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.

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S&P, Nasdaq rise on last day of 2012, Apple advances

NEW YORK (Reuters) - Stocks extended gains, with the Nasdaq up 1 percent on Monday on news that the majority of Senate Republicans are expected to support a tentative deal on the "fiscal cliff."

The market also got a lift from news that President Barack Obama will make a statement on the fiscal cliff at 1:30 p.m. EST at an event with "middle-class Americans," the White House said.

The Dow Jones industrial average <.dji> was up 82.99 points, or 0.64 percent, at 13,021.10. The Standard & Poor's 500 Index <.spx> was up 12.66 points, or 0.90 percent, at 1,415.09. The Nasdaq Composite Index <.ixic> was up 37.11 points, or 1.25 percent, at 2,997.43.

(Reporting by Angela Moon; Editing by Jan Paschal)

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Japan’s New Premier Backs More Nuclear Plants

TOKYO — The newly elected prime minister of Japan, Shinzo Abe, said Sunday that he would seek to build nuclear reactors, reversing within a week in office a campaign pledge to move Japan away from nuclear power.

Pool photo by Itsuo Inouye

Prime Minister Shinzo Abe at the Fukushima Daiichi nuclear plant on Saturday. He said Sunday that he wanted more built.

The statement about the reactors came in Mr. Abe’s first televised interview since taking office. During his five days as prime minister, he had hinted that he would take a closer look at nuclear power.

“They will be completely different from those at the Fukushima Daiichi nuclear power plant,” he told the national television network TBS. Multiple meltdowns at the plant after an earthquake last year forced more than 100,000 people to flee their homes.

“With public understanding, we will be building anew,” Mr. Abe said.

He did not specify where or when. Building nuclear power plants would depart from the direction of the previous government of Yoshihiko Noda, who had pledged to phase out nuclear power by 2040.

It also appeared to go against a campaign platform adopted by Mr. Abe’s Liberal Democratic Party that aims “to establish an economy and society that does not need to rely on nuclear power.” The platform also said Japan would put the development of alternative energy sources, like solar and wind, ahead of nuclear power, and made no mention of new nuclear plants.

Though fervent antinuclear protests across the country have kept all but two of Japan’s 50 reactors off line, Mr. Abe is betting that Japan’s silent majority will condone a return to nuclear to help bolster the economy.

Mr. Abe’s pro-business Liberal Democrats won a landslide victory in parliamentary elections this month, campaigning on promises to take bolder measures to kick-start Japan’s moribund economy. The nation’s biggest business lobby, the Keidanren, has publicly urged the government to restart the nation’s reactors.

Signaling what could be rocky relations with Tokyo’s neighbors, Mr. Abe, who returned as a prime minister after a yearlong stint in 2006-7, also hinted that he may replace or void apologies from 1993 and 1995 for Japan’s having used women as sex slaves during World War II and for past colonial rule and aggression in Asia.

In a separate interview with The Sankei Shimbun, a national daily, he said his previous administration had found no evidence that the women who served as sex slaves to Japan’s wartime military had, in fact, been coerced. The Japanese government will seek to communicate that view, the newspaper quoted Mr. Abe as saying.

A perceived lack of remorse by Japan for its colonial and wartime history has been severely criticized, especially by South Korea and China, which bore the brunt of Japan’s colonial aggressions.

Japan is already embroiled in territorial spats with the two nations, heightening tensions over the past year.

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Angry Birds, YouTube among top apps of 2012

TORONTO (Reuters) – Angry Birds, Instagram and Facebook continued to be among the most downloaded apps of the year but rising stars also earned coveted spots on smartphones and tablets.

This year consumers spent on average two hours each day using mobile applications, an increase of 35 percent over last year, according to analytics firm Flurry. The number is expected to continue growing in 2013.

“2012 was a transformative tipping point in the way consumers use apps,” said Craig Palli, a vice president at mobile marketing company Fiksu, adding that the biggest shift is in consumers’ eagerness to turn to apps for a broad range of day-to-day tasks.

Categories such as social networking, media and entertainment, photo editing, and games, continued to captivate consumer interest, with YouTube and Angry Birds being the top free and paid apps respectively at Apple’s App Store.

Meanwhile, several apps released this year quickly joined the ranks of the top downloaded and revenue grossing apps of the year.

The game Draw Something for iPhone and Android quickly gained widespread popularity when it was released in February, and despite dropping off, is still the second most downloaded paid app of the year Android and Apple devices.

“It had a big run and other multi-player puzzle-oriented games like newcomers LetterPress and ScrambleWithFriends proved popular, too,” Palli said. “But in many respects these titles were inspired by the more revolutionary Words With Friends.”

Songza, a music-discovery app for iPhone, Android and Kindle Fire, saw significant growth in both the United States and Canada, where it is now one of the top free apps on the App Store.

Paper, a sketchbook app for the iPad, is estimated to be one of the top grossing apps released this year according to Distimo, an app analytics company. It was named by Apple as the iPad app of the year.

But the real revolution, according to Palli, is among consumers who are eager to turn to apps for their day-to-day tasks, such as finding a taxi or hotel, following current events or increasingly, making payments.

“It is really consumers who are turning to apps first and traditional methods second,” said Palli.

Uber and Hailo, which allow users to book limos and taxis, and AirBnB and HotelTonight, for finding accommodations, began to move mainstream in 2012, Palli said.

Payment apps such as Square, and Apple’s introduction of the Passbook has further positioned the smartphone as a digital wallet.

This year, during major events such as the Olympics, Hurricane Sandy and the U.S. presidential election, the top apps on the App Store reflected those events, said Palli, showing the demand for keeping up with current events through apps.

(Editing by Patricia Reaney and Bill Trott)

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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.

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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.

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Obama says failure to reach fiscal deal would hurt markets

WASHINGTON (Reuters) - Financial markets would be affected adversely if U.S. lawmakers fail to agree on a "fiscal cliff" deal before Tuesday, President Barack Obama said in an interview broadcast on Sunday, while urging Congress to act quickly to extend tax cuts for middle-class Americans.

Lawmakers are seeking a last-minute deal that would set aside $600 billion in tax increases and across-the-board government spending cuts that are set to start within days. If Congress does not make that happen, the first bill brought up in the new year would be to reduce taxes for middle-income families, Obama told NBC's "Meet the Press."

"Now I think that over the next 48 hours, my hope is that people recognize that, regardless of partisan differences, our top priority has to be to make sure that taxes on middle-class families do not go up. That would hurt our economy badly," Obama said in the interview taped on Saturday.

"We can get that done. Democrats and Republicans both say they don't want taxes to go up on middle-class families. That's something we all agree on. If we can get that done, that takes a big bite out of the 'fiscal cliff.' It avoids the worst outcomes," Obama added.

Low income tax rates first put in place under Republican former President George W. Bush are due to expire at the end of the day on Monday - the last day of 2012.

Obama said that failing to reach a deal would have a negative impact on financial markets.

"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 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," he said.

RARE SENATE SESSION ON SUNDAY

Obama met with congressional leaders at the White House on Friday and declared himself cautiously optimistic about the chances of an agreement, but he noted in the interview that nothing had materialized since then.

"I was modestly optimistic yesterday, but we don't yet see an agreement. And now the pressure's on Congress to produce," he said.

The Senate is 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.

Obama sketched out what he believed to be the most likely scenarios the end the back-and-forth between both sides. Either the congressional leaders would come up with a deal, or Democrats in the Senate would bring a bill to the floor seeking an up-or-down vote to extend tax cuts for middle income earners.

"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," he said.

Obama chided Republicans for resisting his call for tax rates to go up for the top two percent of U.S. earners despite what he viewed as significant compromises on his part to cut spending and reform expensive social programs for the poor and elderly.

"They say that their biggest priority is making sure that we deal with the deficit in a serious way, but the way they're behaving is that their only priority is making sure that tax breaks for the wealthiest Americans are protected. That seems to be their only overriding, unifying theme," Obama said.

"The offers that I've made to them have been so fair that a lot of Democrats get mad at me. I mean I offered to make some significant changes to our entitlement programs in order to reduce the deficit," he said.

(Reporting by Jeff Mason; Editing by David Brunnstrom)

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Letter From Washington: Lessons From the 2012 U.S. Election

WASHINGTON — The 2012 U.S. elections, though not seminal, revealed much about the nature and direction of U.S. politics.

A divided government may be ingrained: At the presidential level, Democrats start with a decided advantage. Changing demographics — more Hispanics and other minorities solidly behind the party; women and young voters moving that way and forming hard-to-break voting habits — cut the Democrats’ way.

The electoral map that decides U.S. presidential contests tilts Democratic. President Barack Obama won the national popular vote by 3.7 percentage points, and carried the electoral map — the number of electors from each state is based indirectly on population — 332 to 206. If you took 1.9 percentage points from Mr. Obama and added them to Mitt Romney’s tally, the Republican would have won the popular vote by more than 125,000 votes. Yet if that formula were then applied to every state in the country, the only ones that would change would be Florida and Ohio. Mr. Obama would have lost the popular vote but would still have won the Electoral College vote, 285 to 253, and thus the presidency.

This is why some states that are reliably Democratic at the presidential level and where Republicans now control the statehouses are trying to change the Electoral College system. Each state controls its own rules. Only two, Maine and Nebraska, award electors by congressional district; everywhere else, it’s winner-takes-all.

Republicans are pondering a shift to the approach used in Maine and Nebraska. They see a possible test case in Pennsylvania, where Mr. Obama won the popular vote by more than five percentage points, rolling up huge margins in Philadelphia and its suburbs and in Pittsburgh. Mr. Romney, however, carried 13 of the 18 congressional districts. If this new system were in effect, the Republicans would have gotten 13 of the state’s 20 electoral votes while getting trounced in the popular vote. If this occurred in mainly Republican states, it would erase the Democrats’ Electoral College advantage.

In elections for the House of Representatives, Republicans already have a structural advantage. Democratic voters, especially minorities, tend to be bunched into a relatively small number of districts.

“The high-density Democratic population makes it more difficult for Democrats to create more competitive districts,” said Nathan Gonzales, congressional analyst for the Rothenberg Political Report, a nonpartisan newsletter on U.S. politics.

It’s this bunching, more than any redistricting edge, that enabled Republicans to retain a lead of 234 seats to 201 in the House of Representatives this year even though Democrats received a million more votes over all in House races. There is little to suggest this advantage will lessen in the years ahead.

Conventions matter more than debates: The news media treat the national political conventions as irrelevant dinosaurs; the presidential debates are depicted as the Super Bowl or World Cup of politics.

It didn’t work out that way this year. The conventions mattered more. Mr. Romney and the Republicans blew a chance at the convention in Tampa, Florida, to reset his candidacy. At their convention in Charlotte, North Carolina, the Democrats stepped up to the challenge, especially with a powerful speech by former President Bill Clinton that set the basis for more positive public attitudes about the U.S. economy.

Mr. Obama’s disastrous performance in his first debate with Mr. Romney certainly mattered, though the duration of the Republican nominee’s bounce was exaggerated. Before that debate, the president was about four points ahead nationally; that was close to his final margin.

Moving to the center is tough in the media age: Richard M. Nixon advised Republicans to run to the right in the primaries and to quickly move to the center in the general election. This formula worked as recently as 1980 for Ronald Reagan. For Democrats, the formula is to run to the left in the primaries and to move to the center in the general election.

This is much harder to do today with the omnipresent news media tracking and assembling every public pronouncement and policy change. Mr. Romney tried to pivot after the primaries; there is little evidence that it worked well. He couldn’t escape earlier assertions that had alienated Hispanics (calling for undocumented workers to choose self-deportation) or women (boasting that he would end U.S. government funding for Planned Parenthood).

There are polls — and polls: Polls done on the cheap, automatic phone calls, some online surveys and partisan polls all missed the mark. More professional polls, with telephone interviews, conducted for the news media and other sources, were accurate in most instances.

Campaigns matter: Improving attitudes about the economy and, to a small degree, the president’s response to Hurricane Sandy, moved the needle in the closing weeks. Mr. Obama was indisputably a better political candidate.

The contrasting campaigns widened the margin. Post-election forums at Harvard University and the University of Pennsylvania, and the campaign e-book “The End of the Line,” by Jonathan Martin and Glenn Thrush of the Web site Politico, illustrated the Obama campaign’s supremacy on tactics: polling, the use of digital and social media, advertising, identifying voters and getting them to the polls.

The biggest advantage was overarching, strategic. “We knew who our guy was and where the country was,” said Stephanie Cutter, Mr. Obama’s deputy campaign manager. “They didn’t seem to have a sense of either.”

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Microsoft Surface trampled at the bottom of the tablet pile this Christmas

While it does have drawbacks just like anything else, Microsoft’s (MSFT) Surface is a great slate for those looking for a fresh new take on the modern tablet. Unfortunately, it doesn’t look like very many people were looking for a fresh new take on the modern tablet this holiday season. In a recent note to investors, R.W. Baird analyst William Power recounted recent conversations had at retailers including Best Buy (BBY) and Staples (SPLS). While speaking with sales reps at the stores, Apple’s (AAPL) iPad was the most highly recommended tablet while Amazon’s (AMZN) Kindle Fire line and Samsung’s (005930) Galaxy Tab line were both recommended as alternatives. Microsoft’s Surface tablet, on the other hand, was not pushed by reps at either chain.

[More from BGR: Purported photo of new BlackBerry phone with QWERTY keyboard leaks]

From Power’s note, as picked up by Barron’s:

[More from BGR: Sprint salesman refuses to sell iPhone to customer, says his ‘fingers are too fat’ to use it]

Microsoft’s Surface, which Best Buy just recently started carrying, was not recommended to us by reps without us asking about it specifically. When asked about sales to date, reps noted that the device was new and indicated that early demand has been modest relative to the iPad and Kindle Fire. We would also note that the device was in stock at every store we contacted […] We contacted Staples stores in an effort to further gauge Microsoft Surface sales, though our impression from speaking with reps was tablets are not a major seller at Staples. Tellingly, Staples doesn’t currently carry the iPad. When pressed for details, Staples reps indicated that Surface volumes have been modest to date. Most reps told us that the primary appeal to Surface buyers is the ability to run Microsoft Office. Consistent with our Best Buy checks, the Surface was also in stock at all Staples stores we contacted. Outside of the Surface, the Google Nexus 10 was cited as another strong tablet option.

Further supporting the idea that Microsoft’s debut tablet wasn’t a big seller this holiday season, Twitter user A.X. Ian did a quick analysis of tweets discussing new tablets during a 24-hour period around Christmas Eve.

Based on his data, 1,795 people tweeted about getting a new iPad during that time span while 250 tweeted about their new Kindle Fires, 100 mentioned their new Nexus 10 tablets and just 36 tweets were posted by users who had received a new Surface.

This article was originally published by BGR

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Just Kidding! Shakira's Baby News Is a Prank

Mom & Babies
Celebrity Baby Blog

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 other 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

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