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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Football: Berbatov's magic moment sinks Stoke






LONDON: Fulham forward Dimitar Berbatov produced a moment of magic to end his side's poor run with a 1-0 win over Stoke at Craven Cottage on Saturday.

Berbatov marked his 200th Premier League appearance with his 85th goal in the English top-flight and it was one of the former Manchester United star's best as he netted a superb volley just before half-time.

Martin Jol's team still needed a second half penalty save from Mark Schwarzer, who kept out Jon Walters' effort, to clinch just their fourth win in 19 Premier League games.

Berbatov and Schwarzer's heroics lifted Fulham to 11th, nine points clear of the relegation zone, and continued the away-day misery for Stoke, who have won just one in their last 23 leagues games on their travels.

Fulham's first sight of goal fell to Berbatov after Sascha Riether's cross picked out the Bulgarian forward for a close-range volley that looped just over.

Bryan Ruiz had the ball in the net moments later but Fulham's celebrations were cut short as referee Lee Probert correctly ruled that the Costa Rican forward had used his hand to score.

Steven Nzonzi needed treatment after a collision with Berbatov left the Stoke midfielder with blood dripping from the bridge of his nose.

Nzonzi still seemed miffed following that incident and he was fortunate to escape with a booking after cuffing Ruiz around the head in an off-the-ball incident.

A ferocious free-kick from Fulham's Greek midfielder Giorgos Karagounis brought the best save of the half from Asmir Begovic.

Stoke sent on American midfielder Brek Shea for his debut when Matthew Etherington hobbled off with a back injury.

Jol's team pushed on and finally broke the deadlock in first half stoppage-time when a cross was only half cleared to Berbatov, who showed superb technique to lash a brilliant volley into the top corner of Begovic's goal.

Fulham defender Philippe Senderos almost gifted Stoke an equaliser immediately after the interval when his attempt to shepherd the ball back to Schwarzer allowed Peter Crouch to nip ahead of him and flick a shot that the Australian saved well.

Schwarzer came to Fulham's rescue again in the 54th minute after Dejagah conceded a penalty when he blocked Shea's cross with his raised arms.

Walters stepped up to take the spot-kick, but the Stoke striker has a poor record with penalties this season and his luck was out again as Schwarzer dived to his right to save.

- AFP/fa



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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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Laptops to be Samajwadi Party's anniversary gift to students

LUCKNOW: UP chief minister AkhileshYadav is set to mark his first year in power by distributing free laptops to students who passed their intermediate examination last year during the anniversary week celebrations of his government from March 10 to 15. Free laptops were promised by Akhilesh as a poll sop for the youth.

In the first phase, 10,000 laptops will be distributed in Lucknow and Mainpuri districts to students from government and government-aided schools. Set to cost the state government a total of Rs 2,800 crore, laptops will be embossed with tamper-proof stickers of Akhilesh and SP chief Mulayam Singh Yadav.

It's not laptop alone that the students will get as 'gift'. The machines will be loaded with an open source operating system (Ubuntu) apart from Windows 7 Home Basic. The systems will also come pre-loaded with MS Office software, a specially designed computer literacy programme for first-time users, spreadsheets, multimedia and cloud computing among other things. A special software, designed by the British Council, will have 'How to Learn English', along with 'Hindi to English' and 'English to Hindi' dictionaries. The students will also have access to a photo gallery, movie maker software, photosynth and an editing software.

In another student-friendly initiative, the laptops will be pre-loaded with sample papers of engineering and medical entrance test papers of AIEEE, IIT-JEE, AIIMS, BITS, NIFT, PMT and CLAT. The laptops will come with webcam, blue tooth, wi-fi compatibility, DVD writer and a media reader. Users will have three language options- Hindi, English and Urdu.

Over 15 lakh units are to be distributed over the next seven months. A call centre will be set up in Lucknow with service centres in every district to cater to the beneficiaries. "The service centres will be made operational before the distribution begins," a senior UPEC official said.

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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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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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Jailed Tymoshenko fit to leave hospital: ministry






KIEV: Ukraine's jailed former prime minister Yulia Tymoshenko is now fit to leave the civilian hospital where she has spent the last nine months with back problems, the health ministry said Friday, paving the way for her return to prison.

A medical commission "has concluded that the patient Y. Tymoshenko no longer needs further treatment or rehabilitation in hospital," the ministry said in a statement.

Tymoshenko, 52, has been in prison since August 2011 but was moved in May last year from her Kharkiv prison to hospital because she was in acute pain from a herniated disc.

The charismatic figurehead of the 2004 Orange Revolution was convicted of abuse of power and jailed for seven years in 2011 after losing a 2010 presidential race to Viktor Yanukovych.

She is currently on trial on separate charges of fraud and tax evasion and was also charged in January with ordering the 1996 gangland-style shooting of a lawmaker.

Her imprisonment has provoked a serious rift between Ukraine and the European Union, which has called the charges against her politically motivated.

- AFP/jc



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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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Now, Jamiat divided over Narendra Modi

NEW DELHI: The Jamiat Ulema-Hind, which virtually controls the Islamic seminary Darul-Uloom at Deoband, appears sharply divided over Gujarat chief minister Narendra Modi.

Jamiat president Maulana Arshad Madni said on Thursday that there was no question of accepting the Gujarat strongman as India's prime minister. "Modi was wholly and solely responsible for the 2002 Gujarat riots. He is protecting and shielding many politicians who were directly involved in the worst communal riots in the country," he told the media.

A few days back, however, Malauna Mahmood Madni, general secretary of the Jamiat, came out with a tacit endorsement of Modi. "There is a change in the Muslim psyche towards Modi, and a section of Muslims voted for him in the recent assembly elections," he had said. "There is a perceptible change, and circumstances are different. Muslims in Gujarat are economically better off than in other states which have so-called secular governments."

Maulani Mahmood Madni, who rebelled against his uncle Maulana Arshad Madni four years back and floated a parallel group, said more innocents were languishing in jails in Maharashtra than in Gujarat.

Maulana Arshad Madni, however, insisted that in a secular country like India, there was no place for Modi. "I am sure and certain that the majority of the people reject his ideology. It is not only Muslims but also members of the majority community who oppose his communal agenda," he said.

Maulana Arshad Madni asked the government to reserve jobs for Muslims. He said the government should not take the support of minorities for granted.

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