House panel seeks compounder group papers in meningitis probe

WASHINGTON (Reuters) – A U.S. congressional committee that oversees drug safety issues has asked a compounding pharmacists’ industry association to provide documents on the group’s role in helping pharmacies in their interactions with federal and state authorities.

The request to the International Academy of Compounding Pharmacists came as the House Energy and Commerce Committee continues an investigation into a deadly meningitis outbreak caused by contaminated compounded drugs.

In a letter released on Friday, 10 lawmakers cited a media report that the group “tutored pharmacists on how to sidestep” U.S. Food and Drug Administration requests for samples that would help the agency assess the quality of compounded drugs.

“Allegations that your association may have encouraged compounding pharmacists to attempt to impede the FDA from evaluating the efficacy and safety of their products, if true, raise serious concerns,” the lawmakers said.

The meningitis outbreak, linked to steroid injections from the Massachusetts-based New England Compounding Center, has sickened 541 people, 36 of whom have died, according to the U.S. Centers for Disease Control and Prevention.

(Reporting by Ros Krasny; Editing by Lisa Von Ahn)

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The Star is Dead. Her Film Isn’t

Three years after actress Brittany Murphy’s untimely death from pneumonia and anemia in 2009, her final film, an indie thriller called Something Wicked, finally completed post-production this week. The Eugene (Ore.) production company Merchant Films, which is currently seeking a distributor for the film, is caught in the unfortunate position of having to market a film without its most recognizable star. As of now, Merchant does not intend to include Murphy’s image in the main posters, says the movie’s writer and producer, Joe Colleran. Still, he says, many distributors have expressed interest in the past few days, and he is hoping for a spring 2013 release. Bloomberg Businessweek spoke with Colleran about how the filmmakers plan to manage in this difficult situation.

How have you had to change plans to market the film?
We did an original deal with Brillstein Entertainment Partners to represent the movie, and they have relationships with major studios. That hasn’t changed. What has changed is the time we delayed it to avoid exploitation. Normally it would be a two-year process. We shot it in Oregon, which takes longer than if you shoot it in Hollywood. The delay has been close to a year.

How will you walk that delicate line of promoting the film without being exploitative?
We don’t intend to run around marketing it as Brittany’s last movie. People know it is. I don’t think there’s any point in mentioning that any further. Her face is not on the key art. We will market it as a very suspenseful thriller. We’ll be marketing the genre of the movie. …You can go out virally, immediately [after her death] and build fan pages, and we didn’t. We thought that would be distasteful. We’re just starting that process now.

A lot of promoting the film involves doing interviews and red carpets.
That is a big difference. We won’t have [Brittany] promoting the movie nationally and internationally. We will not be able to have Brittany go on Letterman and Leno to do nationwide publicity, which she was excited to do. She was what they would have built the marketing campaign around. The other stars will have to replace her. The lead actress [Shantel VanSanten] is tremendous. They are very excited. They have larger responsibilities now, and they are anxious to promote it, because they really do look good in this movie.

Was the film altered after her death in any way?
No. There was only one scene she shot that was not in the film. It was one of the alternate endings. We’ll probably put it on the DVD so fans can see the different endings.

Tell me about finding a distributor for this film.
Genre movies—which are basically everything besides drama and comedy: action, thrillers, sci-fi—have a very loyal following. There’s a large segment of the younger audience, which is a key audience for distributors, that just goes to genre movies. The movie will probably get an R rating, which means the core audience will be 17 to 29, with a crossover of up to 34, because that’s what Brittany’s fan base is. That is the key audience that distributors go after, because they are easy to market to, they know where to find them, and they are frequent moviegoers.

Are you worried about critics?
Genre movies generally don’t tend to get critical acclaim anyway. Even if you’re a huge success like Twilight, critics trash it. Most critics don’t flock to genre movies. Fortunately, the audience we’re going after is not dependent on critics. They are dependent on word of mouth from their peers.

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Ghana election, test of democratic reputation

ACCRA, Ghana (AP) — Voters in Ghana were selecting their next president and a 275-seat parliament in elections Friday, solidifying the West African nation‘s reputation as a beacon of democracy in the region.

Some 14 million people are expected to turn out. President John Dramani Mahama, in office for only five months, is running against seven contenders. A former vice president, Mahama became president in July after the unexpected death of former President John Atta Mills. The 54-year-old is also a former minister and parliamentarian and has written an acclaimed biography, “My First Coup d’Etat.”

His main challenger is Nana Akufo-Addo, a former foreign minister and the son of one of Ghana’s previous presidents. The contender lost the 2008 election to Mills by less than 1 percent. Both men are trying to make the case that they will use the nation’s newfound oil wealth to help the poor.

Ghana, a nation of 25 million, is one of the few established democracies in the region as well as the fastest-growing economy. But a deep divide still exists between those benefiting from the country’s oil, cocoa and mineral wealth and those left behind financially.

In an interview on the eve of the vote, Akufo-Addo told The Associated Press that the first thing he will do if elected is begin working on providing free high school education for all. “It’s a matter of great concern to me,” he said, adding that he plans to use the nation’s oil wealth to educate the population, industrialize the economy and create better jobs for Ghanaians.

Policy-oriented and intellectual, Akufo-Addo is favored by the young and urbanized voters. He was educated in England and comes from a privileged family. The ruling party has depicted him as elitist, which Akufo-Addo calls “a little PR construct.”

“The idea that merely because you are born into privilege that automatically means you are against the welfare of the ordinary people, that’s nonsense,” he said.

Ghana had one of the fastest growing economies in the world in 2011. Allegations of corruption against the ruling party are rife.

Akufo-Addo said that if elected, he would not be able to weed out corruption in the government overnight.

“It’s a long fight,” he said. “But we build the institutions that can fight it.”

He said that in 30 years in politics he has never been accused of corruption.

Many analysts believe Mahama and Akufo-Addo are neck-and-neck.

Results are expected to be announced by Sunday, but could be delayed. If no one wins an absolute majority, a second round of voting will be held on December 28.

All candidates have signed a peace pact and have promised to accept the results of Friday’s poll.

Ghana, a nation of 25 million, has previously held five transparent elections in a row. Nearby Mali, which was also considered a model democracy, was plunged into chaos this March following a military coup.

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Associated Press writer Francis Kokutse contributed to this report from Accra, Ghana.

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Windows 8: A ‘Christmas gift for someone you hate’

Microsoft (MSFT) is no stranger to criticism these days, and the company’s new Windows 8 platform is once again the target of a scathing review from a high-profile user. Well-known Internet entrepreneur and MIT professor Philip Greenspun handed Windows 8 one of its most damning reviews yet earlier this week, calling the new operating system a “Christmas gift for someone you hate.” Greenspun panned almost every aspect of Microsoft’s new software, noting that Microsoft had four years to study Android and more than five to examine iOS, but still couldn’t build a usable tablet experience.

“The only device that I can remember being as confused by is the BlackBerry PlayBook,” Greenspun wrote on his blog after using Windows 8 on a Dell (DELL) XPS One All-in-One desktop PC. The acclaimed computer scientist noted that Microsoft omitted all of the best features from the most popular touch-focused platforms and instead created a user interface he describes as a “dog’s breakfast.”

“Suppose that you are an expert user of Windows NT/XP/Vista/7, an expert user of an iPad, and an expert user of an Android phone… you will have no idea how to use Windows 8,” Greenspun wrote.

He continued, “Some functions, such as ‘start an application’ or ‘restart the computer’ are available only from the tablet interface. Conversely, when one is comfortably ensconced in a touch/tablet application, an additional click will fire up a Web browser, thereby causing the tablet to disappear in favor of the desktop. Many of the ‘apps’ that show up on the ‘all apps’ menu at the bottom of the screen (accessible only if you swipe down from the top of the screen) dump you right into the desktop on the first click.”

The only praise Greenspun offered was that “some of the supplied apps are wonderful,” pointing to Microsoft’s Bing Finance application as an example.

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Latest James Bond movie breaks UK box office record

LONDON (Reuters) – “Skyfall“, the 23rd official James Bond movie, has become the most successful film in British box office history, earning 94.3 million pounds ($ 152 million), its producers said on Wednesday.

The tally, earned over 40 days, surpasses the previous record of 94.0 million pounds set by 2009 3D adventure film “Avatar” over its 11 month run in UK cinemas, although the figures do not take inflation into account.

Skyfall, which has been well received by critics, stars Daniel Craig in his third outing as 007, and is directed by Sam Mendes.

In it Bond and British spymaster M, played by Judi Dench, are pitted against technological wizard Silva (Javier Bardem) who is bent on revenge.

“We are very proud of this film and thank everybody, especially Daniel Craig and Sam Mendes, who have contributed to its success,” said co-producers Michael G. Wilson and Barbara Broccoli in a statement.

Globally, Skyfall has some way to go to match Avatar. It has earned $ 870 million in ticket sales around the world, according to movie tracking site Boxofficemojo.com, compared with Avatar’s record $ 2.8 billion.

According to the same website, Avatar’s adjusted box office total comes in at 14th in cinema history, with the 1939 classic “Gone With the Wind” in pole position.

(Reporting by Mike Collett-White, editing by Paul Casciato)

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Breast Cancer Vaccine a Reality for Women With HER-2 Negative Cancers

COMMENTARY | NeuVax, a breast cancer vaccine, is entering phase III trials. The drug’s manufacturer, Galena Biopharma, announced on Dec. 5, that it signed a distribution deal with TEVA Pharmaceuticals. TEVA will handle the global commercialization and distribution of the drug once it is out of trials. It is about time this is moving forward. We need to make progress toward ending this disease.

What is NeuVax?

A vaccine called NeuVax is close to being a reality for breast cancer patients. NeuVax is a vaccine, the first of its kind, to prevent breast cancer from recurring. A recurrence is when breast cancer returns to the same breast. If breast cancer appears in the other breast, it is not a recurrence but a new cancer.

Most women have a 15-20 percent chance of breast cancer recurring, even after a mastectomy. The implications of the vaccine are huge. It reduces the chance of breast cancer recurrence in women with node-positive, HER-2 negative breast cancers. About 75 percent of all breast cancer is HER-2 negative. The vaccine is given after the standard course of treatment is completed. It is not a replacement for radiation or chemotherapy. I would gladly try a vaccine over the currently available long-term recurrence preventions — all are hormone based and carry awful side effects.

Phase III trials

Unfortunately for me, there are no trials available in Arkansas. Even if there were, I am not eligible because my cancer is HER-2 positive, and I am thankfully, node-negative. This means that the cancer is not in my lymph system. Phase III trials are when the drug is actually tested in random settings on humans. This drug seems to be very promising. Right now, phase III trials are open in the United States and Canada. Israel will have at least four phase III trials opening soon. You can see if there are trials near you at the NeuVax website.

This vaccine has the potential to replace hormone therapies like tamoxifen and aromatase inhibitors. Both types of drugs have serious side effects. A vaccine, taken over the course of three years, reduces the time a patient needs to take medications and it helps to prevent recurrence. Hopefully the phase III trials go well and we get this vaccine available to breast cancer patients soon.

Lynda Altman was diagnosed with breast cancer in November 2011. She writes a series for Yahoo! Shine called “My Battle With Breast Cancer.”

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Wall Street gains as Apple rebounds; fiscal talks eyed

NEW YORK (Reuters) – Stocks managed slight gains by midday on Thursday as Broadcom‘s upbeat guidance and a turnaround in Apple shares helped lift technology stocks, while investors monitored news from Washington for signs of progress on the “fiscal cliff” negotiations.

Apple erased initial losses of as much as 3.7 percent at the open, which briefly brought the market capitalization of the world’s largest publicly traded company below $ 500 billion. By midday, Apple‘s stock was up 2.3 percent at $ 551.35 – a day after its worst drop in four years.

Tech stocks also got a lift from chipmaker Broadcom , up 2.2 percent at $ 33.06 a day after it forecast fourth-quarter revenue at the high end of its target range, citing slightly better-than-expected sales in its mobile business.

The S&P technology index <.gspt> gained 1 percent and ranked as the best performer among the S&P 500‘s 10 major sectors. The PHLX semiconductor index <.sox> rose 0.9 percent.</.sox></.gspt>

But budget discussions commanded center stage for investors. President Barack Obama said there could be a quick deal to avert the “fiscal cliff” – huge tax hikes and spending cuts set to begin in January, possibly driving the U.S. economy back into recession next year – if Republican leaders agree to raise tax rates for those making more than $ 250,000 a year.

While Republican leaders in the U.S. House of Representatives insist that raising tax rates on the rich is not negotiable, some GOP lawmakers now see it as inevitable to avoid the fiscal cliff.

“It’s really being held hostage to (the fiscal cliff negotiations) and the stock action of Apple,” said Bruce Zaro, chief technical strategist at Delta Global Asset Management in Boston.

“We’re back in the mode of there’s a direct correlation between the market and Apple – traders seems to be focused on the movement of Apple, and what its impact is on the indices.”

Without action from Congress in the next few weeks, tax cuts on capital gains and dividends will expire at the end of 2012.

The Dow Jones industrial average <.dji> gained 8.64 points, or 0.07 percent, to 13,043.13. The Standard & Poor’s 500 Index <.spx> added 2.66 points, or 0.19 percent, to 1,411.94. The Nasdaq Composite Index <.ixic> climbed 19.82 points, or 0.67 percent, to 2,993.52.</.ixic></.spx></.dji>

Apple Inc’s rank in China’s smartphone market fell to No.6 in the third quarter as it faces tougher competition from Chinese brands, research firm IDC said on Thursday. Apple‘s 6.4 percent drop on Wednesday was its worst daily performance since December 2008 and dragged the Nasdaq Composite Index down 0.8 percent for the day.

Sirius XM Radio shares rose 1.8 percent to $ 2.83 after its board approved a $ 2 billion stock repurchase and declared a special dividend, giving a big payout to its largest shareholder, Liberty Media .

Garmin shares rose 4.7 percent to $ 41.56 after Standard & Poor’s said it would add the navigation device maker to the S&P 500 index. Garmin will replace R.R. Donnelley & Sons after the close of trading on December 11.

(Reporting by Chuck Mikolajczak; Editing by Jan Paschal)

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PlayStation 3 was the world’s No.1 Netflix streaming device this year

There are dozens of devices that can stream Netflix (NFLX), but only one can machine be crowned the king of the living room. According to Netflix, that device is Sony’s (SNE) PlayStation 3 console. Without revealing any specific figures, Netflix announced on its blog “in the U.S. and globally, PS3 is the largest TV-connected platform in terms of Netflix viewing” and that “at times, PS3 even surpassed the PC in hours of Netflix enjoyment to become our No. 1 platform overall.” 

Netflix’s blog is quick to mention why the PS3 is the most popular streaming device this year, applauding it for being the first console to have 1080p HD video and 5.1-channel Dolby Digital Plus surround sound, post-play, second screen controls, subtitles and easy app updates.

While the Xbox 360 is gaining ground in terms of how many hours users spend watching videos on it, streaming video services such as Netflix requires an Xbox LIVE Gold subscription. One reason why the PlayStation 3 might be leading Netflix streaming is because it doesn’t require a subscription fee to have access to the Netflix app, or any other streaming video app such as Amazon (AMZN) Instant Video.

“The PlayStation and Netflix communities both share a strong passion for high quality entertainment,” Sony Computer Entertainment of America CEO and president Jack Tretton said. “Netflix provides a fantastic experience for watching TV shows and movies on PS3, and our joint development will continue to produce innovations for our customers that further demonstrate PS3 as the true home for entertainment in the living room.”

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“The Message” deemed greatest hip hop song ever

LOS ANGELES (Reuters) – The 1982 hit “The Message” by Grandmaster Flash and the Furious Five was named the greatest hip hop song of all time on Wednesday, in the first such list by Rolling Stone magazine to celebrate the young but influential music genre.

“The Message,” which tops a list of 50 influential hip hop songs, was the first track “to tell, with hip hop‘s rhythmic and vocal force, the truth about modern inner-city life in America,” Rolling Stone said.

Grandmaster Flash and the Furious Five, a hip hop collective from the south Bronx in New York, was formed in 1978 and became one of the pioneers of the hip hop genre.

The full list spanned songs ranging from Sugarhill Gang’s 1979 hit “Rapper’s Delight,” which came in at No. 2, to Kanye West‘s 2004 hit “Jesus Walks,” which landed at No. 32.

“It’s a list that would have been a lot harder to do ten or 15 years ago because hip hop is so young,” Nathan Brackett, deputy managing editor of Rolling Stone, told Reuters.

“We’ve reached the point now where hip hop acts are getting into the (Rock and Roll) Hall Of Fame… it just felt like the right time to give this the real Rolling Stone treatment.”

Rolling Stone‘s top 10 featured mostly hip hop veterans, such as Run-D.M.C.’s 1983 track “Sucker M.C.’s,” Dr. Dre and Snoop Dogg’s 1992 hit “Nuthin’ But A ‘G’ Thang,” Public Enemy’s 1990 song “Fight The Power” and Notorious B.I.G’s 1994 hit “Juicy.”

Other influential artists in the top 50 songs included Beastie Boys, who came in at No. 19 with “Paul Revere,” and recordings by Jay-Z, Eminem, Missy Elliot, Outkast, Lauryn Hill, LL Cool J, Nas and the late rapper 2Pac.

The list of 50 songs was compiled by a 33-panel of members comprising Rolling Stone editors and hip hop experts. They included musician Ahmir “Questlove” Thompson of The Roots, who Brackett described as “an incredible encyclopedia” of both old and new hip hop knowledge.

Brackett noted that some songs considered to be one-hit wonders, such as Audio Two’s 1988 hit “Top Billin’,” made the final selection.

“The references in those songs become the building blocks of all these other songs down the road … they become touchstones, really part of the meat of hip hop songs going forward,” Brackett said.

The full list will be released online at RollingStone.com and in the pop culture magazine on newsstands on December7. The issue will feature four different covers of Eminem, Jay-Z, Notorious B.I.G. and 2Pac.

(Reporting By Piya Sinha-Roy, editing by Jill Serjeant)

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Lundbeck anticipates new drug “feast”

LONDON (Reuters) – Danish group Lundbeck is looking forward to a “feast” of new drugs to refresh its product line-up, kicking off next week with a possible European Union green light for a novel medicine to treat alcohol abuse.

In all, there is scope for regulatory approval of three medicines in 2013 – an impressive tally for a small company focused on brain disorders – as well as a potential partnership deal for a drug to fight the symptoms of Alzheimer’s disease.

“Sometimes people say it is feast or famine for this industry and we are in a feast phase, especially considering our size,” chief executive Ulf Wiinberg told Reuters.

Lundbeck needs these new drugs to replace lost sales from antidepressant Cipralex, sold as Lexapro in the United States, which is now coming off patent.

Doubts about the company’s ability to make the transition from reliance on Cipralex has taken its toll on the stock in recent months, with the shares underperforming the European drugs sector by 23 percent this year.

There have even been suggestions the Lundbeck Foundation, which owns a 70 percent stake, might delist the drugmaker.

Wiinberg said this option had not be discussed. “If we were working on it I would say something, but I have nothing to say.”

While Wiinberg has already said earnings will stall until 2015 as a result of patent losses, he is increasingly confident the pieces are in place to lift sales in the medium term.

The next catalyst could come as early as December 13 or 14, when Lundbeck expects the European Medicines Agency to decide whether or not to recommend Selincro for alcohol dependence. A positive decision would lead to approval early next year.

The drug is breaking new ground in an uncertain market, and Wiinberg said it was “a bit of a joker in our portfolio”. Analysts currently pencil in only modest sales.

More important will be the verdict from regulators in North America and Europe later next year on a new antidepressant being developed with Japanese partner Takeda Pharmaceutical that analysts see as a potential $ 1-$ 2 billion-a-year seller.

Developing new treatments for depression has proved an uphill battle for drugmakers in recent times but vortioxetine has produced encouraging clinical trial results and its unique mode of action and flexible dosing could make it a winner.

The third approval prospect for next year is Abilify Maintena, a once-monthly version of schizophrenia drug Abilify that Lundbeck is working on with Otsuka.

Further out, Lundbeck is developing a drug for the symptoms of Alzheimer’s – a more modest ambition than that of disease-modifying treatments which have so far failed to gain much traction in tackling the underlying causes of the disorder.

That drug will be ready to go into final-stage clinical testing next year and Wiinberg said he would look to strike a partnership deal for the product, known as LuAE58054, at the same time as preparing for Phase III trials.

(Editing by Dan Lalor)

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