdo as needed treatments to control their chronic discomfort and allow them to lead normal lives without endangering their health.

But some speakers before the panel implored the experts not to recommend another potentially addictive opioid.

“Today we have a chance to save people,” said Avi Israel, father of an 18-year-old boy who suffered from Crohn’s disease and committed suicide after becoming addicted to hydrocodone that was prescribed to slow his bowels.

“Ask yourself this question,” he added, “do we really need another narcotic pill to help anybody with pain? We can’t handle what we have.”

Earlier on Friday, the panel conducted separate and sharply divided votes on safety and efficacy.

Committee members voted 9-5 to find that the drug was not safe for treating patients with moderate to severe chronic pain, after voting 7-6 to find the treatment effective against pain. A panel member later changed her vote on efficacy from “no” to “yes,” saying she had made a technical error.

(Editing by Carol Bishopric and Matthew Lewis)

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Exclusive: Google to replace M&A chief

SAN FRANCISCO (Reuters) – Google Inc is replacing the head of its in-house mergers and acquisitions group, David Lawee, with one of its top lawyers, according to a person familiar with the matter.

Don Harrison, a high-ranking lawyer at Google, will replace Lawee as head of the Internet search company‘s corporate development group, which oversees mergers and acquisitions, said the source, who spoke anonymously because he was not authorized to speak publicly.

Google is also planning to create a new late-stage investment group that Lawee will oversee, the source said.

Google declined to comment. Lawee and Harrison could not immediately be reached for comment.

One of the Internet industry’s most prolific acquirers, Google has struck more than 160 deals to acquire companies and assets since 2010, according to regulatory filings. Many of Google’s most popular products, including its online maps and Android mobile software, were created by companies or are based on technology that Google acquired.

Harrison, Google’s deputy general counsel, will head up the M&A group at a time when the company is still in the process of integrating its largest acquisition, the $ 12.5 billion purchase of smartphone maker Motorola Mobility, which closed in May.

And he takes over at a time when the Internet search giant faces heightened regulatory scrutiny, with the U.S. Federal Trade Commission and the European Commission conducting antitrust investigations into Google’s business practices. Several recent Google acquisitions have undergone months of regulatory review before receiving approval.

As deputy general counsel, Harrison has been deeply involved in the company’s regulatory issues and many of its acquisitions. He joined Google more than five years ago and has completed more than 70 deals at the company, according to biographical information on the Google Ventures website.

Harrison is an adviser to Google Ventures, the company’s nearly four-year old venture division which provides funding for start-up companies.

While most of Google’s acquisitions are small and mid-sized deals that do not meet the threshold for disclosure of financial terms, Google has a massive war chest of $ 45.7 billion in cash and marketable securities to fund acquisitions.

Lawee, who took over the M&A group in 2008, has had hits and misses during his tenure. Google shut down social media company Slide one year after acquiring it for $ 179 million, for example.

The planned late-stage investment group has not been finalized, the source said. The fund might operate separately from Google Ventures, according to the source.

“Think of it as a private equity fund inside of Google,” the source said.

The company recently said it would increase the cash it allocates to Google Ventures to $ 300 million a year, up from $ 200 million, potentially helping it invest in later-stage financing rounds.

Google finished Friday’s regular trading session down 1 percent, or $ 6.92, at $ 684.21.

(Reporting By Alexei Oreskovic; editing by Carol Bishopric and Jim Loney)

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Toronto mayor to stay in power pending appeal of ouster

TORONTO (Reuters) – Toronto Mayor Rob Ford can stay in power pending an appeal of a conflict of interest ruling that ordered him out of his job as leader of Canada’s biggest city, a court ruled on Wednesday.

Madam Justice Gladys Pardu of the Ontario Divisional Court suspended a previous court ruling that said Ford should be ousted. Ford’s appeal of that ruling is set to be heard on January 7, but a decision on the appeal could take months.

Justice Pardu stressed that if she had not suspended the ruling, Ford would have been out of office by next week. “Significant uncertainty would result and needless expenses may be incurred if a by-election is called,” she said.

If Ford wins his appeal, he will get to keep his job until his term ends at the end of 2014. If he loses, the city council will either appoint a successor or call a special election, in which Ford is likely to run again.

“I can’t wait for the appeal, and I’m going to carry on doing what the people elected me to do,” Ford told reporters at City Hall following the decision.

Ford, a larger-than-life character who took power on a promise to “stop the gravy train” at City Hall, has argued that he did nothing wrong when he voted to overturn an order that he repay money that lobbyists had given to a charity he runs.

Superior Court Justice Charles Hackland disagreed, ruling last week that Ford acted with “willful blindness” in the case, and must leave office by December 10.

Ford was elected mayor in a landslide in 2010, but slashing costs without cutting services proved harder than he expected, and his popularity has fallen steeply.

He grabbed unwelcome headlines for reading while driving on a city expressway, for calling the police when a comedian tried to film part of a popular TV show outside his home, and after reports that city resources were used to help administer the high-school football team he coaches.

The conflict-of-interest drama began in 2010 when Ford, then a city councillor, used government letterhead to solicit donations for the football charity created in his name for underprivileged children.

Toronto’s integrity commissioner ordered Ford to repay the C$ 3,150 ($ 3,173) the charity received from lobbyists and companies that do business with the city.

Ford refused to repay the money, and in February 2012 he took part in a city council debate on the matter and then voted to remove the sanctions against him – despite being warned by the council speaker that voting would break the rules.

He pleaded not guilty in September, stating that he believed there was no conflict of interest as there was no financial benefit for the city. The judge dismissed that argument.

In a rare apology after last week’s court ruling, he said the matter began “because I love to help kids play football”.

Ford faces separate charges in a C$ 6 million libel case about remarks he made about corruption at City Hall, and is being audited for his campaign finances. The penalty in the audit case could also include removal from office.

(Reporting by Claire Sibonney; Editing by Janet Guttsman, Russ Blinch, Nick Zieminski; and Peter Galloway)

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Comedian Katt Williams a no-show at arraignment

SEATTLE (AP) — Comedian Katt Williams didn’t show up at an arraignment hearing in Seattle to face assault charges stemming from several run-ins with people and police last weekend.

Williams’ attorney, Thomas McAllister, told the judge Thursday that his client was under the impression that he didn’t have to attend the hearing, citing information from a Seattle Times article. McAllister says Williams is back in California.

The Times reports (http://bit.ly/VJzMhX ) that the judge rescheduled the hearing for next week.

Authorities say Williams struck a man over the head with a microphone while performing Friday night, threw chairs at fans, and threatened a bar manager with a pool cue over the weekend.

Authorities say officers had to restrain Williams before he was taken into custody after the bar incident.

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Information from: The Seattle Times, http://www.seattletimes.com

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Beyond mobile: Telcos hook up hospitals, cars and coffeemakers

BARCELONA (Reuters) – In Barcelona’s Hospital Del Mar, Telefonica is doing more than connecting phone lines – it is also developing a lucrative new business keeping patients’ hearts in good shape.

A heart-monitoring program put in place by Telefonica is just one kind of machine-to-machine (M2M) technology that telecom operators are racing to develop for sectors including healthcare, automotive, transportation and energy.

Carriers such as Vodafone, Deutsche Telekom, AT&T, Verizon, China Mobile, and France Telecom are betting that M2M will be a significant source of growth as the number of connected devices climbs to 12 billion or more by 2020.

In cars, for example, mobile technology can be used to automatically call emergency services after a road accident. In offices, France Telecom uses it to tell companies when their coffee machines need re-stocking, while energy companies are equipping homes with ‘smart meters’ to track consumption and permit differential pricing.

The potential prize is billions of dollars in new business for telecom groups, many of which are otherwise faced with declining sales, and the promise of big cost savings for their customers.

Yet turning the ‘Internet of Things’ into a real business will not be easy for big telcos, since the market is far more complicated than their traditional sales of mobile and Internet contracts to consumers and companies.

To succeed, they have to develop an understanding of a range of industries, their specific needs and regulatory constraints. They also have to outfox a phalanx of new competitors such as start-ups in Silicon Valley, app developers, and corporate giants like IBM, General Electric and Philips.

Analysts’ forecasts vary widely on the size of the M2M market and how much of it telcos can win, since the biggest opportunity comes not from putting a mobile SIM card in devices but from providing the software and services to make them work.

Machina Research predicts revenue of 714 billion euros ($ 933 billion) by 2020 for M2M overall. Informa Telecoms & Media’s Jamie Moss says the market is growing slowly and will reach 217 million connections and $ 9.3 billion for telcos by end 2014. They earned $ 5.7 billion from M2M this year, dwarfed by the roughly $ 1.14 trillion from mobile services in the same period.

“I am very convinced that M2M will be a profit driver,” said Matthew Key, who heads Telefonica’s digital unit, which aims to earn 500-800 million euros in annual M2M revenue by 2015.

“But we need to sell more than just basic connectivity by adding know-how and a complete service, and build the business locally step by step.”

NEW TERRITORY

The opportunity and the challenges for telcos in M2M are on display at the Hospital Del March

Every morning, patients recovering from heart attacks use equipment installed in their homes by Telefonica to weigh themselves, take their blood pressure and answer a few questions on their symptoms via a touch screen. The information is transmitted to nurses at the seaside hospital’s cardiac unit who follow up by phone if they have any concerns.

The program has had a positive effect on mortality rates, reduced hospital visits and saved 9,000 euros per cardiac patient since it began two years ago, according to doctors.

Nurse Ana Linas said the system was so simple to use that an illiterate elderly woman was among the patients able to use it.

Yet the hospital, which experienced some video connectivity problems that were quickly resolved by Telefonica, has no plans to expand the project because of the costs involved.

“You have to hire trained people so that it all works. Although costs fall a lot later on, the initial investment is high in staff and equipment,” said doctor Cristina Enjuanes.

With budgets under pressure and doctors often reluctant, getting the investment needed to roll out telehealth schemes can be an uphill struggle.

Telefonica wants to roll out the heart-monitoring program elsewhere in Spain and is also investing heavily in projects in Britain with the National Health Service.

“I cannot tell you when it will ramp up. What I can feel is that we are getting closer to it … We will know soon the speed at which demand will move, and whether there is finally an opportunity to create a totally new (business) category,” said Jose Perdomo, head of Telefonica’s e-Health division.

Telefonica has had more success rolling out e-health in Latin American markets such as Brazil and Chile, where more medical care is provided via the private sector than in Europe.

CARS AND HOMES

The M2M gold rush has sent some telcos on the acquisition trail to get technology and expertise. AT&T bought U.S. start-up Xanboo and has used its technology to develop security services for the home, as well as tools for homeowners to control their heating, lighting and appliances from a mobile phone.

Verizon paid $ 612 million in June for Hughes Telematics and plans to build on the company’s expertise in M2M software for tracking truck fleets, as well as crash detection, emergency calling, and maintenance needs for cars. Hughes has a worldwide contract with Volkswagen and a U.S. contract with Mercedes.

John Stratton, Verizon’s vice-president for enterprise, said the Hughes deal would allow it to gain know-how in the software needed to boost the profitability of M2M contracts beyond the few dollars earned from the connection itself.

“If we only transport the bits of data in M2M projects, that has relatively modest value, less than 10 percent of the market opportunity overall,” he said in an interview.

“The next big piece is the solutions on top, which is what motivated us to buy Hughes.”

Korea Telecom’s experience launching a taxi fleet management service powered by M2M technology demonstrates the point. Initially it earned about $ 5 a month per taxi for tracking taxi locations with mobile technology. It boosted that to $ 50 per month and signed five-year instead of two-year contracts by selling a software platform and call center as a package with the taxi tracking.

Telefonica invested 2 million euros in a Spanish start-up called addFleet that makes a free taxi-calling app for consumers, and a paid version for taxi owners to track cars.

“There is no global market for taxi cabs, so you need to go local first,” said Telefonica Digital chief Key.

Martin Garner, an analyst at consultancy CCS Insight, said telecom operators would have to adapt if they are to succeed in making M2M a mass technology, adding that for now the market was growing slower than they would have hoped.

“We do think there is a big world in M2M for the telcos,” said Garner. “But they have to go and take it: it will not come to them.”

($ 1 = 0.7652 euros)

(Additional reporting by Harro Ten Wolde, Robert-Jan Bartunek and Roberta Cowan; Editing by Will Waterman)

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Death toll from Philippine typhoon nears 300

NEW BATAAN, Philippines (AP) — Stunned parents searching for missing children examined a row of mud-stained bodies covered with banana leaves while survivors dried their soaked belongings on roadsides Wednesday, a day after a powerful typhoon killed nearly 300 people in the southern Philippines.

Officials fear more bodies may be found as rescuers reach hard-hit areas that were isolated by landslides, floods and downed communications.

At least 151 people died in the worst-hit province of Compostela Valley when Typhoon Bopha lashed the region Tuesday, including 78 villagers and soldiers who perished in a flash flood that swamped two emergency shelters and a military camp, provincial spokeswoman Fe Maestre said.

Disaster-response agencies reported 284 dead in the region and 14 fatalities elsewhere from the typhoon, one of the strongest to hit the country this year.

About 80 people survived the deluge in New Bataan with injuries, and Interior Secretary Mar Roxas, who visited the town, said 319 others remained missing.

“These were whole families among the registered missing,” Roxas told the ABS-CBN TV network. “Entire families may have been washed away.”

The farming town of 45,000 people was a muddy wasteland of collapsed houses and coconut and banana trees felled by Bopha’s ferocious winds.

Bodies of victims were laid on the ground for viewing by people searching for missing relatives. Some were badly mangled after being dragged by raging flood waters over rocks and other debris. A man sprayed insecticide on the remains to keep away swarms of flies.

A father wept when he found the body of his child after lifting a plastic cover. A mother, meanwhile, went away in tears, unable to find her missing children. “I have three children,” she said repeatedly, flashing three fingers before a TV cameraman.

Two men carried the mud-caked body of an unidentified girl that was covered with coconut leaves on a makeshift stretcher made from a blanket and wooden poles.

Dionisia Requinto, 43, felt lucky to have survived with her husband and their eight children after swirling flood waters surrounded their home. She said they escaped and made their way up a hill to safety, bracing themselves against boulders and fallen trees as they climbed.

“The water rose so fast,” she told AP. “It was horrible. I thought it was going to be our end.”

In nearby Davao Oriental, the coastal province first struck by the typhoon as it blew from the Pacific Ocean, at least 115 people perished, mostly in three towns that were so battered that it was hard to find any buildings with roofs remaining, provincial officer Freddie Bendulo and other officials said.

“We had a problem where to take the evacuees. All the evacuation centers have lost their roofs,” Davao Oriental Gov. Corazon Malanyaon said.

The International Federation of Red Cross and Red Crescent Societies issued an urgent appeal for $ 4.8 million to help people directly affected by the typhoon.

The sun was shining brightly for most of the day Wednesday, prompting residents to lay their soaked clothes, books and other belongings out on roadsides to dry and revealing the extent of the damage to farmland. Thousands of banana trees in one Compostela Valley plantation were toppled by the wind, the young bananas still wrapped in blue plastic covers.

But as night fell, however, rain started pouring again over New Bataan, triggering panic among some residents who feared a repeat of the previous day’s flash floods. Some carried whatever belongings they could as they hurried to nearby towns or higher ground.

After slamming into Davao Oriental and Compostela Valley, Bopha roared quickly across the southern Mindanao and central regions, knocking out power in two entire provinces, triggering landslides and leaving houses and plantations damaged. More than 170,000 fled to evacuation centers.

As of Wednesday evening, the typhoon was over the South China Sea west of Palawan province. It was blowing northwestward and could be headed to Vietnam or southern China, according to government forecasters.

The deaths came despite efforts by President Benigno Aquino III’s government to force residents out of high-risk communities as the typhoon approached.

Some 20 typhoons and storms lash the northern and central Philippines each year, but they rarely hit the vast southern Mindanao region where sprawling export banana plantations have been planted over the decades because it seldom experiences strong winds that could blow down the trees.

A rare storm in the south last December killed more than 1,200 people and left many more homeless.

The United States extended its condolences and offered to help its Asian ally deal with the typhoon’s devastation. It praised government efforts to minimize the deaths and damage.

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Associated Press writers Jim Gomez, Teresa Cerojano and Oliver Teves in Manila contributed to this report.

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Syria loads chemical weapons, waits for green light

U.S. Secretary of State Hillary Clinton attends the "Friends of Syria" confernence in Paris. (AP)U.S. officials say the Syrian military has loaded active chemical weapons into bombs and is awaiting a final order from embattled President Bashar Assad to use the deadly weapons against its own people.

NBC News reports that on Wednesday the Syrian military loaded sarin gas into aerial bombs that could be deployed from dozens of aircraft.

The last large-scale use of sarin was in 1988, when former Iraqi President Saddam Hussein's forces killed 5,000 Kurds in a single attack.

However, U.S. officials told NBC that the sarin bombs had not yet been loaded onto planes but added if Assad gives the final order, "there's little the outside world can do to stop it."

The Syrian government has previously insisted that it would not use chemical weapons against its own people.

For months, the Obama administration has described the Assad regime as being on the verge of collapse. If the Syrian government were to be toppled from outside forces or from within, it would be the first nation possessing weapons of mass destruction to do so.

U.S. Secretary of State Hillary Clinton has as recently as last week warned of the possibility that Assad could use chemical weapons against his own people. After meeting other NATO foreign ministers in Brussels last week, Clinton told the gathering, "Our concerns are that an increasingly desperate Assad regime might turn to chemical weapons, or might lose control of them to one of the many groups that are now operating within Syria."

"We have sent an unmistakable message that this would cross a red line and those responsible would be held to account," she said.

At the end of the meeting, NATO Secretary General Anders Fogh Rasmussen backed up Clinton's threat, declaring that the international community could take military action against Assad and his forces.

"The possible use of chemical weapons would be completely unacceptable for the whole international community and if anybody resorts to these terrible weapons I would expect an immediate reaction from the international community," Rasmussen told reporters.

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Grammys spread the love with 6 top nominees

NASHVILLE, Tenn. (AP) — The Grammy Awards celebrated the diversity of music as six different artists tied for lead nominee — Kanye West, Jay-Z, Frank Ocean, Dan Auerbach of The Black Keys, Mumford & Sons and fun.

Auerbach received five nominations as a member of the Keys and also is up for producer of the year, earning a spot with the others at the top of the list as the Grammy’s primetime television special came to his hometown Wednesday night.

“We’re speechless,” Auerbach said in a statement to The Associated Press from Germany, where he’s on tour with drummer Patrick Carney.

The rockers little resemble any of the other acts at the top of the list. The nominations for Jay-Z and West, two of hip-hop’s most important figures, is a familiar refrain. Each has routinely been at or near the top of the nominations list for the last several years.

Indie pop band fun., a featured performer during the show, aired live from Nashville’s Bridgestone Arena on CBS, rode the success of its anthemic hit “We Are Young” featuring Janelle Monae to sweep of the major categories, earning nods for best new artist, song and record for “We Are Young” and album of the year for “Some Nights.” The band’s producer Jeff Bhasker is up for four nominations.

“When you call your band fun. with a period at the end of the sentence, you set a very high standard for yourself and for fun itself,” Taylor Swift, the concert’s co-host, said in introducing them. “Fortunately this band from New York has lived up to the name in the best possible way.”

R&B singer Ocean, whose mother was in attendance, made a bold social statement earlier this year when he noted he had a same-sex relationship in the liner notes of his new album “channel ORANGE,” and The Recording Academy rewarded him with the major nominations best new artist, record for “Thinkin Bout You” and album of the year.

And British folk-rock band Mumford & Sons, which made an auspicious debut in front of an international audience during the 2011 Grammys, is up for album of the year for “Babel,” one of 2012′s best-selling releases.

Miguel, who helped Ocean shake up the R&B world this year, and jazz great Chick Corea join the Keys with five nominations apiece. Nas and recording engineer Bob Ludwig join Bhasker at four apiece.

There were no major snubs. Most of 2012′s inescapable hits are represented in some way — Gotye’s “Somebody That I Used To Know” is up for record of the year and Carly Rae Jepsen’s “Call Me Maybe” garnered a song of the year nod. Drake, Rihanna and Nashville residents Swift, Kelly Clarkson, Jack White and best new artist nominee Hunter Hayes were among 16 nominees with three nods.

In many ways the nominations reflect a singles-driven year when no album rose to the level of acclaim as Adele’s “21″ or West’s “My Beautiful Dark Twisted Fantasy,” which dominated the Grammys last February.

Rock, relegated to second stage in the era of electronic dance music, made something of a comeback, and young bands are peppered in with the nominees we’ve come to expect each year.

The best new artist category is a great example of this year’s diversity. From the minimalist R&B of Ocean, the pop-influenced sounds of fun. and Hayes, the soulful rock of Alabama Shakes and the Americana swing of The Lumineers, there’s little resemblance between the acts.

“I think people listen to a lot of types of music and Spotify has proven that, and iPod has proven that,” Lumineers member Wes Schultz said. “Radio stations don’t prove that. … Every person in that audience tonight, I saw them freaking out about various artists that have no relationship to each other.”

Alabama Shakes drummer Steve Johnson noted the diversity in the category after the show, then made a surprising statement: “If I were on the other side of the fence, I’d vote Frank Ocean personally.”

The members of fun. were “dorking it up” as they learned about their nominations, lead singer Nate Reuss said, and were especially excited to show up in the album of the year category, which also included Ocean’s major label debut, the Keys’ “El Camino,” Mumford’s “Babel” and White’s “Blunderbuss.”

“It’s been an incredible year in music,” guitarist Jack Antonoff said. “It feels like alternative music is back, looking at album of the year, especially those nominations. We couldn’t be more proud to be in there. … I think when we were sitting in our chairs out there, when we saw Jack White up there, that’s when we really pinched ourselves. We felt so honored to be in the same category.”

The 55th annual Grammy Awards will be held Feb. 10 in Los Angeles. Trophies will be handed out in 81 categories.

The 5-year-old nominations show was held outside Los Angeles for the first time and showcased Music City for its growing role in the music industry. The Bridgestone Arena marked the largest venue the show has been held in and it may have been a dress rehearsal for a chance to host the main awards show sometime in the future.

LL Cool J returned as host, sharing duties with Swift, whose hit song “We Are Never Ever Getting Back Together” earned a nod in the jam-packed record of the year category. She was joined by fun., Gotye, Clarkson’s “Stronger (What Doesn’t Kill You),” The Black Keys‘ “Lonely Boy” and Ocean’s “Thinkin Bout You.”

Song of the year nominees were Ed Sheeran’s “The A Team,” Miguel’s “Adorn,” Jepsen’s “Call Me Maybe,” Clarkson’s “Stronger (What Doesn’t Kill You)” and fun.’s “We Are Young.”

Swift and LL Cool J opened the show by putting together a beat-box version of Swift’s hit “Mean.” Hayes displayed his versatility while announcing the best pop vocal album by singing snippets of each star’s hit song. Maroon 5 played headliner, singing three songs mid-show before finishing off the live broadcast. The group stuck around for an hourlong performance afterward for the crowd in attendance.

Assisted by Monae, fun. reimagined “We Are Young” with orchestral strings as the crowd sang along, Ne-Yo, in wine-colored bowler, kicked things up with a cadre of dancers on his new club-infused song “Let Me Love You.” And the show tipped its hat to Nashville with a salute to Johnny Cash by Dierks Bentley and The Band Perry.

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Online:

http://grammy.com

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Follow AP Music Writer Chris Talbott: http://twitter.com/Chris_Talbott.

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Pfizer breast cancer drug delays progression 18 months

(Reuters) – An experimental drug showed impressive effectiveness and safety in a mid-stage trial against a common form of advanced breast cancer, lifting Pfizer Inc shares nearly 2 percent.

The favorable results prompted the drugmaker to plan large late-stage trials of the drug next year. If approved, the medicine could fetch multi-billion dollar sales, industry analysts said.

The drug, called PD-0332991, delayed by more than 18 months the worsening of symptoms for postmenopausal women with the most common form of breast cancer. Data from the study of the drug was presented on Wednesday at the annual San Antonio Breast Cancer Symposium.

The medicine, which blocks enzymes known as CDK4 and 6 kinases, was taken in combination with a standard drug called letrozole among women who were estrogen receptor positive – meaning tumors grow in response to estrogen – and HER2-negative, meaning that the HER2 protein is not causing the cancer. Such patients make up about 60 percent of breast cancer cases.

Patients had either locally advanced tumors or cancer that had spread to other parts of the body.

Those taking both drugs went an average of 26.1 months before tumors worsened. That compared with 7.5 months for those taking letrozole, but not PD-0332991. The 18.6 month difference was considered statistically significant.

“In a disease where a several-month improvement in progression-free survival is considered impressive, we view an 18.6-month improvement in PFS as remarkable,” said analyst Jon LeCroy of MKM Partners. He predicted Pfizer will introduce the medicine in 2017.

Letrozole is the chemical name of Femara, a Novartis drug that belongs to a class of treatments called aromatase inhibitors that block production of estrogen.

Side effects seen in patients taking the drug combination included anemia, fatigue and neutropenia – a decline in white blood cells called neutrophils that can put patients at higher risk of infection.

“If approved in a front-line breast cancer setting, this drug has the potential to generate $ 2 billion to $ 6 billion” in worldwide sales for these types of breast cancer patients, said Mark Schoenebaum, an analyst with ISI Group, of PD-0332991.

Schoenebaum, who had not previously predicted any revenue for the drug, said the medicine could provide considerable “upside” to Pfizer revenue if it is cleared by regulators.

He noted that researchers have not yet disclosed to what degree the Pfizer drug might have prolonged patient survival.

Pfizer had released some data from the trial in May, but released updated findings on Wednesday.

Shares of Pfizer closed up 46 cents, or 1.8 percent, at $ 25.64 on the New York Stock Exchange on Wednesday.

(Reporting By Ransdell Pierson; Editing by Tim Dobbyn)

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In brewing rivalry, Instagram trims ties to Twitter

SAN FRANCISCO (Reuters) – Facebook Inc’s recently acquired photo-sharing service Instagram removed a key element of its integration with Twitter, signaling a deepening rift between two of the Web’s dominant social media companies.

Instagram Chief Executive Kevin Systrom said Wednesday his company turned off support for Twitter “cards” in order to drive Twitter users to Instagram’s own website. Twitter “cards” are a feature that allows multimedia content like YouTube videos and Instagram photos to be embedded and viewed directly within a Twitter message.

The move marked the latest clash between Facebook and Twitter since April, when Facebook, the world’s no. 1 social network, outbid Twitter to nab fast-growing Instagram in a cash-and-stock deal valued at the time at $ 1 billion. The acquisition closed in September for roughly $ 715 million, reflecting Facebook’s recent stock drop.

The companies’ ties have been strained since. In July, Twitter blocked Instagram from using its data to help new Instagram users find friends.

Beginning earlier this week, Twitter’s users began to complain in public messages that Instagram photos did not seem to display properly on Twitter’s website.

Systrom confirmed Wednesday that his company had decided its users should view photos on Instagram’s own Web pages and took steps to change its policies.

“We believe the best experience is for us to link back to where the content lives,” Systrom said in a statement, citing recent improvements to Instagram’s website.

“A handful of months ago, we supported Twitter cards because we had a minimal Web presence,” Systrom said, noting that the company has since released new features that allow users to comment about and “like” photos directly on Instagram’s website.

The move escalates a rivalry in the fast-growing social networking sector, where the biggest players have sought to wall off access to content from rival services and to their ranks of users.

“They’re both competing for slices of the same pie, the pie being users’ attention,” said Ray Valdes, an analyst with research firm Gartner.

If Facebook decides to offer advertising on Instagram, it’s important that the users visit Instagram’s own website, said Valdes. “If the eyeballs are elsewhere, you have less to work with in terms of monetization,” he said.

Photos are among the most popular features on both Facebook and Twitter, and Instagram’s meteoric rise in recent years has further proved how picture-sharing has become a key front in the battle for social Internet supremacy.

Instagram, which has 100 million users, allows consumers to tweak the photos they take on their smartphones and share the images with friends, a feature that Twitter has reportedly also begun to develop. Twitter’s executive chairman, Jack Dorsey, was an early investor in Instagram and had hoped to acquire it before Facebook CEO Mark Zuckerberg made a successful bid.

When Zuckerberg announced the acquisition in an April blog post, he highlighted Instagram’s inter-connectivity with other social networks.

“We think the fact that Instagram is connected to other services beyond Facebook is an important part of the experience,” Zuckerberg wrote. “We plan on keeping features like the ability to post to other social networks.”

A Twitter spokesman declined comment Wednesday, but a status message on Twitter’s website confirmed that users are “experiencing issues,” such as “cropped images” when viewing Instagram photos on Twitter.

(Reporting By Alexei Oreskovic and Gerry Shih; Editing by Nick Zieminski and Leslie Adler)

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