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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Las Vegas Strip Shooting Suspect ID'd

Las Vegas police identified a suspect today in a shooting on the strip that caused a Maserati to hit a taxi and burst into flames, killing three people.

Ammar Harris, 26, has been named a suspect in the Thursday skirmish that killed three people, including rapper Kenny Clutch.

The altercation between Harris and Clutch, 27, whose legal name was Kenneth Cherry Jr., is believed to have originated in the valet area of a Las Vegas hotel, police said.

Police said Harris fired several rounds into a Maserati that was being driven by Cherry as both vehicles continued northbound on glitzy Las Vegas Boulevard.

The rapper's expensive sports car careened out of control after he was shot, slamming into several cars, including a taxi. The impact caused the cab to burst into flames, killing the driver, Michael Boldon and a female passenger. Witnesses said it looked like the car exploded.

"He was a number one guy," Carolyn Jean Trimble, Boldon's sister, told ABC News.

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"I looked out my window and I could see one vehicle down here on the corner of the intersection totally engulfed in flames," witness John Lamb told ABC News.

Boldon, 62, and his passenger, who has not yet been identified, were both killed, as was Clutch.

Timble said her brother loved driving his taxi around Vegas.

"He came to live with me in Las Vegas last year to help take care of our mother, and the first day he got here he said, 'I have to get a job.' The second day, I came home from work, and he said he got a job," she recalled.

"He says, 'You'll never guess what it is,' and I said, 'what,' and he said, 'taxi cab driver,' and we both fell out laughing," Trimble said. "He loved that job. He never complained. He'd come home and tell me stories about what happened, who he picked up."

Boldon was a single father who raised a 36-year-old son and was a new grandfather. His grandson was named after him, Trimble said.

"Of all the people to take from this earth," she said. "But I guess the Lord needed him."

A passenger in the Maserati was hit and sustained only a minor injury to his arm. Clutch died at University Medical Center.

His father, Kenneth Cherry Sr., expressed his grief for the loss of his son while speaking with ABC News.

"This is something you never really, really ever want to experience as a parent, to lose a child before you go," he said.

Harris is described as 5-foot-11 and 180 pounds. Anyone with information is asked to contact the Las Vegas Metro Police Department's homicide division.

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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)

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China reports second fatal case of bird flu this year

BEIJING: A man in southwestern China has died of bird flu, health authorities said Saturday, becoming the second fatality from the H5N1 virus this year.

The 31-year-old died in hospital in the city of Guiyang on Friday, the Guizhou province health department said in a statement, adding that no other human cases of avian flu had been reported in the province.

Another city resident, a 21-year-old woman, died from the virus earlier this month.

The Xinhua news agency said both of them had come into close contact with birds but it was not known if the cases were related.

The H5N1 virus typically spreads from birds to humans through direct contact, but experts fear it could mutate into a form transmissible between humans with the potential to trigger a pandemic.

More than 365 people have died of bird flu globally since the virus re-emerged in 2003, according to the World Health Organization.

Its figures show that China saw 25 deadly cases of the virus between 2003 and 2009 before numbers tailed off to one fatality in each of the three following years. The deadliest year of the past decade in China saw eight deaths in 2006.

China is considered one of the nations most at risk from bird flu epidemics because it has the world's biggest poultry population and many chickens in rural areas are kept close to humans.

China has in the past been accused of covering up the extent of bird flu outbreaks, exacerbating fears when new cases are reported.

Separate outbreaks among birds were reported last year in the northern region of Ningxia and the remote northwestern region of Xinjiang, prompting massive culls of chickens.

- AFP/ir

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Polling begins in Meghalaya

SHILLONG: Polling began to elect 60 members to the ninth Meghalaya Assembly from among 345 candidates today with an electorate of 15.3 lakh.

Banned Khasi organisation, Hynniewtrep National Liberation Council, has called a 36-hour bandh from 6 PM yesterday till today in the seven districts of Khasi and Jaintia Hills region.

Prominent candidates in the fray are Chief Minister Mukul Sangma, Home Minister H D R Lyngdoh, Education Minister R C Laloo, Congress president D D Lapang, UDP president Don Kupar Roy, former Leader of Opposition and son of P A Sangma Conrad K Sangma and his brother James Sangma.

The Congress has put up candidates in all 60 seats, and ally United Democratic Party in 50.

Of the 15 parties in the fray, the P A Sangma-led National Peoples' Party is contesting at 32 seats, the NCP at 21 and the BJP in 13.

Among the candidates are 25 women. Of the 2,845 polling stations, 900 have been declared 'hyper-sensitive'.

Booths along the international border and the inter-state border with Assam have also been categorised as 'hyper-sensitive'.

The BSF, which has been put on maximum alert along the 498-km border, has deployed 10,000 personnel.

Ninety-one companies of central paramilitary forces have been deployed in the state to maintain law and order and 44 companies in the militant-hit Garo Hills region.

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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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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.

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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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Cricket: Hyderabad Test still on, says Australia chief

SYDNEY: Australia plan to play the second Test against India in Hyderabad as scheduled next week despite deadly bomb attacks in the city on the eve of the Test series opener, reports said on Friday.

The twin blasts on Thursday killed 14 people and wounded dozens more in a busy neighbourhood in the southern Indian city, raising questions over whether Australia would play the second Test starting on March 2.

But Cricket Australia chief executive James Sutherland told Fairfax newspapers the match was still on as planned as Australia prepared for the opening match in the four-Test series in Chennai starting later Friday.

"As far as I'm concerned we are playing the second Test in Hyderabad next week. That's where we are at," said Sutherland, who is with the team in Chennai.

Sutherland told Fairfax he was happy to continue to Hyderabad where the team is scheduled to arrive on Wednesday.

"We've got great confidence in the BCCI (Board of Control for Cricket in India) and the relevant authorities here to be able to prepare as best as possible for whatever issues may change from day to day," he said.

"We're very comfortable with everything that has been done so far on this tour."

"We'll obviously take advice from relevant authorities and work with the BCCI and others here to make assessments around Hyderabad but at the same time plans have been in place for a long time," Sutherland said.

"At this stage I wouldn't be calling into question things going ahead in Hyderabad."

He added that team manager Gavin Dovey had sent players text messages overnight updating them on the blasts and that security had been stepped up.

Dozens of extra police reportedly surrounded the Chennai hotel where the Australian and Indian teams are staying.

Captain Michael Clarke said his players were focused on the Chennai game.

"From the team's point of view, our focus is wholly and solely on the field because we've got people off the field who are experts in what is going on. We'll be advised by them," he said.

"Our thoughts and prayers are with all the people of Hyderabad who have been affected."

Earlier, media reports raised doubts over the tour.

"Australia's cricket tour of India has been plunged into uncertainty," said the Herald-Sun newspaper, while the Sydney Morning Herald carried a headline "Hyderabad Test in doubt as bombings rock city".

Australia pulled out of a tour to Pakistan in 2008 over security concerns after a series of bombings in the troubled country. They also refused to play any matches in the 1996 World Cup in Sri Lanka after bombings there.

Cricket Australia, which said the safety of players was paramount, earlier said the tourists had received "no information to suggest there is any threat to the team" but that talks were ongoing.

The attacks targeted a Hindu district in the city, a hub of India's computing industry in the southern state of Andhra Pradesh, home to local offices of Google and Microsoft among other Western IT companies.

After the blasts, the Foreign Affairs Department in Canberra warned Australians following the tour in India that terror attacks could happen anywhere.

"We advise you to exercise a high degree of caution in India at this time because of the risk of terrorism, civil unrest, crime and vehicle accidents," the department said.

"Terrorist attacks could occur anywhere at any time in India with little or no warning," it said.

"Possible targets include public places in New Delhi, Mumbai and other major cities, and Indian security and political interests."

However, the overall level of advice for Australians in India has not changed, with the department recommending people exercise a high degree of caution.

No major international cricket has been played in Pakistan since a deadly attack on the Sri Lankan team bus by armed militants in Lahore in 2009.

- AFP/ck

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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.

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