Skip to main content

Posts

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

Medtronic takes 'first step' toward U.S. sale of artificial pancreas

Type 1 diabetics, who run the risk of dangerously low blood sugar, may be a step closer to getting help from a crude artificial pancreas device that can read blood sugar levels and automatically turn off the flow of insulin after a clinical trial showed the device is safe. The long-awaited results of the clinical trial may pave the way for U.S. approval of the device, made by Medtronic, which already sells insulin pumps with an automatic shutoff feature in 50 countries outside the United States. The feature is meant to guard against delivering insulin to diabetics their blood sugar is already too low.   As many as 3 million Americans have type 1 diabetes, in which the immune system destroys cells in the pancreas that make insulin. Type 1 diabetes must monitor their blood sugar and take insulin several times a day. Too little insulin can cause high blood sugar, increasing the risk of long-term complications such as eye damage, kidney failure and heart disease. But too much insulin

Scientists warn against complacency on deadly H7N9 bird flu

A new and deadly strain of bird flu that emerged in China in February but seems to have petered out in recent months could reappear later this year when the warm season comes to an end - and could spread internationally, scientists said on Monday. A study by researchers in China and Hong Kong found only one human case of the H7N9 bird flu strain has been identified since early May.   In the preceding months, the virus, which was unknown in humans until February, has infected more than 130 people in China and Taiwan, killing 37 of them, according to the World Health Organization (WHO). "The warm season has now begun in China, and only one new laboratory-confirmed case of H7N9 in human beings has been identified since May 8, 2013," the researchers wrote in a study published in The Lancet medical journal. But they added: "If H7N9 follows a similar pattern to H5N1, the epidemic could reappear in the autumn." H5N1 is another deadly strain of bird flu which emerge

India's Ranbaxy falls on media report of U.S. FDA query on plant

Shares of Ranbaxy Laboratories Ltd fell as much as 2.3 percent on Monday after newspaper Business Standard reported the U.S. Food and Drug Administration had raised concerns about a plant in northern India, citing unidentified sources. _0"> Business Standard said the FDA had issued form 483 to Ranbaxy regarding its Mohali plant. That form is issued when U.S. inspectors see conditions they believe may violate U.S. rules. A Ranbaxy spokesman declined to comment when asked if the drug maker had received the 483 form.   "We continue to make regulatory submissions from Mohali and will commercialize products from Mohali when we get approvals," he said. The U.S. FDA was not immediately reachable for comment. Ranbaxy shares were down 1.8 percent at 0355 GMT (11.55 p.m. EDT Sunday), compared with a 0.7 percent fall in the broader NSE index. (Reporting by Kaustubh Kulkarni and Rafael Nam; Editing by Michael Urquhart)

Novartis tests copy of Amgen's Enbrel in late-stage trial

Sandoz, the generics unit of Novartis, has launched a late-stage trial with its biosimilar version of Amgen's Enbrel, consolidating its leading position in developing cheaper copies of complex biotech drugs. _0"> With the start of the major study of its version of Enbrel, or etanercept, Sandoz now has seven Phase III clinical trials across five biosimilar molecules - more than any other company in the industry.   Sandoz said on Monday the new trial aimed to confirm the biosimilarity of its product versus Enbrel in patients with moderate to severe chronic plaque-type psoriasis. Results will be used to support U.S. and European regulatory filings. Unlike traditional chemical drugs, biotech medicines consist of proteins derived from living organisms that cannot be replicated exactly. Generic copies, therefore, are more difficult to develop and market. IMS Health, a provider of data for the healthcare industry, expects global spending on biosimilars to increase to between

Germany's SMA says device to store solar energy can cut bills

SMA Solar, Germany's largest solar company, is launching an battery set that will allow households to store surplus daytime solar energy for use in the evening, cutting energy bills. German households pay some of the highest prices in Europe for electricity because they pick up much of the cost of subsidizing cleaner energy production.   SMA Solar, which is up against fierce Asian competition, says it can help owners of solar panels use more of their self-generated power. It is Germany's largest solar company and the world's largest maker of solar inverters, a component that helps to feed solar-generated energy into the electricity grid. The company says its combined inverter battery will give a four-person household up to three hours of extra energy during the evening. The device will go on the market in the second half of this year. "The discussion is no longer about returns from solar panel installations, as was the case in the past. People now want to know h

In Alaska's oilfields, drones countdown to takeoff

No pilot was required when the Aeryon Scout took off into the leaden skies of Alaska to inspect a stretch of oil pipeline. The miniature aircraft was guided by an engineer on the ground, armed only with a tablet computer. The 20-minute test flight, conducted by BP Plc last fall, was a glimpse of a future where oil and gas companies in the Arctic can rely on unmanned aircraft to detect pipeline faults, at a fraction of the cost of piloted helicopter flights.   It could become reality as soon as 2015, when the Federal Aviation Administration (FAA) opens up American skies for the commercial use of unmanned aircraft, popularly known as drones. While technical shortcomings and strict regulation are likely to limit the use of drones in the near term, the rules governing public airspace will be more relaxed in the wilderness of Alaska than in the lower 48 states, industry experts say. "We're going to take baby steps," said Gary Shane, a consultant who works as a senior pro

Indonesian fires worsen, Singapore smog sets record

Indonesia deployed military planes on Friday to fight forest fires that blanketed neighboring Singapore in record levels of hazardous smog for a third day in one of Southeast Asia's worst air-pollution crises. As Singaporeans donned face masks and pulled children from playgrounds and Malaysia closed schools in the south, the deliberately-lit fires grew bigger in some areas. Whipped up by winds, the blazes added to fears over health problems and diplomatic tension in Singapore, Malaysia and Indonesia. "The winds are picking up and the weather isn't very good at the moment, so the fires in some places are getting bigger," said Gunawan, a firefighter who like many Indonesians goes by one name. "We are working as hard as possible to control the fires...but we're facing difficult conditions." Indonesia blamed eight companies, including Jakarta-based PT Sinar Mas Agro Resources and Technology (SMART) and Asia Pacific Resources International (APRIL), for

Thunderstorms knock out power to thousands in upper Midwest

Severe storms producing wind gusts up to 85 mph, heavy rain and lightning strikes in Minnesota and Wisconsin early on Friday, knocked down trees and power lines and at one point left more than 176,000 customers without power. _0"> An area stretching from the Dakotas through Wisconsin was bracing for more storms, some severe, later on Friday and possible flooding after reports of three to four inches of rain fell in some communities already, the National Weather Service said.   "The weather pattern is pretty much going to be stationary tonight and through the weekend so we are concerned about the severe weather and also the potential for flooding," said Jacob Beitlich, a weather service meteorologist in the Twin Cities. The storms developed in the Dakotas and powered southeast through Minnesota into Wisconsin, bringing heavy straight-line wind damage with a gust of 85 mph at the heart of it northwest of the Twin Cities, he said. The weather service also has issue

Obama speech on U.S. climate measures could come Tuesday: sources

President Barack Obama is likely to roll out a number of measures on climate policy, potentially including a strategy to limit greenhouse gas emissions from existing power plants, in a speech on Tuesday, sources familiar with the plans told Reuters. _0"> The potential move on power utilities, which account for roughly 40 percent of the nation's carbon dioxide emissions, will come as Obama sets the fight to curb climate change as a priority for his second term.   Regulations are still pending on yet-to-be-built power plants, after the Environmental Protection Agency in April missed a deadline to roll out emissions rules. But environmentalists have been pushing the administration to go after a bigger target, and set tighter standards for the roughly 1,400 coal-fired burners that are already feeding the nation's electric grid. Earlier this week, the White House's top energy and climate adviser, Heather Zichal, said that Obama will take several steps to make tackl

Floods shut down Canada's oil capital, four may be dead

The heaviest floods in decades shut down the Canadian oil capital of Calgary on Friday, with an evacuation of the downtown core and tens of thousands of residents forced to leave their homes. Police said four people may have died in the town of High River, located about 60 km (37 miles) south of Calgary, including a woman who was swept away with her camper and a man seen falling from a canoe in the swollen Highwood River.   Some 1,200 troops were helping with the evacuations. "This is a tragic situation," Alberta Premier Alison Redford said at a press conference. "I think in the circumstances the response has been incredibly effective but that doesn't mean that people aren't impacted. This is a natural disaster." Around 100,000 people of Calgary's 1.1 million residents, were ordered to leave their homes, while smaller communities were evacuated elsewhere in the Western Canadian province. By mid-afternoon, rivers had flooded roads and bridges, forc

Raging wildfires force evacuation of two Colorado towns

Three wildfires sparked by lightning raged out of control in rugged Colorado mountain terrain on Friday, prompting the evacuation of two towns and menacing a third. The West Fork Fire Complex - consisting of two separate fires in Rio Grande County in southern Colorado - forced 600 residents of South Fork to flee as high winds helped the blazes grow from 12,000 acres to 30,000 acres overnight.   "The fire behavior we saw yesterday was so extreme, it was ... unprecedented," said Eric Norton, a fire behavior analyst with the National Incident Management Organization. A smoke plume from the blazes billowed 30,000 feet into the air, and firefighters reported 100-foot (30-meter) flames. A string of fires have claimed at least two lives, charred hundreds of square miles and torched hundreds of homes across the western United States and in Alaska, which is baking in a heat wave. The blazes, coming just as firefighters near Colorado Springs have contained the state's most d

Crews break ground on largest California dam removal

Demolition crews on Friday began work on the biggest dam removal in California, a project aimed at protecting homes threatened by the aging, obsolete structure and restoring spawning grounds for native trout. Plans call for the 94-year-old San Clemente Dam, built on the Carmel River about 120 miles south of San Francisco, to be torn down in stages over three years, followed by rerouting of the river around the dam site and wildlife restoration.   "In 10 years, when you come to the site, you won't be able to tell there was a dam there," said Jeff Szytel, founder of contractor Water Systems Consulting, who is overseeing the project. The demolition is part of a larger safety and restoration effort that will include removal of a smaller dam downstream from San Clemente and recycling of sediment that has built up in the reservoir behind the dam. The dam was designed to divert Carmel River water to the Monterey Peninsula, but with the reservoir nearly filled with silt tha

Singapore smog eases as Indonesian planes waterbomb fires

Air quality in Singapore improved significantly to "moderate" pollution levels on Saturday, as Indonesian planes waterbombed raging forest fires and investigators scrambled to determine the cause of one of Southeast Asia's worst air pollution crises. Indonesia's environment minister said eight domestic firms were suspected of being responsible for the blazes on Sumatra island that blanketed neighboring Singapore in record levels of hazardous smog. The parent companies of the Indonesian firms included Malaysia-listed Sime Darby and Singapore's Wilmar Group.   A senior presidential aide on Friday also blamed units of Jakarta-based PT Sinar Mas Agro Resources and Technology (SMART) and Asia Pacific Resources International (APRIL) for the fires. "We will take legal action whoever they are," Environment Minister Balthasar Kambuaya told reporters. "Any companies from Indonesia , Malaysia or Singapore, they will be legally processed." But Indone

Canada's oil capital to be shut for days after flooding

Southern Alberta braced for more disruption on Saturday from floods that killed at least three people, forced about 100,000 from their homes and blacked out the center of Canada's oil capital, Calgary. Communities to the south and east of Calgary were on high alert as flood waters moved across the region. But with rainfall easing, a few residents began returning to damaged homes and authorities were hopeful that the worst might be over.   "It's morning in Calgary! Sunny, water levels are down, and our spirit remains strong," Calgary Mayor Naheed Nenshi said on Twitter. "We're not out of this, but maybe have turned (the) corner." The floods followed some 36 hours of unusually heavy rainfall - some communities received six months of their normal rainfall in under two days. Evacuations started on Thursday in Calgary and in smaller cities. Utility Enmax switched off power to central Calgary on Friday afternoon lest water damage its downtown facilities,