Novartis drug helps patients with rare inflammatory diseases
















ZURICH (Reuters) – Novartis‘ Ilaris helps reduce patients’ symptoms and the frequency of attacks in two rare inflammatory diseases, mid-stage studies showed, as the Swiss drugmaker looks to expand the use of the medicine.


Results of two separate studies on Sunday in patients with Familial Mediterranean Fever (FMF) and TRAPS – rare genetic diseases which can cause fever, rash and joint pain – both met their primary endpoints, Novartis said in a statement.













Both studies are being presented at the American College of Rheumatology (ACR) meeting in Washington D.C.


Ilaris or ACZ885, which blocks a protein called interleukin-1 beta that is thought to increase inflammation, is already sold for treating cryopyrin-associated periodic syndromes, a rare inflammatory disorder.


Novartis is also hoping to file the drug this year for regulatory approval in systemic juvenile idiopathic arthritis (SJIA), a debilitating disease that can affect a child’s growth.


Results of the phase II study showed the drug helped 100 percent of FMF patients reduce the frequency of attacks by at least 50 percent during three months of treatment.


Eight of the nine patients in the trial did not have an attack during the three months and blood markers of inflammation also normalized.


There are currently no approved treatments for FMF or TRAPS, rare genetically-inherited anti-inflammatory diseases, which can affect both children and adults.


Novartis is hoping to show the drug can be beneficial in treating rare inflammatory diseases after receiving a setback last year when U.S. health regulators rejected Ilaris for use in gout over concerns about side effects.


New data from a mid-stage study on the use of Ilaris in TRAPS showed that patients who came off therapy after being treated with the drug did not have a relapse for three months on average.


Earlier data from the study showed that 90 percent of patients experienced a significant improvement in symptoms after just one week of treatment with Ilaris. This rose to 95 percent after two weeks.


(Reporting by Caroline Copley; Editing by Elaine Hardcastle)


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Israel kills Gaza rocket crewman in second day of clashes
















GAZA (Reuters) – An Israeli air strike killed a Palestinian militant in the Hamas-governed Gaza Strip on Sunday as a surge in cross-border violence entered its second day, local officials said.


Islamic Jihad, a smaller faction than Hamas which often operates independently, identified the dead man as one of its own, saying he was a member of a rocket crew hit by an Israeli missile in Jabalya, northern Gaza.













The Israeli military confirmed carrying out an air strike in the area. The death brought to six the number of Palestinians killed by Israel since four of its troops were hurt in a missile attack on their jeep along the Gaza boundary fence.


Islamic Jihad said it had fired 70 short-range rockets and mortar bombs across the border since Saturday, salvoes which drove Israeli residents to blast shelters. At least one Israeli, in the town of Sderot, was wounded, ambulance workers said.


Israel described the jeep ambush as part of a Palestinian strategy of trying to curb its countermeasures against possible cross-border infiltration. Israeli forces often mount hunts for tunnels and landmines on the inside of the Gaza boundary, creating a no-go zone for Palestinians.


“Of course we don’t accept their attempt to change the rules,” Defence Minister Ehud Barak told Israel’s Army Radio.


“The essence of the struggle is over the fence. We intend to enable the IDF (Israel Defence Forces) to work not just on our side but on the other side as well.”


Palestinians said four of Saturday’s dead were civilians hit by an Israeli tank shell while paying respects at a crowded mourning tent in Gaza’s Shijaia neighborhood. Israel denies targeting civilians.


The bloodshed puts internal pressure on Hamas, which, though hostile to the Jewish state, has sat out some of the recent rounds of violence as it tried to consolidate its Gaza rule and reach out to neighboring Egypt and other foreign powers.


Israel blames Hamas for any attacks emanating from Gaza, but has shown little appetite for a major sweep of the territory which might strain its own fraught ties to the new Islamist-rooted government in Cairo.


(Writing by Dan Williams; Reporting by Nidal al-Mughrabi; Editing by Todd Eastham)


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IBM surprised by Avantor lawsuit, calls claims exaggerated
















(Reuters) – IBM, which is being sued by chemicals manufacturer Avantor Performance Materials for fraud and breach of contract in connection with a software project, said the accusations were blown out of proportion and that it was surprised by the move.


“We believe the allegations in the complaint are exaggerated and misguided and are surprised that Avantor chose to file suit,” the company said late on Friday in an emailed statement.













IBM said it had “met its contractual obligations and delivered a solution that Avantor continued to use in its operations.”


Avantor, which produces chemicals and raw materials for pharmaceutical products, laboratory chemicals and chemicals used in the electronics industry, filed a lawsuit on Thursday in the U.S. District Court for the District of New Jersey.


It said it was seeking tens of million in damages from IBM, which according to the lawsuit, had misrepresented the capabilities of a software program that runs on a platform by SAP, resulting “in a near standstill” of Avantor’s business.


(Reporting By Nicola Leske; Editing by Vicki Allen)


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Two senators restart talks on U.S. immigration reform plan

(Reuters) - Two key U.S. senators are restarting bipartisan talks on U.S. immigration reform that will include a path to citizenship for illegal immigrants already in the country, Senator Charles Schumer said on Sunday.


Appearing on NBC's "Meet the Press," the Democrat Schumer said he has spoken with Republican Senator Lindsey Graham and they have agreed to resume talks that broke off two years ago.


"And I think we have a darned good chance using this blueprint to get something done this year. The Republican Party has learned that being ... anti-immigrant doesn't work for them politically. And they know it," Schumer said.


President Barack Obama, re-elected last week with overwhelming support from Hispanic voters, in 2010 called the proposal unveiled by Graham and Schumer a "promising framework" on immigration reform. But the plan never got off the ground.


Obama's support among Hispanics was about 66 percent in the election, according to Reuters/Ipsos polling data.


There are an estimated 12 million illegal immigrants in the United States, most of them Hispanics.


The Graham and Schumer plan has four components: requiring high-tech, fraud-proof Social Security cards to ensure that illegal workers cannot get jobs; strengthening border security and enforcement of immigration laws; creating a process for admitting temporary workers; and implementing a path to legal status for immigrants already in the country.


Schumer said the plan embraces "a path to citizenship that's fair, which says you have to learn English, you have to go to the back of the line, you've got to have a job, and you can't commit crimes."


Many Republican leaders have taken a hard position against illegal immigrants. Obama's unsuccessful Republican challenger, Mitt Romney, said during the campaign that illegal immigrants should "self-deport" from the country.


Since the election, some influential conservative voices, including television commentator Sean Hannity, have announced support for immigration reform that includes a path to citizenship for illegal immigrants in the United States with no criminal record.


House of Representatives Speaker John Boehner, the top Republican in Congress, said on Friday that the U.S. immigration system is broken, and that Obama had to take the lead. Boehner has said he is confident Republicans could find common ground with the president.


The Obama administration announced in June it would relax U.S. deportation rules so that many young illegal immigrants who came to the United States as children can stay in the country and work.


The change would allow illegal immigrants who, among other criteria, are younger than 30 years old and have not been convicted of a felony to apply for work permits.


(Reporting by Will Dunham; Editing by Doina Chiacu)


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China says Hollywood putting pinch on domestic films
















BEIJING (Reuters) – China‘s films are taking a hit from a trade deal that allows for more U.S. movie imports, the country’s broadcast regulator said on Sunday, with their share of the box office take sliding even as the industry’s total revenues outpace those of last year.


The movie pact, which exempted 14 films from China’s annual quota of 20 foreign films per year, was hammered out in February during a trip to the United States by Vice President Xi Jinping, the man expected to take the ruling Communist Party‘s top spot after a congress held this week in Beijing.













After signing the deal, the number of American films in China and their proportion of revenues have increased by a “large margin”, Vice Minister of the State Administration of Radio, Film and Television Tian Jin said.


“The past dominance of domestic films in the Chinese market has been shaken,” Tian told a press briefing on the sidelines of the congress held once every five years.


China’s 2012 box office revenues reached 13.27 billion yuan ($ 2.12 billion) at the end of October, Tian said, already outpacing revenues from all of 2011. But the share of revenues for domestically produced films was only 41.4 percent, constituting “a huge drop”.


Tian said the U.S. film industry is reaping massive profits while domestic producers are under greater pressure, mainly because Chinese movies cannot compete with the Hollywood spectacles.


“The competitiveness of Chinese-made films must be raised,” he said.


Chinese film industry experts have said that Hollywood’s looming shadow means Chinese producers need to focus on quality if they are going to elevate their appeal to a Chinese audience.


February’s deal stemmed from a victory in a 2009 U.S. World Trade Organization case that challenged Beijing’s restrictions on import and distribution of copyright-protected materials.


The U.S. movie industry has long complained about China’s tight restrictions on foreign films, which they say helps fuel demand for pirated DVDs that are widely available in China.


It also argued that it was being boxed out of a booming market, as the fast-growing Chinese middle class spends more money in theatres.


The Chinese film market is seen as one of the largest potential markets for Hollywood, but it has also been tightly controlled by the state-owned China Film Group.


Chinese films frequently compete for international awards, but winners overseas are often not those supported by China’s government, which tend to fan nationalist and patriotic sentiment.


(Reporting by Michael Martina; Editing by Nick Macfie)


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Abbott hepatitis C drugs bring high cure rates in trial
















(Reuters) – A trio of oral medicines from Abbott Laboratories Inc to treat hepatitis C produced unprecedented cure rates in patients who had failed to benefit from standard treatment, as well as very high cure rates for newly treated patients, Abbott said on Saturday.


Detailed data from the mid-stage trial, called Aviator, were released Saturday at the annual meeting of the American Association for the Study of Liver Disease (AASLD) in Boston.













Investors and patients have very high hopes for the Abbott drugs – a protease inhibitor called ABT-450, a polymerase inhibitor ABT-333 and ABT-267 from a class known as NS5A inhibitors. They are used without interferon, an injectable standard treatment that causes flu-like symptoms.


Abbott said it plans to move ahead with large Phase III studies of the three drugs, used either with or without the standard antiviral pill ribavirin, based on favorable results seen in patients treated for eight weeks or twelve weeks in the Aviator study. Patients in the study had the most common, and hardest-to-treat, strain of hepatitis C known as Genotype 1.


Some 93 percent of patients who failed prior therapy had a sustained virologic response (SVR), meaning they were considered cured, after 12 weeks of taking the trio of new drugs, plus ribavirin.


“Nobody anywhere has broken the 50 percent mark in (cure rates) for this population,” Scott Brun, a senior Abbott research executive said in an interview. “These are robust results.”


Abbott said it aims to be the first company to market an interferon-free regimen to patients with Genotype 1 infections.


Four of 448 patients in the study discontinued treatment due to adverse events, a dropout rate that Abbott said suggested the medicines were very well tolerated.


About 97 percent of previously untreated patients were considered cured after 12 weeks of treatment with the three Abbott drugs, plus ribavirin. Moreover, similarly impressive cure rates were seen among patients taking the three drugs, plus ribavirin, for 8 weeks.


Without ribavirin, 87 percent of previously untreated patients were considered cured after 12 weeks on Abbott’s three drugs, Abbott said.


A pair of new hepatitis C drugs approved last year, Vertex Pharmaceuticals Inc’s Incivek and Merck & Co’s Victrelis, significantly boosted cure rates and cut treatment duration to as low as 24 weeks for some patients. But the protease inhibitors must still be taken with interferon, an injected drug that often causes severe flu-like symptoms that lead many hepatitis patients to delay or discontinue treatment.


Gilead Sciences Inc, Bristol-Myers Squibb Co and Vertex are racing to develop interferon-free treatment regimens. They are expected to become blockbuster products, if approved, because of their far shorter treatment times and better cure rates, compared with existing drug regimens.


Many analysts view Gilead as current leader both on timing and perceived advantages of its experimental hepatitis C program.


An estimated 3 million Americans are believed infected with the virus, which quietly damages the liver over years or decades and is the biggest reason for liver transplants in the United States. Abbott said as many as 170 million people worldwide are infected.


(Reporting By Ransdell Pierson; Editing by Vicki Allen)


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Twin explosions strike southern Syrian city
















BEIRUT (AP) — Syria‘s state-run news agency says two large explosions have struck the southern city of Daraa, causing multiple casualties and heavy material damage.


SANA did not immediately give further information or say what the target of Saturday’s explosions was.













The Britain-based Syrian Observatory for Human Rights says the blasts went off near a branch of the country’s Military Intelligence in Daraa.


The Observatory, which relies on a network of activists on the ground, says the explosions were followed by clashes between regime forces and rebels fighting to topple President Bashar Assad.


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Feline Frisky With Cats That Look Like Pin-Up Girls


















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How 'poor judgment' felled military star Petraeus

WASHINGTON (Reuters) - David Petraeus was a star on the battlefield, commanding the Iraq and Afghanistan wars, but was undone by "poor judgment" in engaging in an extramarital affair that led to his downfall as CIA director.


Just two days after his 60th birthday, Petraeus stepped down from the spy agency where he had held the top office since September 6, 2011.


"After being married for over 37 years, I showed extremely poor judgment by engaging in an extramarital affair. Such behavior is unacceptable, both as a husband and as the leader of an organization such as ours. This afternoon, the President graciously accepted my resignation," Petraeus told the shadow warriors he commanded at CIA.


It was a stunning downfall for a revered military man who was seen as one of the top American leaders of his generation and was once considered a potential contender for the White House.


Petraeus was credited with pulling Iraq from the brink of all-out civil war and for battlefield successes in Afghanistan after overseeing a surge of 30,000 troops ordered by President Barack Obama in late 2009. He became known for counter-insurgency strategies that were seen as gaining ground against the Taliban in Afghanistan.


"I don't think he was professionally overrated. His were genuine accomplishments," said James Carafano, a war historian with the conservative Heritage Foundation think tank.


At the time of his nomination to the CIA post, some Washington insiders had said the White House wanted to find a prominent position for Petraeus to ensure he would not be recruited by Republicans as a challenger to the 2012 Obama-Biden ticket.


When he was nominated to lead the CIA there were some concerns in intelligence circles that the high-profile four-star Army general might not be able to lead from the shadows as appropriate for a spy chief.


But once he took over the head office at the U.S. spy agency, Petraeus kept a decidedly low public profile.


Senate Intelligence Committee Chairman Dianne Feinstein, a Democrat, expressed regret about the resignation of "one of America's best and brightest" and said it was an "enormous loss" for the country.


"At CIA, Director Petraeus gave the agency leadership, stature, prestige and credibility both at home and abroad. On a personal level, I found his command of intelligence issues second to none," she said.


RESIGNATION ACCEPTED


After accepting his resignation about a year-and-a-half after nominating Petraeus to the CIA post, Obama said: "By any measure, he was one of the outstanding General officers of his generation, helping our military adapt to new challenges, and leading our men and women in uniform through a remarkable period of service in Iraq and Afghanistan, where he helped our nation put those wars on a path to a responsible end."


Earlier this week, in a Newsweek article entitled "General David Petraeus's Rules for Living," he listed 12 lessons for leadership. Number 5 was: "We all will make mistakes. The key is to recognize them and admit them, to learn from them, and to take off the rear­ view mirrors - drive on and avoid making them again."


In 2010 Petraeus stepped into the breach as the new commander of U.S. forces in Afghanistan to replace General Stanley McChrystal who was fired by Obama in a scandal over an article in which McChrystal and his aides made mocking comments about the president and some of his top advisers.


In 2009 Petraeus was diagnosed with early-stage prostate cancer and underwent radiation treatment. The media-friendly general joked at that time at a Washington event that reporters were only gathered "to see if the guy is still alive."


Petraeus, born in Cornwall, New York, lives in Virginia with his wife Holly. They have two grown children, a son who was an Army Ranger who served in Afghanistan, and a daughter.


Petraeus's wife, Holly, is an activist and volunteer who champions military families, and she continued that work after her husband retired from the military and moved to the CIA.


She currently is assistant director of the office of servicemember affairs at the Consumer Financial Protection Bureau, where she tries to keep unscrupulous lenders from taking advantage of military personnel. The bureau was championed by Harvard law professor Elizabeth Warren, who was elected to the Senate from Massachusetts this week.


Holly Petraeus is the daughter of four-star General William Knowlton, who was superintendent of the U.S. Military Academy at West Point when Petraeus was a cadet.


She briefed the press at the Pentagon on her efforts recently and was introduced by Defense Secretary Leon Panetta, who called her "a true friend of the Department of Defense and a dedicated member of our military family."


Petraeus has four Defense Distinguished Service Medal awards, three Distinguished Service Medal awards, the Bronze Star Medal for valor, and the State Department Distinguished Service Award.


He has a doctorate in international relations from Princeton University.


(Additional reporting by David Alexander, Matt Spetalnick and Diane Bartz; Editing by Warren Strobel and Jackie Frank)

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Chen Guang-who? Chinese official claims ignorance of blind activist
















BEIJING (Reuters) – Despite causing a huge diplomatic incident between the world’s two largest economies earlier this year, the Chinese official in charge of the hometown of blind legal activist Chen Guangcheng said on Friday that he has no idea who he was.


Chen, one of China’s most prominent human rights advocates, slipped away from under the noses of guards and eyes and ears of surveillance equipment around his village home near Linyi in eastern Shandong province in late April.













He then sought refuge at the U.S. embassy in Beijing for six days, embarrassing China and creating an awkward backdrop for U.S. Secretary of State Hillary Clinton’s visit which happened to fall at the same time.


But asked on the sidelines of a party congress in Beijing about Chen, Linyi’s Communist Party boss Zhang Shaojun deadpanned.


“I’ve never heard (of him),” Zhang told Reuters, before hurrying away into a closed-door meeting.


In May, Chen told Reuters that an unnamed central government official had promised to investigate accusations that local officials engineered his jailing on false charges and subsequent 19 months of extra-judicial house arrest and abuse.


But Zhang, a portly man with thinning hair, said he knew of no such investigation.


“I’ve never heard of this matter,” he said.


Robbed of his sight as a child, the rural-born Chen taught himself law and drew international attention in 2005 after accusing officials of enforcing late-term abortions and sterilizations.


Following intense negotiations between Chinese and U.S. officials, Chen left the embassy and was allowed to apply for a visa to study abroad. He is currently a visiting fellow at the New York University School of Law.


(Reporting by Gabriel Wildau; Editing by Ben Blanchard)


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