EU agency rejects Sanofi, Isis cholesterol drug






LONDON (Reuters) – European regulators on Friday recommended against approval of Sanofi and Isis Pharmaceutical‘s drug Kynamro for treatment of a rare genetic disorder that causes unusually high cholesterol.


The European Medicines Agency said it was concerned about the medicine’s safety, noting that a high proportion of patients stopped taking it within two years, mainly due to side effects such as flu-like symptoms, injection site reactions and liver toxicity.






The European rebuff contrasts with a green light for the drug, known generically as mipomersen, by a U.S. advisory panel in October.


Sanofi’s Genzyme unit said it was disappointed by the decision and planned to request a re-examination.


(Reporting by Ben Hirschler)


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Construction output decline slows







Output in the UK construction industry fell in October, down 5.1% from the same month last year, according to the Office for National Statistics (ONS).






Compared with the previous month, construction output rose 8.3%.


Construction is a component of gross domestic product (GDP), which measures the value of everything produced in the economy.


This figure is the first contributor to the eagerly-awaited fourth quarter GDP, which will be released next month.


The year-on-year construction output figure has fallen for 14 of the past 15 months, although October’s fall was the smallest decline since February.


Output had dropped 13.2% in September, compared with September 2011.


Figures for each of the 12 previous months were revised by the ONS, although it said the revisions had had a “negligible” effect on GDP figures.


The month-on-month growth mirrors the result of the Markit/CIPS Construction Purchasing Managers’ Index for October, which was released last month and suggested fractional growth in the sector.


At the time, Markit economist Tim Moore said: “The bigger picture remains bleak,”


The Office for Budget Responsibility has predicted that the UK economy will contract slightly in the whole of 2012, which would mean a negative reading for GDP for the last three months of the year.


The construction sector reading has a relatively small weighting in the GDP figures.


It is outweighed by the service sector, the October figures for which are due to be released on Friday 21 December.


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Aides: Chavez in tough fight, may miss swearing-in






CARACAS, Venezuela (AP) — Somber confidants of President Hugo Chavez say he is going through a difficult recovery after cancer surgery in Cuba, and one close ally is warning Venezuelans that their leader may not make it back for his swearing-in next month.


Information Minister Ernesto Villegas said Wednesday night that Chavez was in “stable condition” and was with close relatives in Havana. Reading a statement, he said the government invites people to “accompany President Chavez in this new test with their prayers.”






Villegas expressed hope about the president returning home for his Jan. 10 swearing-in for a new six-year term, but said in a written message on a government website that if Chavez doesn’t make it, “our people should be prepared to understand it.”


Villegas said it would be irresponsible to hide news about the “delicateness of the current moment and the days to come.” He asked Venezuelans to see Chavez’s condition as “when we have a sick father, in a delicate situation after four surgeries in a year and a half.”


Moving to prepare the public for the possibility of more bad news, Vice President Nicolas Maduro looked grim when he acknowledged that Chavez faced a “complex and hard” process after his latest surgery.


At the same time, officials sought to show a united front amid the growing worries about Chavez’s health and Venezuela’s future. Key leaders of Chavez’s party and military officers appeared together on television as Maduro gave updates on Chavez’s condition.


“We’re more united than ever,” said Maduro, who was flanked by National Assembly President Diosdado Cabello and Oil Minister Rafael Ramirez, both key members of Chavez’s inner circle. “We’re united in loyalty to Chavez.”


Analysts say Maduro could eventually face challenges in trying to hold together the president’s diverse “Chavismo” movement, which includes groups from radical leftists to moderates, as well as military factions.


Tapped by the 58-year-old president over the weekend as his chosen political heir, Maduro is considered to be a member of radical left wing of Chavez’s movement that is closely aligned with Cuba’s communist government.


Cabello, a former military officer who also wields power within Chavez’s movement, shared the spotlight with Maduro by speaking at a Mass for Chavez’s health at a military base.


Just returned from being with Chavez for the operation, Cabello called the president “invincible” but said “that man who is in Havana … is fighting a battle for his life.”


After Chavez’s six-hour operation Tuesday, Venezuelan television broadcast religious services where people prayed for Chavez, interspersed with campaign rallies for upcoming gubernatorial elections.


On the streets of Caracas, people on both sides of the country’s deep political divide voiced concerns about Chavez’s condition and what might happen if he died.


At campaign rallies ahead of Sunday’s gubernatorial elections, Chavez’s candidates urged Venezuelans to vote for pro-government candidates while they also called for the president to get well.


“Onward, Commander!” gubernatorial candidate Elias Jaua shouted to a crowd of supporters at a rally Wednesday. Many observers said it was likely Chavez’s candidates could get a boost from their supporters’ outpouring of sympathy for Chavez.


Opposition leader Henrique Capriles, who lost to Chavez in the October presidential election and is running against Jaua, complained Wednesday that Chavez’s allies are taking advantage of the president’s health problems to try to rally support. He took issue with Jaua’s statement to supporters that “we have to vote so that the president recovers.”


Maduro looked sad as he spoke on television, his voice hoarse and cracked at times after meeting in the pre-dawn hours with Cabello and Ramirez. The pair returned to Venezuela about 3 a.m. after accompanying Chavez to Cuba for his surgery.


“It was a complex, difficult, delicate operation,” Maduro said. “The post-operative process is also going to be a complex and hard process.”


Without giving details, Maduro reiterated Chavez’s recent remarks that the surgery presented risks and that people should be prepared for any “difficult scenarios.”


The constitution says presidents should be sworn in before the National Assembly, and if that’s not possible then before the Supreme Court.


Former Supreme Court magistrate Roman Duque Corredor said a president cannot delegate the swearing-in to anyone else and cannot take the oath of office outside Venezuela. A president could still be sworn in even if temporarily incapacitated, but would need to be conscious and in Venezuela, Duque told The Associated Press.


If a president-elect is declared incapacitated by lawmakers and is unable to be sworn in, the National Assembly president would temporarily take charge of the government and a new presidential vote must be held within 30 days, Duque said.


Chavez said Saturday that if an election had to be held, Maduro should be elected president.


The dramatic events of this week, with Chavez suddenly taking a turn for the worse, had some Venezuelans wondering whether they were being told the truth because just a few months ago the president was running for his fourth presidential term and had said he was free of cancer.


Lawyer Maria Alicia Altuve, who was out in bustling crowds in a shopping district of downtown Caracas, said it seemed odd how Maduro wept at a political rally while talking about Chavez.


“He cries on television to set up a drama, so that people go vote for poor Chavez,” Altuve said. “So we don’t know if this illness is for that, or if it’s that this man is truly sick.”


Some Chavez supporters said they found it hard to think about losing the president and worried about the future. His admirers held prayer vigils in Caracas and other cities this week, holding pictures and singing hymns.


Chavez has undergone four cancer-related surgeries since June 2011. He has also undergone months of chemotherapy and radiation treatments. Throughout his treatments, Chavez has kept secret some details of his illness, including the exact location and type of the tumors.


Ecuadorean President Rafael Correa wished his close ally the best, while also acknowledging the possibility that cancer might end his presidency. “Chavez is very important for Latin America, but if he can’t continue at the head of Venezuela, the processes of change have to continue,” Correa said at a news conference in Quito.


___


Associated Press writer Christopher Toothaker contributed to this report.


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iPad mini deemed a ‘game changer,’ outgrew Kindle Fire by nearly 50%






Smaller tablets in the 7-inch range have been on the market for more than two years now, but it looks like it took Apple (AAPL) just one month to vault to the top of the category. Mobile advertising firm Millennial Media recently published the findings of a study pitting the iPad mini against Amazon’s (AMZN) popular Kindle Fire, which has been an extremely popular iPad alternative since it first launched last year. According to Millennial, iPad mini usage grew about 50% faster during early November than the Kindle Fire did immediately following its successful launch last year, as measured by ad impressions served by the firm’s network.


Millennial found that impressions served to the iPad mini in early November grew at an average daily rate of 28%. In the weeks following the Kindle Fire’s launch last year, usage of Amazon’s tablet grew roughly 19% each day.






“In the first weeks after the iPad mini went on sale, we saw an average daily growth in impressions of 28 percent. Last holiday season, Amazon launched the Kindle Fire to much anticipation, Millennial Media’s Matt Mills wrote on the company’s blog. “As a comparison, we saw Kindle Fire impressions grow at an average daily rate of 19 percent in the first two weeks after it went on sale last year. So, by our math it looks like Apple could have itself another massive holiday season.”


Mills called the iPad mini a “game changer” and said he expects “a massive amount” of iPad mini tablets to be given as gifts this holiday season.


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CVS Caremark sees Obamacare as expansion opportunity






(Reuters) – CVS Caremark Corp is looking at changes in U.S. healthcare as an opportunity to serve more customers, whether they are picking up prescriptions, getting them through the mail, or stopping by an in-house MinuteClinic for a checkup.


The company, formed when drugstore chain CVS bought pharmacy benefits manager Caremark in 2007 in a $ 27 billion all-stock deal, is set to give details on its strategy as it meets with analysts and investors in New York on Thursday. It also plans to discuss its 2013 financial forecasts.






The coming year stands to be a busy one for the healthcare sector as the United States prepares for 30 million people to join the ranks of insured patients under the Affordable Care Act, or Obamacare, starting in 2014. At the same time, the large population of aging baby boomers and rising demand for specialty drugs stand to be opportunities for companies such as CVS.


The industry is already seeing rapid growth in the number of people signing up for Medicare Part D prescription plans.


“You’ve got 10,000 baby boomers becoming eligible for Medicare every day now,” CVS Chief Executive Larry Merlo said, referring to the health insurance plan for seniors. “The change is upon us and it will evolve over the next several years.”


Merlo asserts that CVS can play a bigger role in getting patients with chronic conditions to stick to their drug regimens, which can save billions of dollars.


About half of Americans suffer from one or more chronic diseases and of those who are newly diagnosed with a chronic disease, such as diabetes, almost 50 percent failed to stick with their drug regimen in the first year, Merlo said.


“The lack of medication adherence is costing our healthcare system some $ 300 billion a year in unnecessary costs,” he said.


While CVS prepares for next year, its main competitors have come under pressure.


Drugstore leader Walgreen Co is trying to lure patients back to its stores after reaching a new contract with Express Scripts Holding Co , CVS Caremark’s largest competitor in the pharmacy benefits manager business (PBM).


In November, Express Scripts said that its business would come under pressure in the weak economy, leaving analysts to question that company’s strategy in the wake of its acquisition of another PBM, Medco Health Solutions.


Merlo declined to comment on whether CVS’s strategy would include any acquisitions, though “bolt-on” acquisitions to support its retail or PBM units are always being reviewed.


CVS also runs roughly 650 MinuteClinic health care clinics, which have seen more patients come in. The day after Thanksgiving was the clinics’ busiest day to date, with 19,000 visits on November 23. CVS expects more than 3 million visits to MinuteClinic in 2012.


Eight of the more than 7,400 CVS stores remain closed after being significantly damaged by Hurricane Sandy. Six should reopen by the end of 2012 and the rest may reopen by the end of the first quarter of 2013, Merlo said.


CVS already said that costs associated with the massive storm would reduce its fourth-quarter earnings by as much as 1 cent per share.


Its third-quarter profit came in a penny ahead of analysts’ expectations, with growth in both the pharmacy benefits management business and the drugstore chain.


(Reporting by Jessica Wohl in Chicago; Editing by Leslie Gevirtz)


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Airlines: 2013 profits to rise thanks to cost cuts






GENEVA (AP) — Airlines‘ profits will improve to $ 8.4 billion in 2013, mainly reflecting cost cuts and restructuring measures taken to compensate for stalling economic growth, the global industry‘s trade group forecast Thursday.


For 2012, the industry anticipates net profits of $ 6.7 billion based on strong second and third quarters — particularly for larger carriers with bigger economies of scale — despite high fuel prices and weaker demand.






But the 2013 results would still be below the $ 8.8 billion earned in 2011 and $ 15.8 billion in 2010. The net profit margin, at 1 percent, would also be well below the 7 to 8 percent officials say is needed to recover capital costs.


The International Air Transport Association‘s annual review focused on the impact of annual world economic growth falling below 2 percent and Brent crude oil trading at $ 109.5 a barrel.


“Airlines have adjusted to this difficult environment through improving efficiency and restructuring,” said Tony Tyler, chief executive of the Geneva-based global trade group.


Tyler told reporters in Geneva that airlines’ financial performance hinged partly on their size.


“Economies of scale are helping larger airlines to cope much better with the difficult environment than small and medium-sized carriers which continue to struggle,” he said.


IATA, whose 240 member airlines carry 84 percent of all passengers and cargo, said the industry’s overall revenue in 2013 is expected to rise to $ 659 billion from $ 637 billion this year, while costs will go up to $ 640 billion from $ 623 billion.


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Australian prank call radio to donate profits to nurse’s family






CANBERRA (Reuters) – The Australian radio station behind a prank call to a British hospital will donate its advertising revenue until the end of the year to a fund for the family of the nurse who apparently took her own life after the stunt, the company said on Tuesday.


Southern Cross Austereo, parent company of Sydney radio station 2Day FM, said it would donate all advertising revenue, with a minimum contribution of A$ 500,000 ($ 525,000), to a memorial fund for the nurse, Jacintha Saldanha, who answered the telephone at the hospital treating Prince William’s pregnant wife, Kate.






The company has suspended the Sydney-based announcers, Mel Greig and Michael Christian, scrapped their “Hot 30″ programme and suspended advertising on the station in the wake of the Saldanha’s death. Southern Cross said it would resume advertising on its station from Thursday.


“It is a terrible tragedy and our thoughts continue to be with the family,” Southern Cross Chief Executive Officer Rhys Holleran said in a statement.


“We hope that by contributing to a memorial fund we can help to provide the Saldanha family with the support they need at this very difficult time.”


(Reporting by James Grubel; Editing by Robert Birsel)


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BlackBerry Messenger 7 adds free Wi-Fi voice calling, split-screen multitasking and more






Research in Motion (RIMM) updated its BlackBerry Messenger to version 7 on Monday, adding a new key feature called “BBM Voice” that “will allow customers to make free voice calls to their BBM contacts around the world over a Wi-Fi connection.” BBM 7 also introduces multitasking with split-screen, which allows users to BBM, check email, or use other apps while on a BBM Voice call; new compatibility with Bluetooth headsets and accessories, 16 new emoticons; direct BBM Update Notification that provides in-app alerts when new versions of an app are available and an easier way to synchronize BBM profiles; Groups; and Contacts with BBIDs for simpler backup and restores. BBM 7 is available as a free update for all BlackBerry smartphones running BlackBerry 6 OS or higher. Users on BlackBerry OS 5 will get BBM Voice “early next year.”


“BBM began as a convenient and effective business messaging tool, and today it is an essential part of daily communications for customers around the world,” said T.A. McCann, RIM’s Vice President of BBM and Social Communities. ”Now, with BBM version 7, customers have a new option: they can text and talk with their BBM contacts near and far, for free.”






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Luke Bryan cleans up at ACAs with 9 awards






Luke Bryan didn’t want the American Country Awards to end.


He cleaned up during the fan-voted show, earning nine awards, including artist and album of the year. His smash hit “I Don’t Want This Night To End” was named single and music video of the year.






Miranda Lambert took home the second most guitar trophies with three. Jason Aldean was named touring artist of the year. Carrie Underwood won female artist of the year, and a tearful Lauren Alaina won new artist of the year.


Bryan, Aldean, Keith Urban, Lady Antebellum and Trace Adkins with Lynyrd Skynrd were among the high-energy performances.


The third annual ACAs were held at Mandalay Bay in Las Vegas Monday night.


___


Online: http://www.theACAs.com


___


Follow http://www.twitter.com/AP_Country for the latest country music news from The Associated Press.


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Novo bets on high-price niche for obesity drug






LONDON (Reuters) – Denmark’s Novo Nordisk is sizing up a high-price niche market for its drug liraglutide as a weight-loss treatment, with the United States the prime opportunity.


The premium-price approach could turn it into a multibillion-dollar-a-year product, the company believes.






Novo is studying the injected drug – already on the market as a treatment for type-2 diabetes under the brand name Victoza – as a therapy for the seriously obese, with pivotal clinical trial results due in the first half of next year.


While some in the industry are sceptical about using so-called GLP-1 diabetes drugs such as liraglutide to fight obesity, Novo’s Chief Science Officer Mads Krogsgaard Thomsen believes the approach can offer cost-effective benefits.


Glucagon-like peptide-1, or GLP-1, drugs work by stimulating insulin release when glucose levels become too high. Their ability to induce weight loss is an added benefit, since type-2 diabetes is linked to obesity.


What is more, the willingness of the U.S. Food and Drug Administration to license new obesity pills from Vivus and Arena Pharmaceuticals last summer shows the door is open to such new medicines, Thomsen said.


“It’s positive. More physicians are now knowledgeable that pharmacotherapy can make a difference and the political establishment in the U.S. now knows that behavior change alone is not enough,” he said in an interview in London.


More than a third of American adults, or some 100 million people, are obese and the figure is rising fast, posing a growing threat to the nation’s health.


Among this population group, liraglutide may help the severely obese, including those with related problems like interrupted breathing during sleep and pre-diabetes, who might otherwise receive stomach surgery.


“We are not going out to treat the 100 million … We see this as solving a problem in a niche of maybe a few million patients,” Thomsen said.


“If you took one million patients and gave them liraglutide at 3.0 milligrams (a day) at the U.S. price that would be a $ 6 billion market.”


When used in diabetes as Victoza, liraglutide is given at daily doses of either 1.2 or 1.8 mg. Novo is betting on a higher dose to produce greater weight-loss in the obese. A key unknown is whether this will produce unacceptable side effects – and Thomsen admits this makes it something of a “joker” in the company’s line-up of new products.


The main adverse effect of Victoza is nausea in some patients, although this is not strong enough in itself to account for the weight loss seen with the drug and Thomsen does not see nausea as a hurdle to regulatory approval.


More worrying, would be any evidence that high-dose liraglutide is linked to pancreatitis.


Given the high safety bar required for a new obesity drug, analysts are currently divided as to whether liraglutide will make it for weight loss – especially given past disappointments with diet drugs such as Sanofi’s Acomplia.


If all goes according to plan, however, Novo aims to file for approval at the end of next year, implying a potential U.S. launch in late 2014 or early 2015 for a product that would add a new string to the bow of the world’s biggest maker of insulin.


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