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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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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Renée Zellweger Puckers Up with Doyle Bramhall II in Hawaii: Photo

By Andrea Billups

02/22/2013 at 11:30 AM EST

Doyle Bramhall II and Renée Zellweger

AKM-GSI

Renée Zellweger was feeling the love – and the surf – during her recent Hawaiian vacation.

Zellweger, 43, joined her boyfriend, musician Doyle Bramhall II, 44, for some kayaking, paddle-boarding and romantic kissing on the beach. Wearing matching black beachwear, the Texas natives were not shy about their happiness, holding hands and smiling broadly as they vacationed together.

But soon it's back to work for Zellweger, who's set to appear on the Oscar telecast Sunday in Los Angeles. The Academy Award winner will reportedly join her Chicago cast as presenters, marking the 10th anniversary of their musical film earning Best Picture honors.

Bramhall, a guitarist and songwriter who toured with Roger Waters and Eric Clapton, was last linked to Sheryl Crow in 2011.

The 85th annual Academy Awards will air live on ABC starting at 7 p.m. ET/4 p.m. PT on Sunday, Feb. 24, from the Dolby Theatre in Hollywood.

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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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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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Nigerian troops surround French family's kidnappers: source

YAOUNDE/MAIDUGURI, Nigeria (Reuters) - Nigerian security forces surrounded the kidnappers of a French family in northeast Borno state on Thursday in an operation to rescue the hostages, a Nigerian military source said.

French, Nigerian and Cameroonian officials earlier denied French media reports that the family, who were seized in Cameroon and taken over the border, had been freed.

The Nigerian military located the hostages and kidnappers between Dikwa and Ngala in the far northeast, the military source in Borno said, asking not to be identified.

Dikwa is less than 80 km (50 miles) from the border with Cameroon where the three adults and four children were taken hostage on Tuesday.

A senior Cameroonian military official declined to comment saying the matter was too sensitive.

Citing a Cameroon army officer, French media reported earlier on Thursday that the hostages had been found alive in a house in northern Nigeria.

"This is a crazy rumor that we cannot confirm. We do not know where is it coming from," Cameroon Communications Minister Issa Tchiroma Bakary told Reuters by telephone from the capital Yaounde.

"What is certain is that the French tourists who were abducted are no longer on our territory. However, we are in touch with the Government of Nigeria to intensify measures to continue the search for them along our common border," he said.

French gendarmes backed by special forces arrived in northern Cameroon on Wednesday to help locate the family, a local governor and French defense ministry official said.

Nigerian military spokesman Sagir Musa earlier also said the report on France's BFM television of the hostages being released was "not true," while Didier Le Bret, the head of the French foreign ministry's crisis center, said the information was "baseless."

The abduction was the first case of foreigners being seized in the mostly Muslim north of Cameroon, a former French colony.

But the region - like others in West and North Africa with porous borders - is considered within the operational sphere of Boko Haram and fellow Nigerian Islamist militants Ansaru.

On Sunday, seven foreigners were snatched from the compound of Lebanese construction company Setraco in northern Nigeria's Bauchi state, and Ansaru took responsibility.

Northern Nigeria is increasingly afflicted by attacks and kidnappings by Islamist militants. Ansaru, which rose to prominence only in recent months, has claimed the abduction in December of a French national who is still missing.

Three foreigners were killed in two failed rescue attempts last year after being kidnapped in northern Nigeria and Ansaru, blamed for those kidnaps, warned this could happen again.

The threat to French nationals in the region has grown since France deployed thousands of troops to Mali to oust al Qaeda-linked Islamists who controlled the country's north.

The kidnapping in Cameroon brought to 15 the number of French citizens being held in West Africa.

(Reporting By Emile Picy and Nicholas Vinocur in Paris; Additional reporting by Joe Brock in Abuja and Bate Felix and John Irish in Dakar; Writing by Bate Felix and John Irish; Editing by Angus MacSwan)

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Taylor Swift Channels Beyoncé at Brit Awards

By Aaron Parsley

02/21/2013 at 11:40 AM EST

Does Sasha Fierce have a pop-country cousin?

During a sassy performance of "I Knew You Were Trouble" at Wednesday's Brit Awards, Taylor Swift shed a white wedding dress to reveal a black embellished jumpsuit, sexy boots – and some familiar moves.

Striking a pose, tossing her hair and even falling to her knees to belt out the hit song, Swift, 23, resembled Beyoncé in her highly buzzed-about Super Bowl halftime performance on Feb. 3. Flip through a carousel of photos from the performance above.

At the awards ceremony at London's O2 arena, Swift handed out the best British female prize to soulful Scottish singer and songwriter Emeli Sandé, who also took home the best album prize for her debut, Our Version of Events.

A nominee for international female solo artist, Swift lost in that category to another American, Lana Del Rey.

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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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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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Bulgarian government resigns amid growing protests

SOFIA (Reuters) - Bulgaria's government resigned on Wednesday after mass protests against high power prices and falling living standards, joining a long list of European administrations felled by austerity during four years of debt crisis.

Prime Minister Boiko Borisov, an ex-bodyguard who took power in 2009 on pledges to root out graft and raise incomes in the European Union's poorest member, faces a tough task of propping up eroding support ahead of an expected early election.

Wage and pension freezes and tax hikes have bitten deep in a country where earnings are less than half the EU average and tens of thousands of Bulgarians have rallied in protests that have turned violent, chanting "Mafia" and "Resign".

Moves by Borisov on Tuesday to blame foreign utility companies for the rise in the cost of heating homes was to no avail and an eleventh day of marches saw 15 people hospitalized and 25 arrested in clashes with police.

"My decision to resign will not be changed under any circumstances. I do not build roads so that blood is shed on them," said Borisov, who began his career guarding the Black Sea state's communist dictator Todor Zhivkov.

A karate black belt, Borisov has cultivated a Putin-like "can-do" image since he entered politics as Sofia mayor in 2005 and would connect with voters by showing up on the capital's rutted streets to oversee the repair of pot-holes.

But critics say he has often skirted due process, sometimes to the benefit of those close to him, and his swift policy U-turns have wounded the public's trust.

The spark for the protests was high electricity bills, after the government raised prices by 13 percent last July. But it quickly spilled over into wider frustration with Borisov and political elites with perceived links to shadowy businesses.

"He made my day," said student Borislav Hadzhiev in central Sofia, commenting on Borisov's resignation. "The truth is that we're living in an extremely poor country."

POLLS, PRICES

The prime minister's final desperate moves on Tuesday included cutting power prices and risking a diplomatic row with the Czech Republic by punishing companies including CEZ, moves which conflicted with EU norms on protection of investors and due process.

CEZ officials were hopeful on Wednesday that it would be able to avoid losing its distribution license after all and officials from the Bulgarian regulator said the company would not be punished if it dealt with breaches of procedure.

But shares in what is central Europe's largest publicly-listed company fell another 1 percent on Wednesday.

If pushed through, the fines for CEZ and two other foreign-owned firms will not encourage other investors in Bulgaria, who already have to navigate complicated bureaucracy and widespread corruption and organized crime to take advantage of Bulgaria's 10-percent flat tax rate.

Financial markets reacted negatively to the turbulence on Wednesday. The cost of insuring Bulgaria's debt rose to a three-month high and debt yields rose some 15 basis points, though the country's low deficit of 0.5 percent of gross domestic product means there is little risk to the lev currency's peg against the euro.

Borisov's interior minister indicated that elections originally planned for July would probably be pulled forward by saying that his rightist GERB party would not take part in talks to form a new government.

MILLIONS GONE

GERB's woes have echoes in another ex-communist EU member, Slovenia, where demonstrators have taken to the streets and added pressure to a crumbling conservative government.

A small crowd gathered in support of Borisov outside Sofia's parliament, which is expected to approve his resignation on Thursday, while bigger demonstrations against the premier were expected in the evening.

Unemployment in the country of 7.3 million is far from the highs hit in the decade after the end of communism but remains at 11.9 percent. Average salaries are stuck at around 800 levs ($550) a month and millions have emigrated, leaving swathes of the country depopulated and little hope for those who remain.

GERB's popularity has held up well and it still led in the latest polls before protests grew in size last weekend, but analysts say the opposition Socialists should draw strength from the demonstrations.

The leftists, successors to Bulgaria's communist party, have proposed tax cuts and wage hikes and are likely to raise questions about public finances if elected.

(Additional reporting by Angel Krasimirov; editing by Patrick Graham)

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