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Credit: Christopher Polk/Getty
Updated: Monday Feb 25, 2013 | 01:00 AM EST
By: Kate Hogan
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.
NEW YORK (Reuters) - U.S. stocks turned negative on Monday, dragged lower by financial and housing shares and a reversal of early market gains based on voting in Italy where there were fears of a hung parliament that could undermine stability in the euro zone.
The Dow Jones industrial average <.dji> fell 5.26 points or 0.04 percent, to 13,995.31, the S&P 500 <.spx> lost 0.24 points or 0.02 percent, to 1,515.36 and the Nasdaq Composite <.ixic> added 5.8 points or 0.18 percent, to 3,167.61.
(Reporting by Rodrigo Campos; Editing by Kenneth Barry)
ALMATY (Reuters) - Major powers will offer Iran some sanctions relief during talks in Almaty, Kazakhstan, this week if Tehran agrees to curb its nuclear program, a U.S. official said on Monday.
But the Islamic Republic could face more economic pain if it fails to address international concerns about its atomic activities, the official said ahead of the February 26-27 meeting in the central Asian state, speaking on condition of anonymity.
"There will be continued sanctions enforcement ... there are other areas where pressure can be put," the official said, on the eve of the first round of negotiations between Iran and six world powers in eight months.
A spokesman for European Union foreign policy chief Catherine Ashton, who leads the talks with Iran on behalf of the powers, said Tehran should understand that there was an "urgent need to make concrete and tangible progress" in Kazakhstan.
Both Russia and the United States stressed there was not an unlimited amount of time to resolve a dispute that has raised fears of a new war in the Middle East.
"The window for a diplomatic solution simply cannot by definition remain open forever. But it is open today. It is open now," U.S. Secretary of State John Kerry told a news conference in London. "There is still time but there is only time if Iran makes the decision to come to the table and negotiate in good faith."
Russian Deputy Foreign Minister Sergei Ryabkov said there was "no more time to waste", Interfax news agency quoted him as saying in Almaty.
The immediate priority for the powers - the United States, Russia, China, Germany, Britain and France - is to convince Iran to halt its higher-grade enrichment, which is a relatively short technical step away from potential atom bomb material.
Iran, which has taken steps over the last year to expand its uranium enrichment activities in defiance of international demands to scale it back, wants a relaxation of increasingly harsh sanctions hurting its lifeline oil exports.
Western officials say the Almaty meeting is unlikely to produce any major breakthrough, in part because Iran's presidential election in June may make it difficult for it to make significant concessions before then for domestic reasons.
But they say they hope that Iran will take their proposals seriously and engage in negotiations to try to find a diplomatic settlement.
"No one is expecting to walk out of here with a deal but ... confidence building measures are important," one senior Western official said.
The stakes are high: Israel, assumed to be the Middle East's only nuclear-armed arsenal, has strongly hinted at possible military action to prevent its old foe from obtaining such arms. Iran has threatened to retaliate if attacked.
GOLD SANCTIONS RELIEF?
The U.S. official said the powers' updated offer to Iran - a modified version of one rejected by Iran in the unsuccessful talks last year - would take into account its recent nuclear advances but also take "some steps in the sanctions arena".
This would be aimed at addressing some of Iran's concerns, the official said, while making clear it would not meet Tehran's demand of an easing of all punitive steps against it.
"We think ... there will be some additional sanctions relief" in the powers' revised proposal," the official said, without giving details.
Western diplomats have told Reuters the six countries will offer to ease sanctions on trade in gold and precious metals if Iran closes its Fordow underground uranium enrichment plant.
Iran has indicated, however, that this will not be enough.
Tehran denies Western allegations it is seeking to develop the capability to make nuclear bombs, saying its program is entirely peaceful. It wants the powers to recognize what it sees as its right to refine uranium for peaceful purposes.
The U.S. official said the powers hoped that the Almaty meeting would lead to follow-up talks soon.
"We are ready to step up the pace of our meetings and our discussions," the official said, adding the United States would also be prepared to hold bilateral talks with Tehran if it was serious about it.
Ashton's spokesman, Michael Mann, said the updated offer to Iran was "balanced and a fair basis" for constructive talks.
(Additional reporting by Yeganeh Torbati and Dimitry Solovyov; Editing by Jon Hemming)
GROSSE POINTE SHORES, Mich. (AP) — Facebook is apologizing for a problem that makes a 104-year-old Michigan woman lie about her age on the social media website.
Marguerite Joseph‘s granddaughter says Facebook won’t let Joseph list her real age.
Gail Marlow says when she tries inputting her grandmother’s birth year as 1908, Facebook changes it to 1928. So for the past two years, the Grosse Pointe Shores centenarian has remained 99 — online, anyway.
Joseph is legally blind and can’t hear well, but Marlow reads and responds to all her Facebook messages.
Marlow tells WDIV-TV (http://bit.ly/Y7HQM2 ) she’d “love to see” Joseph’s real age posted and chalks it up to “a glitch in the system.”
Facebook spokesman Andrew Noyes told The Associated Press on Wednesday that it’s working to fix a problem limiting used of pre-1910 birthdates.
___
Information from: WDIV-TV, http://www.clickondetroit.com
Social Media News Headlines – Yahoo! News
02/24/2013 at 08:40 AM EST
From left: Bradley Cooper, Oscar, Jessica Chastain
AFP/Getty; Wireimage; Splash News Online
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.
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We're looking forward to a fun, fashion-filled night – see you then!
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
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
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)
While BlackBerry (BBRY) lets its enterprise guard down to focus more on wooing the consumer market, Samsung (005930) appears poised to attack the enterprise market and pick up where BlackBerry left off. The Wall Street Journal on Friday followed up a Reuters report from last month, stating that Samsung is readying a full-scale attack on businesses using momentum from its massive success in the consumer market.
[More from BGR: The insane pricing of the new HTC One]
The paper states that Samsung has “hired dozens of executives and salespeople from rivals and from mobile-security companies, while investing in other smaller, mobile security and data firms.” An earlier report suggested that Samsung plans to unveil its own enterprise platform next week that will compete with BlackBerry 10, however the Journal claims Samsung is focused on convincing companies that its Android-powered smartphones are already just as secure as BlackBerry devices.
[More from BGR: ‘Anonymous’ becomes latest victim in Twitter hacking spree]
According to the report, Samsung bosses in South Korea have made enterprise sales a ”top three priority.”
This article was originally published on BGR.com
Gadgets News Headlines – Yahoo! News
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.
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
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
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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