Dow soars 2% after deal to avoid 'cliff'










NEW YORK (Reuters) - Stocks kicked off the new year with their best day in over a year on Wednesday, sparked by relief over a last-minute deal in Washington to avert the "fiscal cliff" of tax hikes and spending cuts that threatened to derail the economy's growth.

In 2013's first trading session, the S&P 500 achieved its biggest one-day gain since December 20, 2011, pushing the benchmark index to its highest close since September 14.

Concerns over Washington's ability to sidestep the cliff had driven the S&P 500 down for five straight sessions, before signs that a resolution was near sent the benchmark index higher on the final trading session of 2012.

The CBOE Volatility Index or the VIX , Wall Street's favorite gauge of investor anxiety, dropped 18.5 percent to 14.68 at the close. The VIX has fallen 35.4 percent over the past two sessions, the biggest 2-day percentage drop in the history of the index.

The Dow Jones industrial average jumped 308.41 points, or 2.35 percent, to 13,412.55 at the close. The Standard & Poor's 500 Index gained 36.23 points, or 2.54 percent, to finish at 1,462.42. The Nasdaq Composite Index climbed 92.75 points, or 3.07 percent, to end at 3,112.26.

U.S. markets were closed on Tuesday for New Year's Day.

Market breadth reflected the strong rally, with 10 stocks rising for every one that fell on the New York Stock Exchange. All 10 of the S&P 500 industry sector indexes gained at least 1 percent. The S&P financial index shot up 2.9 percent.

The S&P Information Technology index gained 3.2 percent, including Hewlett-Packard , which climbed 5.4 percent to $15.02. HP's gain followed a miserable 2012 when the stock fell nearly 45 percent as one of the S&P 500's worst performers for 2012.

On Tuesday, Congress passed a bill to prevent huge tax hikes and delay spending cuts that would have pushed the world's largest economy off a "fiscal cliff" and possibly into recession.

The vote avoided steep income-tax increases for a majority of Americans, but failed to resolve a major showdown over cutting the budget deficit, leaving investors and businesses with only limited clarity about the outlook for the economy. Spending cuts of $109 billion in military and domestic programs were temporarily delayed, and another fight over raising the U.S. debt limit also looms.

"We got through the fiscal cliff. The next big thing, and probably more contentious thing, is negotiating the debt ceiling and possibly entitlement reform in early 2013," said Jim Russell, senior equity strategist for U.S. Bank Wealth Management in Cincinnati.

Hard choices about budget cuts and the critical need to raise the debt ceiling will confront Congress about the same time in two months "so the fur will be flying," Russell said.

U.S. stocks ended 2012 with the S&P 500 up 13.4 percent for the year, as investors largely shrugged off worries about the fiscal cliff. For the year, the Dow gained 7.3 percent and the Nasdaq jumped 15.9 percent.

Bank shares rose following news that U.S. regulators are close to securing another multibillion-dollar settlement with the largest banks to resolve allegations that they unlawfully cut corners when foreclosing on delinquent borrowers.

Bank of America Corp rose 3.7 percent to $12.03 and Citigroup Inc gained 4.3 percent to $41.25. The KBW bank index rose 3.2 percent.

Shares of Zipcar Inc surged 47.8 percent to $12.18 after Avis Budget Group Inc said it would buy Zipcar for about $500 million in cash to compete with larger rivals Hertz and Enterprise Holdings Inc. Avis advanced 4.8 percent to $20.77.

Shares of Apple rose 3.2 percent to $549.03, helping to lift the S&P information technology index up 3.2 percent following a report that the most valuable tech company has started testing a new iPhone and a new version of its iOS software.

Economic data from the Institute for Supply Management showed U.S. manufacturing ended 2012 on an upswing despite fears about the fiscal cliff, but the Commerce Department reported that construction spending fell in November for the first time in eight months.

Volume was heavy, with about 7.8 billion shares traded on the New York Stock Exchange, the NYSE MKT and the Nasdaq, well above the 2012 daily average of 6.42 billion.

(Reporting by Chuck Mikolajczak; Editing by Jan Paschal)

Read More..

House Republicans balk at fiscal cliff deal










WASHINGTON (Reuters) - A months-long battle over the U.S. "fiscal cliff" headed to a close on Tuesday as the House of Representatives moved toward final approval of a bipartisan deal meant to prevent Washington from pushing the world's biggest economy into recession.

The Republican-controlled House was expected to back a tax hike on the top U.S. earners shortly before midnight on Tuesday, ending weeks of high-stakes budget brinkmanship that threatened to spook consumers and throw financial markets into turmoil.






Approval of the bill would be a victory for President Barack Obama, who campaigned for re-election last November on a promise to raise taxes on the wealthiest but faced stiff opposition from congressional Republicans.

Republicans had earlier considered adding hundreds of billions of dollars in spending cuts after the bill had already passed the Senate with strong bipartisan support. That would have triggered further partisan warfare and pushed the crisis well past a self-imposed January 1 deadline.

But party leaders abandoned the effort after determining they lacked the votes.

"We've gone as far as we can go and I think people are ready to bring it to a conclusion," Republican Representative Jack Kingston of Georgia said. "We fought the fight."

Rules Committee Chairman David Dreier, a Republican, predicted the House would back the Senate bill, which also postpones for two months $109 billion in spending cuts on military and domestic programs set for 2013.

The bill easily cleared a procedural hurdle by a bipartisan vote of 408 to 10.

Lawmakers have struggled to find a way to head off across-the-board tax hikes and spending cuts that began to take effect at midnight, a legacy of earlier failed budget deals that is known as the fiscal cliff.

Strictly speaking, the United States went over the cliff in the first minutes of the New Year because Congress failed to produce legislation to halt $600 billion of tax hikes and spending cuts scheduled for this year.

TAX HIKES FOR WEALTHIEST

While many Republicans were uneasy with the tax hikes and wanted more spending cuts in the bill, they seemed to realize that the fiscal cliff would begin to damage the economy once financial markets and federal government offices returned to work on Wednesday. Opinion polls show the public would blame Republicans if a deal were to fall apart.

House Republicans had earlier considered adding $330 billion in spending cuts over 10 years to the Senate bill, which raises taxes on the wealthiest U.S. households by $620 billion over the same period.

But Senate Democrats refused to consider any changes to their bill, which passed 89 to 8 in a rare display of unity early Tuesday.

That measure, which passed the Senate at around 2 a.m., would raise income taxes on families earning more than $450,000 per year and limit the amount of deductions they can take to lower their tax bill.

Low temporary rates that have been in place for the past decade would be made permanent for less-affluent taxpayers, along with a range of targeted tax breaks put in place to fight the 2009 economic downturn.

However, workers would see up to $2,000 more taken out of their paychecks annually with the expiration of a temporary payroll tax cut.

The non-partisan Congressional Budget Office said the Senate bill would increase budget deficits by nearly $4 trillion over the coming 10 years, compared to the budget savings that would occur if the extreme measures of the cliff were to kick in.

But the bill would actually save $650 billion during that time period when measured against the tax and spending policies that were in effect on Monday, according to the Committee for a Responsible Federal Budget, an independent group that has pushed for more aggressive deficit savings.

(Additional reporting by Rachelle Younglai, Thomas Ferraro and David Lawder; Writing by Andy Sullivan; Editing by Alistair Bell and Eric Beech)

Read More..

Playboy Hugh Hefner marries his ‘runaway bride’






LOS ANGELES (AP) — Hugh Hefner is celebrating the new year as a married man once again.


The 86-year-old Playboy magazine founder exchanged vows with his “runaway bride,” Crystal Harris, at a private Playboy Mansion ceremony on New Year’s Eve. Harris, a 26-year-old “Playmate of the Month” in 2009, broke off a previous engagement to Hefner just before they were to be married in 2011.






Playboy said on Tuesday that the couple celebrated at a New Year’s Eve party at the mansion with guests that included comic Jon Lovitz, Gene Simmons of KISS and baseball star Evan Longoria.


The bride wore a strapless gown in soft pink, Hefner a black tux. Hefner’s been married twice before but lived the single life between 1959 and 1989.


Entertainment News Headlines – Yahoo! News





Title Post: Playboy Hugh Hefner marries his ‘runaway bride’
Rating:
100%

based on 99998 ratings.
5 user reviews.
Author: Fluser SeoLink
Thanks for visiting the blog, If any criticism and suggestions please leave a comment




Read More..

Ground Zero Volunteers Face Obstacles to Compensation





On the day the terrorists flew into the World Trade Center, the Wu-Tang Clan canceled its meeting with a record mixer named Richard Oliver, so Mr. Oliver rushed downtown from his Hell’s Kitchen apartment to help out.




He said he spent three sleepless days at ground zero, tossing body bags. “Then I went home, ate, crashed, woke up,” he said. He had left his Dr. Martens boots on the landing outside his apartment, where he said they “had rotted away.”


“That was kind of frightening,” he continued. “I was breathing that stuff.”


After the Sept. 11 attacks, nothing symbolized the city’s rallying around like many New Yorkers who helped at ground zero for days, weeks, months, without being asked. Now Mr. Oliver, suffering from back pain and a chronic sinus infection, is among scores of volunteers who have begun filing claims for compensation from a $2.8 billion fund that Congress created in 2010.


But proving they were there and eligible for the money is turning out to be its own forbidding task.


The other large classes of people who qualify — firefighters, police officers, contractors, city workers, residents and students — have it relatively simple, since they are more likely to have official work orders, attendance records and leases to back them up. But more than a decade later, many volunteers have only the sketchiest proof that they are eligible for the fund, which is expected to make its first awards early this year. (A separate $1.5 billion treatment fund also was created.)


They are volunteers like Terry Graves, now ill with lung cancer, who kept a few business cards of people she worked with until 2007, then threw them away. Or Jaime Hazan, a former Web designer with gastric reflux, chronically inflamed sinuses and asthma, who managed to dig up a photograph of himself at ground zero — taken from behind.


Or Mr. Oliver, who has a terse two-sentence thank-you note on American Red Cross letterhead, dated 2004, which does not meet the requirement that it be witnessed or sworn.


“For some people, there’s great records,” said Noah H. Kushlefsky, whose law firm, Kreindler & Kreindler, is representing volunteers and others who expect to make claims. “But in some respects, it was a little bit of a free-for-all. Other people went down there and joined the bucket brigade, talked their way in. It’s going to be harder for those people, and we do have clients like that.”


As documentation, the fund requires volunteers to have orders, instructions or confirmation of tasks they performed, or medical records created during the time they were in what is being called the exposure zone, including the area south of Canal Street, and areas where debris was being taken.


Failing that, it will be enough to submit two sworn statements — meaning the writer swears to its truth, under penalty of perjury — from witnesses describing when the volunteers were there and what they were doing.


Proving presence at the site might actually be harder than proving the illness is related to Sept. 11, since the rules now allow a host of ailments to be covered, including 50 kinds of cancer, despite an absence of evidence linking cancer to ground zero.


A study by the New York City health department, just published in the Journal of the American Medical Association, found no clear association between cancer and Sept. 11, though the researchers noted that some cancers take many years to develop.


Unlike the original compensation fund, administered by Kenneth Feinberg, which dealt mainly with people who were killed or maimed in the attack, “This one is dealing with injuries that are very common,” said Sheila L. Birnbaum, a former mediator and personal injury defense lawyer, who is in charge of the new fund. “So it’s sort of a very hard process from the fund’s point of view to make the right call, and it requires some evidence that people were actually there.”


Asked how closely the fund would scrutinize documents like sworn statements, Ms. Birnbaum said she understood how hard it was to recreate records after a decade, and was going on the basic assumption that people would be honest.


In his career as a record mixer, Mr. Oliver, 56, has been associated with 7 platinum and 11 gold records, and 2 Grammy credits, which now line the walls of his condominium in College Point, Queens. He said he first got wind of the Sept. 11 attacks from a client, the Wu-Tang Clan. “One of the main guys called me: ‘Did you see what’s on TV? Because our meeting ain’t going to happen,’ ” he recalled.


Having taken a hazmat course after high school, he called the Red Cross and was told they needed people like him. “I left my soon-to-be-ex-wife and 1-year-old son and went down,” he said. “I came back three days later,” after surviving on his own adrenaline, Little Debbie cakes handed out to volunteers and bottled water. After working for three days setting up a morgue, he was willing to go back, he said, but “they said we have trained people now, thank you very much for your service.”


Read More..

Tough decisions await new Tribune Co. board









When the new seven-member Tribune Co. board officially convenes for the first time in the next few weeks, the group of media and entertainment executives will name the company's executive officers. Then comes the bigger job of assessing a diverse portfolio of broadcasting and publishing assets, with an eye toward maximizing the value of the Chicago-based media company.


Whether that means buying, selling or keeping the company intact is a story that will begin to unfold in 2013. But insiders say the new owners — senior creditors Oaktree Capital Management; Angelo, Gordon & Co.; and JPMorgan Chase & Co. — won't be in a rush to make those decisions after a contentious four-year journey through Chapter 11 bankruptcy left the reorganized company in strong financial shape.


"We're really looking forward to the opportunities and the possibilities with this asset base, with over $11 billion in debt removed from the balance sheet," said Ken Liang, a managing director at Oaktree and a member of the new board.








Tribune Co. plunged into bankruptcy in December 2008, saddled with $13 billion in debt from real estate investor Sam Zell's heavily leveraged buyout one year earlier. It emerged from bankruptcy Monday, relatively debt-free and generating cash.


The company owns 23 television stations, including WGN-Ch. 9; national cable channel WGN America; eight daily newspapers, including the Chicago Tribune; and other media assets, all of which the reorganization plan valued at $4.5 billion after cash distributions and new financing.


Tribune Co.'s biggest challenge has been declining revenue and cash flow as the advertisers that sustained it through the years defected to digital media alternatives. But 2012 was a slight improvement, likely boosted in part by election year ad spending in the company's broadcasting unit.


Data released Monday by the company showed that after several years of revenue declines, including a 3 percent drop to $3.1 billion in 2011, sales for the first three quarters of 2012 were flat at $2.3 billion compared with the same period a year earlier. Cash flow was even better: After dropping 12 percent in 2011 to about $370 million, cash flow increased 17 percent during the first three quarters of 2012, to $240 million.


Los Angeles-based investment firm Oaktree is the largest equity owner, with 23 percent of the company. All of Oaktree's distressed-debt holdings have a 10-year investment window, though the average is three or four years, executives said. That time frame usually includes an operating phase, which is where Tribune Co. now stands.


Some experts expect that phase to be relatively brief.


"I think they are temporary owners," said Marshall Sonenshine, chairman of New York banking firm Sonenshine Partners and a professor at Columbia University Business School. "They're not really there to be long-term shareholders of media assets."


While eventually selling the assets is part of Oaktree's distressed-debt investment strategy, it doesn't preclude a longer run, including strengthening the company through strategic acquisitions, Liang said. And with Tribune Co.'s balance sheet cleaned up, the timing of any asset sales will be at their discretion.


The new board also includes Tribune Co. CEO Eddy Hartenstein; Ross Levinsohn, who recently left as interim chief executive of Yahoo Inc.; Craig Jacobson, an entertainment lawyer; Peter Murphy, a former strategy executive at Walt Disney Co. and Caesars Entertainment; Bruce Karsh, Oaktree's president; and Peter Liguori, a former top television executive at Fox and Discovery, who is expected to be named CEO of Tribune Co.


The makeup of the board and the expected choice of Liguori as CEO suggests that broadcasting will be the operational focus for Tribune Co., according to insiders and media analysts. Priorities are expected to include developing WGN America, which lags cable networks such as FX and TBS in revenue, ratings and cash flow, analysts said.


"It's clear that, in a sense, we have a new Tribune media company, and it's going in a direction that many people thought it would be going," said media analyst Ken Doctor. "It makes the company entertainment leaning versus news leaning."


Meanwhile, in the face of digital competition and sagging industry revenue, Tribune Co.'s newspaper holdings have declined to $623 million in total value, according to financial adviser Lazard. While some analysts expect the newspapers to be bundled and delivered to an assortment of potential new owners — everyone from Rupert Murdoch to Warren Buffett has expressed interest in acquiring one or more of the nameplates — they are still profitable and may remain in the Tribune Co. fold for some time, according to insiders.


Tribune reporters Michael Oneal and Becky Yerak contributed.


rchannick@tribune.com


Twitter @RobertChannick





Read More..

AP: Democratic sources say 'fiscal cliff' deal reached









Racing against the clock, the White House reached agreement with congressional Republicans late Monday on a deal to prevent across-the-board tax increases and spending cuts to government programs from taking effect at midnight, according to administration and Senate Democratic officials.


These officials said a New Year's Eve vote in the Senate to ratify the deal was possible later in the evening, barring opposition from majority Democrats.


There was no immediate confirmation from aides to the top Republicans in Congress, Sen. Mitch McConnell and House Speaker John Boehner.











Vice President Joseph Biden headed for the Capitol to brief the Democratic rank and file.


The officials who described the developments did so on condition of anonymity, saying they were not authorized to discuss the details.


Hours earlier, President Barack Obama said, "It appears that an agreement to prevent this New Year's tax hike is within sight. ... But it's not done," he added of legislation that redeems his campaign pledge to raise taxes on the wealthy while sparing the middle class.


Even by the dysfunctional standards of government-by-gridlock, the activity at both ends of historic Pennsylvania Avenue was remarkable as the White House and Congress struggled over legislation to prevent a "fiscal cliff" of tax increases and spending cuts.


As darkness fell on the last day of the year, Obama, Biden and their aides were at work in the White House, and lights burned in the House and Senate. Democrats complained that Obama had given away too much in agreeing to limit tax increases to incomes over $450,000, far above the $250,000 level he campaigned on. Yet some Republicans recoiled at the prospect of raising taxes at all.


A late dispute over the estate tax produced allegations of bad faith from all sides.


Senate Republican leader Mitch McConnell — shepherding final talks with Biden — agreed with Obama that an overall deal was near. In remarks on the Senate floor, he suggested Congress move quickly to pass tax legislation and "continue to work on finding smarter ways to cut spending" next year.


The White House and Democrats initially declined the offer, preferring to prevent the cuts from kicking in at the Pentagon and domestic agencies alike. Officials said they might yet reconsider, although there was also talk of a short-term delay in the reductions.


While the deadline to prevent tax increases and spending cuts was technically midnight, passage of legislation by the time a new Congress takes office at noon on Jan. 3, 2013 — the likely timetable — would eliminate or minimize any inconvenience for taxpayers.


For now, more than the embarrassment of a gridlocked Congress working through New Year's Eve in the Capitol was at stake.


Economists in and out of government have warned that a combination of tax hikes and spending cuts could trigger a new recession, and the White House and Congress have spent the seven weeks since the Nov. 6 elections struggling for a compromise to protect the economy.


Even now, with time running out, partisan agendas were evident.


Obama used his appearance to chastise Congress, and to lay down a marker for the next round of negotiations early in 2013 when Republicans intend to seek spending cuts in exchange for letting the Treasury to borrow above the current debt limit of $16.4 trillion.


"Now, if Republicans think that I will finish the job of deficit reduction through spending cuts alone — and you hear that sometimes coming from them ... then they've got another think coming. ... That's not how it's going to work at least as long as I'm president," he said.


"And I'm going to be president for the next four years, I think," he added.


Officials in both parties said agreement had been reached to prevent tax increases on most Americans, while letting rates rise on individual income over $400,000 and household earnings over $450,000 to a maximum of 39.6 percent from the current 35 percent. That marked a victory for Obama, who campaigned successfully for re-election on a platform of requiring the wealthy to pay more.


Officials said any agreement would also raise taxes on the value of estates exceeding $5 million to 40 percent, but a late dispute emerged on that point as well as on spending cuts. Democrats accused Republicans of making a 11th-hour demand to have the $5 million threshold rise each year to take inflation into account. GOP officials said the White House had agreed to the proposal on Sunday night, a claim administration officials disputed.





Read More..

Zynga carries out planned games shutdown, including “Petville”






SAN FRANCISCO (Reuters) – Social games publisher Zynga Inc confirmed on Monday that it has carried out 11 of the planned shutdowns of 13 game titles, with “Petville” being the latest game on which it pulled the plug.


Zynga in October said it would shut down 13 underperforming titles after warning that its revenues were slowing as gamers fled from its once-popular titles published on the Facebook platform in large numbers and sharply revised its full-year outlook.






The San Francisco-based company announced the “Petville” shutdown two weeks ago on its Facebook page. All the 11 shutdowns occurred in December.


The 11 titles shut down or closed to new players include role-playing game “Mafia Wars 2,” “Vampire Wars,” “ForestVille” and “FishVille.”


“In place of ‘PetVille,’ we encourage you to play other Zynga games like ‘Castleville,’ ‘Chefville,’ ‘Farmville 2,’ ‘Mafia Wars’ and ‘Yoville,’” the company told players on its ‘PetVille’ Facebook page. “PetVille” players were offered a one-time, complimentary bonus package for virtual goods in those games.


“Petville,” which lets users adopt virtual pets, has 7.5 million likes on Facebook but only 60,000 daily active users, according to AppData. About 1,260 users commented on the game’s Facebook page, some lamenting the game’s shutdown.


Zynga has said it is shifting focus to capture growth in mobile games. It also applied this month for a preliminary application to run real-money gambling games in Nevada.


Zynga is hoping that a lucrative real-money market could make up for declining revenue from games like “FarmVille” and other fading titles that still generate the bulk of its sales.


Zynga shares were up 1 percent at $ 2.36 in afternoon trade on Monday on the Nasdaq.


(Reporting By Malathi Nayak; Editing by Leslie Adler)


Gaming News Headlines – Yahoo! News





Title Post: Zynga carries out planned games shutdown, including “Petville”
Rating:
100%

based on 99998 ratings.
5 user reviews.
Author: Fluser SeoLink
Thanks for visiting the blog, If any criticism and suggestions please leave a comment




Read More..

Is Tom Cruise still a go-to action hero? Hollywood, “Jack Reacher” say yes






LOS ANGELES (TheWrap.com) – Given his age and the tough year he’s had in the tabloids, is Tom Cruise still a go-to guy when Hollywood is looking for an action hero?


The answer is yes, based on the performance of his current movie, Paramount‘s “Jack Reacher.” It’s taken in $ 45 million in the 10 days since opening with $ 15.6 million in a very crowded and competitive holiday market. Its second week was a solid $ 14 million, and it’s added $ 22 million from overseas.






Holiday movies tend to have legs and “Reacher” has yet to roll out in the majority of major foreign territories, so both of those numbers, particularly the international, will be growing. All signs point to it surpassing $ 200 million at the worldwide box office. That’s not a blockbuster figure, and Paramount is staying mum on a sequel, but with a $ 60 million budget, “Jack Reacher” will make money for Paramount.


There were questions coming in. With his divorce from Katie Holmes and subsequent custody battle, Cruise is carrying plenty of public relations baggage. His foray earlier this year into musicals with “Rock of Ages” was critically applauded but proved a box-office dud. That’s on top of his well-known support for Scientology.


He’s 50 now, which might be the new 40 in the real world, but is starting to get on in years in the realm of action heroes. Daniel Craig is 44. Jeremy Renner is 41. We are a long way from “Top Gun” – that was 1986 – so it probably won’t be too, too long until “The Expendables” franchise comes calling for Cruise.


But in the meantime, “Reacher” is going to be profitable for Paramount and Cruise’s portrayal of the tough, ex-military drifter has drawn critical kudos, so there’s a bit of momentum now. And it’s clear from his upcoming schedule that Hollywood is still convinced he can carry an action film.


Next for Cruise will be two sci-fi movies: Universal’s “Oblivion” is due in April and “All You Need is Kill” is set for March 2014 from Warner Bros. After that, there’s a potential “Van Helsing” remake at Universal and “Mission: Impossible 5″ is on Paramount‘s 2015 slate.


His recent track record at the box office, particularly when you look at his performance in the action genre, suggests the studios are making a pretty good bet.


“Rock of Ages” may have crumpled, but “Mission: Impossible – Ghost Protocol” was a huge hit for Paramount, taking in nearly $ 700 million worldwide in 2011. “Knight & Day,” from Fox in 2010, and “Valkyrie,” from United Artists in 2008, both made over $ 200 million worldwide.


Supporting roles in “Tropic Thunder” and “Lions for Lambs” preceded those, but those came on the heels of two Paramount movies: “Mission Impossible 3,” which made nearly $ 400 million worldwide in 2006, and “War of the Worlds,” which did $ 592 million in the previous year.


The bottom line: Hollywood is still convinced you can still take Tom Cruise, movie action hero, to the bank.


Movies News Headlines – Yahoo! News





Title Post: Is Tom Cruise still a go-to action hero? Hollywood, “Jack Reacher” say yes
Rating:
100%

based on 99998 ratings.
5 user reviews.
Author: Fluser SeoLink
Thanks for visiting the blog, If any criticism and suggestions please leave a comment




Read More..

F.D.A. Approves Sirturo, a New Tuberculosis Drug





The Food and Drug Administration announced on Monday that it had approved a new treatment for multidrug-resistant tuberculosis that can be used as an alternative when other drugs fail.




The drug, to be called Sirturo, was discovered by scientists at Janssen, the pharmaceuticals unit of Johnson & Johnson, and is the first in a new class of drugs that aims to treat the drug-resistant strain of the disease.


Tuberculosis is a highly infectious disease that is transmitted through the air and usually affects the lungs but can also affect other parts of the body, including the brain and kidneys. It is considered one of the world’s most serious public health threats. Although rare in the United States, multidrug-resistant tuberculosis is a growing problem elsewhere in the world, especially in poorer countries. About 12 million people worldwide had tuberculosis in 2011, according to Johnson & Johnson, and about 630,000 had multidrug-resistant TB.


A study in September in The Lancet found that almost 44 percent of patients with tuberculosis in countries like Russia, Peru and Thailand showed resistance to at least one second-line drug, or a medicine used after another drug had already failed.


Treating drug-resistant tuberculosis can take years and can cost 200 times as much as treating the ordinary form of the disease


“This is quite a milestone in the story of therapy for TB,” Dr. Paul Stoffels, the chief scientific officer at Johnson & Johnson, said in an interview. He said the approval was the first time in 40 years that the agency had approved a drug that attacked tuberculosis in a different way from the current treatments on the market. Sirturo works by inhibiting an enzyme needed by the tuberculosis bacteria to replicate and spread throughout the body.


Sirturo, also known as bedaquiline, would be used on top of the standard treatment, which is a combination of several drugs. Patients with drug-resistant tuberculosis often must be treated for 18 to 24 months.


Even as it announced the approval, however, the F.D.A. also issued some words of caution.


“Multidrug-resistant tuberculosis poses a serious health threat throughout the world, and Sirturo provides much-needed treatment for patients who have don’t have other therapeutic options available,” Edward Cox, director of the office of antimicrobial products in the F.D.A.’s center for drug evaluation and research, said in a statement. “However, because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don’t have other treatment options.”


The consumer advocacy group Public Citizen opposed approval in a letter to the F.D.A. in mid-December, saying that the results of a limited clinical trial showed that patients using bedaquiline were five times as likely to die than those on the standard drug regimen to treat the disease.


“Given that bedaquiline belongs to an entirely new class of drugs, it is entirely feasible that death in some cases was due to some unmeasured toxicity of the drug,” the letter said.


Sirturo carries a so-called black box warning for patients and health care professionals that the drug can affect the heart’s electrical activity, which could lead to an abnormal and potentially fatal heart rhythm. The warning also notes deaths in patients treated with Sirturo. Nine patients who received Sirturo died compared with two patients who received a placebo. Five of the deaths in the Sirturo group and all of the deaths in the placebo arm seemed to be related to tuberculosis, but no consistent reason for the deaths in the remaining Sirturo-treated patients could be identified.


Doctors Without Borders and the Bill and Melinda Gates Foundation, both active in the fight against tuberculosis and other global diseases, applauded the F.D.A.’s decision.


Jan Gheuens, interim director of the TB Program for the Gates Foundation, called it a “long-awaited event” and said the fight against TB had not benefited from new drugs in the way H.I.V. had. Beyond the benefits of the drug itself, he said the quick approval process could be a model for other drugs sorely needed in the developing world.


He also suggested, however, that more trials should be conducted to get a better understanding of the side effects that led to the black box warning.


The F.D.A. approved bedaquiline under an accelerated program that allows the agency to conditionally approve drugs that are viewed as filling unmet medical needs with less than the usual evidence that they work. The drug’s approval was based on studies that showed it killed bacteria more quickly than a control group taking the standard regimen, but it did not measure whether in the end patients actually fared better on bedaquiline. Johnson & Johnson will conduct larger clinical trials to investigate whether the drug performs as predicted.


In a statement responding to Public Citizen’s letter, a spokeswoman for Johnson & Johnson said the company was committed to supporting appropriate use of Sirturo and would “work to ensure Sirturo is used only where treatment alternatives are not available.”


Dr. Stoffels said the hope was that other new tuberculosis drugs would also be approved that, when used in combination with bedaquiline, could shorten and simplify the current standard of treatment. “That is still a long time away,” he acknowledged, but “this is a first step in a new regimen for TB.”


Read More..

Tribune Co. emerges from bankruptcy









The last day of 2012 is the first of a new era for Tribune Co.

After spending more than four years embroiled in a contentious Chapter 11 bankruptcy case, the reorganized Chicago-based media company emerged Monday under new owners and a newly appointed board, freed from its massive debt and facing an uncertain future.

Senior creditors Oaktree Capital Management, Angelo, Gordon & Co. and JPMorgan Chase & Co. are set to take control of Tribune Co.’s storied portfolio of publishing and broadcasting assets, including the Chicago Tribune, officials said.

It was an almost anticlimactic end to a long and painful chapter in Tribune Co.'s 165-year history. Late Sunday, the new Tribune Co. named its board of directors, filed notification with the Delaware bankruptcy court where the bulk of legal wrangling took place and declared its existence.

"It took a long time to get here," said Ken Liang, a managing director at Oaktree and a new member of the board. "It was a tough restructuring. We're pretty excited about the exit."

The new board also will include Tribune Co. CEO Eddy Hartenstein; Ross Levinsohn, who recently left as interim chief executive of Yahoo Inc.; Craig Jacobson, a well-known entertainment lawyer; Peter Murphy, a former strategy executive at Walt Disney Co. and Ceasars Entertainment; Bruce Karsh, Oaktree president; and Peter Liguori, a former top television executive at Fox and Discovery.

Liguori is expected to be named chief executive of Tribune Co. going forward.

Hartenstein, who is publisher of the Los Angeles Times, has been CEO of Tribune Co. since May 2011. He will remain in the role until the board convenes its first meeting in the next several weeks, where it will name the company’s executive officers, according to a company statement.

“Tribune will emerge from the bankruptcy process as a multi-media company with a great mix of profitable assets, strong brands in major markets and a much-improved capital structure,” Hartenstein said in the statement.

Tribune Co. owns 23 television stations, including WGN-Ch. 9, WGN America, eight daily newspapers and other media assets, all of which the reorganization plan valued at $4.5 billion after cash distributions and new financing. Eventually, all the assets are expected to be sold, according to the new owners.

They take the reins of a company that saw its worth essentially cut in half since 2007, when Chicago billionaire Sam Zell took it private in an $8.2 billion leveraged buyout. The rapid decline was mostly due to falling newspaper valuations in the face of digital competition. The anticipated hiring of Liguori suggests that broadcasting will be the operational focus going forward, according to several media analysts.

Los Angeles-based Oaktree, the largest shareholder, with about 23 percent of the equity, appointed two of seven board members. Both Angelo Gordon and JPMorgan have roughly a 9 percent stake and appointed one seat each. The three jointly appointed two more board members, with the final seat occupied by the chief executive.

Among the outgoing board members is Zell, whose deal was seen at the time as an alternative to the squabbles within Tribune Co. that threatened to break apart the then-publicly traded company. But the Great Recession and plummeting advertising revenues across all media, especially the struggling newspaper industry, made the company’s resulting $13 billion debt load untenable.

Tribune Co. filed for Chapter 11 bankruptcy protection in December 2008. Zell blamed a “perfect storm” of industry and economic forces. But the bankruptcy case turned on charges leveled by junior creditors that saddling the company with such a debt burden left it insolvent from the outset.

Led by an aggressive distressed debt fund called Aurelius Capital Management, the junior creditors pressed litigation that stretched out the case for three and a half years in a Delaware court before U.S. Bankruptcy Judge Kevin Carey confirmed the reorganization plan in July. An emergency appeal to stay that decision was dismissed by the 3rd U.S. Circuit Court of Appeals in September. In November, the Federal Communications Commission signed off on waivers needed to transfer Tribune Co.’s broadcast properties to the new ownership, clearing the last hurdle to its emergence from Chapter 11.

“Usually, bankruptcy cases like this take much less time and cost less money,” said Douglas Baird, a bankruptcy expert and law professor at the University of Chicago.

Baird said legal fees for most large corporate bankruptcies run 3 to 4 percent of the company’s total worth. The Tribune Co. case, which will likely cost the company more than $500 million in legal and other professional fees, was more than twice that percentage, due to both the extended litigation and the company’s declining valuation.

Before cash distributions and new financing, a 2012 analysis by financial adviser Lazard valued the broadcasting assets, including the TV stations, WGN-AM 720, CLTV and national cable channel WGN America, at $2.85 billion. Other strategic assets, such as online job site CareerBuilder and cable channel Food Network, are worth $2.26 billion.

Tribune Co.’s newspaper holdings, including the Tribune, Los Angeles Times and six other daily publications, have withered to $623 million in total value, according to Lazard. In 2006, entertainment mogul David Geffen made a $2 billion cash offer for the Los Angeles Times.

Read More..