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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Las Vegas Strip Shooting Suspect ID'd

Las Vegas police identified a suspect today in a shooting on the strip that caused a Maserati to hit a taxi and burst into flames, killing three people.

Ammar Harris, 26, has been named a suspect in the Thursday skirmish that killed three people, including rapper Kenny Clutch.

The altercation between Harris and Clutch, 27, whose legal name was Kenneth Cherry Jr., is believed to have originated in the valet area of a Las Vegas hotel, police said.

Police said Harris fired several rounds into a Maserati that was being driven by Cherry as both vehicles continued northbound on glitzy Las Vegas Boulevard.

The rapper's expensive sports car careened out of control after he was shot, slamming into several cars, including a taxi. The impact caused the cab to burst into flames, killing the driver, Michael Boldon and a female passenger. Witnesses said it looked like the car exploded.

"He was a number one guy," Carolyn Jean Trimble, Boldon's sister, told ABC News.

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"I looked out my window and I could see one vehicle down here on the corner of the intersection totally engulfed in flames," witness John Lamb told ABC News.

Boldon, 62, and his passenger, who has not yet been identified, were both killed, as was Clutch.

Timble said her brother loved driving his taxi around Vegas.

"He came to live with me in Las Vegas last year to help take care of our mother, and the first day he got here he said, 'I have to get a job.' The second day, I came home from work, and he said he got a job," she recalled.

"He says, 'You'll never guess what it is,' and I said, 'what,' and he said, 'taxi cab driver,' and we both fell out laughing," Trimble said. "He loved that job. He never complained. He'd come home and tell me stories about what happened, who he picked up."

Boldon was a single father who raised a 36-year-old son and was a new grandfather. His grandson was named after him, Trimble said.

"Of all the people to take from this earth," she said. "But I guess the Lord needed him."

A passenger in the Maserati was hit and sustained only a minor injury to his arm. Clutch died at University Medical Center.

His father, Kenneth Cherry Sr., expressed his grief for the loss of his son while speaking with ABC News.

"This is something you never really, really ever want to experience as a parent, to lose a child before you go," he said.

Harris is described as 5-foot-11 and 180 pounds. Anyone with information is asked to contact the Las Vegas Metro Police Department's homicide division.

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Italians head to polls in crucial vote for euro zone

ROME (Reuters) - Italians vote on Sunday in one of the most closely watched elections in years with markets nervous about whether it will produce a strong government to pull Italy out of recession and help resolve the euro zone debt crisis.

A huge final rally by anti-establishment-comedian-turned-politician Beppe Grillo on Friday before a campaigning ban kicked in has highlighted public anger at traditional parties and added to uncertainty about the election outcome.

Polling booths will open between 02:00 am-04:00 pm EST on Sunday and 01:00 am-09:00 am EST on Monday. Exit polls will come out soon after voting ends and official results are expected by early Tuesday.

The election will be followed closely by financial markets with memories still fresh of the potentially catastrophic debt crisis that brought technocrat Prime Minister Mario Monti to power more than a year ago.

Italy, the euro zone's third-largest economy, is stuck in deep recession, struggling under a public debt burden second only to Greece's in the 17-member currency bloc and with a public weary of more than a year of harsh austerity policies.

Italy's Interior Ministry has urged some 47 million eligible voters to not let bad weather forecasts put them off, and said it was prepared to handle even snowy conditions in some northern regions to ensure everyone had a chance to vote.

Final polls published two weeks ago showed center-left leader Pier Luigi Bersani with a five-point lead, but analysts disagree about whether he will be able to form a stable majority that can push though the economic reforms Italy needs.

Bersani is now thought to be just a few points ahead of center-right rival Silvio Berlusconi, the four-times prime minister who has promised tax refunds and staged a media blitz in an attempt to win back voters in recent weeks.

While the center left is still expected to gain control of the lower house thanks to rules that guarantee a strong majority to whichever party wins the most votes nationally, a much closer battle will be fought in the Senate, which any government also needs to control in order to be able to pass laws.

Seats in the upper house are awarded on a region-by-region basis, meaning that support in key regions can decisively influence the overall result.

Pollsters still believe the most likely outcome is a center-left government headed by Bersani and possibly backed by Monti, who is leading a centrist coalition.

But strong campaigning by Berlusconi and the fiery Grillo, who has drawn tens of thousands to his election rallies, have thrown the election wide open, causing concern that there may be no clear winner.

Whatever government emerges from the vote will have the task of pulling Italy out of its longest recession for 20 years and reviving an economy largely stagnant for two decades.

The main danger for Italy and the euro zone is a weak government incapable of taking firm action, which would rattle investors and could ignite a new debt crisis.

Monti replaced Berlusconi in November 2011 after the euro zone's third-largest economy came close to Greek-style financial meltdown while the center-right government was embroiled in scandals.

The former European Commissioner launched a tough program of spending cuts, tax hikes and pension reforms which won widespread international backing and helped restore Italy's credibility abroad after the scandals of the Berlusconi era.

Italy's borrowing costs have since fallen sharply after the European Central Bank pledged it was prepared to support countries undertaking reforms by buying unlimited quantities of their bonds on the markets.

But economic austerity has fuelled anger among Italians grappling with rising unemployment and shrinking disposable incomes, encouraging many to turn to Grillo, who has tapped into a national mood of disenchantment.

(Reporting by Catherine Hornby; Editing by Jason Webb)

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China gold output up nearly 12% in 2012: report

SHANGHAI: Gold production in China, the world's second largest market for the precious metal, surged nearly 12 percent year-on-year last year despite a slowdown in the domestic economy, state media reported.

Output rose to 403.1 tonnes in 2012, up 11.66 percent from 2011, the official Xinhua news agency said late Saturday, quoting figures from the Ministry of Industry and Information Technology.

China is the world's second largest consumer of gold after India. A global industry group, the World Gold Council, has put China's consumer demand for gold at 776.1 tonnes last year, flat from 2011.

The council attributed the stable Chinese demand to a slowdown in the domestic economy and consolidation in gold prices which discouraged investors, according to its latest report released this month.

China's economy -- the world's second largest -- grew at its slowest pace in 13 years in 2012, expanding 7.8 percent from the year before.

But the economy has been showing renewed vigour since late last year, with growth accelerating in the final three months of 2012 to 7.9 percent, snapping seven straight quarters of weakening expansion.

"The signs of economic improvement bode well for gold demand in China, although the indications are for a steady firming of demand rather than for strong growth," the World Gold Council said.

China's Ministry of Industry said domestic gold prices dropped in December last year as worries over the US "fiscal cliff" caused uncertainty.

US lawmakers clinched a last-gasp deal to avoid the fiscal cliff of tax hikes and spending cuts.

China's gold producers recorded a combined 35 billion yuan ($5.6 billion) in profits last year, up just 4.0 percent from 2011, the ministry said.

- AFP

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300% rise in terror financing cases: Report

NEW DELHI: Over 1,400 instances of terror financing in country's economic channels were red-flagged by intelligence and security agencies last year, a latest report of the finance ministry says, marking a 300% jump in such suspicious transactions.

The Financial Intelligence Unit (FIU), which functions under the ministry, has reported that it had received 1,444 reports during 2011-12 from agencies like the intelligence bureau, the Research and Analysis Wing and those in the economic domain and affiliated to the Income Tax and Customs departments.

The figure of such reports from these agencies stood at 428 during 2010-11, the agency says.

"The FIU also supports the efforts of domestic intelligence and law enforcement agencies against terror financing by providing information specifically requested by them, either by searching its database or by calling specific information from the reporting entities," the report says.

The FIU is the national agency responsible for receiving, analyzing and disseminating suspicious transaction reports (STRs) to security and anti-money laundering and tax evasion departments of the country.

The agency also reported a more than 100 per cent rise in the number of STRs received during 2011-12 as it collected a total of 69,224 such reports during this period as compared to 20,698 STRs during 2010-11.

The instances of reportage of fake currency in Indian banking channels are also on the rise, the FIU says.

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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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Cyberattacks Bring Attention to Security Reform

Recent accusations of a large-scale cyber crime effort by the Chinese government left many wondering what immediate steps the president and Congress are taking to prevent these attacks from happening again.

On Wednesday, the White House released the administration's Strategy on Mitigating the Theft of U.S. Trade Secrets as a follow-up to the president's executive order. The strategy did not outwardly mention China, but it implied U.S. government awareness of the problem.

"We are taking a whole of government approach to stop the theft of trade secrets by foreign competitors or foreign governments by any means -- cyber or otherwise," U.S. Intellectual Property Enforcement Coordinator Victoria Espinel said in a White House statement.

As of now, the administration's strategy is the first direct step in addressing cybersecurity, but in order for change to happen Congress needs to be involved. So far, the Cyber Intelligence Sharing and Protection Act (CISPA) is the most notable Congressional legislation addressing the problem, despite its past controversy.

Last April, CISPA was introduced by House Intelligence Committee Chairman Mike Rogers, R-Mich., and Rep. Dutch Ruppersberger, D-Md. The act would allow private companies with consumer information to voluntarily share those details with the NSA and the DOD in order to combat cyber attacks.

Peter Parks/AFP/Getty Images

The companies would be protected from any liabilities if the information was somehow mishandled. This portion of the act sounded alarm bells for CISPA's opponents, like the ACLU, which worried that this provision would incentivize companies to share individuals' information with disregard.

CISPA passed in the House of Representatives, despite a veto threat from the White House stemming from similar privacy concerns. The bill then died in the Senate.

This year, CISPA was reintroduced the day after the State of the Union address during which the president declared an executive order targeting similar security concerns from a government standpoint.

In contrast to CISPA, the executive order would be initiated on the end of the government, and federal agencies would share relevant information regarding threats with private industries, rather than asking businesses to supply data details. All information shared by the government would be unclassified.

At the core of both the executive order and CISPA, U.S. businesses and the government would be encouraged to work together to combat cyber threats. However, each option would clearly take a different route to collaboration. The difference seems minimal, but has been the subject of legislative debates between the president and Congress for almost a year, until now.

"My response to the president's executive order is very positive," Ruppersberger told ABC News. "[The president] brought up how important information sharing is [and] by addressing critical infrastructure, he took care of another hurdle that we do not have to deal with."

Addressing privacy roadblocks, CISPA backers said the sharing of private customer information with the government, as long as personal details are stripped, is not unprecedented.

"Think of what we do with HIPAA in the medical professions; [doctors do not need to know] the individual person, just the symptoms to diagnose a disease," Michigan Gov. John Engler testified at a House Intelligence Committee hearing in an attempt to put the problem into context.

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Abe vows to revive Japanese economy, sees no escalation with China

WASHINGTON (Reuters) - Japanese Prime Minister Shinzo Abe told Americans on Friday "I am back and so is Japan" and vowed to get the world's third biggest economy growing again and to do more to bolster security and the rule of law in an Asia roiled by territorial disputes.

Abe had firm words for China in a policy speech to a top Washington think-tank, but also tempered his remarks by saying he had no desire to escalate a row over islets in the East China Sea that Tokyo controls and Beijing claims.

"No nation should make any miscalculation about firmness of our resolve. No one should ever doubt the robustness of the Japan-U.S. alliance," he told the Center for Strategic and International Studies.

"At the same time, I have absolutely no intention to climb up the escalation ladder," Abe said in a speech in English.

After meeting U.S. President Barack Obama on his first trip to Washington since taking office in December in a rare comeback to Japan's top job, he said he told Obama that Tokyo would handle the islands issue "in a calm manner."

"We will continue to do so and we have always done so," he said through a translator, while sitting next to Obama in the White House Oval Office.

Tension surged in 2012, raising fears of an unintended military incident near the islands, known as the Senkaku in Japan and the Diaoyu in China. Washington says the islets fall under a U.S.-Japan security pact, but it is eager to avoid a clash in the region.

Abe said he and Obama "agreed that we have to work together to maintain the freedom of the seas and also that we would have to create a region which is governed based not on force but based on an international law."

Abe, whose troubled first term ended after just one year when he abruptly quit in 2007, has vowed to revive Japan's economy with a mix of hyper-easy monetary policy, big spending, and structural reform. The hawkish leader is also boosting Japan's defense spending for the first time in 11 years.

"Japan is not, and will never be, a tier-two country," Abe said in his speech. "So today ... I make a pledge. I will bring back a strong Japan, strong enough to do even more good for the betterment of the world."

'ABENOMICS' TO BOOST TRADE

The Japanese leader stressed that his "Abenomics" recipe would be good for the United States, China and other trading partners.

"Soon, Japan will export more, but it will import more as well," Abe said in the speech. "The U.S. will be the first to benefit, followed by China, India, Indonesia and so on."

Abe said Obama welcomed his economic policy, while Deputy Chief Cabinet Secretary Katsunobu Kato said the two leaders did not discuss currencies, in a sign that the U.S. does not oppose "Abenomics" despite concern that Japan is weakening its currency to export its way out of recession.

The United States and Japan agreed language during Abe's visit that could set the stage for Tokyo to join negotiations soon on a U.S.-led regional free trade agreement known as the Trans-Pacific Partnership.

In a carefully worded statement following the meeting between Obama and Abe, the two countries reaffirmed that "all goods would be subject to negotiations if Japan joins the talks with the United States and 10 other countries.

At the same time, the statement envisions a possible outcome where the United States could maintain tariffs on Japanese automobiles and Japan could still protect its rice sector.

"Recognizing that both countries have bilateral trade sensitivities, such as certain agricultural products for Japan and certain manufactured products for the United States, the two governments confirm that, as the final outcome will be determined during the negotiations, it is not required to make a prior commitment to unilaterally eliminate all tariffs upon joining the TPP negotiations," the statement said.

Abe repeated that Japan would not provide any aid for North Korea unless it abandoned its nuclear and missile programs and released Japanese citizens abducted decades ago to help train spies.

Pyongyang admitted in 2002 that its agents had kidnapped 13 Japanese in the 1970s and 1980s. Five have been sent home, but Japan wants better information about eight who Pyongyang says are dead and others Tokyo believes were also kidnapped.

Abe also said he hoped to have a meeting with new Chinese leader Xi Jinping, who takes over as president next month, and would dispatch Finance Minister Taro Aso to attend the inauguration of incoming South Korean President Park Geun-hye next week.

(Additional reporting by Jeff Mason and Doug Palmer; Editing by David Brunnstrom and Paul Simao)

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Taiwan ex-president's prison term extended

TAIPEI: Taiwan's former president Chen Shui-bian, jailed for corruption in 2009, has had his prison term extended by 18 months to 20 years due to a further bribery conviction.

Chen, 62, was already serving an 18 1/2-year term for corruption and money-laundering convictions relating to his 2000-2008 presidency -- charges he says stem from a vendetta by the current Beijing-friendly government.

The high court ruled Friday that Chen should serve the extra time for taking bribes from businessmen in a high-profile financial merger case. He was convicted of the offences in December.

Chen's wife Wu Shu-chen also saw her jail term extended to 20 years, although she has been spared from serving her sentence due to poor health.

The couple were also ordered to pay a total fine of Tw$450 million (US$15 million), the court said in a statement.

They face further charges in other cases, but legal experts say their sentences are unlikely to be extended again as individuals can only serve a maximum of 20 years in jail unless a life term is imposed.

Chen's supporters have urged the government to grant him parole for medical treatment saying he is suffering from depression and other health problems. He has been undergoing treatment in a Taipei public hospital since September.

Chen and his family have been accused of laundering millions of dollars by sending political donations and secret diplomatic funds abroad, and taking kickbacks on government contracts.

Chen insists that the charges against him are part of a politically motivated vendetta carried out by Taiwan's current government in retaliation for his eight years in power, when he promoted Taiwan's independence from China.

-AFP/fl

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59-hour countdown for Isro's PSLV-C20 begins

CHENNAI: The 59-hour countdown for the February 25 launch of Polar Satellite Launch Vehicle to put into orbit seven satellites, including Indo-French spacecraft SARAL, commenced at 6.56am today at the Satish Dhawan Space Centre in the spaceport of Sriharikota.

The Launch Authorisation Board earlier cleared the launch schedule for February 25 at 5.56 PM from the first launch pad in Sriharikota, about 90 kms from here, Isro sources said.

PSLV-C20, the 23rd PSLV Mission of Isro, would put the 400 kg Indo-French satellite and six others into orbit.

SARAL refers to Satellite with ARgos and ALtika. The French space agency CNES has developed ARgos and ALtikameter for analysing the ocean.

The rehearsal launch of PSLV - C20 with the primary satellite SARAL and six other foreign satellites has been completed satisfactorily, the sources said.

The other six auxiliary payloads are - two each from Canada, Austria and one each from Denmark and the United Kingdom.

President Pranab Mukherjee is likely to witness the launch along with Andhra Pradesh chief minister Kiran Kumar Reddy.

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