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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Wall Street edges up after Italy exit polls

NEW YORK (Reuters) - Stocks opened slightly higher on Monday after initial polls showed pro-reform center-leftists could win the Italian general election, though caution remained as defensive sectors led gains on the S&P 500.

The Dow Jones industrial average <.dji> rose 41.47 points or 0.3 percent, to 14,042.04, the S&P 500 <.spx> gained 6.81 points or 0.45 percent, to 1,522.41 and the Nasdaq Composite <.ixic> added 18.79 points or 0.59 percent, to 3,180.61.

(Editing by Kenneth Barry)

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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 at 6 p.m. ET when we roll out the red carpet for our PEOPLE.com VIPs.

Here's what you can expect:
• Tune in to our 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 Oscars ballot – and make your own Academy Awards picks
• Tweet with our editors at #PeopleOscars
• 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

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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 announces uranium finds, days before nuclear talks

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

State news agency IRNA quoted a report by the Atomic Energy Organisation of Iran (AEOI) which said the reserves were discovered in northern and southern coastal areas and had trebled the amount outlined in previous estimates.

There was no independent confirmation. With few uranium mines of its own, Western experts had previously thought that Iran 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 AEOI, was quoted as saying at Iran's annual nuclear industry conference.

The timing of the announcement suggested 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, known as the P5+1, are set 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 fissile purity of 20 percent demonstrates its intent to develop a nuclear weapons capability, an allegation the Islamic republic denies.

FROM MINE TO CENTRIFUGE

The enriched uranium required for use in nuclear reactors or weapons is produced in centrifuges that spin uranium hexafluoride gas (UF6) at high speeds. The UF6 is derived from yellow cake, a concentrate from uranium ore discovered in mines.

Iran's reserves of raw uranium now stood at around 4,400 tonnes, taking into account 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 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 Gulf, Sea of Oman, Khuzestan province and the Caspian Sea.

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 that 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 two sides in 2012.

"We are meeting all of our obligations under the nuclear Non-Proliferation Treaty and we should be able to benefit from our rights. We don't accept more responsibilities and less rights," Saeed Jalili, Iran's chief nuclear negotiator, was quoted as telling Saturday's conference.

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 centre of the country.

Western diplomats say the P5+1 will reiterate demands for the suspension of uranium enrichment to a purity of 20 percent, the closure of Iran's Fordow enrichment plant, increased access for International Atomic Energy Agency inspectors and 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 P5+1 group wants to start constructive talks with Tehran it needs to present a valid proposal," said Jalili. "It needs to put its past errors to one side ... to win the trust of the Iranian nation."

In a statement issued before the Iranian announcement, 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 Almaty are a chance which I hope Iran takes," he said.

(Additional reporting by Alexandra Hudson in Berlin; Editing by Mark Trevelyan)

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Reeva Steenkamp's Father: If Oscar Pistorius Speaks the Truth, 'I Can Perhaps Someday Forgive Him'

By Stephen M. Silverman

02/23/2013 at 09:30 AM EST

Oscar Pistorius and Reeva Steenkamp

Elite/EMPICS Entertainment/ABACA

Having been freed on bail Friday as he awaits trial for the premeditated murder of his girlfriend Reeva Steenkamp, Oscar Pistorius "will have to live with his conscience," her father said Saturday.

Speaking to the Beeld newspaper (and translated by the BBC), Barry Steenkamp – referring to Pistorius's claim that he fatally fired his gun four times at Reeva because he thought an intruder had broken into his house – said: "If it didn't happen the way he says it did, he must suffer and he will suffer."

Steenkamp also said, "It does not matter how much money he has and how good his legal team is, he will have to live with his conscience. But if he speaks the truth, I can perhaps someday forgive him."

The next hearing for the Paralympian, 26, is scheduled for June 4.

Besides setting bail at $114,000 – the amount is considered high for a murder trial in South Africa, reports The New York Times – Magistrate Nair Desmond also ordered Pistorius to relinquish firearms and passports, and to stay away from his home, because it is an official crime scene.

In addition, he is not permitted to contact witnesses, leave Pretoria without official permission or use drugs or alcohol. He is to report to a police station twice every week.

Arnold Pistorius, an uncle speaking on behalf of the family, told reporters Friday, "We are relieved by the fact that Oscar got bail today, but at the same time, we are in mourning for Reeva Steenkamp and her family."

Oscar Pistorius is reportedly staying at Arnold's home in an upscale part of Pretoria. News photos showed the athlete being picked up from the courtroom and driven away by his sister, Aimee.

Reeva Steenkamp's mother June told Beeld that the Pistorius family had sent a bouquet of flowers.

"But what does it mean?" she said. "Nothing."

Read More..

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..

Oscar Pistorius to Be Released on Bail

Breaking News

By Stephen M. Silverman

02/22/2013 at 09:25 AM EST

Oscar Pistorius, Feb. 22, 2013

AP

Prosecutors in South Africa were defeated Friday in their effort to deny bail for "Blade Runner" Oscar Pistorius, the double-amputee track star accused of the premeditated Feb. 14 murder of his girlfriend, Reeva Steenkamp.

Pistorius will be released on U.S. $114,000 bail, CNN reports.

Chief Magistrate Desmond Nair announced his decision in a packed Pretoria courtroom Friday afternoon. Over the past four days during the bail hearing, both authorities and Pistorius's legal team agreed that he killed Steenkamp, 29, but the athlete says he killed her accidentally after he mistook her for an intruder.

In final arguments Friday morning, prosecutor Gerrie Nel, having called the accused a flight risk, told the judge that Pistorius, 26, didn't deserve bail. CNN reports. "He must realize that long-term imprisonment is almost guaranteed," said Nel. "He might think he'll be acquitted."

The prosecutor also said: "We all know that a lot of important people were granted bail and they stayed in the country. But lots of very important people have escaped."

"What kind of life would he lead if he were to flee?" asked the magistrate.

"A life of freedom," Nel replied.

The judge later said in lengthy remarks leading up to his decision Friday that he did not find that it had been established that Pistorius posed a flight risk. Nair also said that he was aware that releasing the accused could lead to "shock and outrage" in the community.

Entering the courtroom Friday, Pistorius bowed his head, and later appeared to be holding back tears when Nel recounted Steenkamp's plight on the fateful night, reports The New York Times.

"I am not saying the planning of the murder of Reeva Steenkamp happened weeks ahead, days ahead," said Nel, according to the newspaper. "I am saying the planning to kill Reeva Steenkamp happened that night."

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Govs to hear Oregon health care plan

SALEM, Ore. (AP) — Oregon Gov. John Kitzhaber will brief other state leaders this weekend on his plan to lower Medicaid costs, touting an overhaul that President Barack Obama highlighted in his State of the Union address for its potential to lower the deficit even as health care expenses climb.

The Oregon Democrat leaves for Washington, D.C., on Friday to pitch his plan that changes the way doctors and hospitals are paid and improves health care coordination for low income residents so that treatable medical problems don't grow in severity or expense.

Kitzhaber says his goal is to win over a handful of other governors from each party.

"I think the politics have been dialed down a couple of notches, and now people are willing to sit down and talk about how we can solve the problem" of rising health care costs, Kitzhaber told The Associated Press in a recent interview.

Kitzhaber introduced the plan in 2011 in the face of a severe state budget deficit, and he's been talking for two years about expanding the initiative beyond his state. Now, it seems he's found people ready to listen.

Hospital executives from Alabama visited Oregon last month to learn about the effort. And the U.S. Department of Health and Human Services announced Thursday that it's giving Oregon a $45 million grant to help spread the changes beyond the Medicaid population and share information with other states, making it one of only six states to earn a State Innovation Model grant.

Kitzhaber will address his counterparts at a meeting of the National Governors Association. His talk isn't scheduled on the official agenda, but a spokeswoman confirmed that Kitzhaber is expected to present.

"The governors love what they call stealing from one another — taking the good ideas and the successes of their colleagues and trying to figure out how to apply that in their home state," said Matt Salo, director of the National Association of Medicaid Directors.

There's been "huge interest" among other states in Oregon's health overhaul, Salo said, not because the concepts are brand new, but because the state managed to avoid pitfalls that often block health system changes.

Kitzhaber persuaded state lawmakers to redesign the system of delivering and paying for health care under Medicaid, creating incentives for providers to coordinate patient care and prevent avoidable emergency room visits. He has long complained that the current financial incentives encourage volume over quality, driving costs up without making people healthier.

Obama, in his State of the Union address this month, suggested that changes such as Oregon's could be part of a long-term strategy to lower the federal debt by reigning in the growing cost of federally funded health care.

"We'll bring down costs by changing the way our government pays for Medicare, because our medical bills shouldn't be based on the number of tests ordered or days spent in the hospital — they should be based on the quality of care that our seniors receive," Obama said.

The Obama administration has invested in the program, putting up $1.9 billion to keep Oregon's Medicaid program afloat over the next five years while providers make the transition to new business models and incorporate new staff and technology.

In exchange, though, the state has agreed to lower per-capita health care cost inflation by 2 percentage points without affecting quality.

The Medicaid system is unique in each state, and Kitzhaber isn't suggesting that other states should adopt Oregon's specific approach, said Mike Bonetto, Kitzhaber's health care policy adviser. Rather, he wants governors to buy into the broad concept that the delivery system and payment models need to change.

That's not a new theory. But Oregon has shown that under the right circumstances massive changes to deeply entrenched business models can gain wide support.

What Oregon can't yet show is proof the idea is working — that it's lowering costs without squeezing on the quality or availability of care. The state is just finishing compiling baseline data that will be used as a basis of comparison.

One factor driving the Obama administration's interest in Oregon's success is the president's health care overhaul. Under the Affordable Care Act, millions more Americans will join the Medicaid rolls after Jan. 1, and the health care system will have to be able to absorb the influx of patients in a logistically and financially sustainable way.

The federal government will pay 100 percent of the costs for those additional patients in the first three years before scaling back to 90 percent in 2020 and beyond.

"There are a lot of governors who are facing the same challenges we're facing in Oregon," Kitzhaber said. "They recognize that the cost of health care is something they're going to have to get their arms around."

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