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.

Read More..

Cyberattacks Bring Attention to Security Reform

Recent accusations of a large-scale cyber crime effort by the Chinese government left many wondering what immediate steps the president and Congress are taking to prevent these attacks from happening again.

On Wednesday, the White House released the administration's Strategy on Mitigating the Theft of U.S. Trade Secrets as a follow-up to the president's executive order. The strategy did not outwardly mention China, but it implied U.S. government awareness of the problem.

"We are taking a whole of government approach to stop the theft of trade secrets by foreign competitors or foreign governments by any means -- cyber or otherwise," U.S. Intellectual Property Enforcement Coordinator Victoria Espinel said in a White House statement.

As of now, the administration's strategy is the first direct step in addressing cybersecurity, but in order for change to happen Congress needs to be involved. So far, the Cyber Intelligence Sharing and Protection Act (CISPA) is the most notable Congressional legislation addressing the problem, despite its past controversy.

Last April, CISPA was introduced by House Intelligence Committee Chairman Mike Rogers, R-Mich., and Rep. Dutch Ruppersberger, D-Md. The act would allow private companies with consumer information to voluntarily share those details with the NSA and the DOD in order to combat cyber attacks.

Peter Parks/AFP/Getty Images

The companies would be protected from any liabilities if the information was somehow mishandled. This portion of the act sounded alarm bells for CISPA's opponents, like the ACLU, which worried that this provision would incentivize companies to share individuals' information with disregard.

CISPA passed in the House of Representatives, despite a veto threat from the White House stemming from similar privacy concerns. The bill then died in the Senate.

This year, CISPA was reintroduced the day after the State of the Union address during which the president declared an executive order targeting similar security concerns from a government standpoint.

In contrast to CISPA, the executive order would be initiated on the end of the government, and federal agencies would share relevant information regarding threats with private industries, rather than asking businesses to supply data details. All information shared by the government would be unclassified.

At the core of both the executive order and CISPA, U.S. businesses and the government would be encouraged to work together to combat cyber threats. However, each option would clearly take a different route to collaboration. The difference seems minimal, but has been the subject of legislative debates between the president and Congress for almost a year, until now.

"My response to the president's executive order is very positive," Ruppersberger told ABC News. "[The president] brought up how important information sharing is [and] by addressing critical infrastructure, he took care of another hurdle that we do not have to deal with."

Addressing privacy roadblocks, CISPA backers said the sharing of private customer information with the government, as long as personal details are stripped, is not unprecedented.

"Think of what we do with HIPAA in the medical professions; [doctors do not need to know] the individual person, just the symptoms to diagnose a disease," Michigan Gov. John Engler testified at a House Intelligence Committee hearing in an attempt to put the problem into context.

Read More..

Abe vows to revive Japanese economy, sees no escalation with China

WASHINGTON (Reuters) - Japanese Prime Minister Shinzo Abe told Americans on Friday "I am back and so is Japan" and vowed to get the world's third biggest economy growing again and to do more to bolster security and the rule of law in an Asia roiled by territorial disputes.

Abe had firm words for China in a policy speech to a top Washington think-tank, but also tempered his remarks by saying he had no desire to escalate a row over islets in the East China Sea that Tokyo controls and Beijing claims.

"No nation should make any miscalculation about firmness of our resolve. No one should ever doubt the robustness of the Japan-U.S. alliance," he told the Center for Strategic and International Studies.

"At the same time, I have absolutely no intention to climb up the escalation ladder," Abe said in a speech in English.

After meeting U.S. President Barack Obama on his first trip to Washington since taking office in December in a rare comeback to Japan's top job, he said he told Obama that Tokyo would handle the islands issue "in a calm manner."

"We will continue to do so and we have always done so," he said through a translator, while sitting next to Obama in the White House Oval Office.

Tension surged in 2012, raising fears of an unintended military incident near the islands, known as the Senkaku in Japan and the Diaoyu in China. Washington says the islets fall under a U.S.-Japan security pact, but it is eager to avoid a clash in the region.

Abe said he and Obama "agreed that we have to work together to maintain the freedom of the seas and also that we would have to create a region which is governed based not on force but based on an international law."

Abe, whose troubled first term ended after just one year when he abruptly quit in 2007, has vowed to revive Japan's economy with a mix of hyper-easy monetary policy, big spending, and structural reform. The hawkish leader is also boosting Japan's defense spending for the first time in 11 years.

"Japan is not, and will never be, a tier-two country," Abe said in his speech. "So today ... I make a pledge. I will bring back a strong Japan, strong enough to do even more good for the betterment of the world."

'ABENOMICS' TO BOOST TRADE

The Japanese leader stressed that his "Abenomics" recipe would be good for the United States, China and other trading partners.

"Soon, Japan will export more, but it will import more as well," Abe said in the speech. "The U.S. will be the first to benefit, followed by China, India, Indonesia and so on."

Abe said Obama welcomed his economic policy, while Deputy Chief Cabinet Secretary Katsunobu Kato said the two leaders did not discuss currencies, in a sign that the U.S. does not oppose "Abenomics" despite concern that Japan is weakening its currency to export its way out of recession.

The United States and Japan agreed language during Abe's visit that could set the stage for Tokyo to join negotiations soon on a U.S.-led regional free trade agreement known as the Trans-Pacific Partnership.

In a carefully worded statement following the meeting between Obama and Abe, the two countries reaffirmed that "all goods would be subject to negotiations if Japan joins the talks with the United States and 10 other countries.

At the same time, the statement envisions a possible outcome where the United States could maintain tariffs on Japanese automobiles and Japan could still protect its rice sector.

"Recognizing that both countries have bilateral trade sensitivities, such as certain agricultural products for Japan and certain manufactured products for the United States, the two governments confirm that, as the final outcome will be determined during the negotiations, it is not required to make a prior commitment to unilaterally eliminate all tariffs upon joining the TPP negotiations," the statement said.

Abe repeated that Japan would not provide any aid for North Korea unless it abandoned its nuclear and missile programs and released Japanese citizens abducted decades ago to help train spies.

Pyongyang admitted in 2002 that its agents had kidnapped 13 Japanese in the 1970s and 1980s. Five have been sent home, but Japan wants better information about eight who Pyongyang says are dead and others Tokyo believes were also kidnapped.

Abe also said he hoped to have a meeting with new Chinese leader Xi Jinping, who takes over as president next month, and would dispatch Finance Minister Taro Aso to attend the inauguration of incoming South Korean President Park Geun-hye next week.

(Additional reporting by Jeff Mason and Doug Palmer; Editing by David Brunnstrom and Paul Simao)

Read More..

Taiwan ex-president's prison term extended

TAIPEI: Taiwan's former president Chen Shui-bian, jailed for corruption in 2009, has had his prison term extended by 18 months to 20 years due to a further bribery conviction.

Chen, 62, was already serving an 18 1/2-year term for corruption and money-laundering convictions relating to his 2000-2008 presidency -- charges he says stem from a vendetta by the current Beijing-friendly government.

The high court ruled Friday that Chen should serve the extra time for taking bribes from businessmen in a high-profile financial merger case. He was convicted of the offences in December.

Chen's wife Wu Shu-chen also saw her jail term extended to 20 years, although she has been spared from serving her sentence due to poor health.

The couple were also ordered to pay a total fine of Tw$450 million (US$15 million), the court said in a statement.

They face further charges in other cases, but legal experts say their sentences are unlikely to be extended again as individuals can only serve a maximum of 20 years in jail unless a life term is imposed.

Chen's supporters have urged the government to grant him parole for medical treatment saying he is suffering from depression and other health problems. He has been undergoing treatment in a Taipei public hospital since September.

Chen and his family have been accused of laundering millions of dollars by sending political donations and secret diplomatic funds abroad, and taking kickbacks on government contracts.

Chen insists that the charges against him are part of a politically motivated vendetta carried out by Taiwan's current government in retaliation for his eight years in power, when he promoted Taiwan's independence from China.

-AFP/fl

Read More..

59-hour countdown for Isro's PSLV-C20 begins

CHENNAI: The 59-hour countdown for the February 25 launch of Polar Satellite Launch Vehicle to put into orbit seven satellites, including Indo-French spacecraft SARAL, commenced at 6.56am today at the Satish Dhawan Space Centre in the spaceport of Sriharikota.

The Launch Authorisation Board earlier cleared the launch schedule for February 25 at 5.56 PM from the first launch pad in Sriharikota, about 90 kms from here, Isro sources said.

PSLV-C20, the 23rd PSLV Mission of Isro, would put the 400 kg Indo-French satellite and six others into orbit.

SARAL refers to Satellite with ARgos and ALtika. The French space agency CNES has developed ARgos and ALtikameter for analysing the ocean.

The rehearsal launch of PSLV - C20 with the primary satellite SARAL and six other foreign satellites has been completed satisfactorily, the sources said.

The other six auxiliary payloads are - two each from Canada, Austria and one each from Denmark and the United Kingdom.

President Pranab Mukherjee is likely to witness the launch along with Andhra Pradesh chief minister Kiran Kumar Reddy.

Read More..

APNewsBreak: 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."

Read More..

Arias Challenged On Pedophilia Claim

Accused murderer Jodi Arias was challenged today by phone records, text message records, and her own diary entries that appeared to contradict her claim that she caught her ex-boyfriend, Travis Alexander, looking at pictures of naked boys.

Arias had said during her testimony that one afternoon in January 2008, she walked in on Alexander masturbating to pictures of naked boys. She said she fled from the home, threw up, drove around aimlessly, and ignored numerous phone calls from Alexander because she was so upset at what she had seen.

The claim was central to the defense's accusation that Alexander was a "sexual deviant" who grew angry and abusive toward Arias in the months after the incident, culminating in a violent confrontation in June that left Alexander dead.

Arias claimed she killed him in self-defense. She could face the death penalty if convicted of murder.

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

Today, prosecutor Juan Martinez, who has been aggressive in questioning witnesses throughout the trial, volleyed questions at her about the claim of pedophilia, asking her to explain why her and Alexander's cell phone records showed five calls back and forth between the pair throughout the day she allegedly fled in horror. Some of the calls were often initiated Arias, according to phone records.

Jodi Arias Doesn't Remember Stabbing Ex-Boyfriend Watch Video

Jodi Arias Murder Trial: Testimony About Ex's Death Watch Video

Arias on Ex-Boyfriend's Death: 'I Don't Remember' Watch Video

She and Alexander also exchanged text messages throughout the afternoon and evening at a time when Arias claims the pedophilia incident occurred. In those messages they discuss logistics of exchanging one another's cars that night. Alexander sends her text messages about the car from a church social event he attended that night that she never mentioned during her testimony.

Arias stuck by her claim that she saw Alexander masturbating to the pictures, and her voice remained steady under increasingly-loud questioning by Martinez.

But Martinez also sparred with Arias on the stand over minor issues, such as when he asked Arias detailed questions about the timing and order of events from that day and Arias said she could not remember them.

"It seems you have problems with your memory. Is this a longstanding thing? Since you started testifying?" Martinez asked.

"No it goes back farther than that. I don't know even know if I'd call it a problem," Arias said.

"How far back does it go? You don't want to call them problems, are they issues? Can we call them issues? When did you start having them?" he asked in rapid succession. "You say you have memory problems, that it depends on the circumstance. Give me the factors that influence that."

"Usually when men like you or Travis are screaming at me," Arias shot back from the stand. "It affects my brain, it makes my brain scramble."

"You're saying it's Mr. Martinez's fault?" Martinez asked, referring to himself in the third person.

"Objection your honor," Arias' attorney finally shouted. "This is a stunt!"

Timeline of the Jodi Arias Trial

Martinez dwelled at one point about a journal entry where Arias wrote that she missed the Mormon baptism of her friend Lonnie because she was having kinky sex with Alexander. He drew attention to prior testimony that she and Alexander used Tootsie Pops and Pop Rocks candy as sexual props.

"You're trying to get across (in the diary entry) that this involved a sexual liaison with Mr. Alexander right?" he asked. "And you're talking about Tootsie Pops and Pop Rocks?"

"That happened also that night," Arias said.

"You were there, enjoying it, the Tootsie Pops and Pop Rocks?" he asked again, prompting a smirk from Arias.

"I enjoyed his attention," Arias said.

Read More..

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)

Read More..

Man charged with outraging modesty of girl

SINGAPORE: A man has been charged with outraging the modesty of a 16-year-old girl.

Toh Boon Cheong, 52, is accused of rubbing his groin area against the girl's hip on board the MRT train travelling from Choa Chu Kang station to Bukit Gombak station.

The alleged incident occurred on 15 January, at about 6:50am.

If convicted, Toh faces up to two years' jail and caning.

- CNA/ck

Read More..

BJP calls for shutdown in Andhra Pradesh

HYDERABAD: The Bharatiya Janata Party (BJP) has called for a shutdown in Andhra Pradesh on Friday to condemn the twin bomb blasts, which killed 14 people and injured over 100.

The Bharatiya Janata Party today demanded the suspension of question hour and said that in the wake of the Hyderabad blasts there should be a discussion the the Parliament over terror.

BJP state president G Kishan Reddy appealed to all people to voluntarily observe the shutdown to protest the blasts and show their sympathies with the victims' families.

Talking to reporters, he said the state government failed to take steps to prevent the blasts despite warnings from the intelligence agencies. He demanded the government to act firmly against terrorists.

Police have stepped up security in the city and other major towns in view of the shutdown call and Friday prayers.

The Bharatiya Janata Party today demanded the suspension of question hour and said that in the wake of the Hyderabad blasts there should be a discussion the the Parliament over terror.

Read More..