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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Russia Sends Aid to Mali as Fighting Flares

MOSCOW — Russia sent a planeload of food, blankets and other aid to war-stricken Mali on Friday, a day after Foreign Minister Sergey V. Lavrov warned about the spread of terrorism in North Africa, which the Russian government has linked to Western intervention in Libya.

Mr. Lavrov met on Thursday with the United Nations special envoy for the region, Romano Prodi, to discuss the situation in Mali, where Russia has supported the French-led effort to oust Islamic militants. But Russia has also blamed the West for the unrest and singled out the French in particular for arming the rebels who ousted the Libyan leader, Col. Muammar el-Qaddafi.

“Particular concern was expressed about the activity of terrorist organizations in the north, a threat to regional peace and security,” the Russian Foreign Ministry said in a statement after the meeting. “The parties agreed that the uncontrolled proliferation of arms in the region in the wake of the conflict in Libya sets the stage for an escalation of tension throughout the Sahel.” The Sahel is a vast region stretching more than 3,000 miles across Africa, from the Atlantic in the west to the Horn of Africa in the east.

In a television interview earlier this month, Mr. Lavrov said, “France is fighting against those in Mali whom it had once armed in Libya against Qaddafi.”

French forces quickly drove Islamist fighters out of the population centers of northern Mali — Timbuktu and Gao, in particular — when France began a military intervention in the country last month. Those dispersed fighters, who are members of Al Qaeda in the Islamic Maghreb and several allied groups, have now begun a small campaign of harassment and terror, dispatching suicide bombers, attacking guard posts, infiltrating liberated cities or ordering attacks by militants hidden among civilians.

On Friday, suicide attackers detonated two car bombs near the town of Tessalit, in Mali’s far north, according to news reports, while Islamist fighters clashed with Malian soldiers further south in Gao, where fighting has flared in recent days.

The twin suicide bombings in Tessalit killed three fighters for the M.N.L.A., an ethnic Tuareg armed group that has allied with the French forces, a spokesman for the group told Agence France-Presse. The attackers were killed as well. On Thursday, a guard and an attacker were killed in a car bombing in Kidal, south of Tessalit, that appeared to target a civilian fuel depot, France’s Defense Ministry said in a statement.

Responsibility for that attack was claimed by the Movement for Oneness and Jihad in West Africa, an offshoot of Al Qaeda in the Islamic Maghreb. The group said it would continue to press its fight, and also intended to retake Gao, hundreds of miles to the south.

“More explosions will happen across our territory,” a group spokesman, Abu Walid Sahraoui, told A.F.P. “Our troops have been ordered to attack,” he said. “If the enemy is stronger, we’ll pull back only to return stronger, until we liberate Gao.”

In central Gao late Thursday morning, Malian and French forces killed about 15 militants from “infiltrated terrorist groups” that had seized the town hall and court, according to France’s Defense Ministry. The initial firefight involved only Malian soldiers and militant fighters, the ministry statement said, but several French armored vehicles and two helicopters were later involved.

Two militants were killed outside a checkpoint north of the city after “sporadically” attacking the Nigerien soldiers standing guard, the Defense Ministry said. As many as six Malian soldiers were reported wounded.

On Friday, sporadic gunfire and at least two rebel rocket attacks were reported in Gao, according to a Malian officer cited by The Associated Press. Most of the militants fled to the east of the city aboard seven vehicles, the officer said.

Russian officials have pointed repeatedly to the unrest in North Africa and political turmoil in Egypt as evidence that the Western-supported Arab Spring has created a dangerous and chaotic situation and potential breeding grounds for terrorists. Russia has also used the examples of Libya and Egypt to justify its opposition to any Western effort to oust the government of President Bashar al-Assad in Syria.

Russia voted in favor of a United Nations Security Council resolution authorizing the deployment of African troops in Mali, but Russia has also stressed that the resolution required the consent of the Malian government.

Russia’s state-controlled weapons company, Rosoboronexport, has been selling small arms to the Malian government and is considering a request to buy additional matériel, including armor and helicopters.

The plane dispatched to the Malian capital, Bamako, by Russian’s Emergency Situations Ministry was carrying about 36 tons of aid cargo, including 45 tents, 2,000 blankets, canned food, cereals and rice.

David Herszenhorn reported from Moscow and Scott Sayare from Paris.

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Jack Nicholson, Dustin Hoffman to Present at Academy Awards

02/22/2013 at 12:40 PM EST

Dustin Hoffman (left) and Jack Nicholson

AP; Getty

Jack's back – at the Oscars.

Legendary actor Nicholson will join Dustin Hoffman as presenters at Sunday's Academy Awards. Both stars are 75.

"Between the two of them, Jack Nicholson and Dustin Hoffman have created more iconic characters than any other pair of actors in the world," says a statement from show producers Craig Zadan and Neil Meron. "Their participation in this year's Oscars completes a list of presenters and performers that truly represents that great breadth and depth of acting talent in film today."

Other presenters include Sandra Bullock, Nicole Kidman, Reese Witherspoon, Salma Hayek Pinault, Melissa McCarthy, Liam Neeson and John Travolta.

Performers for this year's show include Adele, Dame Shirley Bassey, Norah Jones and Barbra Streisand.

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

TV Watch

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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