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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Fiery Last-Lap Daytona Crash Injures 15 Fans

A fiery last-lap crash at the Daytona International Speedway injured a number of spectators today, who were seen being carried away from the stands on stretchers.

Fifteen spectators were taken to the hospital, according to ESPN, with one on the way to surgery with head trauma.

The 12-car crash happened moments before the end of the Nationwide race, and on the eve of the Daytona 500, one of NASCAR's biggest events.

The crash was apparently triggered when driver Regan Smith's car, which was being tailed by Brad Keselowski on his back bumper, spun to the right and shot up the track. Smith had been in the lead and said after the crash he had been trying to throw a "block."

Rookie Kyle Larson's car slammed into the wall that separates the track from the grandstands, causing his No. 32 car to go airborne and erupt in flames.

When a haze of smoke cleared and Larson's car came to a stop, he jumped out uninjured.

His engine and one of his wheels were sitting in a walkway of the grandstand.

"I was getting pushed from behind," Larson told ESPN. "Before I could react, it was too late."

Driver Michael Annett was taken to the hospital after he slammed head-on into a barrier during the chaos. NASCAR officials told ESPN the driver was awake and alert.

Tony Stewart pulled out the win, but in victory lane, what would have been a celebratory mood was tempered by concern for the injured fans.

"We've always known this is a dangerous sport," Stewart said. 'But it's hard when the fans get caught up in it."

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Rockets hit Aleppo, killing at least 29: monitor

BEIRUT (Reuters) - Rockets struck eastern districts of Aleppo, Syria's biggest city, on Friday, killing at least 29 people and trapping a family of 10 in the ruins of their home, activists in the city said.

"There are families buried under the rubble," said an activist called Baraa al-Youssef, speaking by Skype after visiting the scene in his Ard al-Hamra neighborhood.

"Nothing can describe it, it's a horrible sight."

Video footage posted by several activists showed a burning building and people carrying the wounded to cars to be ferried to hospital. It was hard to gauge the scale of the damage in the night-time footage but rubble was clearly visible on the ground.

Rami Abdulrahman of the British-based Syrian Observatory for Human Rights said three explosions shook Aleppo and reported at least 29 people had been killed. Another 150 were wounded, he said, and the final death toll was likely to be higher.

Youssef said 30 houses were destroyed by a single rocket.

On Tuesday activists said at least 20 people were killed when a large missile of the same type as Russian-made Scuds hit the rebel-held district of Jabal Badro.

(Reporting by Mariam Karouny and Dominic Evans; Editing by Stephen Powell)

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US budget cuts can be avoided: Obama

WASHINGTON: President Barack Obama insisted Friday that mandatory government budget cuts set to kick in on March 1 -- known as the sequester -- were not "inevitable."

The cuts to defence and domestic spending were mandated in an agreement between Obama and his Republican foes to end a previous budget battle.

"I never think that anything is inevitable, we always have the opportunity to make the right decisions," Obama told reporters following a White House meeting with visiting Japanese Prime Minister Shinzo Abe.

"Hope springs eternal."

The consequences of the threatened sequester were supposed to be so punishing that Democrats and Republicans would have no choice but to reach a deal to reduce the deficit.

Obama also attempted to reassure financial markets in case the cuts do go forward.

"Unlike issues like the debt ceiling, the sequester going into effect will not threaten the world financial system, it's not the equivalent of the US defaulting on its obligations," Obama said.

"What it does mean though is that if the US is growing slower, other countries are growing slower."

Obama wants to use a "balanced" mix of spending cuts and tax revenue increases achieved by closing loopholes used by the wealthy to cut the US deficit, and says he will not sign a bill that harms the middle class.

Republicans, who lost a previous showdown with Obama over raising tax rates for the rich, say the debate over hiking taxes is closed.

They say they are willing to close loopholes, but only in the context of a sweeping reform of the tax code, and maintain that Obama wants to use proceeds from any immediate revenue rises for more bloated government spending.

Hundreds of thousands of public employees and private contractors are threatened by the cuts.

- AFP/jc

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Hyderabad, hotbed of home-grown terror, under lens

NEW DELHI: For the veterans of security establishment the bomb blasts have revived concerns about the critical nature of Hyderabad and surroundings in the growth of home-grown terrorism in India.

Officials point out that Hyderabad has been intricately linked to the growth of the present phase of domestic terrorism. When the first definite information about Muslim youth going to Pakistan for terror camps emerged more than a decade ago, with Hyderabad resident Shahid Bilal as a key figure, the government was alarmed at the highest levels. Once India confirmed that over 60 youth have gone across to Pakistan from Andhra Pradesh and Karnataka in 2005-06 the issue was taken up with Bangladeshi and Nepalese governments because most of them were going via either of these countries.

"Even if the bombers are from outside, they have received local logistical support," says one official. "There is a history here," he says about Hyderabad's brush with blasts as well as with fringe sympathisers.

A day before the twin blasts, the National Investigation Agency (NIA) had, in fact, filed its first charge sheet in the case of Bangalore-Hubli-Nanded terror module run from Saudi Arabia by LeT-HuJI handlers. One name among the 12 accused stood out: Obaidur Rehman. The 26-year-old Hyderabad resident is the nephew of Maulana Mohammed Naseeruddin, a radical preacher presently languishing in a Gujarat jail in connection with the murder of Gujarat home minister Haren Pandya.

The charge sheet also mentioned the man handling the group from Saudi Arabia as Farhatullah Ghori, maternal uncle of slain HuJI operative Shahid Bilal. Both belong to Hyderabad.

The blasts that followed the charge sheet have only come as a grim reminder of the Andhra Pradesh capital having become a favourite recruiting ground for terror groups. In fact, the city has been in terror crosshairs for close to a decade and a half providing strong base to both LeT and HuJI.

According to intelligence agencies, Hyderabad first came on terror radar in late '90s with several radical religious organizations becoming a springboard to youth taking to terror. While there was an entrenched sense of victimhood and injustice post Babri masjid demolition among Muslims in the state, their anger was first organized and harnessed by Mohammed Abdul Shahid alias Shahid Bilal under aegis of HuJI.

The first effects of this endeavor manifested itself in the terror attack on the office of Hyderabad Special Task Force in 2003. Bilal's maternal uncle Farhatullah Ghori's name prominently cropped up in the investigations. He was also a suspect in the Akshardham Temple attack in Gujarat in 2002.

Following this, Bilal was found to be instrumental in conducting several blasts across south India between 2004 and 2007. During this period he also helped 26/11 accused and LeT operative Zabiuddin Ansari alias Abu Jundal escape to Pakistan via Bangladesh along with his associate Fayyaz Kagzi after the 2006 Aurangabad arms haul in Maharashtra. In October 2007, Bilal was himself killed in Karachi along with his brother Samad. However, sources say, he has five more brothers who are in Pakistan and elsewhere. And the network he has left behind across India, Pakistan and Saudi Arabia keeps recruiting people for Jihadi activities.

In 2008, Maulana Naseeruddin's son, Riyazuddin Nasir, was arrested in Dharwad, Karnataka for planning to carry out terror strikes in the state. In 2012, with Obaidur Rehman's arrest in the Bangalore terror module, the city again struggled to shake off the terror tag.

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Jodi Arias' Friends Believe in Her Innocence

Accused murderer Jodi Arias believes she should be punished, but hopes she will not be sentenced to death, two of her closest friends told ABC News in an exclusive interview.

Ann Campbell and Donavan Bering have been a constant presence for Arias wth at least one of them sitting in the Phoenix, Ariz., courtroom along with Arias' family for almost every day of her murder trial. They befriended Arias after she first arrived in jail and believe in her innocence.

Arias admits killing her ex-boyfriend Travis Alexander and lying for nearly two years about it, but insists she killed Alexander in self defense. She could face the death penalty if convicted of murder.

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Nevertheless, she is aware of the seriousness of her lies and deceitful behavior.

The women told ABC News that they understand that Arias needs to be punished and Arias understands that too.

"She does know that, you know, she does need to pay for the crime," Campbell said. "But I don't want her to die, and I know that she has so much to give back."

Catching Up on the Trial? Check Out ABC News' Jodi Arias Trial Coverage

The lies that Arias admits she told to police and her family have been devastating to her, Bering said.

""She said to me, 'I wish I didn't have to have lied. That destroyed me,'" Donovan said earlier this week. "Because now when it's so important for her to be believed, she has that doubt. But as she told me on the phone yesterday, she goes, 'I have nothing to lose.' So all she can do is go out there and tell the truth."

During Arias' nine days on the stand she has described in detail the oral, anal and phone sex that she and Alexander allegedly engaged in, despite being Mormons and trying to practice chastity. She also spelled out in excruciating detail what she claimed was Alexander's growing demands for sex, loyalty and subservience along with an increasingly violent temper.

Besides her two friends, Arias' mother and sometimes her father have been sitting in the front row of the courtroom during the testimony. It's been humiliating, Bering said.

"She's horrified. There's not one ounce of her life that's not out there, that's not open to the public. She's ashamed," she said.

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French, Malian forces fight Islamist rebels in Gao

GAO, Mali (Reuters) - French and Malian troops fought Islamists on the streets of Gao and a car bomb exploded in Kidal on Thursday, as fighting showed little sign of abating weeks before France plans to start withdrawing some forces.

Reuters reporters in Gao in the country's desert north said French and Malian forces fired at the mayor's office with heavy machineguns after Islamists were reported to have infiltrated the Niger River town during a night of explosions and gunfire.

French Defense Minister Jean-Yves Le Drian told a news conference in Brussels that Gao was back under control after clashes earlier in the day.

"Malian troops supported by French soldiers killed five jihadists and the situation is back to normal," he said.

In Kidal, a remote far north town where the French are hunting Islamists, residents said a car bomb killed two. A French defense ministry source reported no French casualties.

French troops dispatched to root out rebels with links to al Qaeda swiftly retook northern towns last month. But they now risk being bogged down in a guerrilla conflict as they try to help Mali's weak army counter bombings and raids.

"There was an infiltration by Islamists overnight and there is shooting all over the place," Sadou Harouna Diallo, Gao's mayor, told Reuters by telephone earlier in the day, saying he was not in his office at the time.

Gao is a French hub for operations in the Kidal region, about 300 km (190 miles) northeast, where many Islamist leaders are thought to have retreated and foreign hostages may be held.

"They are black and two were disguised as women," a Malian soldier in Gao who gave his name only as Sergeant Assak told Reuters during a pause in heavy gunfire around Independence Square.

Six Malian military pickups were deployed in the square and opened fire on the mayor's office with the heavy machineguns. Two injured soldiers were taken away in an ambulance.

French troops in armored vehicles later joined the battle as it spilled out into the warren of sandy streets, where, two weeks ago, they also fought for hours against Islamists who had infiltrated the town via the nearby river.

Helicopters clattered over the mayor's office, while a nearby local government office and petrol station was on fire.

A Gao resident said he heard an explosion and then saw a Malian military vehicle on fire in a nearby street.

Paris has said it plans to start withdrawing some of its 4,000 troops from Mali next month. But rebels have fought back against Mali's weak and divided army, and African forces due to take over the French role are not yet in place.

Islamists abandoned the main towns they held but French and Malian forces have said there are pockets of Islamist resistance across the north, which is about the size of France.

CAR BOMB

Residents reported a bomb in the east of Kidal on Thursday.

"It was a car bomb that exploded in a garage," said one resident who went to the scene but asked not to be named.

"The driver and another man were killed. Two other people were injured," he added.

A French defense ministry official confirmed there had been a car bomb but said it did not appear that French troops, based at the town's airport, had been targeted.

Earlier this week, a French soldier was killed in heavy fighting north of Kidal, where French and Chadian troops are hunting Islamists in the Adrar des Ifoghas mountains, which border Algeria.

Operations there are further complicated by the presence of separatist Tuareg rebels, whose rebellion triggered the fighting in northern Mali last year but were sidelined by the better-armed Islamists.

Having dispatched its forces to prevent an Islamist advance south in January, Paris is eager not to become bogged down in a long-term conflict in Mali. But their Malian and African allies have urged French troops not to pull out too soon.

(Additional reporting by Emanuel Braun in Gao, Adama Diarra in Bamako, David Lewis and John Irish in Dakar and Adrian Croft in Brussels; Writing by David Lewis; Editing by Jason Webb and Roger Atwood)

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Singapore trade expands 1.1% in 2012

SINGAPORE: Singapore's total external trade rose by 1.1 per cent in 2012, a contrast to the 8.0 per cent rise seen in the previous year.

The trade growth is lower than the previously projected range of between 3.0 and 4.0 per cent, said IE Singapore in its news release on Friday.

This, IE Singapore said, is due to poor trade performance in 4Q 2012.

Total trade reached S$984.9 billion in 2012, higher than the previous year's achievement of S$974.4 billion.

On a year-on-year basis, Singapore's total trade dropped by 2.9 per cent in 4Q 2012, following the previous quarter's decrease of 2.2 per cent due to decreases in both oil and non-oil trade.

Non-oil domestic exports (NODX) rose by 0.5 per cent in 2012, following the preceding year's increase of 2.2 per cent, due to higher shipments of non-electronic exports.

IE Singapore said the 0.5 per cent growth is lower than their projected 2012 growth of 2.0 to 3.0 per cent. This is due to a worse than expected NODX's performance in 4Q 2012.

Looking ahead, IE Singapore said projected total trade for 2013 is maintained at between 3.0 and 5.0 per cent while projected NODX growth for 2013 is kept at between 2.0 and 4.0 per cent.

- CNA/fa

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British intel had warned of Indian Mujahideen attack

NEW DELHI: The British intelligence had warned India about a possible terrorist attack by the homegrown terror outfit, Indian Mujahideen (IM). The alert led to a general nationwide alert on Wednesday.

The British intelligence alert is believed to have been received by Indian agencies just as British PM David Cameron was about to land in Mumbai on Monday. The input did not speak of any specific movements of terrorists or any particular module. Sources said it may have been based on inputs gathered by the heightened British intelligence gathering in the region ahead of Cameron's visit.

On Wednesday, a general alert was issued by the Intelligence Bureau (IB) about a possible attack by the IM. The alert was based on the British input, and came after several weeks of silence about any IM activity.

There are no dependable inputs with agencies until now about any IM module being active of late, sources said. However, investigations of recent times have indicated that the entire network of the homegrown terror group may not have been unearthed.

The IM tentacles are not just limited to some Indian cities, but it also has very strong affiliations among the Indian diaspora. The activities of IM are believed to have regular funding from West Asian countries. Also, some of the first Indian terrorists to have emerged in the communally vicious times of the 1990s — mostly having undergone terror training in Pakistan — are now based in the Gulf region. Among them is C A M Basheer, a former senior SIMI leader.

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Flu shot doing poor job of protecting older people

ATLANTA (AP) — It turns out this year's flu shot is doing a startlingly dismal job of protecting older people, the most vulnerable age group.

The vaccine is proving only 9 percent effective in those 65 and older against the harsh strain of the flu that is predominant this season, the Centers for Disease Control and Prevention said Thursday.

Health officials are baffled as to why this is so. But the findings help explain why so many older people have been hospitalized with the flu this year.

Despite the findings, the CDC stood by its recommendation that everyone over 6 months get flu shots, the elderly included, because some protection is better than none, and because those who are vaccinated and still get sick may suffer less severe symptoms.

"Year in and year out, the vaccine is the best protection we have," said CDC flu expert Dr. Joseph Bresee.

Overall, across the age groups studied, the vaccine's effectiveness was found to be a moderate 56 percent, which means those who got a shot have a 56 percent lower chance of winding up at the doctor with the flu. That is somewhat worse than what has been seen in other years.

For those 65 and older, the vaccine was only 27 percent effective against the three strains it is designed to protect against, the worst level in about a decade. It did a particularly poor job against the tough strain that is causing more than three-quarters of the illnesses this year.

It is well known that flu vaccine tends to protect younger people better than older ones. Elderly people have weaker immune systems that don't respond as well to flu shots, and they are more vulnerable to the illness and its complications, including pneumonia.

But health officials said they don't know why this year's vaccine did so poorly in that age group.

One theory, as yet unproven, is that older people's immune systems were accustomed to strains from the last two years and had more trouble switching gears to handle this year's different, harsh strain.

The preliminary data for senior citizens is less than definitive. It is based on fewer than 300 people scattered among five states.

But it will no doubt surprise many people that the effectiveness is that low, said Michael Osterholm, a University of Minnesota infectious-disease expert who has tried to draw attention to the need for a more effective flu vaccine.

Among infectious diseases, flu is considered one of the nation's leading killers. On average, about 24,000 Americans die each flu season, according to the CDC.

This flu season started in early December, a month earlier than usual, and peaked by the end of year. Hospitalization rates for people 65 and older have been some of the highest in a decade, at 146 per 100,000 people.

Flu viruses tend to mutate more quickly than others, so a new vaccine is formulated each year to target the strains expected to be the major threats. CDC officials have said that in formulating this year's vaccine, scientists accurately anticipated the strains that are circulating this season.

Because of the guesswork involved, scientists tend to set a lower bar for flu vaccine. While childhood vaccines against diseases like measles are expected to be 90 or 95 percent effective, a flu vaccine that's 60 to 70 percent effective in the U.S. is considered pretty good. By that standard, this year's vaccine is OK.

For senior citizens, a flu vaccine is considered pretty good if it's in the 30 to 40 percent range, said Dr. Arnold Monto, a University of Michigan flu expert.

A high-dose version of the flu shot was recently made available for those 65 and older, but the new study was too small to show whether that has made a difference.

The CDC estimates are based on about 2,700 people who got sick in December and January. The researchers traced back to see who had gotten shots and who hadn't. An earlier, smaller study put the vaccine's overall effectiveness at 62 percent, but other factors that might have influenced that figure weren't taken into account.

The CDC's Bresee said there is a danger in providing preliminary results because it may result in people doubting — or skipping — flu shots. But the figures were released to warn older people who got shots that they may still get sick and shouldn't ignore any serious flu-like symptoms, he said.

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Online:

CDC report: http://www.cdc.gov/mmwr

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