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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Pistorius Family: 'Law Must Run Its Course'

South African Olympian Oscar Pistorius is spending time his family today after the athlete was freed on $113,000 bail Friday.

"We realise that the law must run its course, and we would not have it any other way," the Olympian's uncle, Arnold Pistorius said in a statement on Saturday.

The Pistorius family expressed their gratitude that the former Olympian was allowed out of jail before the trial.

"This constitutes a moment of relief under these otherwise very grave circumstances" said Arnold Pistorius."We are extremely thankful that Oscar is now home."

Pistorius, 26, is charged with premeditated murder in the Valentine's Day shooting of his girlfriend Reeva Steenkamp.

While the prosecution argued that the world-renowned athlete was a flight risk and had a history of violence, South African Magistrate Desmond Nair, who presided over the case, disagreed.

FULL COVERAGE: Oscar Pistorius

"He regards South Africa as his permanent place of abode, he has no intention to relocate to any other country" Nair said during his two hour ruling, before concluding with, "the accused has made the case to be released on bail."

'Blade Runner' Murder Charges: Oscar Pistorius Out on Bail Watch Video

Oscar Pistorius Granted Bail in Murder Case Watch Video

Pistoriuis will have to adhere to strict conditions to stay out of jail before the trial. He must give up all his guns, he cannot drink alcohol or return to the home where the shooting occurred, and he must check in with a police department twice a week.

Oscar Pistorius is believed to be staying at an uncle's house as he awaits trial.

RELATED: Oscar Pistorius Case: Key Elements to the Murder Investigation

During the hearing, the prosecution argued that Pistorius shot Steenkamp after an argument, while the defense laid out an alternate version of events saying Pistorius mistook his girlfriend for an intruder.

Nair took issue with the head detective originally in charge of the case, who he said "blundered" in gathering evidence and was removed from the case after it was revealed he is facing attempted murder charges.

RELATED: Oscar Pistorius Case: Lead Det. Hilton Botha to Be Booted From Investigation Team

After the magistrate's decision, cheers erupted in the courtroom from the Pistorius camp. Pistorius' trial is expected to start in six to eight months, with his next pre-trial court date in June.

Reeva Steenkamp Family Reaction

Steenkamp's father, Barry Steenkamp told the South African Beeld newspaper that the 26-year-old athlete will "suffer" if he is lying about accidentally shooting 29-year-old model.

PHOTOS: Oscar Pistorius Charged with Murder

Barry Steenkamp went on to say that the Pistorius will have to "live with his conscience" if he intentionally shot Reeva.

The Associated Press contributed to this report.

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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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Catholic priests should be able to marry: British cardinal

LONDON: Roman Catholic priests should be able to marry and have children, Britain's most senior cardinal said on Friday.

Cardinal Keith O'Brien, who will be part of the conclave tasked with choosing a new pope to replace Benedict XVI, said the church's requirement for priests to be celibate was not of "divine origin" and should be reconsidered.

"Many priests have found it very difficult to cope with celibacy as they lived out their priesthood, and felt the need of a companion, of a woman, to whom they could get married and raise a family of their own," the 74-year-old told the BBC.

"The celibacy of the clergy, whether priests should marry -- Jesus didn't say that.

"There was a time when priests got married, and of course we know at the present time in some branches of the church -- in some branches of the Catholic church -- priests can get married," he added.

"So that is obviously not of divine origin and it could get discussed again."

O'Brien will have a say in who succeeds Benedict after he stands down on February 28.

He said he had not yet decided who should take over leadership of the world's 1.2 billion Catholics, but suggested it could be time for a younger pontiff, possibly from the developing world.

"I would be open to a pope from anywhere if I thought it was the right man, whether it was Europe or Asia or Africa or wherever," he added.

Benedict stunned the world last week by becoming the first pope in more than 700 years to resign voluntarily.

No clear favourite has emerged, although the 85-year-old's announcement that he lacked the strength to lead the church indicates the need for a younger pope.

- AFP/jc

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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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Oscar Pistorius Granted Bail in Murder Case

Oscar Pistorius was granted bail today in a South African court, meaning he can be released from jail for the six to eight months before his trial for the allegedly premeditated killing of his girlfriend Reeva Steenkamp.

Magistrate Desmond Nair, in reading his lengthy decision, said, "The issue before me is whether this accused, being who is and the assets he has [here], would seek to duck and dive all over the world."
His conclusion:
"I cannot find that he is a flight risk."

Nair said, "The accused has made a case to be released on bail."

PHOTOS: Paralympics Champion Charged in Killing

The judge also said he had to weigh whether Pistorius would be a danger to others. He noted that Pistorius has been accused of using foul language against people in arguments and once threatened to break someone's legs, but he said that was different from someone with an arrest record of violence.

"I appreciate that a person is dead, but I don't think that is enough," he said.

Nair also said he could not be influenced by the public's "shock and outrage" if Pistorius is released.

A member of Pistorius' defense team told ABC News, "he is going to be released today."

Despite the ruling, prosecutors displayed confidence, with one of them emerging from the courthouse today to say, "We still believe we have the evidence to convict Oscar Pistorius."

The court set bail at about $113,000 (1 million rand) and June 4 as the date for Pistorius' next court appearance.

The other bail conditions are: Pistorius cannot leave the country; he must hand over his passports; he cannot return to his home as long as it's an active crime scene; he needs permission to leave the Pretoria area; he must visit a police station on a daily basis and be available to a probation officer at all times via cellphone; he is not allowed any communication with prosecution witnesses; he cannot drink alcohol; and he must relinquish his firearms.

"Do you understand?" the magistrate asked him.

"Yes, sir," Pistorius replied.

Alexander Joe/AFP/Getty Images

'Blade Runner' Shocker: Lead Detective Replaced Watch Video

Speaking for the family, Arnold Pistorius, the Olympian's uncle, said, "Although we are obviously relieved that Oscar has been granted bail, this is still a very sad time for the family of Reeva and for us.

"We are grateful that the Magistrate recognized the validity and strength of our application. As the family, we are convinced that Oscar's version of what happened on that terrible night will prove to be true."

The judge's ruling came on the fourth and final day of the bail hearing for Pistorius, the Olympian accused of murdering his girlfriend on Valentine's Day.

Pistorius, who gained global acclaim for racing at the 2012 London Olympics, shot his model-girlfriend through a closed bathroom. He says he killed Reeva Steenkamp accidentally, but prosecutors alleged that he took a moment to put on his prosthetic legs, indicating that he thought out and planned to kill Steenkamp when he shot her three times through the bathroom door.

Pistorius sobbed today in court. Barry Roux, his defense attorney, said the prosecution misinterpreted the assigning of intent, meaning that the runner's intent to shoot at a supposed intruder in his home cannot be transferred to someone else who was shot -- in this case, Steenkamp.

"He did not want to kill Reeva," Roux told the court.

FULL COVERAGE: Oscar Pistorius Case

When Magistrate Nair, who overheard the bail hearing, asked Roux what the charges should be if Pistorius intended to kill an intruder, the defense attorney responded that he should be charged with culpable homicide.

Culpable homicide is defined in South Africa as "the unlawful negligent killing of a human being."

Roux also made light of the prosecution's argument that Pistorius is a flight risk, saying that every time the double-amputee goes through airport security, it causes a commotion. He said that Pistorius' legs need constant maintenance and he needs medical attention for his stumps.

The prosecution argued today that the onus was on Pistorius to provide his version of events, and his version was improbable.

Prosecutor Gerrie Nel also spoke of Pistorius' fame and his disability, even relating him to Wikipedia founder Julian Assange, who is now confined to Ecuador's London Embassy, where he has been granted political asylum.
"[Assange's] facial features are as well known as Mr. Pistorius' prostheses," Nel said.

Nel argued that Pistorius' prostheses do not set him apart, stating that it's no different to any other feature, and the court cannot be seen to treat people with disabilities accused of a crime, or famous people accused of crime, any differently.

Pistorius has said that in the early hours of Feb. 14 he was closing his balcony doors when he heard a noise from the bathroom. Fearing an intruder, and without his prosthetic legs on, he grabbed a gun from under his bed and fired through the closed bathroom door, he told the court.

But prosecutors say that's implausible, that the gun's holster was found under the side of the bed where Steenkamp slept, and that Pistorius would have seen she wasn't there. Prosecutors also say the angle at which the shots were fired shows Pistorius was already wearing his prosthetics when he fired.

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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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New death from SARS-like virus in Saudi Arabia

GENEVA: Another person suffering from a SARS-like virus has died in Saudi Arabia, the World Health Organization said on Thursday, bringing the worldwide number of fatalities from the mystery illness to seven.

The Saudi health ministry informed the UN's health body that the patient had been hospitalised on January 29 and died on February 10, WHO said in a statement.

A laboratory had confirmed on February 18 that the person had died from the so-called novel coronavirus (NCoV), it added.

This brings the number of cases of the virus that have so far been reported to the WHO to 13. The virus was first detected in the middle of last year, with six previous fatalities -- three in Saudi Arabia, two in Jordan and one in Britain.

The news comes just days after a person suffering from the virus died in hospital in central England on Sunday.

That patient, who had a pre-existing health condition, was one of three people in the same family with the virus, which appeared to have been caught by one of the family members during a recent visit to the Middle East and Pakistan.

Even before the death in Britain, the WHO had on Saturday urged its member states to keep a close eye on any cases of severe acute respiratory infections, like pneumonia, and to "carefully review any unusual patterns."

Health authorities should test for NCoV in cases of unexplained pneumonia or other severe, "progressive or complicated respiratory illnesses not responding to treatment, particularly in persons travelling from or resident in areas of the world known to be affected," it said.

It also urged testing of any health workers showing such symptoms, and thorough investigations of clusters of cases, regardless of where they occur in the world.

WHO meanwhile did not recommend any travel or trade restriction in connection with the virus.

Coronaviruses cause most common colds but can also cause SARS (severe acute respiratory syndrome).

The new virus however is different from SARS, especially in that it causes rapid kidney failure.

A SARS epidemic killed more than 800 people when it swept out of China in 2003, sparking a major international health scare.

- AFP/fa

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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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