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 (kad-SY'-luh) 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 double-shot of anti-tumor poison.

Cancer researchers say the drug may offer a clear advantage over older drugs because it delivers more medication with fewer side effects.

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.

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.

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 co-developed by South San Francisco-based Genentech and ImmunoGen Inc., of Waltham, Mass. ImmunoGen developed the technology that binds the drug ingredients 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 33 cents, or 2.27 percent, to $14.63 in midday trading.

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HP lifts Wall Street, S&P on pace for first weekly loss of year

NEW YORK (Reuters) - Stocks rose on Friday, rebounding off two days of losses as Dow component Hewlett-Packard surged on strong results, but the S&P 500 was on track to end a seven-week-long streak of gains.

The S&P shed 1.9 percent over the previous 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 when the Federal Reserve's meeting minutes for January suggested stimulus measures may be halted sooner than thought.

Still, the index is up nearly 6 percent for the year and held the 1,500 support level despite the recent declines, a sign of a positive bias in the market.

"The market is addicted to Fed stimulus and gets withdrawal shakes every time that's threatened, but now we're resuming our course and remain much more attractively valued than other asset classes," said Rex Macey, chief investment officer at Wilmington Trust in Atlanta, Georgia.

Hewlett-Packard Co jumped 9.6 percent to $18.74 as the top boost on both the Dow and S&P 500 after the PC maker's quarterly revenue and forecasts beat expectations. The company cut costs under Chief Executive Meg Whitman's turnaround plan. The S&P technology sector <.splrct> was up 0.8 percent.

The Dow Jones industrial average <.dji> was up 69.41 points, or 0.50 percent, at 13,950.03. The Standard & Poor's 500 Index <.spx> was up 7.74 points, or 0.52 percent, at 1,510.16. The Nasdaq Composite Index <.ixic> was up 18.26 points, or 0.58 percent, at 3,149.75.

For the week, the Dow is off 0.2 percent in its third straight week of slight losses, the S&P is off 0.6 percent and the Nasdaq is off 1.3 percent.

Also buoying tech stocks were gains in semiconductor companies after Marvell Technology Group Ltd forecast results this quarter that were largely above analysts' expectations. Marvell gained market share in the hard-disk drive and flash-storage businesses. The stock rose 2.5 percent to $9.71.

In addition, Texas Instruments Inc raised its dividend by a third and boosted its stock buyback program, lifting shares 5.1 percent to $34.16 while the PHLX semiconductor index <.sox> gained 1.8 percent.

"Dividends growing are another way the market's level is justified, if not especially attractive at these levels," said Macey, who manages about $20 billion in assets.

On the downside, Abercrombie & Fitch dropped 7.6 percent to $45.34 after the clothing retailer reported a drop in fourth-quarter comparable sales, even as its latest quarterly earnings topped estimates.

Insurer American International Group Inc posted fourth-quarter results that beat analysts' expectations. Shares advanced 3 percent to $38.43.

According to Thomson Reuters data through Friday morning, of 439 companies in the S&P 500 that have reported results, 70 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 6 percent, according to the data, above a 1.9 percent forecast at the start of the earnings season.

(Editing by Kenneth Barry)

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HTC settles FTC charges that it fails to secure software

WASHINGTON (Reuters) – HTC America, a maker of cell phones that use Android and Windows software, has agreed to settle Federal Trade Commission charges that it failed to take adequate steps to eliminate security flaws that put smartphone and tablet users’ data at risk, the agency said on Friday.

HTC America, a subsidiary of HTC Corp in Taiwan, made millions of phones with programming flaws that allowed third-party applications to evade Android’s permission-based security model, the FTC said in a release.

The settlement requires HTC to establish a comprehensive security program and patch the software holes, the FTC said.

(Reporting By Diane Bartz)

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The Duggars Visit Asia on Upcoming TLC Special: Catch a Sneak Peek

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By Tim Nudd

02/21/2013 at 12:50 PM EST

Kids, we're not in Arkansas anymore.

One of America's most populous family, the Duggars, visit the world's most populous country, China, as part of a longer trip to Asia captured in a three-episode special coming to TLC in March.

Getting 25 Duggars and their 40 suitcases to the airport is a struggle all its own. But then they tour Japan and China, where the familiar logistical challenges are compounded by the cultural differences.

Their adventures find them experimenting with local food, riding Rickshaws, donning traditional Geisha dress and fighting as Samurai warriors.

In Beijing, they finally negotiate the subway and get to Tiananmen Square, only to find themselves to be something of a tourist attraction in their own right.

19 Kids and Counting: Duggars Do Asia will air on TLC on March 12, 19 and 26 at 9ET/PT.

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Flu shot did poor job against worst bug in seniors

ATLANTA (AP) — For those 65 and older, this season's flu shot is only 9 percent effective against the most common and dangerous flu bug, according to a startling new government report.

Flu vaccine tends to protect younger people better than older ones and never works as well as other kinds of vaccines. But experts say the preliminary results for seniors are disappointing and highlight the need for a better vaccine.

For all age groups, the vaccine's effectiveness is moderate at 56 percent, which is nearly as well as other flu seasons, the Centers for Disease Control and Prevention said Thursday.

For those 65 and older, it is 27 percent effective against the three strains in the vaccine, the lowest in about a decade but not far below from what's expected. But the vaccine did a particularly poor job of protecting older people against the harshest flu strain, which is causing most of the illnesses this year. CDC officials say it's not clear why.

Vaccinations are now recommended for anyone over 6 months, and health officials stress that some vaccine protection is better than none at all. While it's likely that older people who were vaccinated are still getting sick, many of them may be getting less severe symptoms.

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

To be sure, the preliminary data for seniors 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. Older people are most vulnerable to flu and its complications, and the nation has seen some of the highest hospitalization rates for people 65 and older in a decade.

Flu viruses tend to mutate more quickly than others, and it's not unusual for multiple strains to be spreading at the same time. A new vaccine is formulated each year targeting the three strains expected to be the major threats. But that involves guesswork.

Because of these challenges, 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. The 56 percent effectiveness figure means people have a 56 percent lower chance of winding up at the doctor for treatment of flu symptoms.

For seniors, 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.

Older people have weaker immune systems that don't respond as well to flu shots. That's why a high-dose version was recently made available for those 65 and older. The new study was too small to show whether that made a difference this year.

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 flu shots and who hadn't. An earlier study put the vaccine's overall effectiveness slightly higher, at 62 percent.

The CDC's Bresee said there's a danger in providing preliminary results because it may result in people doubting — or skipping — flu shots. But the data was 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.

The new data highlights an evolution in how experts are evaluating flu vaccine effectiveness. For years, it was believed that if the viruses in the vaccine matched the ones spreading around the country, then the vaccine would be effective. This year's shot was a good match to the bugs going around this winter, including the harsher H3N2 that tends to make people sicker.

But the season proved to be a moderately severe one, with many illnesses occurring in people who'd been vaccinated.

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Online:

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

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Wall Street extends losses, Nasdaq down 1 percent

DEAR ABBY: My boyfriend, "Doug" (24), and I (22) have been in a long-distance relationship for a year, but we were friends for a couple of years before that. I had never had a serious relationship before and lacked experience. Doug has not only been in two other long-term relationships, but has had sex with more than 15 women. One of them is an amateur porn actress.I knew about this, but it didn't bother me until recently. Doug had a party, and while he was drunk he told one of his buddies -- in front of me -- that he should watch a certain porn film starring his ex-girlfriend. ...

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IHT Rendezvous: Europe's Jobless Youth: Should the Old Make Way?

LONDON — A British minister has advised people aged over 60 to go to university and update their skills if they want to continue working.

With youth unemployment on the rise across Europe, it might seem an odd time to be encouraging older people to keep working rather than take a well-earned break and free up jobs for a younger generation.

But with pension funds in deficit and the number of over-60s on the rise, governments and individuals are under pressure to accept that a graying work force will have to work longer.

“There is nothing stopping older people applying for university,” David Willetts, Britain’s higher education minister, said this week. “If they can benefit from it, they should have that opportunity.”

The rules have been eased to allow people of any age to take out student loans to help finance their university education.

“If people need it in order to keep up to date with changes in their jobs, that is an opportunity they are going to take,” the Daily Telegraph quoted the minister as saying.

The advice comes at a time, however, when growing numbers of young Europeans are emigrating in order to find jobs that are unavailable at home.

“From Ireland to Greece, young Europeans are now the ones desperately seeking exit strategies from economies in free fall,” according to The Guardian.

László Andor, the European Union’s employment commissioner, recently quoted jobless figures indicating that 1 in 4 young people under 25 were out of work, a total of 5.7 million, in the 27 member states.

In a special report on Thursday the EurActiv Web site said the Continent faced a digital brain drain as a consequence of a generation of educated young people leaving Europe to seek work elsewhere.

It said the situation was particularly bad in southern states where unemployment was highest. In countries such as Spain, the mass exodus of young, educated people amounted to a brain drain “the likes of which has not been seen since the end of the Spanish Civil War in 1939.”

For those who stay at home — whether they are 25 or 65 — there is clearly no guarantee that university degrees will get them jobs.

When a British coffee chain recently advertised for staff at one of its new stores, it received 1,701 applications for just eight jobs. Among the rejected candidates were a number of jobless new graduates.

Should older people be encouraged to keep working? Or should they step aside to widen the job market for jobless newcomers? Tell us what you think.

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Sean Lowe: Tierra Made Me Feel Like 'Such a Fool'

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The Bachelor

02/20/2013 at 12:15 PM EST

Sean Lowe and Tierra on The Bachelor

No regrets? Not so fast.

In his PEOPLE.com blog, The Bachelor's Sean Lowe has written about how he never saw Tierra LiCausi behaving badly – despite what the other women told him about the controversial contestant, who is now engaged.

But after watching, Sean realized the women were right.

"Man, I was such a fool," Sean, told host Chris Harrison on Sean Tells All special Tuesday night. "I really do feel like I was duped."

In fact, Sean, 28, who had an immediate connection with Tierra, says he never should have met her that first night.

"Tierra never should have come on this show. She's not suited for this show," he said. "She doesn't know how to handle herself in this environment. She's a woman who ... simply can't get along with her peers."

Not only did Tierra waste his time, Sean says, he witnessed her "getting into arguments and fights with the sweetest, best people in the house."

But no one may be more upset about Tierra than the women who was sent home instead of Tierra, Jackie Parr, on a two-on-one date in Montana.

I wouldn't have kept [Tierra]," Sean said on Tuesday's special. "I wish I would have kept Jackie on the two-on-one."

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Drug overdose deaths up for 11th consecutive year

CHICAGO (AP) — Drug overdose deaths rose for the 11th straight year, federal data show, and most of them were accidents involving addictive painkillers despite growing attention to risks from these medicines.

"The big picture is that this is a big problem that has gotten much worse quickly," said Dr. Thomas Frieden, head of the Centers for Disease Control and Prevention, which gathered and analyzed the data.

In 2010, the CDC reported, there were 38,329 drug overdose deaths nationwide. Medicines, mostly prescription drugs, were involved in nearly 60 percent of overdose deaths that year, overshadowing deaths from illicit narcotics.

The report appears in Tuesday's Journal of the American Medical Association.

It details which drugs were at play in most of the fatalities. As in previous recent years, opioid drugs — which include OxyContin and Vicodin — were the biggest problem, contributing to 3 out of 4 medication overdose deaths.

Frieden said many doctors and patients don't realize how addictive these drugs can be, and that they're too often prescribed for pain that can be managed with less risky drugs.

They're useful for cancer, "but if you've got terrible back pain or terrible migraines," using these addictive drugs can be dangerous, he said.

Medication-related deaths accounted for 22,134 of the drug overdose deaths in 2010.

Anti-anxiety drugs including Valium were among common causes of medication-related deaths, involved in almost 30 percent of them. Among the medication-related deaths, 17 percent were suicides.

The report's data came from death certificates, which aren't always clear on whether a death was a suicide or a tragic attempt at getting high. But it does seem like most serious painkiller overdoses were accidental, said Dr. Rich Zane, chair of emergency medicine at the University of Colorado School of Medicine.

The study's findings are no surprise, he added. "The results are consistent with what we experience" in ERs, he said, adding that the statistics no doubt have gotten worse since 2010.

Some experts believe these deaths will level off. "Right now, there's a general belief that because these are pharmaceutical drugs, they're safer than street drugs like heroin," said Don Des Jarlais, director of the chemical dependency institute at New York City's Beth Israel Medical Center.

"But at some point, people using these drugs are going to become more aware of the dangers," he said.

Frieden said the data show a need for more prescription drug monitoring programs at the state level, and more laws shutting down "pill mills" — doctor offices and pharmacies that over-prescribe addictive medicines.

Last month, a federal panel of drug safety specialists recommended that Vicodin and dozens of other medicines be subjected to the same restrictions as other narcotic drugs like oxycodone and morphine. Meanwhile, more and more hospitals have been establishing tougher restrictions on painkiller prescriptions and refills.

One example: The University of Colorado Hospital in Aurora is considering a rule that would ban emergency doctors from prescribing more medicine for patients who say they lost their pain meds, Zane said.

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Stobbe reported from Atlanta.

___

Online:

JAMA: http://www.jama.ama-assn.org

CDC: http://www.cdc.gov

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AP Medical Writer Lindsey Tanner can be reached at http://www.twitter.com

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Wall Street dips after rally, energy shares weaker

NEW YORK (Reuters) - Stocks dipped on Wednesday, with energy shares falling as investors found few reasons to buy following a rally that has held major indexes near five-year highs for three weeks.

In addition, investors waited for the minutes from the Federal Open Market Committee's January meeting due at 2 p.m. (1900 GMT) for clues to the interest rate outlook.

Traders said there were unconfirmed rumors in the market that a troubled hedge fund was selling assets.

"I heard the chatter about a hedge fund liquidating things today but how big, I don't know. Certainly it sparks concern," said Michael James, senior trader at Wedbush Morgan in Los Angeles.

A jump in January of permits for future home building offered hope the housing market's recovery remains on track. A separate report showed wholesale prices rose last month for the first time in four months.

The S&P 500 has jumped about 7 percent so far this year, and is on track for its eighth straight week of gains. However, many of those weekly gains have been slight, with equities trading within a narrow range for the past few weeks, suggesting valuations may be stretched at current levels.

"The market seems very tired and listless, and investors are prone to take profits now as they wait for the music to stop," said Matt McCormick, money manager at Bahl & Gaynor in Cincinnati.

Energy companies were among the weakest, hurt by disappointing corporate results and a 2.4 percent drop in crude oil prices.

Newfield Exploration fell 5.8 percent to $25.73 while Devon Energy Corp fell 1.6 percent to $59.60. Both companies posted fourth-quarter losses, with Devon hurt as it wrote down the value of its assets by $896 million due to weak natural gas prices.

Groundbreaking to build new U.S. homes fell 8.5 percent in January but new permits for construction rose to a 4 1/2-year high while producer prices rose in January for the first time in four months.

Investors will look to the minutes from the Fed's January meeting for any indication as to how long the Fed will keep buying $85 billion in bonds each month to bolster U.S. employment. Economic data should enable the Fed to maintain its easy monetary policy.

The Dow Jones industrial average <.dji> dropped 16.03 points, or 0.11 percent, to 14,019.64. The Standard & Poor's 500 Index <.spx> dropped 5.81 points, or 0.38 percent, to 1,525.13. The Nasdaq Composite Index <.ixic> dropped 13.82 points, or 0.43 percent, to 3,199.77.

Shares of OfficeMax Inc fell 3.8 percent to $12.51 while Office Depot slumped 13 percent to $4.37 as the companies announced a $1.2 billion merger agreement. The shares had risen sharply earlier this week after a source said a deal would be announced. Rival Staples Inc fell 3.5 percent.

Toll Brothers Inc lost 4 percent to $35.43 after the largest luxury homebuilder in the United States, reported first-quarter results well below analysts' estimates.

The stock is up 9 percent so far this year, building on jump of nearly 60 percent in 2012.

"Valuations appear a bit high at these levels, and if I was in a name that had seen a huge run, I'd want to take some chips off the table," said McCormick, who helps oversee about $8.2 billion in assets.

SodaStream dropped 6.5 percent to $49.04 after the seller of home carbonated drink maker machines posted fourth-quarter earnings and provided a 2013 outlook.

According to Thomson Reuters data through Tuesday morning, of the 405 companies in the S&P 500 that have reported results, 71 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 5.7 percent, according to the data, above a 1.9 percent forecast at the start of the earnings season.

(Editing by Kenneth Barry)

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