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Updated: Monday Dec 31, 2012 | 11:45 AM EST
WASHINGTON (AP) — The Food and Drug Administration on Monday approved a Johnson & Johnson tuberculosis drug that is the first new medicine to fight the deadly infection in more than four decades.
The agency approved J&J's pill, Sirturo, for use with older drugs to fight a hard-to-treat strain of tuberculosis that has not responded to other medications. However, the agency cautioned that the drug carries risks of potentially deadly heart problems and should be prescribed carefully by doctors.
Roughly one-third of the world's population is estimated to be infected with the bacteria causing tuberculosis. The disease is rare in the U.S., but kills about 1.4 million people a year worldwide. Of those, about 150,000 succumb to the increasingly common drug-resistant forms of the disease. About 60 percent of all cases are concentrated in China, India, Russia and Eastern Europe.
Sirturo, known chemically as bedaquiline, is the first medicine specifically designed for treating multidrug-resistant tuberculosis. That's a form of the disease that cannot be treated with at least two of the four primary antibiotics used for tuberculosis.
The standard drugs used to fight the disease were developed in the 1950s and 1960s.
"The antibiotics used to treat it have been around for at least 40 years and so the bacterium has become more and more resistant to what we have," said Chrispin Kambili, global medical affairs leader for J&J's Janssen division.
The drug carries a boxed warning indicating that it can interfere with the heart's electrical activity, potentially leading to fatal heart rhythms.
"Sirturo provides much-needed treatment for patients who have don't have other therapeutic options available," said Edward Cox, director of the FDA's antibacterial drugs office. "However, because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don't have other treatment options."
Nine patients taking Sirturo died in company testing compared with two patients taking a placebo. Five of the deaths in the Sirturo group seemed to be related to tuberculosis, but no explanation was apparent for the remaining four.
Despite the deaths, the FDA approved the drug under its accelerated approval program, which allows the agency to clear innovative drugs based on promising preliminary results.
Last week, the consumer advocacy group Public Citizen criticized that approach, noting the drug's outstanding safety issues.
"The fact that bedaquiline is part of a new class of drug means that an increased level of scrutiny should be required for its approval," the group states. "But the FDA had not yet answered concerns related to unexplained increases in toxicity and death in patients getting the drug."
The FDA said it approved the drug based on two mid-stage studies enrolling 440 patients taking Sirturo. Both studies were designed to measure how long it takes patients to be free of tuberculosis.
Results from the first trial showed most patients taking Sirturo plus older drugs were cured after 83 days, compared with 125 days for those taking a placebo plus older drugs. The second study showed most Sirturo patients were cured after 57 days.
NEW YORK (Reuters) - U.S. stocks jumped on Monday after a deal emerged from negotiations in Washington to avert the "fiscal cliff," sources familiar with the talks said.
Equities surged in a thinly traded session, on track to break a five-day streak of losses, as the sources said a majority of Senate Republicans were expected to support the legislation.
If adopted by Congress and President Barack Obama, the plan would sidestep a combination of tax hikes and spending cuts that many feared could push the economy into recession.
The deal, which would still need to be approved by both the Senate and House of Representatives, would raise tax rates for individuals with annual income over $400,000 a year but permanently extend middle class tax cuts.
"The market just wants this resolved and especially resolved in a way where the impact is pushed as far down the road as possible," said Paul Mendelsohn, chief investment strategist at Windham Financial Services in Charlotte, Vermont. "That is exactly what the market wants and I'm hoping that is what they deliver."
President Barack Obama is scheduled to speak on the fiscal cliff at 1:30 p.m.
"Right now the market is up 70 points, an hour from now we could be down 70 points, it all depends on what these people say," Mendelsohn said.
The Dow Jones industrial average <.dji> was up 50.38 points, or 0.39 percent, at 12,988.49 after trimming some of its gains. The Standard & Poor's 500 Index <.spx> was up 9.73 points, or 0.69 percent, at 1,412.16. The Nasdaq Composite Index <.ixic> was up 31.37 points, or 1.06 percent, at 2,991.68.
The S&P 500 is now up 12.4 percent for the year, compared with a flat performance in 2011. The Dow is about 6.4 percent higher and the Nasdaq is up 15 percent.
Gains in Apple Inc , the most valuable U.S. company, helped lift the Nasdaq. The stock rose 3.2 percent to $525.71, lifting the S&P information technology sector <.gspt> up 1 percent. For the year so far, Apple is up 29.1 percent.
The Dow was lifted by Caterpillar Inc
While a deal on the cliff is not yet official, investors may be ready to take on more risk next year in hopes of a greater reward.
Bank stocks rose after a New York Times report that U.S. regulators are nearing a $10 billion settlement with several banks that would end the government's efforts to hold lenders responsible for faulty foreclosure practices.
Bank of America Corp
Financial stocks were among the strongest of the year, with the S&P financial index surging 24.5 percent for 2012 so far. Bank of America is the top-performing Dow component, with its stock price more than doubling over the past 12 months.
(Editing by Kenneth Barry)
Our most popular Asia posts of 2012, by the number of readers and/or the number of comments:
China Calls for ‘No Delay’ on Gun Controls in U.S. This recent post on China’s reaction to the Newtown shooting tragedy brought nearly 200 comments, some enraged at China’s hypocrisy, some enraged at the American gun lobby and a few saying that China, despite any hypocrisy, wasn’t wrong.
China Demands Apology From U.S. This post, about Chen Guangcheng, the 40-year-old human rights lawyer taken in by the U.S. Embassy in Beijing before leaving for New York, also generated nearly 200 comments.
The Best Countries to Be a Woman — and the Worst. After the recent events in India surrounding the rape and murder of a woman, the debate that ensued in the discussion of this post — whether India really was as bad for women as the poll respondents (experts in gender relations) said; worse than Saudi Arabia and China — takes on a new light.
From Milk to Peas, a Chinese Food-Safety Mess. Many of the 125 comments on this post came from outraged readers in China complaining about their government’s failure to safeguard their lives and their children’s.
Watch Your Language! (In China, They Really Do). Before China shut out most content from The New York Times, the International Herald Tribune and Rendezvous, China was home to the third-largest number of Rendezvous readers, outranked only by the United States and Canada. Ironic.
East Asia’s Sea Disputes: Scar Tissue from War Wounds. This analysis, in August, about Chinese activists being arrested by the Japanese Coast Guard for planting flags on one of the Senkaku/Diaoyu islands, was just one of many seeking to explain a host of Asian territorial disputes, and the rising stakes.
A Telling Language Lesson in Hong Kong. When Leung Chun-ying, the new chief executive of Hong Kong, made his inaugural speech in Mandarin rather than Cantonese, it generated nearly 100 comments that showed the depth of the divide that still separates Hong Kong and the mainland. (As did this post, one of Rendezvous’s first, in January.)
It was not all geopolitics. This post on basketball phenom Jeremy Lin, Did ESPN Cross the Line Into Racism? received more than 100 comments, many touching on the role and view of Asian-Americans in the United States and globally. But our first post on Mr. Lin was back on Feb. 5: Asian-American Christian Basketball Star.
And this story generated nearly 100,000 page views: Finally, Outrage in China Against Bear Farming. Similarly, this story received more than 100 comments: The Slaughter of Elephants in Vietnam Is Nearly Complete.
‘Gangnam Style’ Becomes Most-Watched Video Ever on YouTube — 805 Million Views. Of course, the video by the K-pop star Psy has since surpassed the billion-view mark. But the comments, and those on an earlier post, showed the ambivalence many Asians felt toward the image of Asian men they said Psy was portraying.
12/29/2012 at 12:00 PM ET
Bill Davila/Startraks
It’s been a year of ups and downs for Katie Holmes, but she’s going out on a high note. Her effortlessly chic outfit earned top honors this week, making her the final best dressed star of 2012.
The stellar look consisted of a fuchsia Narciso Rodriguez dress and champagne bow-accented heels, topped off with an unexpected olive-green military-inspired trench worn to The Late Show with David Letterman in N.Y.C. The winning ensemble was a bright departure for the star, who tends to opt for more subdued colors. And the risk paid off because more than 6,000 PEOPLE.com readers gave it their style seal of approval.
PHOTOS: SEE THE TOP 10 BEST DRESSED STARS ON PEOPLE.COM THIS WEEK!
In a close second is Jessica Chastain (who had the number-one spot last week) in a leopard-print mini and a black coat, plus tights and lace-up boots, which she slipped into after her Broadway show in N.Y.C.
Click here to check out who else ranked in the top 10 and vote for your favorite looks of the week. Tell us: Does Holmes deserve the top spot? If not, who does?
–Jennifer Cress
WASHINGTON (Reuters) - Hopes rose on Sunday that lawmakers could reach at least a limited deal to prevent the still-recovering economy from tumbling off a "fiscal cliff" at the New Year, sending the country into another recession.
Aides to Senate Majority Leader Harry Reid, a Democrat, and Senate Republican leader Mitch McConnell worked on a compromise over the weekend to stop automatic tax hikes for most Americans on January 1. Any agreement needs to be rushed through both chambers of Congress before midnight on Monday.
The main focus of negotiations was tax hikes on the wealthy, an increase sought by President Barack Obama but opposed by Republicans, particularly fiscal conservatives in the House of Representatives.
"Well, there are certainly no breakthroughs yet between Senator McConnell and Senator Reid, but there's a real possibility of a deal," Senator Charles Schumer, a Democrat from New York, said on the ABC program "This Week."
"I don't disagree with Chuck," said Senator Jon Kyl, a Republican from Arizona.
Another Republican senator, Lindsey Graham, conceded that an agreement would end up raising income taxes on the wealthy, thus sparing the rest of the country from the looming income tax hikes.
"President Obama is going to get tax rate increases. The president won," Graham tweeted, echoing earlier comments he made on "Fox News Sunday." He told the show that the chances of a bipartisan deal before the New Year's deadline were "exceedingly good."
Obama has alternatively offered Republicans a deal to increase income taxes for households earning over $250,000 a year, and over $400,000 a year.
Any deal on taxes in the Senate might meet resistance in the House from conservative Republicans.
If the politicians cannot agree, then tax increases and across-the-board government spending cuts will begin on January 1. That would take $600 billion out of the economy, push unemployment up and curb federal spending.
"I think people don't want to go over the cliff if we can avoid it," said Graham, a conservative.
Putting pressure on Congress, Obama made a rare appearance on a Sunday television talk show where he warned of the fallout on financial markets if the two sides did not reach an agreement.
"If people start seeing that on January 1st this problem still hasn't been solved, that we haven't seen the kind of deficit reduction that we could have, had the Republicans been willing to take the deal that I gave them ... then obviously that's going to have an adverse reaction in the markets," Obama said on NBC's "Meet the Press."
He said he would avoid tax increases for most Americans, even if the talks fall apart.
"And if all else fails, if Republicans do in fact decide to block it, so that taxes on middle class families do in fact go up on January 1st, then we'll come back with a new Congress on January 4th and the first bill that will be introduced on the floor will be to cut taxes on middle class families," Obama said.
The Senate - where the Democrats hold sway - was scheduled to hold a rare Sunday session beginning at 1 p.m. EST (1800 GMT), but it was not clear whether the chamber would have fiscal-cliff legislation to act upon.
The Republican-controlled House also returns on Sunday and can vote on any deal in the evening if need be.
(Additional reporting by Tabassum Zakaria, Fred Barbash and Richard Cowan. Writing by Alistair Bell)
Apple’s (AAPL) share of the global tablet market is in decline now that low-cost Android slates are proliferating, but the iPad still appears to be the most used tablet by a huge margin. Ad firm Chitika regularly monitors tablet traffic in the United States and Canada and in its latest report, Apple’s iPad was responsible for almost 90% of all tablet traffic across the company’s massive network.
[More from BGR: Samsung looks to address its biggest weakness in 2013]
Using a sample of tens of millions of impressions served to tablets between December 8th and December 14th this year, Chitika determined that various iPad models collectively accounted for 87% of tablet traffic in North America. That figure is down a point from the prior month but still represents a commanding lead in the space.
[More from BGR: New purported BlackBerry Z10 specs emerge: 1.5GHz processor, 2GB RAM, 8MP camera]
The next closest device line, Amazon’s (AMZN) Kindle Fire tablet family, had a 4.25% share of tablet traffic during that period, up from 3.57% in November. Samsung’s (005930) Galaxy tablets made up 2.65% of traffic, up from 2.36%, and Google’s (GOOG) Nexus 7 and Nexus 10 tablets combined to account for 1.06% of tablet traffic in early December.
“Despite these gains by some of the bigger players in the tablet marketplace, there has been a negligible impact to Apple’s dominant usage share,” Chitika wrote in a post on its blog.
This article was originally published by BGR
Gadgets News Headlines – Yahoo! News
12/28/2012 at 11:00 AM ET
XPosure
Hold off on the congratulations — at least for now.
News and social media sites lit up on Thursday after Shakira‘s boyfriend, FC Barcelona soccer star Gerard Piqué, posted a message on Twitter, announcing the arrival of their baby boy.
“”Our son has been born!” he wrote in Spanish. “We’re very happy! Thank you all for your messages!”
But the baby buzz was short-lived after the father-to-be’s fan following started calling out the coincidental timing of it all — Dec. 28 is Dia de Los Santos Inocentes in Spain and parts of Latin America, a holiday much like April Fools’ Day.
And all bets on baby’s birth were officially off when Piqué confessed to his prank with a follow-up message Friday morning.
“He has a name! His name is Innocence!” he Tweeted. “Happy Day of the Innocents to everyone!”
– Aaron Parsley and Anya Leon
NAIROBI, Kenya (AP) — The director of the Pumwani Maternity Hospital, located in a hardscrabble neighborhood of downtown Nairobi, freely acknowledges what he's accused of: detaining mothers who can't pay their bills. Lazarus Omondi says it's the only way he can keep his medical center running.
Two mothers who live in a mud-wall and tin-roof slum a short walk from the maternity hospital, which is affiliated with the Nairobi City Council, told The Associated Press that Pumwani wouldn't let them leave after delivering their babies. The bills the mothers couldn't afford were $60 and $160. Guards would beat mothers with sticks who tried to leave without paying, one of the women said.
Now, a New York-based group has filed a lawsuit on the women's behalf in hopes of forcing Pumwani to stop the practice, a practice Omondi is candid about.
"We hold you and squeeze you until we get what we can get. We must be self-sufficient," Omondi said in an interview in his hospital office. "The hospital must get money to pay electricity, to pay water. We must pay our doctors and our workers."
"They stay there until they pay. They must pay," he said of the 350 mothers who give birth each week on average. "If you don't pay the hospital will collapse."
The Center for Reproductive Rights, which filed the suit this month in the High Court of Kenya, says detaining women for not paying is illegal. Pumwani is associated with the Nairobi City Council, one reason it might be able to get away with such practices, and the patients are among Nairobi's poorest with hardly anyone to stand up for them.
Maimouna Awuor was an impoverished mother of four when she was to give birth to her fifth in October 2010. Like many who live in Nairobi's slums, Awuor performs odd jobs in the hopes of earning enough money to feed her kids that day. Awuor, who is named in the lawsuit, says she had saved $12 and hoped to go to a lower-cost clinic but was turned away and sent to Pumwani. After giving birth, she couldn't pay the $60 bill, and was held with what she believes was about 60 other women and their infants.
"We were sleeping three to a bed, sometimes four," she said. "They abuse you, they call you names," she said of the hospital staff.
She said saw some women tried to flee but they were beaten by the guards and turned back. While her husband worked at a faraway refugee camp, Awuor's 9-year-old daughter took care of her siblings. A friend helped feed them, she said, while the children stayed in the family's 50-square-foot shack, where rent is $18 a month. She says she was released after 20 days after Nairobi's mayor paid her bill. Politicians in Kenya in general are expected to give out money and get a budget to do so.
A second mother named in the lawsuit, Margaret Anyoso, says she was locked up in Pumwani for six days in 2010 because she could not pay her $160 bill. Her pregnancy was complicated by a punctured bladder and heavy bleeding.
"I did not see my child until the sixth day after the surgery. The hospital staff were keeping her away from me and it was only when I caused a scene that they brought her to me," said Anyoso, a vegetable seller and a single mother with five children who makes $5 on a good day.
Anyoso said she didn't have clothes for her child so she wrapped her in a blood-stained blouse. She was released after relatives paid the bill.
One woman says she was detained for nine months and was released only after going on a hunger strike. The Center for Reproductive Rights says other hospitals also detain non-paying patients.
Judy Okal, the acting Africa director for the Center for Reproductive Rights, said her group filed the lawsuit so all Kenyan women, regardless of socio-economic status, are able to receive health care without fear of imprisonment. The hospital, the attorney general, the City Council of Nairobi and two government ministries are named in the suit.
___
Associated Press reporter Tom Odula contributed to this report.
NEW YORK (Reuters) - Stocks fell on Friday, putting the S&P 500 on track for a fifth straight decline, as President Barack Obama and top congressional leaders were set to make a last-ditch attempt to steer the country away from severe fiscal austerity next year.
Obama and lawmakers from both political parties will meet at the White House on Friday afternoon for talks in an effort to agree on a solution before a New Year's deadline to keep large tax hikes and spending cuts from taking effect. Economists say that combination of automatic higher taxes and lower government spending - known as the "fiscal cliff" - could push the U.S. economy into a recession.
Trading was volatile and stocks rebounded from their session lows after unconfirmed reports that President Obama was about to offer a new plan to Republicans.
But investors' pessimism about achieving anything more than a stop-gap deal by the deadline was reflected in the benchmark S&P 500's drop of 1.3 percent so far this week. The broad index was on pace for its worst weekly performance since mid-November.
A five-day decline would be the S&P 500's longest losing streak in three months.
"There's a pretty good chance that we won't have something in hand by year-end," said Jonathan Golub, chief U.S. equity strategist at UBS, in New York. "It should be pretty obvious that that is now the majority case."
Golub, however, said investors were still counting on a deal that would avoid most of the tax hikes and spending cuts next year even if it does come after the deadline.
"It is widely believed that we're going to get a deal," he said. "We are not going to go over the cliff to the extent that we have a huge economic contraction."
With time running short, members of Congress may attempt to pass a retroactive fix to neutralize tax increases and spending cuts soon after the automatic fiscal policies come into effect on January 1.
The Dow Jones industrial average <.dji> fell 65.65 points, or 0.50 percent, to 13,030.66. The Standard & Poor's 500 Index <.spx> dropped 6.03 points, or 0.43 percent, to 1,412.07. The Nasdaq Composite Index <.ixic> slipped 7.29 points, or 0.24 percent, to 2,978.62.
"It doesn't matter which side wins, but at this point, nobody wants to play a game where there aren't rules," said Joe Costigan, director of equity research at Bryn Mawr Trust, in Bryn Mawr, Pennsylvania.
"So everybody is talking about what the prospects are for changes in the rules. But at the end of the day, nothing is happening."
Highlighting Wall Street's sensitivity to developments in Washington, stocks tumbled slightly more than 1 percent on Thursday after Senate Majority Leader Harry Reid warned that a deal was unlikely before the deadline. But late in the day, the three major U.S. stock indexes rebounded and ended down just 0.1 percent after the U.S. House of Representatives said it would hold an unusual Sunday session to work on a fiscal solution.
With many investors away for the holiday-shortened week, volume is expected to remain light and that could exacerbate the stock market's swings.
Positive economic data failed to alter the market's downtrend.
The National Association of Realtors said contracts to buy previously owned U.S. homes rose in November to their highest level in 2-1/2 years, while a report from the Institute for Supply Management-Chicago showed business activity in the U.S. Midwest expanded in December.
Barnes & Noble Inc
Shares of magicJack VocalTec Ltd
The U.S.-listed shares of Canadian drugmaker Aeterna Zentaris Inc surged 16.1 percent to $2.52 after the company said it had reached an agreement with the U.S. Food and Drug Administration on a special protocol assessment by the FDA for a Phase 3 registration trial in endometrial cancer with AEZS-108 treatment.
(Reporting by Edward Krudy; Editing by Jan Paschal)
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