FDA approves new targeted breast cancer drug

WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.

The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.

Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.

"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."

Cobleigh helped conduct the key studies of the drug at the Chicago facility.

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.

The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.

Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.

Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.

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Investors face another Washington deadline

NEW YORK (Reuters) - Investors face another Washington-imposed deadline on government spending cuts next week, but it's not generating the same level of fear as two months ago when the "fiscal cliff" loomed large.

Investors in sectors most likely to be affected by the cuts, like defense, seem untroubled that the budget talks could send stocks tumbling.

Talks on the U.S. budget crisis began again this week leading up to the March 1 deadline for the so-called sequestration when $85 billion in automatic federal spending cuts are scheduled to take effect.

"It's at this point a political hot button in Washington but a very low level investor concern," said Fred Dickson, chief market strategist at D.A. Davidson & Co. in Lake Oswego, Oregon. The fight pits President Barack Obama and fellow Democrats against congressional Republicans.

Stocks rallied in early January after a compromise temporarily avoided the fiscal cliff, and the Standard & Poor's 500 index <.spx> has risen 6.3 percent since the start of the year.

But the benchmark index lost steam this week, posting its first week of losses since the start of the year. Minutes on Wednesday from the last Federal Reserve meeting, which suggested the central bank may slow or stop its stimulus policy sooner than expected, provided the catalyst.

National elections in Italy on Sunday and Monday could also add to investor concern. Most investors expect a government headed by Pier Luigi Bersani to win and continue with reforms to tackle Italy's debt problems. However, a resurgence by former leader Silvio Berlusconi has raised doubts.

"Europe has been in the last six months less of a topic for the stock market, but the problems haven't gone away. This may bring back investor attention to that," said Kim Forrest, senior equity research analyst at Fort Pitt Capital Group in Pittsburgh.

OPTIONS BULLS TARGET GAINS

The spending cuts, if they go ahead, could hit the defense industry particularly hard.

Yet in the options market, bulls were targeting gains in Lockheed Martin Corp , the Pentagon's biggest supplier.

Calls on the stock far outpaced puts, suggesting that many investors anticipate the stock to move higher. Overall options volume on the stock was 2.8 times the daily average with 17,000 calls and 3,360 puts traded, according to options analytics firm Trade Alert.

"The upside call buying in Lockheed solidifies the idea that option investors are not pricing in a lot of downside risk in most defense stocks from the likely impact of sequestration," said Jared Woodard, a founder of research and advisory firm condoroptions.com in Forest, Virginia.

The stock ended up 0.6 percent at $88.12 on Friday.

If lawmakers fail to reach an agreement on reducing the U.S. budget deficit in the next few days, a sequester would include significant cuts in defense spending. Companies such as General Dynamics Corp and Smith & Wesson Holding Corp could be affected.

General Dynamics Corp shares rose 1.2 percent to $67.32 and Smith & Wesson added 4.6 percent to $9.18 on Friday.

EYES ON GDP DATA, APPLE

The latest data on fourth-quarter U.S. gross domestic product is expected on Thursday, and some analysts predict an upward revision following trade data that showed America's deficit shrank in December to its narrowest in nearly three years.

U.S. GDP unexpectedly contracted in the fourth quarter, according to an earlier government estimate, but analysts said there was no reason for panic, given that consumer spending and business investment picked up.

Investors will be looking for any hints of changes in the Fed's policy of monetary easing when Fed Chairman Ben Bernake speaks before congressional committees on Tuesday and Wednesday.

Shares of Apple will be watched closely next week when the company's annual stockholders' meeting is held.

On Friday, a U.S. judge handed outspoken hedge fund manager David Einhorn a victory in his battle with the iPhone maker, blocking the company from moving forward with a shareholder vote on a controversial proposal to limit the company's ability to issue preferred stock.

(Additional reporting by Doris Frankel; Editing by Kenneth Barry)

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India Ink: What They Said: Could the Hyderabad Explosions Have Been Prevented?

As more information emerges about the most recent bombs in Hyderabad, many in India have begun to question the role of state and central government authorities, intelligence agencies and local police, asking whether they could have done more to prevent the attacks.

Less than two days before the two explosions in Hyderabad on Thursday evening, which killed at least 15 people and injured more than 100, the central government warned state officials of the possibility of a terror attack. In the days before the bombs exploded, CCTV cameras in the area had been disabled but were not repaired.

India Ink talked to intelligence experts Friday about the bombings and the difficulty of preventing terrorism attacks, even when there is some warning. Government officials also spoke publicly about the explosions.

J. N. Rai, former additional director of the Intelligence Bureau, India’s internal intelligence-gathering agency, in a telephone interview:

All alerts in intelligence are of a general nature. If you have specific information, you will arrest the guys and prevent the event.

Alerts that include a specific place, specific time or specific operation are next to impossible to provide. Even the guys who are planting the explosives may not know until the very last minute where they are going to plant them. Or someone is told to go park a cycle in one place, and they don’t know what’s on the cycle.

These alerts are so routine that you cannot act upon them. With more use of technology and online communication, it has become more difficult. The terrorist modules use code language. So it has become more difficult to detect.

At times we get information that some members of networks visited a particular town, so we send an alert to that town. But that is not of much use. At times we learn that a particular module is collecting explosives and arms and giving training, so we interpret that they are gearing up for a big operation.

One guy was arrested, and he said that he did a recce at Dilsukh Nagar in 2011. You cannot make much out of that.

Ajit Doval, former director of the Intelligence Bureau, in a telephone interview:

If you do not have any information, it is an intelligence failure. But if you have some information, and even then you cannot prevent the event, then it is the failure of the government.

All the intelligence inputs are of a generic nature. It is up to the government agencies to develop those generic inputs into actionable inputs. You need to do lots of followup on the ground. It can be done by hard work. However nebulous or generic the intelligence input is, it is to be followed by ground work by the state police.

S. A. Huda, director general of Andhra Pradesh state police, in a telephone interview:

It is too early and too premature. We’re getting back to the scene. We’ll not do ball and ball commentary.

The moment we give some information, the terrorists get an alert. It’s happened so many times before.

There have been no arrests as yet. It’s painstaking work. We don’t want to jump the gun.

Sushma Swaraj, leader of opposition in the Lok Sabha, or lower house of Parliament, during the Parliament session on Friday:

This is a very unfortunate, painful and shameful act. These events are not an opportunity for the blame game; they are an opportunity to fight terrorism together with determination. But that we can do only if we have a common thinking. I feel sorry that a common thinking to fight terrorism is not emerging in our country.

On many occasions we advocate for the human rights of terrorists and advocate to deal with them softly.

On many occasions, the central government gives an input to the state government and thinks that their job is over. In this case, this has happened. The home minister said that the input was shared with the state government.

If you have the input and even after that the incident takes place, then the failure is doubled. What was the central government doing, what was the state government doing? These are the questions which come up after every terrorist incident.

We all understand that terrorism is not to seen in religious terms or in any color. A terrorist is a terrorist. If the whole country starts fighting terrorism with this spirit, if the whole country gets together and political parties get together, we will be able to defeat terrorism.

Sushil Kumar Shinde, Home Affairs Minister, during the Parliament session on Friday:

I extend my heartfelt condolences for the bereaved families who lost their near and dear ones in the blasts. The Government is committed to combat such cowardly terror attack and it shall make all possible efforts to apprehend the perpetrators and masterminds behind the blasts and ensure that they are punished as per the law. (Read his full statement.)

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Josh Brolin & Diane Lane: Inside Their Up-and-Down Marriage

By Dahvi Shira

02/22/2013 at 07:30 AM EST

Diane Lane and Josh Brolin

Steve Granitz/Wireimage

Josh Brolin and Diane Lane's eight-year marriage is ending in divorce, but the road wasn't always rocky for the occasionally tumultuous pair.

"We're very similar in that celebrity is not a necessity," Brolin, 45, told PEOPLE in 2003, after meeting his soon-to-be-bride, 48, the previous year through stepmom Barbra Streisand. "Everything is easy."

The simplicity seemingly continued for Brolin and his beauty, who wed the following year in a ceremony at the actor's central California ranch.

Though there was a bit of a rocky start to their marriage, the pair got on track in 2005. As Lane told PEOPLE at the time, "I feel much better having a strong man with me who makes me feel embraced and secure. It's wonderful."

With her first marriage to actor Christopher Lambert behind her, Lane went on to say, "I wasn't going to go relationship shopping with my young daughter. I didn't want her to get attached to something that wasn't going to last."

In 2008, Lane praised Brolin, telling Redbook: "It's just invigorating to be around him. Josh completes me because I'm so attracted to his otherness."

On Thursday, reps confirmed the pair split, with a source telling PEOPLE, "They've been separated for several months. This was a hard decision for both of them to make. They were together for 11 years, the relationship just ran its course."

News of the breakup came almost two months after Brolin was held for public intoxication just before midnight on New Year's Eve 2013. Released without charge, the actor was spotted without his wedding ring the following day, donning sunglasses, in Venice, Calif., where he seemed unfazed by the trouble as he ate with a male friend at Sauce on Hampton.

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Flu shot doing poor job of protecting older people

ATLANTA (AP) — It turns out this year's flu shot is doing a startlingly dismal job of protecting older people, the most vulnerable age group.

The vaccine is proving only 9 percent effective in those 65 and older against the harsh strain of the flu that is predominant this season, the Centers for Disease Control and Prevention said Thursday.

Health officials are baffled as to why this is so. But the findings help explain why so many older people have been hospitalized with the flu this year.

Despite the findings, the CDC stood by its recommendation that everyone over 6 months get flu shots, the elderly included, because some protection is better than none, and because those who are vaccinated and still get sick may suffer less severe symptoms.

"Year in and year out, the vaccine is the best protection we have," said CDC flu expert Dr. Joseph Bresee.

Overall, across the age groups studied, the vaccine's effectiveness was found to be a moderate 56 percent, which means those who got a shot have a 56 percent lower chance of winding up at the doctor with the flu. That is somewhat worse than what has been seen in other years.

For those 65 and older, the vaccine was only 27 percent effective against the three strains it is designed to protect against, the worst level in about a decade. It did a particularly poor job against the tough strain that is causing more than three-quarters of the illnesses this year.

It is well known that flu vaccine tends to protect younger people better than older ones. Elderly people have weaker immune systems that don't respond as well to flu shots, and they are more vulnerable to the illness and its complications, including pneumonia.

But health officials said they don't know why this year's vaccine did so poorly in that age group.

One theory, as yet unproven, is that older people's immune systems were accustomed to strains from the last two years and had more trouble switching gears to handle this year's different, harsh strain.

The preliminary data for senior citizens is less than definitive. It is based on fewer than 300 people scattered among five states.

But it will no doubt surprise many people that the effectiveness is that low, said Michael Osterholm, a University of Minnesota infectious-disease expert who has tried to draw attention to the need for a more effective flu vaccine.

Among infectious diseases, flu is considered one of the nation's leading killers. On average, about 24,000 Americans die each flu season, according to the CDC.

This flu season started in early December, a month earlier than usual, and peaked by the end of year. Hospitalization rates for people 65 and older have been some of the highest in a decade, at 146 per 100,000 people.

Flu viruses tend to mutate more quickly than others, so a new vaccine is formulated each year to target the strains expected to be the major threats. CDC officials have said that in formulating this year's vaccine, scientists accurately anticipated the strains that are circulating this season.

Because of the guesswork involved, scientists tend to set a lower bar for flu vaccine. While childhood vaccines against diseases like measles are expected to be 90 or 95 percent effective, a flu vaccine that's 60 to 70 percent effective in the U.S. is considered pretty good. By that standard, this year's vaccine is OK.

For senior citizens, a flu vaccine is considered pretty good if it's in the 30 to 40 percent range, said Dr. Arnold Monto, a University of Michigan flu expert.

A high-dose version of the flu shot was recently made available for those 65 and older, but the new study was too small to show whether that has made a difference.

The CDC estimates are based on about 2,700 people who got sick in December and January. The researchers traced back to see who had gotten shots and who hadn't. An earlier, smaller study put the vaccine's overall effectiveness at 62 percent, but other factors that might have influenced that figure weren't taken into account.

The CDC's Bresee said there is a danger in providing preliminary results because it may result in people doubting — or skipping — flu shots. But the figures were released to warn older people who got shots that they may still get sick and shouldn't ignore any serious flu-like symptoms, he said.

___

Online:

CDC report: http://www.cdc.gov/mmwr

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Stock futures rise after HP earnings, German data

NEW YORK (Reuters) - Stock index futures rose on Friday, indicating the S&P 500 may halt a two-day losing skid, boosted by positive economic data from Europe and better-than-expected earnings from Hewlett-Packard.

The S&P 500 <.spx> has dropped 1.9 percent over the past two sessions, its worst two-day drop since early November, putting the index on pace for its first weekly decline of the year. The retreat was triggered by minutes from the Federal Reserve's January meeting released earlier in the week which suggested stimulus measures may end earlier than thought.

Still, the index is up more than 5 percent for the year and has held the 1,500 support level.

Hewlett-Packard Co climbed 4.7 percent to $17.90 in premarket trading after the No. 1 personal computer maker's quarterly revenue and forecasts beat Wall Street expectations as it continued to cut costs under CEO Meg Whitman's turnaround plan.

The German Ifo business climate indicator for February rose to 107.4, its best one-month rise in more than two years, boosting optimism after Thursday's disappointing PMI data stoked concerns over the euro zone economy.

S&P 500 futures rose 6.4 points and were above fair value, a formula that evaluates pricing by taking into account interest rates, dividends and time to expiration on the contract. Dow Jones industrial average futures gained 28 points, and Nasdaq 100 futures added 10.5 points.

Insurer American International Group Inc reported fourth-quarter results that beat analysts' expectations, although Chief Executive Robert Benmosche said some employee bonuses will be smaller this year because the company did not meet all of its performance targets. Shares advanced 3.8 percent to $38.68 in premarket trading.

Marvell Technology Group Ltd rose 4.5 percent to $9.90 in premarket trade after the chipmaker forecast results this quarter that were largely above analysts' expectations as it gained market share in the hard-disk drive and flash-storage businesses.

Fellow chipmaker Texas Instruments Inc raised its quarterly dividend by a third and said it would buy back an additional $5 billion in stock.

According to Thomson Reuters data through Thursday morning, of 427 companies in the S&P 500 that have reported results, 69.3 percent have exceeded analysts' expectations, compared with a 62 percent average since 1994 and 65 percent over the past four quarters.

Fourth-quarter earnings for S&P 500 companies are estimated to have risen 5.9 percent, according to the data, above a 1.9 percent forecast at the start of the earnings season.

European shares advanced after the better-than-expected German survey, with the pan-European FTSEurofirst 300 index <.fteu3> up 1.1 percent. <.eu/>

Asian shares recouped some of the previous session's steep falls as investors reassessed concerns that the Federal Reserve may end its ultra-soft monetary policy earlier than expected, but weak U.S. and European data capped Friday's recovery.

(Editing by Bernadette Baum)

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Car Bomb In Syrian Capital Kills At Least 31, Opposition Says

Sana/European Pressphoto Agency

An injured man was carried near the site of a car bomb explosion in Damascus on Thursday.

In renewed violence reaching the center of the Syrian capital, a car bomb exploded in Damascus on Thursday near the headquarters of President Bashar al-Assad’s ruling party, killing more than two dozen people, mainly civilians but also some security forces, according to opposition sources.

The violence coincided with renewed talks among Mr. Assad’s adversaries who met in Cairo on Thursday to discuss the terms on which the opposition Syrian National Coalition is prepared to talk about a negotiated settlement to the conflict.

Reuters quoted a draft communiqué under discussion by the group as saying it was prepared to negotiate, but Mr. Assad and his security force commanders were “not part of any political solution in Syria.”

The Syrian Observatory for Human Rights, an anti-Assad group based in Britain that has a network of contacts in Syria, reported that at least 31 people were killed by the bomb which exploded in the neighborhood of Mazraa.

Syrian state television said two children were wounded, while Al Ikhbariya, a pro-government television channel, showed footage of two dead bodies and body parts in a park.

The area where the bomb exploded was near the headquarters of Mr. Assad’s ruling Baath Party and the Russian Embassy. State television and the Syrian Observatory also said that mortar shells exploded near the Syrian Army General Command in the center of the capital, but there were no reported casualties.

The strikes were the latest to extend to the heart of the Syrian capital.

Reports this week appeared to show that rebel shells have reached new areas in Damascus.

State media and opposition activists reported on Wednesday that mortar rounds had hit the Tishreen sports stadium in the downtown neighborhood of Baramkeh. The state news agency, SANA, said the explosion killed an athlete from the Homs-based soccer team Al Wathba as he was practicing.

Government forces hit a rebel command center in a suburb east of the capital on Wednesday, injuring a founder of the Liwaa al-Islam brigade, Sheik Zahran Alloush, the brigade said in a statement.

On Tuesday, activists reported that up to seven mortar rounds had been fired by fighters of the Free Syrian Army toward Mr. Assad’s Tishreen Palace in Damascus.

There were no immediate reports of casualties, and it was not known whether Mr. Assad was there at the time. The palace, surrounded by a park, is in a wealthy area that has largely been insulated from the insurgency and it lies less than a mile from the main presidential palace.

Syrian rebels are entrenched in suburbs south and east of the capital, but they have been unable to push far into the center, although they strike the area with occasional mortars and increasingly frequent car bombs.

Such indiscriminate attacks, however, risk killing passers-by, exposing the rebels to charges that they are careless with civilian life and property. Many Damascus residents are undecided in the civil war and fear their ancient city will be ravaged like Aleppo and other urban centers to the north.

At the same time, the government has decimated pro-rebel suburbs with airstrikes and artillery, leaving vast areas depopulated or terrorized.

Fighting continued also for control of the main civilian airport in Aleppo on Wednesday.

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Lou Myers, A Different World Actor, Dies

By Tim Nudd

02/21/2013 at 08:25 AM EST

TV, film and stage actor Lou Myers, best known for playing Mr. Gaines on the sitcom A Different World in the '80s and early '90s, has died at 77.

Myers passed away at the Charleston Area Medical Center in his native state of West Virginia after battling pneumonia for several months, TMZ.com reported.

Myers was born in Chesapeake, W.V., the son of a Cabin Creek coal miner, according to the Charleston Gazette. After attending West Virginia State University, he got his first acting break as an understudy in the Broadway play The First Breeze of Summer.

He went on to appear in more than a dozen films, including How Stella Got Her Groove Back and The Wedding Planner.

On television, he had roles on ER, JAG and NYPD Blue, but is best remembered for playing Vernon Gaines on A Different World, which was a spin-off from The Cosby Show.

On Broadway, Myers appeared in productions including Oprah Winfrey's The Color Purple and Cat on a Hot Tin Roof. He won an NAACP Image Award for his portrayal of the Stool Pigeon in the play King Hedley II.

An accomplished piano player, Myers also sang jazz and blues with the touring company of Negro Music in Vogue.

He is survived by his mother, Dorothy Jeffries, 95, a son, Melvin Myers, and two grandsons, Brayden and Christian, the Gazette said.

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Adults get 11 percent of calories from fast food

ATLANTA (AP) — On an average day, U.S. adults get roughly 11 percent of their calories from fast food, a government study shows.

That's down slightly from the 13 percent reported the last time the government tried to pin down how much of the American diet is coming from fast food. Eating fast food too frequently has been seen as a driver of America's obesity problem.

For the research, about 11,000 adults were asked extensive questions about what they ate and drank over the previous 24 hours to come up with the results.

Among the findings:

— Young adults eat more fast food than their elders; 15 percent of calories for ages 20 to 39 and dropping to 6 percent for those 60 and older.

— Blacks get more of their calories from fast-food, 15 percent compared to 11 percent for whites and Hispanics.

— Young black adults got a whopping 21 percent from the likes of Wendy's, Taco Bell and KFC.

The figures are averages. Included in the calculations are some people who almost never eat fast food, as well as others who eat a lot of it.

The survey covers the years 2007 through 2010 and was released Thursday by the Centers for Disease Control and Prevention. The authors couldn't explain why the proportion of calories from fast food dropped from the 13 percent found in a survey for 2003 through 2006.

One nutrition professor cast doubts on the latest results, saying 11 percent seemed implausibly low. New York University's Marion Nestle said it wouldn't be surprising if some people under-reported their hamburgers, fries and milkshakes since eating too much fast food is increasingly seen as something of a no-no.

"If I were a fast-food company, I'd say 'See, we have nothing to do with obesity! Americans are getting 90 percent of their calories somewhere else!'" she said.

The study didn't include the total number of fast-food calories, just the percentage. Previous government research suggests that the average U.S. adult each day consumes about 270 calories of fast food — the equivalent of a small McDonald's hamburger and a few fries.

The new CDC study found that obese people get about 13 percent of daily calories from fast food, compared with less than 10 percent for skinny and normal-weight people.

There was no difference seen by household income, except for young adults. The poorest — those with an annual household income of less than $30,000 — got 17 percent of their calories from fast food, while the figure was under 14 percent for the most affluent 20- and 30-somethings with a household income of more than $50,000.

That's not surprising since there are disproportionately higher numbers of fast-food restaurants in low-income neighborhoods, Nestle said.

Fast food is accessible and "it's cheap," she said.

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Stock futures lower following jobless claims data

TORONTO, Feb 20 (Reuters) - Canada's Rebecca Marino, a rising star in women's tennis, stepped away from the sport in search of a normal life on Wednesday, weary of battling depression and cyber-bullies. Ranked number 38 in the world two years ago, the 22-year-old admitted she had long suffered from depression and was no longer willing to make the sacrifices necessary to reach the top. "After thinking long and hard, I do not have the passion or enjoyment to drive myself to the level I would like to be at in professional tennis," Marino explained in a conference call. ...

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