Hurricane’s death toll rises to 65 in Caribbean

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PORT-AU-PRINCE, Haiti (AP) — As Americans braced Sunday for Hurricane Sandy, Haiti was still suffering.


Officials raised the storm-related death toll across the Caribbean to 65, with 51 of those coming in Haiti, which was pelted by three days of constant rains that ended only on Friday.





















As the rains stopped and rivers began to recede, authorities were getting a fuller idea of how much damage Sandy brought on Haiti. Bridges collapsed. Banana crops were ruined. Homes were underwater. Officials said the death toll might still rise.


“This is a disaster of major proportions,” Prime Minister Laurent Lamothe told The Associated Press, adding with a touch of hyperbole, “The whole south is under water.”


The country’s ramshackle housing and denuded hillsides are especially vulnerable to flooding. The bulk of the deaths were in the southern part of the country and the area around Port-au-Prince, the capital, which holds most of the 370,000 Haitians who are still living in flimsy shelters as a result of the devastating 2010 earthquake.


Santos Alexis, mayor of the southern city of Leogane, said Sunday that the rivers were receding and that people were beginning to dry their belongings in the sun.


“Things are back to being a little quiet,” Alexis said by telephone. “We have seen the end.”


Sandy also killed 11 in Cuba, where officials said it destroyed or damaged tens of thousands of houses. Deaths were also reported in Jamaica, the Bahamas and Puerto Rico. Authorities in the Dominican Republic said the storm destroyed several bridges and isolated at least 130 communities while damaging an estimated 3,500 homes.


Jamaica’s emergency management office on Sunday was airlifting supplies to marooned communities in remote areas of four badly impacted parishes.


In the Bahamas, Wolf Seyfert, operations director at local airline Western Air, said the domestic terminal of Grand Bahamas‘ airport received “substantial damage” from Sandy’s battering storm surge and would need to be rebuilt.


Latin America News Headlines – Yahoo! News



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Apple's iPad mini packs full-sized punch but screen inferior: reviews

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SAN FRANCISCO (Reuters) - Apple Inc's entry in the accelerating mobile tablet race squeezes about 35 percent more viewing space onto a lighter package than rival devices from Google or Amazon.com Inc, but it sports inferior resolution and a lofty price tag, two influential reviewers wrote on Tuesday.


The iPad mini, which starts at $329 versus the $199 for Google's Nexus 7 and Amazon's Kindle Fire HD, is easy to hold with one hand, eliminating a drawback of the 10-inch iPad, Wall Street Journal columnist Walt Mossberg wrote in one of the first major reviews of a gadget introduced last week.


Both Mossberg and New York Times columnist David Pogue offered kudos for cramming most of its full-sized cousin's functions onto a smaller device, as advertised.


But the iPad mini's 1024 x 768 resolution was a big step backwards from the iPad's much-touted Retina display, and underperformed the rival Kindle and Nexus, the two reviewers agreed.


Mossberg said Apple chose to go with a lower-quality display because the existing 250,000-plus iPad applications could only run unmodified in two resolutions - and the higher level would have sapped too much power.


"The lack of true HD gives the Nexus and Fire HD an advantage for video fans. In my tests, video looked just fine, but not as good as on the regular iPad," Mossberg wrote.


The original iPad was launched in 2010 and went on to upend the personal computer industry, spawning a raft of similar devices. The iPad mini marks Apple's first foray into a smaller 7-inch segment that Amazon's Kindle Fire now dominates, demonstrating demand exists for such a device.


Apple, making its boldest consumer hardware move since Tim Cook took the helm from late co-founder Steve Jobs, hopes the smaller tablet can beat back incursions onto its home turf of consumer electronics.


"In shrinking the iconic iPad, Apple has pulled off an impressive feat," Mossberg wrote. "It has managed to create a tablet that's notably thinner and lighter than the leading small competitors with 7-inch screens, while squeezing in a significantly roomier 7.9-inch display.


"And it has shunned the plastic construction used in its smaller rivals to retain the iPad's sturdier aluminum and glass body."


Mossberg, whose reviews are followed closely by consumers and tech companies alike, wrote that the iPad mini did as advertised by bringing the full-sized iPad experience onto a smaller screen.


He noted, however, that the device was too large to fit easily into pockets. It exhibited battery life of about 10 hours and 27 minutes, an hour more than the Kindle Fire at the same settings, but about 17 minutes less than the Nexus 7.


"By pricing the Mini so high, Apple allows the $200 class of seven-inch Android tablets and readers to live," Pogue wrote.


"But the iPad Mini is a far classier, more attractive, thinner machine. It has two cameras instead of one. Its fit and finish are far more refined. And above all, it offers that colossal app catalog, which Android tablet owners can only dream about."


(Reporting By Edwin Chan; Editing by Ken Wills)


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‘Homeland’ hits series high, Showtime sets record

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LOS ANGELES, Oct 30 (TheWrap.com) – Showtime‘s “Homeland” hit a series high with its Sunday episode — and it helped to deliver a first-time honor for the network, Showtime said Tuesday.


With “Dexter,” in its seventh season, inching up 5 percent from last week to score 2.28 million total viewers, Sunday marked the first time that Showtime has aired two back-to-back episodes of original series that have drawn more than 2 million viewers each in a single night.





















“Homeland” drew 2.07 million viewers with its 10 p.m. airing Sunday, jumping 19 percent from the previous week and delivering the highest viewership to date for the series, which cleaned up at the Emmy Awards earlier this year.


Between its 10 p.m. airing and an encore showing, “Homeland” brought in a total of 2.29 million viewers, making for the highest-rated night of the series, now in its second season.


Meanwhile, “Dexter” delivered its highest viewership since the seventh-season premiere with its 9 p.m. airing. Along with an encore airing, it drew a total of 2.81 million viewers.


(Editing By Zorianna Kit)


TV News Headlines – Yahoo! News



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Sensitive New Sensor Detects Prostate Cancer in Early Stages

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British scientists have designed a prototype of a highly sensitive scanner that can detect diseases such as prostate cancer and HIV in very early stages. They consider their discovery extremely useful in countries where high-tech detection equipment is scarce.


The researchers, from Imperial College London, reported that their new visual sensor technology is 10 times more sensitive than traditional disease detectors that measure biomarkers in the body, according to Medical News Today.





















The team tested the sensor’s accuracy in looking for a biomarker known as p24 that’s associated with HIV in human blood samples. They tested other samples for the Prostate Specific Antigen (PSA) marker, one indicator of prostate cancer.


The National Cancer Institute predicts that more than 240,000 men in the United States will be diagnosed with prostate cancer in 2012 and that more than 28,000 of them will die. A male newborn has a one in six chance of developing this disease.


The two standard ways of detecting this cancer are a digital rectal exam and a PSA test. In early stages, many cases have no symptoms. According to the Mayo Clinic, use of the PSA test is debatable because studies have never proven that the blood test saves lives. It can yield suspicious results even when the patient merely has an infection.


The new sensor detects prostate cancer by looking for PSA in a blood sample. With a positive result, irregular clumps of nanoparticles form and emit a specific blue shade inside the disposable container. For a negative test, the nanoparticles separate and form shapes that resemble a ball. The process creates a red hue. Both colors are visible to the naked eye.


The ultra-sensitive sensor could detect certain diseases at much earlier stages than current technology can find. It found miniscule levels of p24 in samples from patients with low HIV viral loads, a result impossible with standard tests like the Enzyme-Linked Immunosorbent Assay (ELISA).


The next step toward implementation is finding a sponsor among not-for-profit global health organizations to oversee the strategy for development, funding, and distribution of the technology.


While use of the sensor in the United States might be years away, the device is of special interest to my family. After years of lower-than-average PSA results, the numbers for my husband, who has a family history of prostate cancer, shot up last year. A test six months later showed even higher numbers.


The urologist performed prostate biopsies that caused bleeding and discomfort for weeks. The results showed no sign of malignancy, calling into question the validity of the two tests. A year later, the numbers mysteriously returned to the low end of the normal range. It would be reassuring to have access to this sensitive new sensor, knowing that it has the capacity to detect prostate cancer in very early stages.


Vonda J. Sines has published thousands of print and online health and medical articles. She specializes in diseases and other conditions that affect the quality of life.


Sexual Health News Headlines – Yahoo! News



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Dozens killed, millions without power in Sandy's wake

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PITTSBURGH (AP) — The most devastating storm in decades to hit the country's most densely populated region upended man and nature as it rolled back the clock on 21st-century lives, cutting off modern communication and leaving millions without power Tuesday as thousands who fled their water-menaced homes wondered when — if — life would return to normal.

A weakening Sandy, the hurricane turned fearsome superstorm, killed at least 50 people, many hit by falling trees, and still wasn't finished. It inched inland across Pennsylvania, ready to bank toward western New York to dump more of its water and likely cause more havoc Tuesday night.  Behind it: a dazed, inundated New York City, a waterlogged Atlantic Coast and a moonscape of disarray and debris — from unmoored shore-town boardwalks to submerged mass-transit systems to delicate presidential politics.

"Nature," said New York City Mayor Michael Bloomberg, assessing the damage to his city, "is an awful lot more powerful than we are."

More than 8.2 million households were without power in 17 states as far west as Michigan. Nearly 2 million of those were in New York, where large swaths of lower Manhattan lost electricity and entire streets ended up underwater — as did seven subway tunnels between Manhattan and Brooklyn at one point, the Metropolitan Transportation Authority said.

The New York Stock Exchange was closed for a second day from weather, the first time that has happened since a blizzard in 1888. The shutdown of mass transit crippled a city where more than 8.3 million bus, subway and local rail trips are taken each day, and 800,000 vehicles cross bridges run by the transit agency.

Consolidated Edison said electricity in and around New York could take a week to restore.

"Everybody knew it was coming. Unfortunately, it was everything they said it was," said Sal Novello, a construction executive who rode out the storm with his wife, Lori, in the Long Island town of Lindenhurst, and ended up with 7 feet of water in the basement.

The scope of the storm's damage wasn't known yet. Though early predictions of river flooding in Sandy's inland path were petering out, colder temperatures made snow the main product of Sandy's slow march from the sea. Parts of the West Virginia mountains were blanketed with 2 feet of snow by Tuesday afternoon, and drifts 4 feet deep were reported at Great Smoky Mountains National Park on the Tennessee-North Carolina border.

With Election Day a week away, the storm also threatened to affect the presidential campaign. Federal disaster response, always a dicey political issue, has become even thornier since government mismanagement of Hurricane Katrina in 2005. And poll access and voter turnout, both of which hinge upon how people are impacted by the storm, could help shift the outcome in an extremely close race.

As organized civilization came roaring back Tuesday in the form of emergency response, recharged cellphones and the reassurance of daylight, harrowing stories and pastiches emerged from Maryland north to Rhode Island in the hours after Sandy's howling winds and tidal surges shoved water over seaside barriers, into low-lying streets and up from coastal storm drains.

Images from around the storm-affected areas depicted scenes reminiscent of big-budget disaster movies. In Atlantic City, N.J., a gaping hole remained where once a stretch of boardwalk sat by the sea. In Queens, N.Y., rubble from a fire that destroyed as many as 100 houses in an evacuated beachfront neighborhood jutted into the air at ugly angles against a gray sky. In heavily flooded Hoboken, N.J., across the Hudson River from Manhattan, dozens of yellow cabs sat parked in rows, submerged in murky water to their windshields. At the ground zero construction site in lower Manhattan, seawater rushed into a gaping hole under harsh floodlights.

One of the most dramatic tales came from lower Manhattan, where a failed backup generator forced New York University's Langone Medical Center to relocate more than 200 patients, including 20 babies from neonatal intensive care. Dozens of ambulances lined up in the rainy night and the tiny patients were gingerly moved out, some attached to battery-powered respirators as gusts of wind blew their blankets.

In Moonachie, N.J., 10 miles north of Manhattan, water rose to 5 feet within 45 minutes and trapped residents who thought the worst of the storm had passed. Mobile-home park resident Juan Allen said water overflowed a 2-foot wall along a nearby creek, filling the area with 2 to 3 feet of water within 15 minutes. "I saw trees not just knocked down but ripped right out of the ground," he said. "I watched a tree crush a guy's house like a wet sponge."

In a measure of its massive size, waves on southern Lake Michigan rose to a record-tying 20.3 feet. High winds spinning off Sandy's edges clobbered the Cleveland area early Tuesday, uprooting trees, closing schools and flooding major roads along Lake Erie.

Most along the East Coast, though, grappled with an experience like Bertha Weismann of Bridgeport, Conn.— frightening, inconvenient and financially problematic but, overall, endurable. Her garage was flooded and she lost power, but she was grateful. "I feel like we are blessed," she said. "It could have been worse."

The presidential candidates' campaign maneuverings Tuesday revealed the delicacy of the need to look presidential in a crisis without appearing to capitalize on a disaster. President Barack Obama canceled a third straight day of campaigning, scratching events scheduled for Wednesday in swing-state Ohio, in Sandy's path. Republican Mitt Romney resumed his campaign with plans for an Ohio rally billed as a "storm relief event."

And the weather posed challenges a week out for how to get everyone out to vote. On the hard-hit New Jersey coastline, a county elections chief said some polling places on barrier islands will be unusable and have to be moved.

"This is the biggest challenge we've ever had," said George R. Gilmore, chairman of the Ocean County Board of Elections.

By Tuesday afternoon, there were still only hints of the economic impact of the storm.

Forecasting firm IHS Global Insight predicted the storm will end up causing about $20 billion in damages and $10 billion to $30 billion in lost business. Another firm, AIR Worldwide, estimated losses up to $15 billion — big numbers probably offset by reconstruction and repairs that will contribute to longer-term growth.

"The biggest problem is not the first few days but the coming months," said Alan Rubin, an expert in nature disaster recovery.

Airports were shut across the East Coast and far beyond as tens of thousands of travelers found they couldn't get where they were going. John F. Kennedy International Airport in New York and Newark International Airport in New Jersey will reopen at 7 a.m. Wednesday with limited service, but LaGuardia Airport will stay closed, officials said.

Sandy began in the Atlantic and knocked around the Caribbean — killing nearly 70 people — and strengthened into a hurricane as it chugged across the southeastern coast of the United States. By Tuesday night it had ebbed in strength but was joining up with another, more wintry storm — an expected confluence of weather systems that earned it nicknames like "superstorm" and, on Halloween eve, "Frankenstorm."

It became, pretty much everyone agreed Tuesday, the weather event of a lifetime — and one shared vigorously on social media by people in Sandy's path who took eye-popping photographs as the storm blew through, then shared them with the world by the blue light of their smartphones.

On Twitter, Facebook and the photo-sharing service Instagram, people tried to connect, reassure relatives and make sense of what was happening — and, in many cases, work to authenticate reports of destruction and storm surges. They posted and passed around images and real-time updates at a dizzying rate, wishing each other well and gaping, virtually, at scenes of calamity moments after they unfolded. Among the top terms on Facebook through the night and well into Tuesday, according to the social network: "we are OK," ''made it" and "fine."

By Tuesday evening, the remnants of Sandy were about 50 miles northeast of Pittsburgh, pushing westward with winds of 45 mph. It was expected to turn toward New York State and Canada during the night.

Although weakening as it goes, the storm will continue to bring heavy rain and flooding, said Daniel Brown of the National Hurricane Center in Miami.

Atlantic City's fabled Boardwalk, the first in the nation, lost several blocks when Sandy came through, though the majority of it remained intact even as other Jersey Shore boardwalks were dismantled. What damage could be seen on the coastline Tuesday was, in some locations, staggering — "unthinkable," New Jersey Gov. Chris Christie said of what unfolded along the Jersey Shore, where houses were swept from their foundations and amusement park rides were washed into the ocean. "Beyond anything I thought I would ever see."

Resident Carol Mason returned to her bayfront home to carpets that squished as she stepped on them. She made her final mortgage payment just last week. Facing a mandatory evacuation order, she had tried to ride out the storm at first but then saw the waters rising outside her bathroom window and quickly reconsidered.

"I looked at the bay and saw the fury in it," she said. "I knew it was time to go."

___

Contributing to this report were Katie Zezima in Atlantic City, N.J.; Alicia Caldwell and Martin Crutsinger in Washington; Colleen Long, Jennifer Peltz, Tom Hays, Larry Neumeister, Ralph Russo and Scott Mayerowitz in New York; Meghan Barr in Mastic Beach, N.Y.; Christopher S. Rugaber in Arlington, Va.; Marc Levy in Harrisburg, Pa.: John Christoffersen in Bridgeport, Conn.; Vicki Smith in Elkins, W.Va.; David Porter in Newark, N.J.; Joe Mandak in Pittsburgh; and Dave Collins in Hartford, Conn.

___

Follow Ted Anthony on Twitter at http://twitter.com/anthonyted

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Ukraine’s opposition doing well in election

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KIEV, Ukraine (AP) —


Ukraine’s opposition parties performed strongly in Sunday’s parliamentary vote, according to an exit poll, but President Viktor Yanukovych‘s party could still retain control of the legislature as its members are likely to sweep individual races across the country.





















The West is paying close attention to the conduct of the vote in the strategic ex-Soviet state, which lies between Russia and the European Union, and serves as a key conduit for transit of Russian energy supplies to many EU countries. An election deemed unfair would likely turn Ukraine further away from the West and toward Moscow.


Opposition parties alleged widespread violations on election day, such as vote-buying and a suspiciously high amount of home voting, but a local election monitor said those violations were isolated. Authorities insisted the election was honest and democratic.


The Fatherland party, led by the jailed charismatic former Prime Minister Yulia Tymoshenko, the Udar (Punch) of world boxing champion Vitali Klitschko and a nationalist party together received more than 50 percent of the vote on party lists, outnumbering Yanukovych’s Party of Regions and its traditional ally, the Communist Party.


Both Yanukovych’s and Tymoshenko’s parties claimed victory, saying the election showed the voters trust them to lead the country.


However, only half of the parliament’s 450 seats are split proportionately between the winning parties. The other half is filled by the winners of single-mandate races, where Yanukovych loyalists are expected to make a strong showing. In the election, each voter had two ballots, one with party names and one with the name of candidates in specific constituencies. No exit poll numbers were available for the individual races.


With Yanukovych under fire over the jailing of his top rival, Tymoshenko; rampant corruption and slow reforms, the opposition made a strong showing.


Tymoshenko’s Fatherland party is poised to get about 25 percent of the proportional vote, the Udar (Punch) led by world boxing champion Vitali Klitschko is set to get around 15 percent and the nationalist Svoboda (Freedom) party receives some 12 percent. The Party of Regions polled 28 percent and the Communists nearly 12 percent.


If the three opposition groups unite, they could get 127 parliament seats versus 98 seats gained by the Regions and Communists. The distribution of the remaining 225 seats is expected to be clear Monday.


Opposition forces hope to garner enough parliament seats to weaken Yanukovych’s power and undo the damage they say he has done: the jailing of Tymoshenko and her top allies, the concentration of power in the hands of the president, the snubbing of the Ukrainian language in favor of Russian, waning media freedoms, a deteriorating business climate and growing corruption.


The strong showing by the far-right Svoboda (Freedom) party which campaigns for the defense of the Ukrainian language and culture but is also infamous for xenophobic and anti-Semitic rhetoric emerged as a surprise and showed the widespread disappointment and anger with the ruling party.


It remains to be seen whether Tymoshenko’s group, Klitschko’s party and Svoboda can forge a strong alliance and challenge Yanukovych.


The election tainted by Tymoshenko’s jailing on charges of abuse of office has also been compromised by the creation of fake opposition parties, campaigns by politically unskilled celebrities, and the use of state resources and greater access to television by Yanukovych’s party.


___


Yuras Karmanau in Kiev contributed to this report.


Europe News Headlines – Yahoo! News



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SAP eyes "long" period of high sales growth: report

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“Argo” rises above “Cloud Atlas” as Sandy spooks

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LOS ANGELES (Reuters) – Acclaimed Iran hostage thriller “Argo” brought home its first box-office win over a quiet weekend, leading movie charts with $ 12.4 million in U.S. and Canadian ticket sales as would-be moviegoers hunkered down for Hurricane Sandy.


The tally for “Argo,” directed by and starring Ben Affleck, topped the $ 9.4 million for new sci-fi drama “Cloud Atlas“. Halloween-themed animated film “Hotel Transylvania” scared up $ 9.5 million from Friday through Sunday, narrowly edging “Cloud Atlas“, studio estimates showed.





















After two weeks in the No. 2 spot, “Argo” moved into the lead and lifted its domestic sales to $ 60.8 million through three weekends.


The movie, produced by Warner Bros. and GK Films for $ 44 million, tells the story of a mission to rescue U.S. government employees from Iran in 1979. The film has earned Oscar buzz after stellar reviews from critics and an “A+” grade from audiences polled by CinemaScore.


Dan Fellman, president of theatrical distribution for Warner Bros., a unit of Time Warner Inc, attributed the film’s jump to “great word-of-mouth”, which he called “the best form of advertising”.


Cloud Atlas“, also from Warner Bros., fell short of industry forecasts for a $ 13 million debut at North American (U.S. and Canadian) theaters. Fellman said the film did better in larger cities, but struggled in the South and Midwest.


The film, starring Tom Hanks and Halle Berry, cost $ 100 million to make. Many in Hollywood thought the story, based on a philosophical novel by David Mitchell, was too complex to bring to the big screen.


The nearly three-hour film with six interweaving stories divided critics, with the harshest reviewers saying it would try audiences’ patience with multiple storylines and century-hopping plots. The film’s stars also shift characters. Hanks, for example, is a shady doctor in the 1840s, a nuclear scientist in the 1970s and a simple valley-dweller in the distant future.


But “Cloud Atlas” also drew praise as an ambitious and well-acted epic. Sixty-one percent of reviews on the Rotten Tomatoes website recommended the film.


Hotel Transylvania” set a record for a September film opening in North America when it opened on September 28, and has performed solidly since then.


In the family comedy, Frankenstein, the Invisible Man and other monsters gather for a party at a high-end resort operated by Dracula. Their celebration is disrupted when a boy discovers the hotel and falls in love with Dracula’s daughter but must deal with her overprotective father.


The president of worldwide distribution for Sony Corp‘s Sony Pictures studio, Rory Bruer, wasn’t entirely surprised that the weeks-old movie beat “Cloud Atlas“, despite the latter movie’s buzz.


“Anything at this point doesn’t surprise me,” Bruer said. “It’s like an annuity that keeps on giving and giving.”


Paul Dergarabedian, box office analyst at Hollywood.com, said the Halloween weekend gave the film a boost, and is “still the number one choice for families” among the spooky seasonal films currently playing.


This weekend was fairly quiet at the box office in North America, which Dergarabedian attributed to Hurricane Sandy, a storm menacing the East Coast of the United States.


However, the new James Bond movie “Skyfall” whipped up a storm of its own overseas, taking $ 77.7 million in 25 countries. The latest installment of the British spy saga took the top spot in all 25 countries, broke the all-time Saturday attendance record in the United Kingdom, and was the biggest film opening there of 2012. It will open in the United States on November 9.


Rounding out the weekend’s top five, low-budget horror sequel “Paranormal Activity 4″ grossed $ 8.7 million at domestic theaters. “Silent Hill: Revelation 3D” and “Taken 2″ tied for fifth place, each pulling in $ 8 million.


Two other new films failed to crack the top five.


New Halloween-themed comedy “Fun Size” brought in $ 4.1 million at domestic theaters, landing in tenth place. The $ 14 million production tells the story of a boy who goes missing among trick-or-treaters, sparking his teen sister’s frantic search to find him before her mother comes home.


Sports drama “Chasing Mavericks” disappointed, failing to break the top ten. The movie stars Gerard Butler in the story of a surfer who tries to conquer one of the biggest waves on Earth.


Silent Hill: Revelation 3D” was released by Open Road Films, a joint venture between theater owners Regal Entertainment Group and AMC Entertainment Inc. Paramount Pictures, a unit of Viacom Inc, released “Fun Size” and “Paranormal Activity 4″.


“Chasing Mavericks” was distributed by News Corp’s 20th Century Fox studio. Sony Corp’s movie division released “Hotel Transylvania“.


(Reporting by Lisa Richwine and Andrea Burzynski; Editing by Will Dunham and Dale Hudson)


Movies News Headlines – Yahoo! News



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U.S. regulator needs new authority over compounding pharmacies: report

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WASHINGTON (Reuters) – The U.S. Food and Drug Administration‘s power to regulate compounded drugs similar to those linked to a deadly meningitis outbreak is legally nonbinding and lacks the authority of stringent standards imposed on drug manufacturers, according to a congressional report released on Sunday.


The report, compiled by the staff of U.S. Representative Edward Markey, a Massachusetts Democrat, drew an immediate response from FDA Commissioner Margaret Hamburg, who said the agency is committed to working with Congress and others to garner “the authority we need to help prevent tragedies like this from happening again.”





















“Over the years, there has been substantial debate within Congress about the appropriate amount of FDA oversight and regulation of compounding pharmacies. But unfortunately, there has been a lack of consensus and many challenges from industry,” Hamburg said in a statement emailed to Reuters.


“As pointed out in the report from Congressman Markey, FDA’s authority over compounding pharmacies is more limited by statute than with drug manufacturers,” she added.


The Markey report and Hamburg’s comments surfaced as Congress has begun preliminary discussions that could give the FDA new powers to oversee compounding pharmacies like the New England Compounding Center, which is at the heart of a fungal meningitis outbreak that has sickened 337 people, including 25 who have died, in 18 states.


But the public health crisis has also stirred debate about how much authority the FDA actually needs. Last week, the advocacy group Public Citizen called on the Department of Health and Human Services to investigate the agency on grounds that it failed to exercise its existing authority to prevent the meningitis outbreak.


The FDA issued a warning letter to NECC in 2006 describing potential health risks including microbial contamination. But there has been little evidence of a follow-up. Congressional investigators also say there is evidence that the FDA and state regulators knew of potential problems at NECC in 2002.


Hamburg has had little to say publicly about the regulatory issue. “FDA’s primary focus right now is containing the immediate crisis, protecting patients and their families from any further harm and completing our investigation,” she said.


Compounding is a traditional pharmacy practice in which a pharmacist alters, mixes or recombines ingredients to make a drug that meets the special needs of a patient with a physician’s prescription. But in recent decades, officials say some compounding operations have grown to resemble full-scale manufacturing without meeting FDA standards.


DOZENS OF WARNING LETTERS


The congressman’s report, based partly on documents gathered by investigators in the House of Representatives, says state governments that are now the chief regulators of pharmacy compounding cannot perform the kind of safety oversight necessary to prevent more drug-related outbreaks from occurring.


The FDA has issued dozens of warning letters against compounding pharmacies since 2001. But the report said the agency has based its enforcement actions on relatively weak, nonbinding guidance documents since a 1997 law granting it oversight of “new drugs” was struck down in U.S. courts more than a decade ago in cases brought by compounders.


“Guidance documents do not establish legally enforceable rights or responsibilities and do not legally bind the public or the FDA,” said a Congressional Research Services report cited by Markey’s staff.


That gives the agency far less power over compounding operations than it has over conventional drug manufacturers, which must submit to stringent safety and efficacy standards.


“Absent clear new authority, FDA’s efforts will ultimately be constrained by gaps in regulatory authority and thwarted by an industry that has historically resisted a federal role for the oversight of its activities,” said Markey.


An aide to Markey, who is on the House Energy and Commerce Committee which is conducting one of two congressional investigations into the outbreak, said the report was compiled from staff research. The aide acknowledged that some of the documents also form part of the House panel’s probe.


Markey has said he will propose legislation to enhance FDA oversight when Congress returns after the November 6 election. The committee is expected to hold hearings by the end of the year.


The report cites FDA documents as saying that compounded drugs may have been responsible for at least 23 deaths and 86 other cases of disease or injury before the current outbreak, related to injectable steroid treatments for back and joint pain first drew public attention last month.


FDA records described by the report also show that 10 of 29 compounded products tested by the FDA in 2003 failed at least one of the regulatory agency’s safety or efficacy tests. Three years later, in 2006, one-third of 36 compounded drug samples failed FDA analytical testing.


“The risks of allowing the safety of compounding pharmacies to go largely unregulated have been recognized for years, and the devastating tragedies of this outbreak will be felt well beyond it,” Markey said.


(Editing by Christopher Wilson)


Medications/Drugs News Headlines – Yahoo! News



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Sandy: East Coast braces for epic hurricane, ‘life-threatening’ storm surge

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Waves crash into a pier in Nags Head, N.C., Oct. 27, 2012. (Gerry Broome/AP)


[UPDATED: 8:00 p.m. ET]


"Superstorm." "The Perfect Storm." "Frankenstorm."


Whatever you want to call it, the East Coast is bracing for Hurricane Sandy, a "rare hybrid storm" that is expected to bring a life-threatening storm surge to the mid-Atlantic coast, Long Island Sound and New York harbor, forecasters say, with winds expected to be at or near hurricane force when it makes landfall sometime on Monday.


According to the National Hurricane Center, the Category 1 hurricane was centered about 280 miles southeast of Cape Hatteras, N.C., and 485 miles south of New York City early Sunday, carrying maximum sustained winds of 75 mph and moving northeast at 15 mph.


[Slideshow: Latest photos from Hurricane Sandy]


New York Mayor Michael Bloomberg ordered the immediate, mandatory evacuation for low-lying coastal areas, including Coney Island, the Rockaways, Brighton Beach, Red Hook and some parts of lower Manhattan along the East River.


"If you don't evacuate, you're not just putting your own life at risk," Mayor Bloomberg said at a news conference Sunday. "You're endangering first responders who may have to rescue you."


New Jersey Governor Chris Christie's message for residents was a bit more blunt. "Don't be stupid," Christie said Sunday afternoon, announcing the suspension of the state's transit system beginning at 12:01 a.m. Monday.


Earlier, New York Governor Andrew Cuomo announced the suspension of all MTA service--including subways, buses, Long Island Railroad and Metro North--beginning at 7 p.m. Sunday. New York City Public Schools will be closed on Monday, the mayor said. The New York Stock Exchange said its trading floor will be closed on Monday, too--the first such shutdown in 27 years, according to the Wall Street Journal.


[Related: Superstorm could impact 60 million]


Sandy is expected to continue on a parallel path along the mid-Atlantic coast later Sunday before making a sharp turn toward the northwest and southern New Jersey coastline on Monday--with the Jersey Shore and New York City in its projected path.


But the path is not necessarily the problem.


"Don't get fixated on a particular track," the Associated Press said. "Wherever it hits, the rare behemoth storm inexorably gathering in the eastern U.S. will afflict a third of the country with sheets of rain, high winds and heavy snow."


(FEMA)


A tropical storm warning has been issued between Cape Fear to Duck, N.C., while hurricane watches and high-wind warnings are in effect from the Virginia to Massachusetts. The hurricane-force winds extend 175 miles from the epicenter of the storm, while tropical storm-force winds extend 500 miles--or roughly 1,000 miles end to end, making Sandy one of the biggest storms to ever hit the East Coast.


"We're looking at impact of greater than 50 to 60 million people," Louis Uccellini, head of environmental prediction for the National Oceanic and Atmospheric Administration, told the Associated Press.


"The size of this alone, affecting a heavily populated area, is going to be history making," Jeff Masters wrote on the Weather Underground blog.


President Barack Obama received a briefing on the storm at Federal Emergency Management Agency headquarters in Washington on Sunday. "My main message to everybody involved is that we have to take this seriously," President Obama said. "[We will] respond big and respond fast."


[Also read: Big storm scrambles presidential race schedules]


"I can be as cynical as anyone," Christie said on Saturday, announcing a state of emergency. "But when the storm comes, if it's as bad as they're predicting, you're going to wish you weren't as cynical as you otherwise might have been."


Meanwhile, emergency evacuations were being mulled by state officials in Connecticut, Massachusetts, Vermont, New Hampshire and even Maine.


In Virginia, Governor Bob McDonnell said 20,000 homes there had already reported power outages.


(Weather.com)


"This is not a coastal threat alone," said FEMA director Craig Fugate said during a media briefing early Sunday. "This is a very large area."


Forecasters also fear the combination of storm surge, high tide and heavy rain--between 3 and 12 inches in some areas--could be life-threatening for coastal residents.


According to the National Hurricane Center summary, coastal water levels could rise anywhere between 1 and 12 feet from North Carolina to Cape Cod, depending on the timing of the "peak surge." A surge of 6 to 11 feet is forecast for Long Island Sound and Raritan Bay, including New York Harbor.


The storm surge in New York Harbor during Hurricane Irene in September 2011, forecasters noted, was four feet.


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