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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Oscars 2013: 'Argo' Wins Best Picture

"Argo" took home the top prize as best picture at the Oscars Sunday night, with first lady Michelle Obama announcing the winner from the White House.

"You directed a hell of a film," co-producer Grant Heslov told director and fellow producer Ben Affleck. "I couldn't be more proud of the film and more proud of our director."

Affleck was snubbed in the directing category but humbly accepted the best picture Oscar as one of the three producers on the film. George Clooney was the third.

Affleck thanked Stephen Spielberg and the other best picture nominees and his wife Jennifer Garner for "working on our marriage."

"It's good, it's work," he said, adding, "but there's no one I'd rather work with."

For Full List of Winners

Acknowledging his last Oscar win, as a screenwriter for "Good Will Hunting," Affleck said, "I was really just a kid. I never thought I would be back here."

In the acting categories, Daniel Day-Lewis won the Oscar for best actor, being the first actor to three-peat in that category. As he accepted the award from Hollywood's greatest actress, Meryl Streep, he joked, "I had actually been committed to play Margaret Thatcher. ... Meryl was Stephen's first choice for Lincoln."

He also thanked his wife, Rebecca Miller, for "living with some very strange men," with each new role that he takes on.

"She's the versatile one in the family and she's been the perfect companion to all of them," he said.

Kevin Winter/Getty Images

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Jennifer Lewis won the award for best actress. She tripped on the stairs on her way to accepting her award but picked herself up and made her way to the stage, earning a standing ovation.

"You're just standing up because you feel bad that I fell and that's embarrassing," she said, before rattling off a list of thank-yous and leaving the stage looking slightly stunned.

Watch Jennifer Lawrence's Oscar Tumble

"Life of Pi," which had a total of 11 nominations, was another big winner of the night. Director Ang Lee took home the Oscar for best director over Stephen Spielberg and David O. Russell.

"Thank you, movie god," Lee said, accepting his award.

As expected, the film took home the first technical awards of the night for cinematography and visual effects. "Life of Pi" also won for best original score.

The first big acting awards of the night went to Christoph Waltz and Anne Hathaway in the supporting actor categories.

In one of the biggest tossups, Waltz claimed the award for supporting actor for his role in "Django Unchained." It was his second Oscar for a Quentin Tarantino film; his first was for Tarantino's "Inglourious Basterds."

PHOTOS: Stars on the Red Carpet

As expected, Hathaway took home the award for best supporting actress for her role as Fantine in "Les Miserables."

"It came true," she said, launching into a breathy speech, in which she thanked the cast and crew, her team and her husband. "The greatest moment of my life was when you walked into it," she said.

Quentin Tarantino won the Oscar for best original screenplay for his slave revenge western "Django Unchained." He thanked his cast.

"I have to cast the right people," he said. "And boy this time did I do it."

Chris Terrio won the award for best adapted screenplay for "Argo," which also won for film editing.

For only the sixth time in Academy history, there was a tie at the Oscars. "Zero Dark Thirty" and "Skyfall" tied for sound editing.

See Other Ties in Academy History

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Cuban leader Raul Castro says he will retire in 2018

HAVANA (Reuters) - Cuban President Raul Castro announced on Sunday he will step down from power after his second term ends in 2018, and the new parliament named a 52-year-old rising star to become his first vice president and most visible successor.

"This will be my last term," Castro, 81, said shortly after the National Assembly elected him to a second five-year tenure.

In a surprise move, the new parliament also named Miguel Diaz-Canel as first vice president, meaning he would take over if Castro cannot serve his full term.

Diaz-Canel is a member of the political bureau who rose through the Communist Party ranks in the provinces to become the most visible possible successor to Castro.

Raul Castro starts his second term immediately, leaving him free to retire in 2018, aged 86.

Former President Fidel Castro joined the National Assembly meeting on Sunday, in a rare public appearance. Since falling ill in 2006 and ceding the presidency to his brother, the elder Castro, 86, has given up official positions except as a deputy in the National Assembly.

The new government will almost certainly be the last headed up by the Castro brothers and their generation of leaders who have ruled Cuba since they swept down from the mountains in the 1959 revolution.

Cubans and foreign governments were keenly watching whether any new, younger faces appeared among the Council of State members, in particular its first vice president and five vice presidents.

Their hopes were partially fulfilled with Diaz-Canel's ascension. He replaces former first vice president, Jose Machado Ventura, 82, who will continue as one of five vice presidents.

Commander of the Revolution Ramiro Valdes, 80, and Gladys Bejerano, 66, the comptroller general, were also re-elected as vice presidents.

Two other newcomers, Mercedes Lopez Acea, 48, first secretary of the Havana communist party, and Salvador Valdes Mesa, 64, head of the official labor federation, also earned vice presidential slots.

Esteban Lazo, a 68-year-old former vice president and member of the political bureau of the Communist Party, left his post upon being named president of the National Assembly on Sunday. He replaced Ricardo Alarcon, who served in the job for 20 years.

Six of the Council's top seven members sit on the party's political bureau which is also lead by Castro.

Castro's announcement came as little surprise to Cuban exiles in Miami.

"It's no big news. It would have been big news if he resigned today and called for democratic elections," said Alfredo Duran, a Cuban-American lawyer and moderate exile leader in Miami who supports lifting the U.S. trade embargo against Cuba. "I wasn't worried about him being around after 2018," he added.

The National Assembly meets for just a few weeks each year and delegates its legislative powers between sessions to the 31-member Council of State, which also functions as the executive through the Council of Ministers it appoints.

Eighty percent of the 612 deputies, who were elected in an uncontested vote February 3, were born after the revolution.

EFFORT TO PROMOTE YOUNGER GENERATION

Raul Castro, who officially replaced his ailing brother as president in 2008, has repeatedly said senior leaders should hold office for no more than two five-year terms.

"Although we kept on trying to promote young people to senior positions, life proved that we did not always make the best choice," Castro said at a Communist Party Congress in 2011.

"Today, we are faced with the consequences of not having a reserve of well-trained replacements ... It's really embarrassing that we have not solved this problem in more than half a century."

Speaking on Sunday, Castro hailed the composition of the new Council of State as an example of what he had said needed to be accomplished.

"Of the 31 members, 41.9 percent are women and 38.6 percent are black or of mixed race. The average age is 57 years and 61.3 percent were born after the triumph of the revolution," he said.

The 2011 party summit adopted a more than 300-point plan aimed at updating Cuba's Soviet-style economic system, designed to transform it from one based on collective production and consumption to one where individual effort and reward play a far more important role.

Across-the-board subsidies are being replaced by a comprehensive tax code and targeted welfare.

Raul Castro has encouraged small businesses and cooperatives in retail services, farming, minor manufacturing and retail, and given more autonomy to state companies which still dominate the economy.

The party plan also includes an opening to more foreign investment.

At the same time, Cuba continues to face a U.S. administration bent on restoring democracy and capitalism to the island and questions about the future largess of oil rich Venezuela with strategic ally Hugo Chavez battling cancer.

(Editing by Kieran Murray and Vicki Allen)

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Swimming: Magnussen reveals sleeping tabs 'tradition'

SYDNEY: World 100m freestyle champion James Magnussen -- who led the much-vaunted 4x100m Australian relay team which bombed spectacularly at the 2012 Olympics -- has claimed taking sleeping tablets was "a tradition".

The team last week admitted taking the prescription drug Stilnox, banned by the Australian Olympic Committee (AOC), as part of a "bonding exercise" ahead of the Games in London, where they failed even to reach the podium.

Five of the six team members took one of the sleeping tablets at a staging camp in Manchester after seeing a movie and going to dinner in a bid to build unity in the fiercely competitive team.

In an interview with Channel Seven aired late Sunday, Magnussen said during dinner that the discussion had turned to what previous relay teams had done to bond and the group had collectively decided to take the drug.

"The tradition had been, and what we did, was take Stilnox on its own with water," he said.

"We then sat around telling jokes, you know laughing, carrying on. It was really, I think, for a lot of us a chance to take a step back from the pressure."

Australian swimmers had previously used Stilnox to ensure a good night's rest before competition until the AOC banned it in the lead-up to London.

But use of the drug had been discouraged as far back as 2005, according to The Australian newspaper, which said former relay swimmers Michael Klim, Ashley Callus and Andrew Lauterstein had all denied taking it as a bonding tradition.

Recreational users of Stilnox often deliberately try to stay awake, which can induce a "high" and even cause hallucinations.

Magnussen, 21, denied he was out of control on the night when the team engaged in misbehaviour including door-knocking and prank-calling teammates but said he would not be repeating the incident.

The swimmer said he had learned "a lot about the repercussions of my behaviour" and admitted to being too arrogant before the Games.

"It has taken me a lot of reflection and a lot of time to admit that," he said. "But again I was inexperienced and I didn't know how big of a deal and how big of an event the Olympics was and how much of a part it was going to play mentally, and I didn't cope with it."

London was Australian swimming's first Games without an individual gold medal since the 1976 Montreal Olympics and marked Australia's lowest medal haul in the sport since Barcelona in 1992 with just one gold, six silver and three bronze.

Two reports into what went wrong in London found the squad lacked leadership and that "toxic" incidents such as drunkenness and bullying had gone unchecked.

-AFP/sb

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Lakhs throng Kumbh on Maghi Poornima

ALLAHABAD: The penultimate bathing day of the 55-day Mahakumbh - Maghi Poornima - began early on Monday at the Sangam here, with lakhs taking an early holy dip in the Ganga.

The day is special as the "Kalpawasi" pilgrims end their month-long penance and sabbatical from worldly life on Maghi Poornima.

More than 1.5 crore devotees are likely to take a holy dip at the Sangam - the confluence of rivers Ganga, Yamuna and the mystical Saraswati today.

The Kumbh mela administration has deployed extra police forces to man major intersections and roads in the sprawling 52 sq km mela premises. Photography has been banned at all bathing ghats, on the basis of a high court directive.

Special traffic arrangements are in place to divert devotees to less congested roads and ensure smooth exit after the ritual bath.

Still haunted by the tragic stampede of February 10 on Mauni Amavasya at the city railway station which left 37 dead, the railway protection force (RPF), civil police and the government railway police (GRP), along with Indian Railways, have made elaborate arrangements for the return of the crowds after bathing.

To meet the extra demand, the railways has opened additional ticketing counters at Prayag Ghat, Rae Bareilly, Lucknow, Faizabad, Ayodhya and Sultanpur.

Extra coaches too have been added to trains plying between Lucknow and Allahabad, a railway official told IANS.

"Additional teams of officials have been sent to all stations and all care is being taken to ensure smooth passage of the Maghi Poornima bathing," senior divisional commercial manager Ashwani Kumar Srivastava said.

The administration is on tenterhooks as it rained during the weekend, making the temporary roads unmotorable; large areas have been turned into swamps by rain.

According to the ascetics at the Kumbh, the auspicious time for bathing began at 1:40 Sunday night; it will continue till 2:01am Tuesday.

"Most people will take a bath during the auspicious time, though technically, bathing time ends at 1:41 pm on Monday, for 'Bhadra' is on till then. The Kalpavasis, who slept on thatched floor, gave up worldly life, cooked for themselves and lived in solitude since Makar Sankranti (Jan 14), will Monday disband their hutments and head back home. They will also take along a plant of Tulsi that they sowed on the first day of their Kalpwas," one ascetic explained to IANS.

The Kumbh, which falls after every 12 years, began this year at Allahabad Jan 14; it is set to conclude March 10, Maha Shivratri day.

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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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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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