Curious about went down backstage during the ceremony? We've got your all-access pass!
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)
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 — Pope Benedict spoke from his window for the last time on Sunday, telling the faithful packed into St. Peter’s Square that the first papal abdication in centuries was God’s will and insisting he was not abandoning the Church.
Four days before the 85-year-old Benedict’s often troubled eight-year rule ends, new talk of scandal hit the cardinals who will choose his successor; one of them, a Scottish archbishop, had to deny news media accusations of misconduct with priests in the 1980s.
With an American cardinal urged not to go to the electoral conclave because of his role in handling sexual abuse cases in the United States, and the Vatican accusing media of running smears to influence the vote, the Church faces a stormy succession.
Benedict, however, defended his shock decision to resign as dictated by his failing health; his address to tens of thousands of well-wishers was met with calls of “Viva il Papa!”
“The Lord is calling me to climb the mountain, to dedicate myself even more to prayer and meditation,” the German-born pontiff said in Italian, his voice strong and clear.
“But this does not mean abandoning the Church. Actually, if God asks this of me, it is precisely because I can continue to serve her with the same dedication and the same love I have shown so far,” he said, adding that he would be serving the Church “in a way more in keeping with my age and my strengths”.
As he spoke, two of the some 117 cardinals who will enter the conclave next month to choose his successor as leader of the 1.2 billion Roman Catholics were mired in controversy.
Britain’s top Catholic cleric, Cardinal Keith O’Brien of Edinburgh, rejected claims in The Observer newspaper that he had been involved in unspecified inappropriate behavior with other priests.
The paper said Cardinal O’Brien, 74, known for his outspoken views against homosexuality, had been reported to the Vatican by three priests and a former priest, who said they had come forward to demand he resign and not take part in the conclave.
“Cardinal O’Brien contests these claims and is taking legal advice,” a spokesman for the cardinal said.
He was the second cardinal to be caught up in controversy over his attendance ahead of the conclave. On Saturday, Catholic activists petitioned Cardinal Roger Mahony to recuse himself from the conclave so as not to insult survivors of sexual abuse by priests committed while he was archbishop of Los Angeles..
In that post from 1985 until 2011, Cardinal Mahony worked to send priests known to be abusers out of state to shield them from law enforcement scrutiny in the 1980s, according to church files unsealed under a federal district. court order last month.
The minds of those in the crowd in St Peter’s Square on Sunday, some holding banners reading “Thank you Holy Father,” were not on scandals, real or potential, but on the Church history unfolding around them.
“It’s bittersweet,” said Sarah Ennis, 21, a student from Minnesota who studies in Rome. “Bitter because we love our Pope Benedict and hate to see him go, but sweet because he is going for a good reason and we are excited to see the next pope.”
Others, however, saw it as a possible harbinger for the Church.
“This is an ill wind blowing,” said Marina Tacconi, a midwife. “It feels like something ugly could happen. I’m 58 years old, I have seen popes come and go. But never one resign.”
The Sunday address was one of Benedict’s last appearances as pontiff before the curtain comes down on a problem-ridden pontificate.
On Wednesday, he will hold his last general audience in St. Peter’s Square and on Thursday he will meet with cardinals and then fly to the papal summer retreat south of Rome.
The papacy will become vacant on Thursday night.
Cardinals will begin meetings the next day to prepare for a secret conclave in the Sistine Chapel.
They have already begun informal consultations by phone and e-mail in the last two weeks since Benedict announced his abdication in order to build a profile of the man they think would be best suited to lead the Church.
On Monday, the pope is expected to issue slight changes to Church rules governing the conclave so that it could start before March 15, the earliest it can be held under a detailed constitution by his predecessor John Paul.
Some cardinals believe a conclave should start sooner than March 15 in order to reduce the time in which the Church will be without a leader. But some in the Church believe that an early conclave would give an unfair advantage to cardinals already in Rome and working in the Curia, the Vatican’s central administration, which has been at the center of accusations of ineptitude that some say led Benedict to step down.
The Vatican appears to be aiming to have a new pope elected by mid-March and then installed before Palm Sunday on March 24 so he can preside at Holy Week services leading to Easter.
From left: Bradley Cooper, Oscar, Jessica Chastain
AFP/Getty; Wireimage; Splash News Online
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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)
There will be no direct financial compensation from the United Nations for the more than 8,000 Haitians who died and the 646,000 sickened by cholera since the disease struck the earthquake-ravaged country in October 2010, Secretary General Ban Ki-moon told the Haitian president this week.
More than 15 months after the United Nations received a legal claim seeking to hold peacekeeping troops responsible for setting off the epidemic, its lawyers declared the claim “not receivable,” citing diplomatic immunity.
At the same time, Partners in Health, the leading nongovernmental health care provider in Haiti, has stepped forward to urge the United Nations to invest more seriously in Mr. Ban’s own largely unfunded anticholera initiative to make amends.
In an Op-Ed article posted Friday night on the Web site of The New York Times, Dr. Louise C. Ivers, the group’s senior health and policy adviser, says the United Nations has “a moral, if not legal, obligation to help solve a crisis it inadvertently helped start.” Evidence, she said, finds the United Nations “largely, though not wholly” culpable for the outbreak of cholera.
To date, Mr. Ban has not acknowledged the reigning scientific theory about the origin of Haiti’s cholera epidemic — that peacekeepers from Nepal imported the cholera and, through a faulty sanitation system at their base, infected a tributary of the country’s largest river.
Dr. Ivers, however, while noting the “causality” of epidemic disease is complex, says that no other reasonable hypothesis for Haiti’s cholera has been put forth.
What makes her comments especially striking is that her organization’s co-founder and chief strategist, Dr. Paul Farmer, served as the United Nations’ deputy special envoy for Haiti for the past three years and was appointed by Mr. Ban in December to lead the very anticholera initiative that she found lacking.
Dr. Farmer declined to comment, but a spokeswoman for Partners in Health said Dr. Ivers’s statements represented the group’s concerns about the 10-year, $2.2 billion anticholera initiative that he was supposed to advise.
The ambitious initiative is intended to upgrade Haiti’s abysmal water and sanitation infrastructure while increasing cholera prevention and treatment efforts, including the expansion of a small cholera vaccination campaign that Partners in Health and a Haitian health care group, Gheskio, undertook last year.
Donors have pledged $215 million. The United Nations said it would contribute $23.5 million — 1 percent of the initiative’s cost, Dr. Ivers said.
In contrast, she said, this year’s budget for the United Nations peacekeeping mission, $648 million, “could more than fund the entire cholera elimination initiative for two years.”
Expressing his “deep sorrow and solidarity with the many Haitian families who lost loved ones in this terrible epidemic,” Nigel Fisher, the new head of the peacekeeping mission, nonetheless said that the United Nations had “mobilized resolutely to combat the disease.” It spent some $118 million on cholera before the initiative was announced, officials have said.
Mr. Ban, through his spokesman, also expressed “his profound sympathy” while announcing on Thursday that the legal claim had been rejected.
Mario Joseph, lead lawyer for the cholera victims, said, “While these sympathies are welcome, they will not stop cholera’s killing or ensure that survivors can go on living after losing breadwinners to cholera.”
The demand, filed in an internal United Nations claims unit, had sought $100,000 for each bereaved family and $50,000 for each cholera survivor.
Mr. Joseph described the United Nations’ terse rejection of a claim filed over a year ago as “disgraceful,” and he and his American colleagues at the Institute for Justice and Democracy in Haiti said they would file a lawsuit in Haiti or abroad.
Though the death rate from cholera has declined significantly since the epidemic initially devastated Haiti, the disease is still coursing through the country. National statistics show a spike of reported cases in December 2012 over that same month in 2011 — 11,220 compared with 8,205.
“The U.N. will not pay,” said a headline Friday on the Web site of Haiti’s Le Nouvelliste newspaper.
“It’s not surprising,” a reader responded.
This article has been revised to reflect the following correction:
Correction: February 23, 2013
An earlier version of this article misrendered a quotation from an Op-Ed article by Dr. Louise C. Ivers. The quotation should have read “largely, though not wholly,” not “largely, if not wholly.”
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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