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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Crash at Daytona Exposes Risks to Fans

The risks of racing extend beyond the drivers.

Fans can wind up in the danger zone, too.

A horrifying crash on the last lap of a race at Daytona International Speedway injured at least 30 fans Saturday and provided another stark reminder of what can happen when a car going nearly 200 mph is suddenly launched toward the spectator areas.

The victims were sprayed with large chunks of debris — including a tire — after rookie Kyle Larson's machine careened into the fencing that is designed to protect the massive grandstands lining NASCAR's most famous track.

"I love the sport," said Shannan Devine, who witnessed the carnage from her 19th-row seat, about 250 feet away. "But no one wants to get hurt over it."

The fencing served its primary purpose, catapulting what was left of Larson's car back onto the track. But it didn't keep potentially lethal shards from flying into the stands.

"There was absolute shock," Devine said. "People were saying, 'I can't believe it, I can't believe it. I've never seen this happen, I've never seen this happen. Did the car through the fence?' It was just shock and awe. Grown men were reaching out and grabbing someone, saying, 'Oh my gosh! Oh my gosh!' It was just disbelief, absolute disbelief."

From Daytona to Le Mans to a rural road in Ireland, auto racing spectators have long been too close to the action when parts start flying. The crash in the second-tier Nationwide race follows a long list of accidents that have left fans dead or injured.

The most tragic incident occurred during the 1955 24 Hours of Le Mans, when two cars collided near the main stands. The wreck sent debris hurtling into the crowd, while one of the cars flipped upside down and exploded in a giant fireball.

Eighty-three spectators and driver Pierre Levegh were killed, and 120 fans were injured.

The Daytona crash began as the field approached the checkered flag and leader Regan Smith attempted to block Brad Keselowski. That triggered a chain reaction, and rookie Kyle Larson hit the cars in front of him and went airborne into the fence.

The entire front end was sheared off Larson's car, and his burning engine wedged through a gaping hole in the fence. Chunks of debris from the car were thrown into the stands, including a tire that cleared the top of the fence and landed midway up the spectator section closest to the track.

"I thought the car went through the fence," Devine said. "I didn't know if there was a car on top of people. I didn't know what to think. I'm an emotional person. I immediately started to cry. It was very scary, absolutely scary. I love the speed of the sport. But it's so dangerous."

The fencing used to protect seating areas and prevent cars from hurtling out of tracks has long been part of the debate over how to improve safety.

Three-time Indianapolis 500 winner Dario Franchitti lost close friend Dan Wheldon at Las Vegas in the 2011 IndyCar season finale, when Wheldon's car catapulted into the fencing and his head struck a support post. Since his death, IndyCar drivers have called for studies on how to improve the safety barriers.

Franchitti renewed the pleas on Twitter after the Daytona crash, writing "it's time (at)Indycar (at)nascar other sanctioning bodies & promoters work on an alternative to catch fencing. There has to be a better solution."

Another fan who witnessed the crash said he's long worried that sizable gaps in the fencing increase the chances of debris getting through to the stands.

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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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Montek's plane waits in air as cows invade airstrip

DHANBAD: A plane carrying Planning Commission deputy chairman Montek Singh Ahluwalia cound not land for quite some time on Saturday due to a cow herd grazing on the airstrip near here and it touched down only after officials stepped in and shooed the cattle away.

The pilot of the plane carrying Ahluwalia noticed some cows grazing at the Tata Steel Jharia division airstrip at Bhauran, about 23km from here, at around 10.50am and made some rounds in the air before the airstrip was cleared of the cattle for the plane to land, superintendent of police of Dhanbad Ravi Kanth Dhan said.

The deputy commissioner (DC) of Dhanbad Prashant Kumar and superintendent of police (SP) were at the airstrip to receive the deputy chairman of the Planning Commission.

When the DC and the SP saw the plane hovering over the airstrip and found that some cattle were grazing, they ordered the officials to immediately clear the airstrip.

The SP said since the airstrip was not fenced, the area is completely exposed to nearby villages that use the ground for grazing their cattle heads. Ahluwalia is in Dhanbad to attend the 35th convocation ceremony at the Indian School of Mines.

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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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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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South African court grants Pistorius bail in murder case

PRETORIA (Reuters) - A South African court granted bail on Friday to Oscar Pistorius, charged with the murder of his girlfriend, after his lawyers argued the "Blade Runner" was too famous to pose a flight risk.

The decision by Magistrate Desmond Nair drew cheers from the athlete's family and supporters, although he appeared unmoved. Pistorius had broken down in tears earlier in the week-long hearing.

The court set bail at 1 million rand ($113,000) and postponed the case until June 4. Pistorius was ordered to hand over firearms and passports, avoid his home and all witnesses in the case, report to a police station twice a week and not to drink alcohol.

The decision followed a week of dramatic testimony about how the athlete shot dead Reeva Steenkamp at his luxury home near Pretoria in the early hours of February 14, Valentine's Day.

Prosecutors said Pistorius, 26, committed premeditated murder when he fired four shots into a locked bathroom door, hitting his girlfriend cowering on the other side. Steenkamp, 29, suffered gunshot wounds to her head, hip and arm.

Pistorius' defense team argued the killing was a tragic mistake, saying the athlete had mistaken Steenkamp for an intruder. They said he was too famous to pose a flight risk and deserved bail to prepare for a case that has drawn worldwide attention.

"He can never go anywhere unnoticed," his lawyer Barry Roux told the court on Friday.

The 26-year-old Olympic and Paralympic star's lower legs were amputated in infancy and he has raced on carbon fiber blades.

The Olympic and Paralympic star faces life in prison if convicted of premeditated murder.

Prosecutors had portrayed him as a cold-blooded killer.

"You cannot put yourself in the deceased's position. It must have been terrifying. It was not one shot. It was four shots," prosecutor Gerrie Nel said on Friday.

SHOTS AND SCREAMS

In an affidavit read out in court, Pistorius said he had been "deeply in love" with Steenkamp, and Roux said his client had no motive for the killing.

Pistorius contends he was acting in self-defense after mistaking Steenkamp for an intruder, and feeling vulnerable because he was unable to attach his prosthetic limbs in time to confront the perceived threat.

He said he grabbed a 9-mm pistol from under his bed and went into the bathroom. He said he fired into the locked door of the toilet, which adjoined the bathroom, in a blind panic in the mistaken belief the intruder was lurking inside.

Witnesses said they heard a gunshots and screams from the athlete's home on an upscale gated community near Pretoria. The community is surrounded by 3-metre-high stone walls and topped with an electric fence.

In a magazine interview a week before her death, published on Friday, Steenkamp, a law graduate and model, spoke about her three-month-old relationship with Pistorius.

"I absolutely adore Oscar. I respect and admire him so much," she told celebrity gossip magazine Heat. "I don't want anything to come in the way of his career."

Police pulled their lead detective off the case on Thursday after it was revealed he himself faces attempted murder charges for shooting at a minibus. He has been replaced by South Africa's top detective.

The arrest of Pistorius last week shocked those who had watched in awe last year as he reached the semi-final of the 400 meters race in the London Olympics.

The impact has been greatest in sports-mad South Africa, where Pistorius was seen as a rare hero who commanded respect from both black and white people, transcending the racial divides that persist 19 years after the end of apartheid.

(Editing by Andrew Roche)

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India sets rules for new bank permits in rural push

MUMBAI : India on Friday unveiled rules for issuing new bank licences in a push to expand financial services into the country's rural hinterland where hundreds of thousands of villages have no banking outlets.

Ninety percent of India's 600,000 villages do not have banking facilities, the Reserve Bank of India says, while fewer than half of the country's 1.2 billion people have a bank account.

Private companies, public-sector groups and non-banking financial firms will be eligible to apply for licences for new banks by setting up financial holding companies, the central bank said in a statement.

Groups seeking to set up a bank "should have a past record of sound credentials and integrity, be financially sound with a successful track record of 10 years", the Reserve Bank said.

The minimum capital needed to set up a bank will five billion rupees (US$91 million).

Also, the new banks will have to open at least a quarter of their branches in rural areas with no such facilities, and foreign shareholdings in any new bank should not exceed 49 percent in the first five years.

The need to set up more banks, especially in rural areas, has become increasingly urgent as the government seeks to pay cash directly to India's poor to ensure more efficient distribution.

Indian conglomerates like the Tata Group and the Anil Ambani Reliance group, which already own financial businesses, have voiced interest in setting up banks.

The Reserve Bank is seeking to follow a path of "financial inclusion", embracing swathes of rural India which have little access to banking services, the bank's governor Duvvuri Subbarao said.

No new Indian bank has been set up since the private Yes Bank in 2004. Yes Bank now is a leading industry player.

India currently has just 26 state-run, 20 private and 40 foreign banks.

Another 2,200 rural and co-operative banks cover other parts of the country.

The Finance Ministry said it hopes the Reserve Bank will be able to start issuing licences for new banks by the end of the next financial year, which runs to March 2014.

"With all going well, with all clearances, by end of the (next) financial year we will see some success," Financial Services Secretary Rajiv Takru told reporters in New Delhi.

- AFP/ch

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Indian Coast Guard inducts a new generation of interceptor boat

MUMBAI: The Indian Navy has added feathers to its armoury with the commission of Indian Coast Guard Ship C-154, the New Generation of Arneson Surface Drive (ASD) Interceptor Boat.

The 28 metres long Interceptor Boat with 75 tonnes displacement can achieve a maximum speed of 35 knots. This Interceptor Boat has been built by M/s Bharati Shipyard Ltd.

The vessel is fitted with state-of-the-art navigation and communication equipment and medium range armament. It is designed for high speed interception, close-coast patrol, low-intensity maritime operations, Search & Rescue and maritime surveillance.

The IB is also capable of operating in shallow water as well as in deep seas. The IB is fitted with 02 main engines of 1630 KW each and ASD system. The IB is provided with advanced navigational and communication equipment.

The Interceptor Boat ICGS C-154 is based at Mumbai under the Administrative and Operational Control of the Commander, No 2 Coast Guard District HQ, Mumbai.

The IB is commanded by Dy Comdt Arvind K Tyagi, TM with a crew of 12 Enrolled Personnel.

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Govs to hear Oregon health care plan

SALEM, Ore. (AP) — Oregon Gov. John Kitzhaber will brief other state leaders this weekend on his plan to lower Medicaid costs, touting an overhaul that President Barack Obama highlighted in his State of the Union address for its potential to lower the deficit even as health care expenses climb.

The Oregon Democrat leaves for Washington, D.C., on Friday to pitch his plan that changes the way doctors and hospitals are paid and improves health care coordination for low income residents so that treatable medical problems don't grow in severity or expense.

Kitzhaber says his goal is to win over a handful of other governors from each party.

"I think the politics have been dialed down a couple of notches, and now people are willing to sit down and talk about how we can solve the problem" of rising health care costs, Kitzhaber told The Associated Press in a recent interview.

Kitzhaber introduced the plan in 2011 in the face of a severe state budget deficit, and he's been talking for two years about expanding the initiative beyond his state. Now, it seems he's found people ready to listen.

Hospital executives from Alabama visited Oregon last month to learn about the effort. And the U.S. Department of Health and Human Services announced Thursday that it's giving Oregon a $45 million grant to help spread the changes beyond the Medicaid population and share information with other states, making it one of only six states to earn a State Innovation Model grant.

Kitzhaber will address his counterparts at a meeting of the National Governors Association. His talk isn't scheduled on the official agenda, but a spokeswoman confirmed that Kitzhaber is expected to present.

"The governors love what they call stealing from one another — taking the good ideas and the successes of their colleagues and trying to figure out how to apply that in their home state," said Matt Salo, director of the National Association of Medicaid Directors.

There's been "huge interest" among other states in Oregon's health overhaul, Salo said, not because the concepts are brand new, but because the state managed to avoid pitfalls that often block health system changes.

Kitzhaber persuaded state lawmakers to redesign the system of delivering and paying for health care under Medicaid, creating incentives for providers to coordinate patient care and prevent avoidable emergency room visits. He has long complained that the current financial incentives encourage volume over quality, driving costs up without making people healthier.

Obama, in his State of the Union address this month, suggested that changes such as Oregon's could be part of a long-term strategy to lower the federal debt by reigning in the growing cost of federally funded health care.

"We'll bring down costs by changing the way our government pays for Medicare, because our medical bills shouldn't be based on the number of tests ordered or days spent in the hospital — they should be based on the quality of care that our seniors receive," Obama said.

The Obama administration has invested in the program, putting up $1.9 billion to keep Oregon's Medicaid program afloat over the next five years while providers make the transition to new business models and incorporate new staff and technology.

In exchange, though, the state has agreed to lower per-capita health care cost inflation by 2 percentage points without affecting quality.

The Medicaid system is unique in each state, and Kitzhaber isn't suggesting that other states should adopt Oregon's specific approach, said Mike Bonetto, Kitzhaber's health care policy adviser. Rather, he wants governors to buy into the broad concept that the delivery system and payment models need to change.

That's not a new theory. But Oregon has shown that under the right circumstances massive changes to deeply entrenched business models can gain wide support.

What Oregon can't yet show is proof the idea is working — that it's lowering costs without squeezing on the quality or availability of care. The state is just finishing compiling baseline data that will be used as a basis of comparison.

One factor driving the Obama administration's interest in Oregon's success is the president's health care overhaul. Under the Affordable Care Act, millions more Americans will join the Medicaid rolls after Jan. 1, and the health care system will have to be able to absorb the influx of patients in a logistically and financially sustainable way.

The federal government will pay 100 percent of the costs for those additional patients in the first three years before scaling back to 90 percent in 2020 and beyond.

"There are a lot of governors who are facing the same challenges we're facing in Oregon," Kitzhaber said. "They recognize that the cost of health care is something they're going to have to get their arms around."

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