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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Wall Street ends lower on growth worries

NEW YORK (Reuters) - U.S. stocks fell for a second straight day on Thursday and the S&P 500 posted its worst two-day loss since November after reports cast doubt over the health of the U.S. and euro-zone economies.

But a late-day rally helped stocks erase some of their losses with most of the pullback concentrated in the technology- heavy Nasdaq. The move suggested investors were still willing to buy on dips even after the sharp losses in the last session.

In Europe, business activity indexes dealt a blow to hopes that the euro zone might emerge from recession soon, showing the downturn across the region's businesses unexpectedly grew worse this month.

"The PMI numbers out of Europe were really a blow to the market," said Jack De Gan, chief investment officer at Harbor Advisory in Portsmouth, New Hampshire. "The market was expecting signs that recovery is still there, but the numbers just highlighted that the euro-zone problem is still persistent."

U.S. initial claims for unemployment benefits rose more than expected last week while the Federal Reserve Bank of Philadelphia said its index of business conditions in the U.S. mid-Atlantic region fell in February to the lowest in eight months.

Gains in Wal-Mart Stores Inc shares helped cushion the Dow. The shares gained 1.5 percent to $70.26 after the world's largest retailer reported earnings that beat expectations, though early February sales were sluggish.

The Dow Jones industrial average <.dji> fell 46.92 points, or 0.34 percent, to 13,880.62 at the close. The Standard & Poor's 500 Index <.spx> lost 9.53 points, or 0.63 percent, to 1,502.42. The Nasdaq Composite Index <.ixic> dropped 32.92 points, or 1.04 percent, to close at 3,131.49.

The two-day decline marked the U.S. stock market's first sustained pullback this year. The Standard & Poor's 500 has fallen 1.8 percent over the period and just managed to hold the 1,500 level on Thursday. Still, the index is up 5.3 percent so far this year.

The abrupt reversal in markets, which started on Wednesday after minutes from the Federal Reserve's January meeting suggested stimulus measures may end earlier than thought, looks set to halt a seven-week winning streak for stocks that had lifted the Dow and the S&P 500 close to all-time highs.

Wall Street will soon face another test with the upcoming debate in Washington over the automatic across-the-board spending cuts put in place as part of a larger congressional budget fight. Those cuts, set to kick in on March 1 unless lawmakers agree on an alternative, could depress the economy.

Semiconductor stocks ranked among the weakest of the day, pressuring the Nasdaq as the Philadelphia Semiconductor Index <.sox> fell 1.8 percent. Intel Corp fell 2.3 percent to $20.25 while Advanced Micro Devices lost 3.7 percent to $2.60 as the S&P 500's biggest percentage decliner.

The Dow also got a helping hand from personal computer maker Hewlett-Packard Co , which rose 2.3 percent to end the regular session at $17.10. The company was scheduled due to report first-quarter results after the closing bell.

Shares of Boeing Co rose 1.6 percent to $76.01 as a senior executive was set to meet with the head of the U.S. Federal Aviation Administration on Friday and present a series of measures to prevent battery failures that grounded its 787 Dreamliner fleet, according to a source familiar with the plans.

In other company news, shares of supermarket operator Safeway Inc jumped 14.1 percent to $22.97 after the company reported earnings that beat expectations.

Shares of VeriFone Systems Inc tumbled nearly 43 percent to $18.24 after the credit-card swipe machine maker forecast first- and second-quarter profits well below expectations.

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

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.

Berry Petroleum Co jumped 19.3 percent to $46.02 after oil and gas producer Linn Energy LLC said it would buy the company in an all-stock deal valued at $4.3 billion, including debt. Linn Energy shares advanced 2.8 percent to $37.68.

About two stocks fell for everyone that rose on the New York Stock Exchange and Nasdaq. About 7.64 billion shares changed hands on the New York Stock Exchange, the Nasdaq and NYSE MKT, well above the 20-day moving average of around 6.6 billion shares.

(Editing by Jan Paschal)

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French, Malian forces fight Islamist rebels in Gao

GAO, Mali (Reuters) - French and Malian troops fought Islamists on the streets of Gao and a car bomb exploded in Kidal on Thursday, as fighting showed little sign of abating weeks before France plans to start withdrawing some forces.

Reuters reporters in Gao in the country's desert north said French and Malian forces fired at the mayor's office with heavy machineguns after Islamists were reported to have infiltrated the Niger River town during a night of explosions and gunfire.

French Defense Minister Jean-Yves Le Drian told a news conference in Brussels that Gao was back under control after clashes earlier in the day.

"Malian troops supported by French soldiers killed five jihadists and the situation is back to normal," he said.

In Kidal, a remote far north town where the French are hunting Islamists, residents said a car bomb killed two. A French defense ministry source reported no French casualties.

French troops dispatched to root out rebels with links to al Qaeda swiftly retook northern towns last month. But they now risk being bogged down in a guerrilla conflict as they try to help Mali's weak army counter bombings and raids.

"There was an infiltration by Islamists overnight and there is shooting all over the place," Sadou Harouna Diallo, Gao's mayor, told Reuters by telephone earlier in the day, saying he was not in his office at the time.

Gao is a French hub for operations in the Kidal region, about 300 km (190 miles) northeast, where many Islamist leaders are thought to have retreated and foreign hostages may be held.

"They are black and two were disguised as women," a Malian soldier in Gao who gave his name only as Sergeant Assak told Reuters during a pause in heavy gunfire around Independence Square.

Six Malian military pickups were deployed in the square and opened fire on the mayor's office with the heavy machineguns. Two injured soldiers were taken away in an ambulance.

French troops in armored vehicles later joined the battle as it spilled out into the warren of sandy streets, where, two weeks ago, they also fought for hours against Islamists who had infiltrated the town via the nearby river.

Helicopters clattered over the mayor's office, while a nearby local government office and petrol station was on fire.

A Gao resident said he heard an explosion and then saw a Malian military vehicle on fire in a nearby street.

Paris has said it plans to start withdrawing some of its 4,000 troops from Mali next month. But rebels have fought back against Mali's weak and divided army, and African forces due to take over the French role are not yet in place.

Islamists abandoned the main towns they held but French and Malian forces have said there are pockets of Islamist resistance across the north, which is about the size of France.

CAR BOMB

Residents reported a bomb in the east of Kidal on Thursday.

"It was a car bomb that exploded in a garage," said one resident who went to the scene but asked not to be named.

"The driver and another man were killed. Two other people were injured," he added.

A French defense ministry official confirmed there had been a car bomb but said it did not appear that French troops, based at the town's airport, had been targeted.

Earlier this week, a French soldier was killed in heavy fighting north of Kidal, where French and Chadian troops are hunting Islamists in the Adrar des Ifoghas mountains, which border Algeria.

Operations there are further complicated by the presence of separatist Tuareg rebels, whose rebellion triggered the fighting in northern Mali last year but were sidelined by the better-armed Islamists.

Having dispatched its forces to prevent an Islamist advance south in January, Paris is eager not to become bogged down in a long-term conflict in Mali. But their Malian and African allies have urged French troops not to pull out too soon.

(Additional reporting by Emanuel Braun in Gao, Adama Diarra in Bamako, David Lewis and John Irish in Dakar and Adrian Croft in Brussels; Writing by David Lewis; Editing by Jason Webb and Roger Atwood)

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PHOTO: Seth MacFarlane Lets Popcorn Fly in New Oscar Promo

02/21/2013 at 04:45 PM EST

Seth MacFarlane isn't crying over spilled popcorn.

Before he gets down to the business of hosting on Sunday's 85th Annual Academy Awards, MacFarlane 39, posed in a lighthearted set of promotional photos, leading up to Hollywood's biggest night.

In one of the shots, the Family Guy creator is holding a tub of popcorn – but in the next, the kernels are flying everywhere, much to the star's delight. In another shot, MacFarlane does his best impression of Oscar himself.

MacFarlane will make his Academy Awards hosting debut live on ABC from the Dolby Theatre in Hollywood.

Previously, MacFarlane shot a silly video promo pretending to be Daniel Day-Lewis.  

Seth MacFarlane

BOB D'AMICO / ABC

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Flu shot did poor job against worst bug in seniors

ATLANTA (AP) — This year's flu shot is doing a startlingly dismal job of protecting senior citizens from the harshest strain this season, proving only 9 percent effective, the government said Thursday.

Health officials don't know why this is so, but it helps explain why so many older people have been hospitalized with the flu this year.

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 urgent need for a better vaccine.

Overall, the vaccine's effectiveness is 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 nearly as good as other flu seasons, the Centers for Disease Control and Prevention said Thursday.

For those 65 and older, it offers far less protection. 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 toughest flu bug, which is causing more than three-quarters of the illnesses this year. CDC officials say it's not clear why.

Vaccinations are 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," and vaccinations are still recommended for senior citizens, 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.

Older people have weaker immune systems that don't respond as well to flu shots and are more vulnerable to the flu and its complications, including pneumonia.

Health officials at a meeting Thursday said they don't know why this year's vaccine did so poorly in that age group. One theory, as yet unproven, is that seniors' 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.

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 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.

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.

A high-dose version of the flu show was recently made available for those 65 and older but 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, smaller study put the vaccine's overall effectiveness at 62 percent but other factors that might influence that figure weren't taken into account.

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

A slate of new vaccines will be available next summer, including some that protect against as many of four strains of flu and some that can be made more quickly. But experts say it's not clear whether they will be any more effective.

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Online:

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

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Wall Street ends down sharply after Fed minutes

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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Major powers to make "substantial and serious offer" to Iran

LONDON (Reuters) - Major powers are ready to make "a substantial and serious offer" to Iran during talks next week in return for concessions on its nuclear program, a Western diplomat said on Wednesday.

He declined to give details of the offer - aimed at reviving efforts to reach a diplomatic solution to long-stalled talks over Iran's disputed nuclear work.

"We will take an offer with us which we believe to be a substantial and serious offer," the diplomat said of talks in Almaty, Kazakhstan. "This is an offer which we think has significant new elements in it."

The West has imposed heavy economic sanctions on Iran to persuade it to abandon those parts of its program the powers suspect are intended to give it nuclear weapons capability.

Iran denies seeking nuclear weapons, saying its nuclear program is for peaceful, civilian purposes only.

"Diplomats are committed to finding a diplomatic solution, but the government of Iran really has to show that it's doing what it says it's doing," the diplomat said, on condition of anonymity.

The five permanent members of the Security Council along with Germany - the so-called P5+1 - will hold talks with Iran in Almaty on February 26.

Western officials in Washington have told Reuters they plan to offer to ease sanctions barring trade in gold and other precious metals in return for Iran shutting its Fordow uranium enrichment plant - a proposal already rejected by Tehran.

The Western diplomat declined to comment on that, nor to say in what way the offer to be made in Almaty would differ.

Another Western diplomat said hopes for the meeting were not "sky high" but the talks were being viewed as an opportunity to engage with Iran. "It's an open and positive offer and we hope that they will respond," he said.

"We've always offered quite a bit. The original offer in 2008 was a very generous offer, very comprehensive and that is still basically there on the table and what we're offering now is more precision about certain elements of that," he added.

The 2008 offer both acknowledged Iran's right to a civilian nuclear program and recognized its need for broader security guarantees against attack.

SANCTIONS SEEN BITING

Western diplomats argue that sanctions are taking their toll on Iran's economy and hoping as a result the new diplomatic push could succeed where past attempts have failed.

The negotiations held by the P5+1 also follow a renewed offer by the United States to hold direct talks with Iran if it showed it was serious about reining in its nuclear program.

Any broader political dialogue between the United States and Iran would be aimed at reducing mistrust dating back to the 1979 Iranian revolution and seizure of the U.S. embassy in Tehran. Such a dialogue would be a means of giving additional momentum to existing negotiations on Tehran's nuclear program.

Iran has given little indication of what it would bring to the table in Almaty.

It rejected the offer of an easing of sanctions on gold trade as unacceptable and its ability to make significant concessions is seen as limited before Iranian presidential elections in June.

It has, however, resumed work to convert small amounts of higher-grade enriched uranium into fuel, a move which would slow its accumulation of stockpiles that could, if enriched further, be used for weapons.

Diplomats say it has also held off from putting into operational additional centrifuges at Fordow where it enriches uranium to 20 percent - a level that can be rapidly turned into weapons-grade material.

The International Atomic Energy Agency is expected to issue shortly its latest report on Iran, which will indicate the size of its stockpiles of enriched uranium and detail other developments in its nuclear program.

(Additional reporting by Lou Charbonneau and Michele Nichols; Editing by Alison Williams)

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Apple’s Retina display for the next-gen iPad mini is reportedly already in development

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Can You Guess Which Star Was First To Wear Elizabeth Taylor's $6 Million Emerald Necklace?

Stylewatch
Style News Now

02/20/2013 at 11:15 AM ET

Nate Beckett/Splash News Online; Popperfoto/Getty

On Tuesday night, Julianne Moore did what few women would be able to: She did justice to one of Elizabeth Taylor‘s most prized pieces of jewelry.

The dazzling emerald-and-diamond necklace, purchased for Taylor by future husband Richard Burton while they were on location for Cleopatra in Rome, was a staple in the legendary star’s wardrobe; she even wore it to accept her Oscar in 1967.

It was one of eight Bulgari pieces that the jewelry house purchased from her 2011 Christie’s auction and now have on display at their Rodeo Drive flagship.

“The room absolutely stopped when [Moore] entered” in the necklace, a source at Bulgari’s pre-Oscars party, thrown to celebrate Taylor’s jewels, tells PEOPLE. “Kirsten Dunst exclaimed, ‘Are you wearing one of her pieces?’”

And Moore looked lovely in the necklace, which sold for more than $6 million at auction, though she went a distinctly non-Taylor route by offsetting it with sleek hair and a very simple Alexander McQueen dress. Regardless, we bet Taylor, who wore her fanciest jewelry to sit around the house, would have been pleased.

Tell us: What would you wear with Taylor’s $6 million emerald necklace?

–Alex Apatoff, reporting by Jennifer Garcia

PHOTOS: SEE MORE OF ELIZABETH TAYLOR’S JAW DROPPING JEWELRY HERE!

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Obama administration tackles colonoscopy confusion

WASHINGTON (AP) — It's one part of the new health care law that seemed clear: free coverage for preventive care under most insurance plans.

Only it didn't turn out that way.

So on Wednesday, the Obama administration had to straighten out the confusion.

Have you gone for a colonoscopy thinking it was free, only to get a hefty bill because the doctor removed a polyp?

No more.

Taking out such precancerous growths as part of a routine colon cancer screening procedure will now be considered preventive care.

"Polyp removal is an integral part of a colonoscopy," the Department of Health and Human Services said in guidance posted on its website. That conclusion has the backing of several leading medical societies, the department noted.

Also addressed in the notice was genetic testing for breast cancer, coverage of over-the-counter products such as aspirin for heart care and nicotine patches for smoking, and birth control for women. Unlike formal regulations, the guidance does not have the force of law, but advocates for patients say insurers would be ill-advised to ignore it.

President Barack Obama's health care law required most private health plans to cover preventive care at no additional charge to patients. It also expanded preventive coverage without copayments for Medicare recipients. For workers and their families, the expense is borne by the company health plan, which passes on some of those costs in the form of higher premiums. Advocates say preventive care saves the health care system money over time.

Colonoscopy is an expensive test that can cost more than $1,000. It's recommended for adults 50 and over, and has become a rite of passage for aging baby boomers.

News that it would be covered free under the health care law got attention, but that was followed quickly by a letdown when many insurers started charging if a polyp or two was discovered and removed during the procedure.

"Insurers were reclassifying it from a preventive test to a diagnostic procedure," said Stephen Finan, policy director for the American Cancer Society Cancer Action Network. "In some cases the cost-sharing was a significant amount of money."

His group was among several that complained to the administration.

Other free preventive services addressed in Wednesday's guidance:

—Insurers must cover testing, if ordered by a doctor, for rare BRCA genes that dramatically increase the risk of breast cancer. Such tests can cost as much as $3,000.

—Over-the-counter products such as aspirin for heart care and nicotine patches for smoking cessation are covered with a doctor's prescription.

—Insurers won't be able to fulfill the law's requirement to cover contraception as preventive care for women if they only pay for birth control pills. A full range of FDA-approved methods must be covered, including long-acting implant and intrauterine devices. Birth control methods for men are not covered as preventive care.

If a health plan does not have a network doctor who performs a particular preventive service, a patient can see a doctor out-of-network without facing copays or additional charges.

Also Wednesday, the government came out with final rules on the benefits that health plans catering to individuals and small businesses will have to offer starting next year, when new insurance markets called exchanges open in each state.

The coverage generally is better than what's now available to people buying individual policies, but close to what medium-size companies offer, with some important improvements in areas such as mental health care.

Benefits include hospital and outpatient care, emergency services, maternity and newborn care, prescriptions, prevention, rehabilitation and ongoing assistance for people with potentially disabling conditions, and dental and vision care for children.

All plans will have to cover the same benefits, but their premiums and cost sharing will vary. There will be four level of coverage — bronze, silver, gold and platinum. Bronze plans will cover 60 percent of expected costs while platinum plans will cover 90 percent.

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Online:

Health and Human Services Department: http://tinyurl.com/au6lzeo

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