FDA approves novel Novartis seasonal flu vaccine
















(Reuters) – The U.S. Food and Drug Administration said on Tuesday it approved a seasonal flu vaccine produced by Novartis using animal cell culture rather than the traditional manufacturing using chicken eggs – a speedier process that could help build stockpiles in the event of a pandemic.


The vaccine, to be sold by the Swiss drugmaker under the brand name Flucelvax, is approved to prevent season influenza in people aged 18 and over, the agency said.













To produce Flucelvax, virus strains for the vaccine are grown in animal cell cultures derived from mammals instead of in chicken eggs. Similar cell culture technology has long been used to produce other types of vaccines, FDA said.


“Today’s approval represents the culmination of efforts to develop a seasonal influenza vaccine using cell culture as an alternative to the egg-based process,” Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.


Using cell cultures rather than chicken eggs allows for a faster start-up of the vaccine manufacturing process in the event of a health crisis, such as a flu pandemic. Traditional flu vaccine production requires a tremendous number of fertilized chicken eggs to grow virus strains and often takes several months before it is ready to be delivered to physicians or pharmacies.


The cell-based process also enables manufacturers to maintain a supply of readily available, previously tested cells for use in vaccine production.


“Modern cell-culture technology will likely become the new standard for influenza vaccine production,” predicted Andrin Oswald, head of Novartis’ vaccines and diagnostics division.


Flucelvax will eventually be manufactured at a new U.S. plant in Holly Springs, North Carolina, once that facility is ready for full-scale commercial production, Novartis said.


The production takes place in a sterile, controlled environment, which significantly reduces the risk of potential impurities, the company said.


In clinical trials, Flucelvax was 83.8 percent effective in preventing flu when compared with a placebo.


A limited supply of the new vaccine will be available for this year’s flu season, Novartis spokeswoman Liz Power said.


Novartis supplies the United States with about 30 million doses of flu vaccine annually, she said.


(Reporting by Bill Berkrot; Editing by Leslie Gevirtz and David Gregorio)


Diseases/Conditions News Headlines – Yahoo! News



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FDA approves novel Novartis seasonal flu vaccine
















(Reuters) – The U.S. Food and Drug Administration said on Tuesday it approved a seasonal flu vaccine produced by Novartis using animal cell culture rather than the traditional manufacturing using chicken eggs – a speedier process that could help build stockpiles in the event of a pandemic.


The vaccine, to be sold by the Swiss drugmaker under the brand name Flucelvax, is approved to prevent season influenza in people aged 18 and over, the agency said.













To produce Flucelvax, virus strains for the vaccine are grown in animal cell cultures derived from mammals instead of in chicken eggs. Similar cell culture technology has long been used to produce other types of vaccines, FDA said.


“Today’s approval represents the culmination of efforts to develop a seasonal influenza vaccine using cell culture as an alternative to the egg-based process,” Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.


Using cell cultures rather than chicken eggs allows for a faster start-up of the vaccine manufacturing process in the event of a health crisis, such as a flu pandemic. Traditional flu vaccine production requires a tremendous number of fertilized chicken eggs to grow virus strains and often takes several months before it is ready to be delivered to physicians or pharmacies.


The cell-based process also enables manufacturers to maintain a supply of readily available, previously tested cells for use in vaccine production.


“Modern cell-culture technology will likely become the new standard for influenza vaccine production,” predicted Andrin Oswald, head of Novartis’ vaccines and diagnostics division.


Flucelvax will eventually be manufactured at a new U.S. plant in Holly Springs, North Carolina, once that facility is ready for full-scale commercial production, Novartis said.


The production takes place in a sterile, controlled environment, which significantly reduces the risk of potential impurities, the company said.


In clinical trials, Flucelvax was 83.8 percent effective in preventing flu when compared with a placebo.


A limited supply of the new vaccine will be available for this year’s flu season, Novartis spokeswoman Liz Power said.


Novartis supplies the United States with about 30 million doses of flu vaccine annually, she said.


(Reporting by Bill Berkrot; Editing by Leslie Gevirtz and David Gregorio)


Diseases/Conditions News Headlines – Yahoo! News



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Japan exports dip for fifth month

















Japan’s exports have fallen for a fifth straight month after demand in China and the European Union (EU) weakened.













Shipment’s fell 6.5% in October, from a year earlier. Exports to China declined 11.6% and were down 20% to the EU.


A territorial dispute with China has dented sales to Japan’s biggest trading partner, while the EU is being hurt by a continuing debt crisis.


Japan’s economy is heavily reliant on exports and a slowdown would hurt growth.


Analysts said that given the uncertain global economic conditions, Japan’s exports may continue to be weak in coming month.


“This is basically the new normal that we have to deal with, well into the next year,” Martin Schulz of Fujitsu Research Institute told the BBC.


The data comes just weeks after Japan reported that its economy contracted in the July to September period.


China impact


China is the world’s second-largest economy and has a huge domestic market that has become vital to many global and regional exporters.


Demand from its consumers is seen as key for countries such as Japan, especially in wake of a slowdown in the western economies.


Continue reading the main story

Japan is being out-competed by China, by South Korea and by its Asian neighbours”



End Quote Martin Schulz Fujitsu Research Institute


However, relations between China and Japan have soured after a territorial dispute flared up in September.


It followed Japan’s purchase of disputed islands in the East China Sea, known as Senkaku in Japan and Diaoyu in China.


The move led to widespread anti-Japan protests in China, which turned violent in some areas with people directing their anger at Japanese brands.


October’s decline in exports followed a 14.1% drop in September.


Analysts said the row may continue to damage trade between the two countries.


“You can’t expect China to drive Japanese exports the way it used to, because of the boycotting of Japanese products there due to a territorial dispute,” said Takeshi Minami, chief economist at Norinchukin Research Institute in Tokyo.


‘Out-competed’


Exports to the to EU, meanwhile, have now fallen for 13 straight months.


Continue reading the main story


Analysts said that as well as the eurozone debt crisis, Japanese exporters were also hurt by the strength of the yen.


A strong yen makes Japanese goods more expensive to foreign buyers, and it gained nearly 7% against the US dollar between March and September this year.


Though the yen has weakened since then, it continues to remain at a level seen as too high by many businesses.


It was trading close to 81.89 yen against the US dollar in Asia trade on Wednesday.


“Japan is being out-competed by China, by South Korea and by its Asian neighbours,” said Fujitsu Research Institute’s Mr Schulz. “This is a problematic situation.”


BBC News – Business



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AP Exclusive: Syrian rebels seize base, arms trove
















BASE OF THE 46TH REGIMENT, Syria (AP) — After a nearly two-month siege, Syrian rebels overwhelmed a large military base in the north of the country and made off with tanks, armored vehicles and truckloads of munitions that rebel leaders say will give them a boost in the fight against President Bashar Assad‘s army.


The rebel capture of the base of the Syrian army’s 46th Regiment is a sharp blow to the government’s efforts to roll back rebels gains and shows a rising level of organization among opposition forces.













More important than the base’s fall, however, are the weapons the rebels found inside.


At a rebel base where the much of the haul was taken after the weekend victory, rebel fighters unloaded half a dozen large trucks piled high with green boxes full of mortars, artillery shells, rockets and rifles taken from the base. Parked nearby were five tanks, two armored vehicles, two rocket launchers and two heavy-caliber artillery cannons.


Around 20 Syrian soldiers captured in the battle were put to work carrying munitions boxes, barefoot and stripped to the waist. Rebels refused to let reporters talk to them or see where they were being held.


“There has never been a battle before with this much booty,” said Gen. Ahmad al-Faj of the rebels Joint Command, a grouping of rebel brigades that was involved in the siege. Speaking on Monday at the rebel base, set up in a former customs office at Syria’s Bab al-Hawa border crossing with Turkey, he said the haul would be distributed among the brigades.


For months, Syria’s rebels have gradually been destroying government checkpoints and taking over towns in the northern provinces of Idlib and Aleppo along the Turkish border.


Rebel fighters say that weapons seized in such battles have been essential to their transformation from ragtag brigades into forces capable of challenging Assad’s professional army. Cross-border arms smuggling from Turkey and Iraq has also played a role, although the most common complaint among rebel fighters is that they lack ammunition and heavy weapons, munitions and anti-aircraft weapons to fight Assad’s air force.


It is unclear how many government bases the rebels have overrun during the 20-month conflict, mostly because they rarely try to hold captured facilities. Staying in the captured bases would make them sitting ducks for regime airstrikes.


“Their strategy is to hit and run,” said Elias Hanna, a retired Lebanese army general and Beirut-based strategic analyst. “They’re trying to hurt the regime where it hurts by bisecting and compartmentalizing Syria in order to dilute the regime’s power.”


The 46th Regiment was a major pillar of the government’s force near the northern city of Aleppo, Syria’s economic hub, and its fall cuts a major supply line to the regime’s army, Hanna said. Government forces have been battling rebels for months over control of Aleppo.


“It’s a tactical turning point that may lead to a strategic shift,” he said.


At the 46th Regiment’s base, about 25 kilometers (15 miles) west of Aleppo, the main three-story command building showed signs of the battle — its walls punctured apparently from rebel rocket attacks. The smaller barracks buildings scattered around the compound, about 2.6 square kilometers (1 square mile) in size, had been looted, with mattresses overturned. A number of buildings had been torched.


Reporters from The Associated Press who visited the base late Monday saw no trace of the government troops who had been defending it — other than the dead bodies of seven soldiers.


Two of them, in camouflage uniforms, lay outside the command building. One of them was missing his head, apparently blown off in an explosion.


The rest were in a nearby clinic. Four dead soldiers were on stretchers set on the floor, one with a large gash in his arm, another with what appeared to be a large shrapnel hole in the back of his head. The last lay on a gurney in another room, his arms and legs bandaged, a bullet hole in his cheek and a splatter of blood on the wall and ceiling behind him as if he had been shot where he lay.


It could not be determined how or when the soldiers had been killed.


The final assault that took the base came after more than 50 days of siege that left the soldiers inside demoralized, according to fighters who took part.


Working together and communicating by radio, a number of different rebels groups divided up the area surrounding the base and each cut the regime’s supply lines, said Abdullah Qadi, a rebel field commander. Over the course of the siege, dozens of soldiers defected, some telling the rebels that those inside were short of food, Qadi said.


The rebels decided to attack Saturday afternoon when they felt the soldiers inside were weak and the rebels had enough ammunition to finish the battle, Qadi said. The battle was over by nightfall on Sunday. Seven rebel fighters were killed in the battle, said al-Faj of the rebels’ Joint Command. Other rebel leaders gave similar numbers.


It remains unclear how many soldiers remained in the base when the rebels launched their attack and what happened to them.


Al-Faj said all soldiers inside were either killed or captured. He said he didn’t know how many were killed, but that the rebels had taken about 50 prisoners, all of whom would be tried in a rebel court. Aside from the 20 prisoners seen at the rebel’s Bab al-Hawa base, the AP was unable to see any other captured soldiers.


The Syrian government does not respond to requests for comment on military affairs and said nothing about the base’s capture. It says the rebels are terrorists backed by foreign powers that seek to destroy the country.


Disorganization has plagued the Syrian opposition since the start of the anti-Assad uprising in March 2011, with exile groups pleading for international help even when they have no control over those fighting inside of Syria.


A newly formed Syrian opposition coalition received a boost Tuesday, when Britain officially recognized it as the sole representative of the Syrian people.


The National Coalition of the Syrian Revolutionary and Opposition Forces was formed in the Gulf nation of Qatar on Oct. 11 under pressure from the United States for a stronger, more united opposition body to serve as a counterweight to more extremist forces.


British Foreign Secretary William Hague said Tuesday the body’s members gave assurances to be a “moderate political force committed to democracy” and that the West must “support them and deny space to extremist groups.”


The United States and the European Union have both spoken well of the body but stopped short of offering it full recognition.


Key to the body’s success will be its ability to build ties with the disparate rebel groups fighting inside Syria. Many rebel leaders say they don’t recognize the new body, and a group of extremist Islamist factions on Monday rejected it, announcing that they had formed an “Islamic state” in Aleppo.


Anti-regime activists say nearly 40,000 people have been killed since Syria’s crisis started 20 months ago.


___


Associated Press write Elizabeth Kennedy contributed reporting from Beirut, Lebanon.


Middle East News Headlines – Yahoo! News



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Eric Stonestreet Wasn’t Drunk, He Swears
















We realize there’s only so much time one can spend in a day watching new trailers, viral video clips, and shaky cell phone footage of people arguing on live television. This is why every day The Atlantic Wire highlights the videos that truly earn your five minutes (or less) of attention. Today:


RELATED: What Happens When You Sing ‘All Night Long’ All Night Long













So if you were one of the few people watching the American Music Awards, (which no one watched) you may have seen Eric Stonestreet be a little tipsy. But that isn’t half as enjoyable as watching Eric Stonestreet watching himself be a little tipsy that night. (Also, wow, he’s sort of a bro.)


RELATED: Modern Family Is Scary


RELATED: ‘Seven Psychocats’ and the 50 Best Bond Moments in 007 Minutes


A few days ago we found out that Paul Rudd was in play called Grace on Broadway because … (wait for it) someone in the balcony puked on the audience members during the play. Four days late we can laugh at the whole thing. Mostly because we weren’t barfed on: 


RELATED: A ‘Mad Men’ Rickroll and the Man That Destroys Carnival Games


RELATED: A Video to Restore Our Faith in Humanity and a Glacier Tsunami


Here’s how to make some magic. What you’ll need: 


(1) Canadian newscaster with chubby fingers


(1) Technology


(1) Drunk piece of technology


Voila: 


And finally. Thanksgiving is upon us!  Today we’re thankful for squirrels who like to eat plastic: 


Wireless News Headlines – Yahoo! News



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Mitt Romney a Twihard? Candidate and Wife Take in “Twilight” Finale
















LOS ANGELES (TheWrap.com) – He may have missed out on becoming leader of the free world when he lost the election to President Obama, but Mitt Romney is keeping busy – with the romantic vampires and werewolves of “Twilight.”


Saturday night, he was spotted with his wife Ann heading into a showing of “Twilight Saga: Breaking Dawn – Part 2″ at a cineplex in Del Mar, Calif., by TMZ. After the movie, they and two young men went to a nearby pizza place, where they reportedly spoke and posed for pictures with patrons.













The Saturday night out for the Romneys was in contrast to the recent movie-viewing by the man who beat him in the election. President Obama last week viewed Oscar hopeful “Lincoln” in a special White House screening with several of the cast members and filmmakers.


There was no word on whether Romney or his wife aligned with Team Edward or Team Jacob.


Celebrity News Headlines – Yahoo! News



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Court rejects Hobby Lobby’s challenge to contraceptive mandate
















OKLAHOMA CITY (Reuters) – A federal judge on Monday denied a legal challenge to President Barack Obama‘s signature health reforms, ruling that the owners of a $ 3 billion arts and crafts chain must provide emergency contraceptives in their group health care plan.


The owners of Hobby Lobby asked to be exempted from providing the “morning after” and “week after” pills on religious grounds, arguing this would violate their Christian belief that abortion is wrong.













Judge Joe Heaton of the U.S. District for the Western District of Oklahoma denied the request for a preliminary injunction.


Heaton ruled that while individual members of the family that owns and operates Hobby Lobby have religious rights, the companies the family owns are secular, for-profit enterprises that do not possess the same rights.


Kyle Duncan, general counsel for the Becket Fund for Religious Liberty in Washington, D.C., which assisted Hobby Lobby in the legal challenge, said Monday’s ruling will be appealed.


Hobby Lobby, the largest non-Catholic U.S. company to go to court over the issue of contraceptives in the Affordable Care Act, is owned by the Green family of Oklahoma City. Patriarch David Green is ranked 79th on Forbes Magazine’s list of the 400 richest Americans with a net worth of $ 4.5 billion.


The family operate 514 Hobby Lobby stores in 41 states and employ 13,240 people. It funds a variety of Christian charities, closes its stores on Sundays and plays inspirational Christian music in its stores.


The Green family also sought contraceptive health insurance exemption for Mardel, their family-owned bookstore and educational supply company that has 35 stores in seven states with 372 employees.


The Oklahoma City-based companies already had been unwittingly providing the emergency contraceptives until they realized they were do so during the debate over provisions of what conservatives have dubbed “Obamacare,” according to court testimony. They discontinued that coverage only recently, testimony showed.


The Food and Drug Administration lists the “morning after” and “week after” pills as emergency contraceptives. But abortion opponents like the Green family consider them abortion-inducing drugs because they are often taken after conception.


Hobby Lobby faces a January 1 deadline to comply with the mandate to provide all FDA-approved contraceptives. Failure to do so would entail a penalty of up to $ 1.3 million per day.


There are more than 40 other lawsuits challenging the health care mandate that requires that all group health plans provide emergency contraceptives, according to the Becket Fund for Religious Liberty.


(Reporting by Steve Olafson; Editing by Nick Carey and Lisa Shumaker)


Medications/Drugs News Headlines – Yahoo! News



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Court rejects Hobby Lobby’s challenge to contraceptive mandate
















OKLAHOMA CITY (Reuters) – A federal judge on Monday denied a legal challenge to President Barack Obama‘s signature health reforms, ruling that the owners of a $ 3 billion arts and crafts chain must provide emergency contraceptives in their group health care plan.


The owners of Hobby Lobby asked to be exempted from providing the “morning after” and “week after” pills on religious grounds, arguing this would violate their Christian belief that abortion is wrong.













Judge Joe Heaton of the U.S. District for the Western District of Oklahoma denied the request for a preliminary injunction.


Heaton ruled that while individual members of the family that owns and operates Hobby Lobby have religious rights, the companies the family owns are secular, for-profit enterprises that do not possess the same rights.


Kyle Duncan, general counsel for the Becket Fund for Religious Liberty in Washington, D.C., which assisted Hobby Lobby in the legal challenge, said Monday’s ruling will be appealed.


Hobby Lobby, the largest non-Catholic U.S. company to go to court over the issue of contraceptives in the Affordable Care Act, is owned by the Green family of Oklahoma City. Patriarch David Green is ranked 79th on Forbes Magazine’s list of the 400 richest Americans with a net worth of $ 4.5 billion.


The family operate 514 Hobby Lobby stores in 41 states and employ 13,240 people. It funds a variety of Christian charities, closes its stores on Sundays and plays inspirational Christian music in its stores.


The Green family also sought contraceptive health insurance exemption for Mardel, their family-owned bookstore and educational supply company that has 35 stores in seven states with 372 employees.


The Oklahoma City-based companies already had been unwittingly providing the emergency contraceptives until they realized they were do so during the debate over provisions of what conservatives have dubbed “Obamacare,” according to court testimony. They discontinued that coverage only recently, testimony showed.


The Food and Drug Administration lists the “morning after” and “week after” pills as emergency contraceptives. But abortion opponents like the Green family consider them abortion-inducing drugs because they are often taken after conception.


Hobby Lobby faces a January 1 deadline to comply with the mandate to provide all FDA-approved contraceptives. Failure to do so would entail a penalty of up to $ 1.3 million per day.


There are more than 40 other lawsuits challenging the health care mandate that requires that all group health plans provide emergency contraceptives, according to the Becket Fund for Religious Liberty.


(Reporting by Steve Olafson; Editing by Nick Carey and Lisa Shumaker)


Medications/Drugs News Headlines – Yahoo! News



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Moody’s downgrades French rating

















The credit ratings agency Moody’s has downgraded France from its top rating.













The country’s debt has been reduced from AAA to AA1 and has kept its negative outlook, meaning it could be downgraded again.


In a statement, Moody’s blamed the risk of a Greek exit from the euro, stalled economic growth and the chances that France will have to contribute to bailing out other countries.


Rival agency Standard & Poor’s downgraded France in January.


Moody’s said the primary reason for the downgrade had been France’s “persistent structural economic challenges” and the threats they pose to economic growth and the government’s coffers.


“These include the rigidities in labour and services markets, and low levels of innovation, which continue to drive France’s gradual but sustained loss of competitiveness and the gradual erosion of its export-oriented industrial base,” Moody’s said.


French finance minister Pierre Moscovici said the downgrade was motivation to pursue structural reforms.


He also blamed the downgrade on the economic management of previous governments and added that France was still committed to cutting its public deficit to 3% of output next year.


BBC News – Business



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Turbulence on Cuba-Italy flight leaves 30 bruised
















ROME (AP) — An airliner flying from Havana to Milan abruptly plunged some 1,000 meters (3,300 feet) when it hit unusually strong turbulence over the Atlantic on Monday, terrifying passengers and leaving some 30 people aboard with bruises and scrapes, airline officials said.


The flight continued to Milan’s Malpensa airport after the plane’s captain determined that it suffered no structural damage and two passengers who are physicians found no serious injuries, Giulio Buzzi, head of the pilots division at Neos Air, told Sky TG24 TV.













The ANSA news agency quoted bruised passenger Edoardo De Lucchi as saying meals were being served when suddenly there was “10 seconds of terror.” He recounted how plates went flying and some passengers not wearing seatbelts bounced about.


Buzzi had said that the drop measured some 3,000 meters (10,000 feet) in a cloudless sky. But Milan daily’s Corriere della Sera’s web site, quoting Neos official Davide Martini, later reported that the plane first bounced up some 500 meters (1,650 feet), then dropped some 1,000 meters (3,300 feet) to some 500 meters (1,650 feet) below the original altitude.


Europe News Headlines – Yahoo! News



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