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Novartis heart drug gets FDA's 'breakthrough' status

Swiss pharmaceuticals company Novartis said on Friday U.S. regulators have given breakthrough therapy status to an investigational treatment for patients with acute heart failure, potentially fast tracking its development and approval. _0"> The U.S. Food and Drug Administration (FDA) created the "breakthrough therapy" designation earlier this year for medicines deemed likely to demonstrate "substantial improvement" over existing drugs.   Novartis said the FDA's decision was supported by efficacy and safety results from a late stage trial of its serelaxin, which also showed serelaxin reduced patient deaths by 37 percent at six months after acute heart failure compared to those who received standard therapy. Novartis said late last year serelaxin was one of the most promising drugs in its pipeline, while Deutsche bank analysts said it could potentially rake in $2.5 billion in annual sales. (Reporting by Martin de Sa'Pinto; Editing by David Cowell

Insight - It takes an army: Tens of thousands of workers roll out Obamacare

Call them Obamacare's army. From the chief actuary at the California health insurance exchange that President Barack Obama's healthcare reform law established to the legions of call center staffers who will help people trying to buy insurance through such state exchanges, the number of people working to implement "Obamacare" has reached the tens of thousands, a Reuters analysis has found.   No one said that overhauling healthcare, which accounts for 17 percent of all national spending, was going to happen with a skeleton crew. State offices that will run insurance exchanges are hiring tens of thousands, either on staff or through outsourcing firms. Federal agencies that are key to implementing the law, such as the Internal Revenue Service, plan to hire thousands more, and private non-profit groups backed by the White House are dispatching thousands of newly hired staffers and volunteers into the field. The number of such workers, obtained through documents and i

Governments weaken EU tobacco curbs to secure agreement

European Union health ministers agreed on Friday to ease tough planned restrictions on tobacco products to overcome opposition from some governments to the draft rules. The ministers rejected a ban on slim cigarettes proposed by the bloc's executive, the European Commission, but said they should be sold in normal-sized packets to reduce their appeal. They also agreed to outlaw menthol cigarettes and other tobacco flavorings. The bloc's health commissioner said that, despite the need for compromise in order to reach an agreement, the spirit of the Commission's original proposals has been retained. "The main thrust is that tobacco should look like tobacco - not like perfume or candy - and that it should taste like tobacco as well," the Maltese commissioner Tonio Borg told a news conference in Luxembourg after the ministerial talks.   Cigarette sales in the 27-nation EU bloc have fallen sharply in recent years but - at about 33 percent - Europe still has a high

Colon cancer screening tied to better outcomes

People who are diagnosed with colon cancer after routine colonoscopies tend to have better outcomes and less advanced cancers than people diagnosed based on symptoms, says a new study. Those who were diagnosed with colon cancer as a result of symptoms were three times more likely to die during the study than the patients diagnosed after colonoscopy screenings, researchers found.   "It's in line with its current use. It shows that colonoscopy appears to be beneficial in reducing deaths in those diagnosed with colorectal cancer," said Dr. Chyke Doubeni, who studies colonoscopy use but wasn't involved in the new research. Colon cancer is the third most common cancer and the second leading cause of cancer death in the U.S., according to the government-backed U.S. Preventive Services Task Force (USPSTF), which recommends that people between ages 50 and 75 get screened by colonoscopy every ten years. During a colonoscopy, a doctor uses a long flexible tube equipped wi

Rapid cooling does little for strained muscles- study

Blasts of super cold air may feel good on overworked muscles, but the increasingly popular form of cryotherapy does not stop muscle soreness or declines in muscle strength, according to a new study. Though other measures of muscle injury, such as swelling and muscle-cell electrical activity, were slightly improved after the rapid cooling, "overall, it's ineffective," said Gaël Guilhem, the lead author of the study and a researcher at the National Institute for Sports in Paris, France .   What athletes are interested in, Guilhem said, is, "'am I (in less pain), am I stronger?' And the answer was, 'no.'" Ice has long been used as a therapy for muscle injury. "It's been the standard treatment for acute injury and chronic injury since the 70s," said Ty Hopkins, a professor at Brigham Young University, who was not part of the study. Since then, approaches to cooling damaged tissues have become more sophisticated, involving machine

Daycare may benefit kids of depressed mothers

Children of depressed mothers are less likely to have emotional problems if they attend daycare, a new Canadian study suggests. Researchers have known that depressed women are more likely to have kids who also develop depression and anxiety disorders, and that those problems can extend through the teenage years. "It's interesting to think of this as a possible type of intervention and a way of supporting mothers in general, but especially mothers who are at risk," said Catherine Herba, from the University of Quebec at Montreal.   The researchers followed close to 1,800 children born in Quebec in 1997-1998 and their mothers through the child's fifth birthday. Women were regularly surveyed about their depression symptoms and reported on their child's emotional problems and separation anxiety, as well as the type of childcare they used. About 19 percent of mothers had depression symptoms during the study period. And as previous research has suggested, their ch

FDA approves Theravance's lung drug for wider use

The U.S. Food and Drug Administration approved Theravance Inc's antibiotic lung drug to treat a type of bacterial pneumonia affecting hospitalized patients, particularly those on ventilators. _0"> The drug, Vibativ, will reach the market in the third quarter of 2013 for its expanded use. The drug is already approved in the United States and Canada to treat bacterial skin infections.   The disease, also known as nosocomial pneumonia, is a serious lung infection as patients, particularly those on ventilators, often cannot fight the infection. The regulator said on Friday that Vibativ will be prescribed only when alternative treatments are not suitable and the expanded use is to treat only bacterial pneumonia due to staphylococcus aureus. ( link.reuters.com/hez98t ) Vibativ is already approved in Europe for the treatment of adults with nosocomial pneumonia. Theravance's shares were up about 2 percent at $38.25 in after-market trading. The shares closed up 10 percen