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Updated: Monday Feb 25, 2013 | 01:30 PM EST




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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 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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Dow, S&P slip after uncertain Italian election

NEW YORK (Reuters) - U.S. stocks mostly fell on Monday on fears that a divided parliament in Italy would get in the way of the country's reforms and hamper the euro zone's stability.


Election projections showed the center-right coalition led by former prime minister Silvio Berlusconi was leading in the race for the Italian Senate, contradicting initial exit polls and raising the specter of deadlock in parliament.


Earlier polls pointing to a center-left victory lifted stocks in Milan and other European markets on investors' belief that they would continue the path to pay down Italian debt, said Art Hogan, managing director of Lazard Capital Markets in New York.


"What we don't want to hear is a renewed fear about a euro- zone fracture," he said.


Last week, the benchmark S&P 500 closed below its 14-day moving average on Wednesday for the first time this year. At midday, the S&P 500 was trading just below that level, now near 1,515.


The index was, nonetheless, still near highs not seen in five years, as bets on a strong U.S. economy have given equities support. The S&P 500's slight fall last week was the first weekly drop after a seven-week string of gains.


Banks and other financial stocks led Monday's decline on concern about the sector's exposure to Italy's massive debt. The KBW Bank Index <.bkx> fell 0.7 percent.


The Dow Jones industrial average <.dji> slipped 18.58 points or 0.13 percent, to 13,981.99. The Standard & Poor's 500 <.spx> shed 2.30 points or 0.15 percent, to 1,513.30. But the Nasdaq Composite <.ixic> rose 3.03 points or 0.10 percent, to 3,164.85.


Barnes & Noble Inc shares climbed 11.9 percent to $15.12 after the bookseller's chairman offered to buy its declining retail business.


The Nasdaq received support from Amgen Inc , up 4.2 percent at $90.47, after a rival issued a voluntary recall of its only drug, an anemia treatment that competes with Amgen's top-selling red blood cell booster, Epogen.


The FTSEurofirst-300 index of top European shares <.fteu3> unofficially closed up 0.1 percent and Italy's main FTSE MIB <.ftmib> ended up 0.7 percent after earlier gaining near 4 percent.


U.S. equities will face a test with the looming debate over the so-called sequestration, U.S. government budget cuts that will take effect starting on Friday if lawmakers fail to reach an agreement over spending and taxes. The White House issued warnings about the harm the cuts are likely to inflict on the economy if enacted.


With 83 percent of the S&P 500 companies having reported results so far, 69 percent beat profit expectations, compared with a 62 percent average since 1994 and 65 percent over the past four quarters, according to Thomson Reuters data.


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 and Jan Paschal)



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In Last Sunday Address as Pope, Benedict Says He Will Continue to Serve


Andrew Medichini/Associated Press


Pope Benedict XVI delivered his final Sunday address from the window of his apartment overlooking St. Peter's Square.







VATICAN CITY — In his last Sunday blessing before he retires, Pope Benedict XVI reassured Catholics that he was not abandoning them but would continue to serve the church even in his retirement.




Romans, pilgrims and curious tourists filled St. Peter’s Square on Sunday for Benedict’s second-to-last public appearance before he steps down on Thursday, the first pope in six centuries to do so willingly.


Reading from prepared remarks as he stood at the window of the Apostolic Palace, Benedict that said he was being called by God “to climb up on the mountain” and to dedicate himself more to “prayer and meditation.”


“This doesn’t mean abandoning the church,” the pope added, to the applause of the crowd. “On the contrary, if God asks me, this is because I can continue to serve” the church “with the same dedication and the same love which I have tried to do so until now, but in a way more suitable to my age and to my strength.”


Cardinals from around the world have begun gathering in Rome to greet Benedict before he retires at 8 p.m. on Thursday. At that point, the cardinals will meet to discuss when to begin the conclave to elect his successor.


One member of the crowd in St. Peter’s Square on Sunday, Jan Cartwright, 61, said she had traveled to Rome from Wales. “We’ve come for the rugby, but we’re Catholic, and it is history, isn’t it,” she said.


Ms. Cartwright said she was surprised that the pope had decided to resign. “We have the queen,” she said. “No one in the royal family would step down, they just go on until they die, really.” But she said she admired Benedict’s decision. “I think it’s a brave thing to do,” she said. “He’s an old man.”


Maria Concetta Campanella from Rome was also in the crowd. “It’s a historic moment,” she said. “It teaches us humility. He teaches us that we can’t sit in our chairs forever, that when the time is right, we have to leave the chair.”


Vito Ugo, an Augustinian monk holding a Brazilian flag, was taking pictures with two of his fellow monks, all dressed in long black robes. “We feel great emotion to be here,” he said.


Asked whether he hoped the cardinals would elect a South American pope in the conclave, Brother Ugo smiled. “It’s what God wants,” he said humbly.


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You're Invited to PEOPLE.com's Oscars Party!









02/24/2013 at 08:40 AM EST







From left: Bradley Cooper, Oscar, Jessica Chastain


AFP/Getty; Wireimage; Splash News Online


Oscars host Seth MacFarlane isn't the only one gearing up for Hollywood's biggest night – we are too!

Be a part of the glamour and excitement Sunday starting at 6 p.m. ET/3 p.m. PT when we roll out the red carpet for our PEOPLE.com VIPs.

Here's what you can expect:
• Tune in to our live red carpet preshow for exclusive A-list interviews
• Be the first to see the gorgeous gowns – and make your own best-dressed list
• Download your own play-along ballot – and vote on your Academy Awards picks
• Tweet with our editors at #PeopleOscars, and watch the conversation on our homepage. We'll be joined by DKNY PR Girl (@dkny), model Coco Rocha (@cocorocha), the hilarious Go Fug Yourself (@fuggirls), @WhoWhatWear and blogger @Possessionista!
• Take our up-to-the-minute Oscars polls

And come back the next day for so much more ...
• See the night's best dresses from all angles with our 360º slideshow
• Come inside the most exclusive Oscars after-parties
• Relive the most memorable quotes of the show
• Get the scoop on the night's biggest shockers and funniest moments everyone is talking about

We're looking forward to a fun, fashion-filled night – see you then!

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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 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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Iran Says It Has Found New Uranium Deposits





DUBAI, United Arab Emirates (Reuters) — Days before resuming talks over its disputed nuclear program, Iran said Saturday that it had found significant new deposits of raw uranium and identified sites for 16 more nuclear power stations.




The state news agency IRNA quoted a report by the Atomic Energy Organization of Iran, which said that the reserves were discovered in northern and southern coastal areas and had tripled the amount outlined in previous estimates.


There was no independent confirmation. Western experts had previously thought that Iran, with few uranium mines of its own, might be close to exhausting its supply of raw uranium.


“We have discovered new sources of uranium in the country, and we will put them to use in the near future,” Fereydoun Abbasi-Davani, head of the Atomic Energy Organization, was quoted as saying at Iran’s annual nuclear industry conference.


The timing of the announcement suggested that Iran, by talking up its reserves and nuclear ambitions, may hope to strengthen its negotiating hand at talks in Kazakhstan on Tuesday with the United States, Russia, China, Britain, France and Germany.


Diplomats say the six powers are willing to offer Iran some relief from international sanctions if it agrees to curb its production of higher-grade enriched uranium.


The West says Iran’s enrichment of uranium to a purity of 20 percent demonstrates its intent to develop a nuclear weapons ability, an allegation the Islamic republic denies.


The enriched uranium required for use in nuclear reactors or weapons is produced in centrifuges that spin uranium hexafluoride gas at high speeds. The gas is derived from yellow cake, a concentrate from uranium ore found in mines.


Iran’s raw uranium reserves now total around 4,400 tons, including discoveries over the past 18 months, IRNA quoted the report as saying.


In another sign that Iran is intent on pushing forward with its nuclear ambitions, the report also said that 16 sites had been identified for the construction of nuclear power stations. It did not specify the exact locations but said they included coastal areas of the Persian Gulf, the Gulf of Oman, Khuzestan Province and the Caspian Sea.


The Iranian authorities have long announced their desire to build more nuclear power plants for electricity production. Only one currently exists, in the southern city of Bushehr, and it has suffered several shutdowns in recent months.


The announcements could further complicate the search for a breakthrough in Kazakhstan, after three unsuccessful rounds of talks between the sides in 2012.


“We are meeting all of our obligations under the Nuclear Nonproliferation Treaty, and we should be able to benefit from our rights,” Saeed Jalili, Iran’s chief nuclear negotiator, was quoted as saying at the conference on Saturday. “We don’t accept more responsibilities and less rights.”


In what Washington has called a provocative move, Iran is also installing new-generation centrifuges, capable of producing enriched uranium much faster, at a site in Natanz in the center of the country.


Western diplomats say the six powers will reiterate demands for the suspension of uranium enrichment to a purity of 20 percent, the closing of Iran’s Fordo enrichment plant, increased access for International Atomic Energy Agency inspectors and an agreement to address concerns on existing uranium stockpiles.


In return, the latest embargoes on gold and metals trading with Iran would be lifted. Iran has criticized the offer and says its rights need to be fully recognized.


If the West wants to start constructive talks with Tehran, “It needs to present a valid proposal,” Mr. Jalili said. In a statement issued before the Iranian announcement, the German foreign minister, Guido Westerwelle, said the six-power group wanted to enter a “substantial negotiation process” over Tehran’s nuclear program.


The talks in Kazakhstan “are a chance which I hope Iran takes,” he said.


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Beyoncé & Blue Ivy Made Readers Smile















02/23/2013 at 01:35 PM EST



What's on the minds of PEOPLE readers this week? We love getting your feedback, and as always, you weighed in with plenty of strong reactions.

From your love of a new photos of Beyoncé's growing daughter Blue Ivy to your sadness over the suicide of country star Mindy McCready, readers responded to what made them mad, sad and also what kept them laughing out loud.

Check out the articles with the top reactions on the site this week, and keep clicking on the emoticons at the bottom of every story to tell us what you think!

LoveThere is no doubt the baby Blue Ivy is a Daddy's girl as new snaps of the child and her mother Beyoncé revealed this week. While her famous parents have kept her out of the spotlight, a photo of Blue Ivy, now 1, was apparently leaked from Beyoncé's HBO documentary, showing mom and daughter sharing the same photogenic smile.

LOLMeanwhile, seeing Taylor Swift in a very Beyoncé-esque costume at the Brit Awards drew some amusement from readers who wondered if Sasha Fierce now has a pop-country cousin.

Wow Chaz Bono has quickly followed through on his goal to lose significant weight, and readers were wowed by inspirational photos that saw him significantly trimmer and 43 pounds lighter. "I've been sticking to a really strict diet," he tells PEOPLE. "It's not any type of starvation thing. I'm just cutting out a lot of stuff and eating primarily protein and vegetables and fruit."

Angry Readers told us they were angered by Kim Kardashian's maternity style as she continues her habit of wearing tight-fitting fashion, even as her pregnancy has moved into its second trimester. Mom-to-be Kardashian, 32, defended her hourglass shape and its limitations with clothes. "I think because I have big boobs it could make me look heavier if I don't, like, show off my waist or something," she told Du Jour magazine.

SadCountry singer Mindy McCready's tragic suicide at 37 saddened readers. After years of dealing with addiction and legal problems, McCready killed herself at her Arkansas home, leaving behind son Zander, 6, with her ex Billy McKnight, and son Zayne, just 10 months.

Check back next week for another must-read roundup, and see what readers are reacting to every day here.

Beyoncé & Blue Ivy Made Readers Smile| Babies, Death, Music News, Beyonce Knowles, Chaz Bono, Kim Kardashian, Mindy Mccready, Taylor Swift

Taylor Swift at the Brit Awards (right) and Beyoncé at the Super Bowl

Getty; PictureGroup

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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 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.


Read More..