FDA approves 1st new tuberculosis drug in 40 years

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.

Read More..

Wall Street up slightly in choppy trade over "cliff" worry

NEW YORK (Reuters) - Wall Street edged higher in a choppy session on Monday, with the S&P 500 on track for double-digit gains for the year, as politicians bargained for a deal to avert the "fiscal cliff."

Taxes were set to rise for many Americans this week unless U.S. lawmakers could cut a last-minute deal, an outcome that was possible but seemed unlikely.

Senate Majority Leader Harry Reid said the Senate would reconvene at 11 a.m. Washington time (1600 GMT) to continue discussions on the fiscal cliff - $600 billion in automatic tax hikes and spending cuts that kick in January 1.

The last trading session of the year is expected to be volatile on low volume and as investors keep a close eye on headlines out of Washington.

"Even if we end up with a deal, it will be just a band-aid, not a real fix. So we will see a volatile session today, with all eyes on the debates, comments out of Washington," said Tim Ghriskey, chief investment officer at Solaris Group in Bedford Hills, New York.

"I'm not expecting a major rally or a selloff," Ghriskey added.

Despite recent declines over the stalemated budget talks, the S&P 500 is up about 11.5 percent for the year compared with a nearly flat performance in 2011. The Dow industrials are about 6 percent higher and the Nasdaq composite is up about 14 percent for 2012.

The Dow Jones industrial average <.dji> was up 7.45 points, or 0.06 percent, at 12,945.56. The Standard & Poor's 500 Index <.spx> was up 4.53 points, or 0.32 percent, at 1,406.96. The Nasdaq Composite Index <.ixic> was up 17.63 points, or 0.60 percent, at 2,977.95.

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 was up 0.4 percent at $11.41 and Citigroup rose 0.2 percent to $39.08.

While midnight is the deadline for a fiscal deal, the government can pass legislation in 2013 that retroactively cancels or moderates the impact of going over the fiscal cliff.

Investors have remained relatively sanguine about the process, believing it will eventually be solved. In the past two months markets have not shown the kind of volatility that was present during the fight to raise the debt ceiling in 2011.

Rather, equities have largely performed well in the last two months, buoyed by signs of economic recovery, an improving housing market and monetary policy designed to stimulate growth and lower unemployment.

However, U.S. stocks dropped on Friday, with significant losses in the last minutes of trading, as prospects for a deal worsened at the beginning of the weekend.

On Sunday, President Barack Obama said on NBC's "Meet the Press" investors could begin to show greater concerns in the new year.

(Reporting By Angela Moon; Editing by Kenneth Barry)

Read More..

To Save Wildlife, and Tourism, Kenyans Take Up Arms

ARCHER’S POST, Kenya — Julius Lokinyi was one of the most notorious poachers in this part of Kenya, accused of single-handedly killing as many as 100 elephants and selling the tusks by the side of the road in the dead of night, pumping vast amounts of ivory into a shadowy global underground trade.

But after being hounded, shamed, browbeaten and finally persuaded by his elders, he recently made a remarkable transformation. Elephants, he has come to believe, are actually worth more alive than dead, because of the tourists they attract. So Mr. Lokinyi stopped poaching and joined a grass-roots squad of rangers — essentially a conservation militia — to protect the wildlife he once slaughtered.

Nowadays he gets up at dawn, slurps down a cup of sugary tea, tightens his combat boots and marches off with other villagers, some who had never picked up a gun before and are little more than volunteers, to fight poachers.

“We got to protect the elephants,” said Mr. Lokinyi, whose hooded eyes now glow with the zeal of a convert.

From Tanzania to Cameroon, tens of thousands of elephants are being poached each year, more than at any time in decades, because of Asia’s soaring demand for ivory. Nothing seems to be stopping it, including deploying national armies, and the bullet-riddled carcasses keep stacking up. Scientists say that at this rate, African elephants could soon go the way of the wild American bison.

But in this stretch of northern Kenya, destitute villagers have seized upon an unconventional solution that, if replicated elsewhere, could be the key to saving thousands of elephants across Africa, conservationists say. In a growing number of communities here, people are so eager, even desperate, to protect their wildlife that civilians with no military experience are banding together, grabbing shotguns and G3 assault rifles and risking their lives to confront heavily armed poaching gangs.

It is essentially a militarized neighborhood watch, with loping, 6-foot-6 former herdsmen acting as the block captains, and the block being miles and miles of zebra-studded bush. These citizen-rangers are not doing this out of altruism or some undying love for pachyderms. They do it because in Kenya, perhaps more than just about anywhere else, wildlife means tourists, and tourists mean dollars — a lot of dollars.

It is not unusual here for a floppy-hatted visitor to drop $700 a night to sleep in a tent and absorb the sights, sounds and musky smells of wondrous game. Much of that money is contractually bound to go directly to impoverished local communities, which use it for everything from pumping water to college scholarships, giving them a clear financial stake in preserving wildlife. The safari business is a pillar of the Kenyan economy, generating more than a billion dollars a year and nearly 500,000 jobs: cooks, cleaners, bead-stringers, safari guides, bush pilots, even accountants to tally the proceeds.

Surprisingly, many jobs in the safari industry can pay as much as poaching. Though the ivory trade may seem lucrative, it is often like the Somali pirate business model, with the entry-level hijacker getting just a minuscule cut of the million-dollar ransoms. While a pound of ivory can fetch $1,000 on the streets of Beijing, Mr. Lokinyi, despite his lengthy poaching résumé, was broke, making it easier to lure him out of the business.

Villagers are also turning against poachers because the illegal wildlife trade fuels crime, corruption, instability and intercommunal fighting. Here in northern Kenya, poachers are diversifying into stealing livestock, printing counterfeit money and sometimes holding up tourists. Some are even buying assault rifles used in ethnic conflicts.

The conservation militias are often the only security forces around, so they have become de facto 911 squads, rushing off to all sorts of emergencies in areas too remote for the police to quickly gain access to and often getting into shootouts with poachers and bandits.

“This isn’t just about animals,” said Paul Elkan, a director at the Wildlife Conservation Society, who is trying to set up community ranger squads in South Sudan modeled on the Kenyan template. “It’s about security, conflict reconciliation, even nation building.”

The rangers tend to be hardened and uneducated, drawn from different ethnic groups and the surplus of unemployed youth. Gabriel Lesoipa was a goat herder; Joseph Lopeiyok, a cattle rustler; John Pameri won his coveted spot because he was fast — at the time he was selected, the first entry requirement was a grueling 11-mile race.

Many are considered warriors in their communities, experts in so-called bushcraft from years of grazing cattle and goats across the thorny savanna — and defending them against armed raiders. They can follow faint footprints across long, thirsty distances and instantly intuit when someone has trespassed on their land.

Read More..

Ashlee Simpson Flaunts Her Hot Bikini Body in Hawaii

By Maggie Coughlan

12/30/2012 at 11:30 AM EST

Ashlee Simpson is sending 2012 off with a bang!

The 28-year-old showed off her svelte figure in a tiny bikini as she splashed along the shores of Oahu, Hawaii on Saturday.

The singer and son Bronx (with Pete Wentz) joined pregnant big sister Jessica, her fiancé Eric Johnson and 7-month-old niece Maxwell Drew for a Hawaiian holiday.

Ashlee – who recently split from Boardwalk Empire actor Vincent Piazza after a year and a half of dating – smiled as she held hands with Bronx, 4.

This holiday season has been all about family for the Simpson clan. Tina Simpson – who filed for divorce from husband of 34 years, Joe Simpson, in October – also joined the girls in Hawaii.

Read More..

Kenya hospital imprisons new mothers with no money

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.

Read More..

World Briefing | Africa: South Africa’s President Gives a Biting Critique of Pets

President Jacob Zuma, left, said in a speech that the idea of having a pet was part of “white culture” and that people should focus on family welfare, the newspaper The Star reported Thursday. The president’s office sought to clarify the remarks, saying that he was encouraging “the previously oppressed African majority” to uphold its own culture. It also suggested the way in which the comments were reported, rather than the comments themselves, was divisive.

During his speech on Wednesday to a crowd in KwaZulu-Natal, Mr. Zuma’s home province, the president said that people who loved dogs more than people had a “lack of humanity” and that some people were trying in vain to “emulate whiteness,” The Star reported. In a statement, the South African presidency said that Mr. Zuma was trying to “decolonize the African mind post-liberation” and enable people to take pride in their heritage and not feel pressure to adopt customs of minority cultures. Animals can be cared for, was the message, but not at the expense of people.

Read More..

Apple still said to account for 87% of North American tablet traffic as Kindle Fire, Nexus 7 gain

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

Title Post: Apple still said to account for 87% of North American tablet traffic as Kindle Fire, Nexus 7 gain
Rating:
100%

based on 99998 ratings.
5 user reviews.
Author: Fluser SeoLink
Thanks for visiting the blog, If any criticism and suggestions please leave a comment

Read More..

Jason Hoppy Wears Wedding Ring After Split from Bethenny Frankel

TV Watch

12/28/2012 at 10:45 AM EST

Jason Hoppy in New York City Dec. 27

Adam Nemser/Startraks

Four days after Jason Hoppy and Bethenny Frankel announced their split, his wedding ring is still in the picture.

Hoppy was photographed at a café in New York City Thursday still wearing the band on his left ring finger

The couple have a 2½-year-old daughter, Bryn.

"It brings me great sadness to say that Jason and I are separating," Frankel, 42, said in a statement Sunday. "This was an extremely difficult decision that as a woman and a mother, I have to accept as the best choice for our family."

Earlier this year, the reality star revealed to PEOPLE that marriage didn't come easily to her.

"You have to fight for everything," she said. "Our core issues are wanting the other person to be somebody they are not."

Read More..

Kenya hospital imprisons new mothers with no money

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.

Read More..

Wall Street skids as U.S. heads for "fiscal cliff"

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 to make a last-ditch attempt to steer the United States away from driving off the "fiscal cliff."

Obama and lawmakers will meet at the White House Friday afternoon for talks before a New Year's deadline to keep large tax hikes and spending cuts from taking effect and threatening the economy with recession.

Investors' pessimism about achieving anything more than a stop-gap deal by the deadline showed in the benchmark S&P index's 1.6 percent decline this week. The broad index was on pace for its worst weekly performance since the U.S. elections.

With time running short, members of Congress may attempt to pass a retroactive fix on tax rises and spending cuts soon after the automatic fiscal policies come into effect on January 1.

"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 took a dive of more than 1 percent on Thursday after Senate Majority Leader Harry Reid warned a deal was unlikely before the deadline. But later the index rebounded after the House of Representatives said it hold an unusual Sunday session to work on a fiscal solution.

With many market participants away for the holiday-shortened week, volume is expected to remain light, which could exacerbate market swings.

The Dow Jones industrial average <.dji> dropped 90.70 points, or 0.69 percent, to 13,005.61. The Standard & Poor's 500 Index <.spx> lost 9.74 points, or 0.69 percent, to 1,408.36. The Nasdaq Composite Index <.ixic> fell 16.25 points, or 0.54 percent, to 2,969.66.

Market breadth was skewed to the negative, with declining stocks outnumbering gainers on the NYSE by 2,044 to 690, while on the Nasdaq, decliners outnumbered advancers 1,466 to 707.

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 rose 8.2 percent to $15.55 after the company said Pearson had agreed to make a strategic investment in its Nook Media subsidiary, but the Nook business will also not meet the bookseller's prior projection for fiscal year 2013.

MagicJack Vocaltec Ltd forecast over $39 million in GAAP revenue and over 70 cents per share in operating income for the fourth quarter and appointed Gerald Vento president and CEO, effective January 1. Shares jumped 6.9 percent to $17.40.

Aeterna Zentaris Inc U.S.-listed shares surged 18.4 percent to $2.57 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 phase 3 registration trial in endometrial cancer with AEZS-108 treatment.

(Reporting by Chuck Mikolajczak; Editing by Kenneth Barry)

Read More..