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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) - 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
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)
NEW DELHI (Reuters) - The body of a woman, whose gang rape provoked protests and rare national debate about violence against women in India, arrived back in New Delhi on Sunday and was cremated at a private ceremony.
Scuffles broke out in central Delhi between police and protesters who say the government is doing too little to protect women. But the 2,000-strong rally was confined to a single area, unlike last week when protests raged up throughout the capital.
Riot police manned barricades along streets leading to India Gate war memorial - a focal point for demonstrators - and, at another gathering point - the centuries-old Jantar Mantar - protesters held banners reading "We want justice!" and "Capital punishment".
Most sex crimes in India go unreported, many offenders go unpunished, and the wheels of justice turn slowly, according to social activists, who say that successive governments have done little to ensure the safety of women.
The unidentified 23-year-old victim of the December 16 gang rape died of her injuries on Saturday, prompting promises of action from a government that has struggled to respond to public outrage.
The medical student had suffered brain injuries and massive internal injuries in the attack and died in hospital in Singapore where she had been taken for treatment.
She and a male friend had been returning home from the cinema, media reports say, when six men on a bus beat them with metal rods and repeatedly raped the woman. The friend survived.
New Delhi has the highest number of sex crimes among India's major cities, with a rape reported on average every 18 hours, police figures show. Reported rape cases rose by nearly 17 percent between 2007 and 2011, according to government data.
Six suspects were charged with murder after her death and face the death penalty if convicted.
In Kolkata, one of India's four biggest cities, police said a man reported that his mother had been gang-raped and killed by a group of six men in a small town near the city on Saturday.
She was killed on her way home with her husband, a senior official said, and the attackers had thrown acid at the husband, raped and killed her, and dumped her body in a roadside pond.
Police declined to give any further details. One officer told Reuters no criminal investigation had yet been launched.
"MISOGYNY"
The leader of India's ruling Congress party, Sonia Gandhi, was seen arriving at the airport when the plane carrying the woman's body from Singapore landed and Prime Minister Mannmohan Singh's convoy was also there.
A Reuters correspondent saw family members who had been with her in Singapore take her body from the airport to their Delhi home in an ambulance with a police escort.
Her body was then taken to a crematorium and cremated. Media were kept away but a Reuters witness saw the woman's family, New Delhi's chief minister, Sheila Dikshit, and the junior home minister, R P N Singh, coming out of the crematorium.
The outcry over the attack caught the government off guard. It took a week for the prime minister to make a statement, infuriating many protesters. Last weekend they fought pitched battles with police.
Issues such as rape, dowry-related deaths and female infanticide rarely enter mainstream political discourse.
Analysts say the death of the woman dubbed "Amanat", an Urdu word meaning "treasure", by some Indian media could change that, though it is too early to say whether the protesters can sustain their momentum through to national elections due in 2014.
U.N. Secretary General Ban Ki-Moon added his voice to those demanding change, calling for "further steps and reforms to deter such crimes and bring perpetrators to justice".
Commentators and sociologists say the incident earlier this month has tapped into a deep well of frustration many Indians feel over what they see as weak governance and poor leadership on social issues.
Newspapers raised doubts about the commitment of both male politicians and the police to protecting women.
"Would the Indian political system and class have been so indifferent to the problem of sexual violence if half or even one-third of all legislators were women?" the Hindu newspaper asked.
The Indian Express said it was more complicated than realizing that the police force was understaffed and underpaid.
"It is geared towards dominating citizens rather than working for them, not to mention being open to influential interests," the newspaper said. "It reflects the misogyny around us, rather than actively fighting for the rights of citizens who happen to be female."
(Additional reporting by Ross Colvin and Diksha Madhokin New Delhi and Sujoy Dhar in Kolkata; Editing by Louise Ireland)
NASA has completed a 43,000 hour stress test — a record for ion thrusters — on a new rocket propulsion system that could extend future space travel to farther reaches of the solar system.
Developed by NASA’s Evolutionary Xenon Thruster Project, the 7-kilowatt ion thruster can burn 10-12 times longer than the conventional chemical thrusters used today. Though not practical for manned-spaceflight, the system could power exploratory rockets that reach outer planets and their moons.
[More from Mashable: NASA Unveils E-books on Hubble, Webb Space Telescopes]
To find out more, watch the video above and let us know your thoughts in the comments.
Photo courtesy of NASA
[More from Mashable: First ‘Alien Earth’ Will Be Found in 2013]
BONUS: 15 Twitter Accounts Every Space Lover Should Follow
Captain Williams is a NASA astronaut who recently completed the first triathlon in space.
Click here to view this gallery.
This story originally published on Mashable here.
Tech News Headlines – Yahoo! News
By Maggie Coughlan
12/30/2012 at 11:30 AM EST
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.
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.
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)
ALEPPO PROVINCE, Syria/BEIRUT (Reuters) - Syria's opposition leader has rejected an invitation from Russia for peace talks, dealing another blow to international hopes that diplomacy can be resurrected to end a 21-month civil war.
Russia, President Bashar al-Assad's main international protector, said on Friday it had sent an invitation for a visit to Moaz Alkhatib, whose six-week-old National Coalition opposition group has been recognized by most Western and Arab states as the legitimate voice of the Syrian people.
But in an interview on Al Jazeera television, Alkhatib said he had already ruled out such a trip and wanted an apology from Moscow for its support for Assad.
"We have clearly said we will not go to Moscow. We could meet in an Arab country if there was a clear agenda," he said.
"Now we also want an apology from (Russian Foreign Minister Sergei) Lavrov because all this time he said that the people will decide their destiny, without foreign intervention. Russia is intervening and meanwhile all these massacres of the Syrian people have happened, treated as if they were a picnic."
"If we don't represent the Syrian people, why do they invite us?" Alkhatib said. "And if we do represent the Syrian people why doesn't Russia respond and issue a clear condemnation of the barbarity of the regime and make a clear call for Assad to step down? This is the basic condition for any negotiations."
With the rebels advancing steadily over the second half of 2012, diplomats have been searching for months for signs that Moscow's willingness to protect Assad is faltering.
So far Russia has stuck to its position that rebels must negotiate with Assad's government, which has ruled since his father seized power in a coup 42 years ago.
"I think a realistic and detailed assessment of the situation inside Syria will prompt reasonable opposition members to seek ways to start a political dialogue," Lavrov said on Friday.
That was immediately dismissed by the opposition: "The coalition is ready for political talks with anyone ... but it will not negotiate with the Assad regime," spokesman Walid al-Bunni told Reuters. "Everything can happen after the Assad regime and all its foundations have gone. After that we can sit down with all Syrians to set out the future."
BRAHIMI TO MOSCOW
Russia says it is behind the efforts of U.N. mediator Lakhdar Brahimi, fresh from a five-day trip to Damascus where he met Assad. Brahimi, due in Moscow for talks on Saturday, is touting a months-old peace plan for a transitional government.
That U.N. plan was long seen as a dead letter, foundering from the outset over the question of whether the transitional body would include Assad or his allies. Brahimi's predecessor, Kofi Annan, quit in frustration shortly after negotiating it.
But with rebels having seized control of large sections of the country in recent months, Russia and the United States have been working with Brahimi to resurrect the plan as the only internationally recognized diplomatic negotiating track.
Russia's Middle East envoy, Deputy Foreign Minister Mikhail Bogdanov, who announced the invitation to Alkhatib, said further talks were scheduled between the "three B's" - himself, Brahimi and U.S. Undersecretary of State William Burns.
Speaking in Damascus on Thursday, Brahimi called for a transitional government with "all the powers of the state", a phrase interpreted by the opposition as potentially signaling tolerance of Assad remaining in some ceremonial role.
But such a plan is anathema to the surging rebels, who now believe they can drive Assad out with a military victory, despite long being outgunned by his forces.
"We do not agree at all with Brahimi's initiative. We do not agree with anything Brahimi says," Colonel Abdel-Jabbar Oqaidi, who heads the rebels' military council in Aleppo province, told reporters at his headquarters there.
Oqaidi said the rebels want Assad and his allies tried in Syria for crimes. Assad himself says he will stay on and fight to the death if necessary.
In the rebel-held town of Kafranbel, demonstrators held up cartoons showing Brahimi speaking to a news conference with toilet bowls in front of him, in place of microphones. Banners denounced the U.N. envoy with obscenities in English.
DIPLOMATS IMPOTENT
Diplomacy has largely been irrelevant to the conflict so far, with Western states ruling out military intervention like the NATO bombing that helped topple Libya's Muammar Gaddafi last year, and Russia and China blocking U.N. action against Assad.
Meanwhile, the fighting has grown fiercer and more sectarian, with rebels mainly from the Sunni Muslim majority battling Assad's government and allied militia dominated by his Alawite sect, an offshoot of Shi'ite Islam.
Still, Western diplomats have repeatedly touted signs of a change in policy from Russia, which they hope could prove decisive, much as Moscow's withdrawal of support for Serbian leader Slobodan Milosevic heralded his downfall a decade ago.
Bogdanov said earlier this month that Assad's forces were losing ground and rebels might win the war, but Russia has since rowed back, with Lavrov last week reiterating Moscow's position that neither side could win through force.
Still, some Moscow-based analysts see the Kremlin coming to accept it must adapt to the possibility of rebel victory.
"As the situation changes on the battlefield, more incentives emerge for seeking a way to stop the military action and move to a phase of political regulation," said Dmitry Trenin, director of the Carnegie Moscow Center.
Meanwhile, on the ground the bloodshed that has killed some 44,000 people continues unabated. According to the pro-opposition Syrian Observatory for Human Rights, a monitoring group based in Britain, 150 people were killed on Thursday, a typical toll as fighting has escalated in recent months.
Government war planes bombarded the town of Assal al-Ward in the Qalamoun district of Damascus province for the first time, killing one person and wounding dozens, the observatory said.
In Aleppo, Syria's northern commercial hub, clashes took place between rebel fighters and army forces around an air force intelligence building in the Zahra quarter, a neighborhood that has been surrounded by rebels for weeks.
(Additional reporting by Omar Fahmy in Cairo, Dominic Evans in Beirut and Steve Gutterman and Alissa de Carbonnel in Moscow; Writing by Peter Graff; Editing by Giles Elgood)
12/28/2012 at 10:45 AM EST
Jason Hoppy in New York City Dec. 27
Adam Nemser/Startraks
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."
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