Alexza's agitation drug gets FDA approval

 Alexza Pharmaceuticals Inc said the U.S. health regulators approved Adasuve, making it the first treatment for schizophrenia and bipolar disorder that can be inhaled.
Adasuve, which delivers an older antipsychotic drug called loxapine, passes through the lungs and into the bloodstream faster than a typical pill. Loxapine is available as an oral drug for schizophrenia.
The company said the product will include a boxed safety warning about potentially dangerous side effects including the potential for fatal bronchial spasms in people with asthma or chronic obstructive pulmonary disorder and a higher risk of death in elderly people with dementia-related psychosis.
Adasuve use will be restricted to mitigate the potential harm of bronchial spasms, Alexza said.
The FDA also required Alexza to conduct a large post- marketing clinical trial of patients to assess the real-world use of the drug.
"We believe that the ability to deliver medications rapidly and non-invasively will be important for patients and the professionals who care for them," Chief Executive Thomas King said in the statement.
Three injectable drugs, Bristol-Myers Squibb's Abilify, Eli Lilly's Zyprexa and Pfizer Inc's Geodon, are currently approved to calm patients with schizophrenia or bipolar disorder.
Adasuve, Alexza's most advanced drug, will be available for commercial launch early in the third quarter of 2013, the company said.
Earlier this month, European health regulators recommended approval of Adasuve.
The FDA denied approval to Adasuve in May, after it found deficiencies at the company's Mountain View, California manufacturing facility during an inspection.
The company's shares fell 12 percent in the after market trading after the trade was halted at $5.79 before the drug- approval announcement.

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Judge denies Texas request for feds to keep funding health program

A judge on Friday denied a request by Texas for an order requiring the federal government to continue providing money for a state health program for low-income women.
U.S. District Judge Walter Smith in Waco, Texas, denied the state's motion for a preliminary injunction that would have prevented the federal Centers for Medicare & Medicaid Services from cutting off Medicaid money for the Women's Health Program.
The federal government pays for most of the cost of the $40-million-a year-program but has told Texas that it will stop at the end of the year because a state decision to exclude Planned Parenthood from the program violates federal law.
Texas decided to enforce a state law that had been on the books for several years barring funding for abortion providers and affiliates.
The program, which does not pay for abortions, provides care such as breast and cervical cancer screenings and birth control, and Planned Parenthood says it serves nearly half the 115,000 Texas women who participate.
The state plans to launch a nearly identical program using only state money.
"Today's decision doesn't change our plans," said Stephanie Goodman, a spokeswoman for the Texas Health and Human Services Commission. "We'll move forward with launching the state program on January 1."
She added: "Our goal remains the same. We're going to continue providing women with family planning services and enforce state law."
But Ken Lambrecht, president and CEO of Planned Parenthood of Greater Texas, said Texas has embarked on a political crusade that has cost Texas women and taxpayers.
"There is no sound reason Texas should jeopardize this important program by cutting off access to the health care provider relied on by nearly half of the women receiving basic, preventive health care through the program," Lambrecht said in a statement.

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Lawmakers play waiting game with 'fiscal cliff' deadline in sight

 With only a week left before a deadline for the United States to go over a "fiscal cliff," lawmakers played a waiting game on Monday in the hope that someone will produce a plan to avoid harsh budget cuts and higher taxes for most Americans from New Year's Day.
Though Republicans and Democrats have spent the better part of a year describing a plunge off the cliff as a looming catastrophe, the nation's capital showed no outward signs of worry, let alone impending calamity.
The White House has set up shop in Hawaii, where President Barack Obama is vacationing.
The Capitol was deserted and the Treasury Department - which would have to do a lot of last-minute number-crunching with or without a deal - was closed.
So were all other federal government offices, with Obama having followed a tradition of declaring the Monday before a Tuesday Christmas a holiday for government employees, notwithstanding the approaching fiscal cliff.
Expectations for some 11th-hour rescue focused largely on Senate Minority Leader Mitch McConnell, a Republican, in part because he has performed the role of legislative wizard in previous stalemates.
But McConnell, who is up for re-election in 2014, was shunning the role this year, his spokesman saying that it was now up to the Democrats in the Senate to make the next move.
"We don't yet know what Senator Reid will bring to the floor. He is not negotiating with us and the president is out of town," said McConnell's spokesman, referring to Senate Majority Leader Harry Reid, a Democrat. "So I just don't know what they're going to do over there," he said.
Two-day-old tweets on leadership websites told the story insofar as it was visible to the public.
House Speaker John Boehner's referred everyone to McConnell. McConnell's tweet passed the responsibility along to Obama, saying it was a "moment that calls for presidential leadership."
Reid's tweet said: "There will be very serious consequences for millions of families if Congress fails to act" on the cliff.
The next session of the Senate is set for Thursday, but the issues presented by across-the-board tax hikes and indiscriminate reductions in government spending, were not on the calendar.
The House has nothing on its schedule for the week, but members have been told they could be called back at 48 hours notice, making a Thursday return a theoretical possibility.
However, aides to the Republican leaders in Congress said there were no talks with Democrats on Monday and none scheduled after negotiations fell off track last week when Boehner failed to persuade House Republicans to accept tax increases on incomes of more than $1 million a year.
"Nothing new, Merry Christmas," an aide to Boehner responded when asked if there was any movement on the fiscal cliff.
But a senior Obama administration official, speaking on condition of anonymity, said White House aides were talking with Senate Democratic staffers about the situation.
SCALED-BACK EXPECTATIONS
If there is some last-minute legislation, Republicans and Democrats agreed on Sunday news shows that it will not be any sort of "grand bargain" encompassing taxes and spending cuts, but most likely a short-term deal putting everything off for a few weeks or months, thereby risking a negative market reaction.
A limited agreement would still need bipartisan support, as Obama has said he would veto a bill that does not raise taxes on the wealthiest Americans.
On Monday, Texas Senator Kay Bailey Hutchison urged fellow Republicans to be flexible.
"We're now at a point where we're not going to get what we think is right for our economy and our country because we don't control government. So we've got to work within the system we have," she told MSNBC.
Two bills in Congress could conceivably form the basis for a last-minute stopgap measure.
Last spring, Republicans in the House passed a measure that would extend Bush-era tax cuts for everyone, reflecting the party's deep reluctance to increase taxes.
The Democratic-controlled Senate passed a bill in August, extending lower tax rates for everyone except the wealthiest Americans - a group defined at that point as households with a net income of $250,000 or above. Obama has since increased that to $400,000 a year, in an effort to win Republican support.
Analysts say Democrats might be able to get the backing of enough Republicans in both the House and Senate, especially if they are willing to raise the number to $500,000.
Under that scenario, lawmakers might also put off spending cuts of $109 billion that would take effect from January and agree to Republican demands for cuts in entitlement programs such as Medicare and Medicaid, the government-run health insurance plans for seniors and the poor.
However, with only a few work days left in Congress after Christmas, there is a good chance that no deal can be worked out and tax rates would then go up, at least briefly, until an agreement is reached in Washington.
"We may go off the cliff on January 1, but we would correct that very quickly thereafter," Democratic Representative John Yarmuth told MSNBC.
The prospects of the United States going over the fiscal cliff dampened enthusiasm on Wall Street for a "Santa rally" in the holiday season, when stocks traditionally rise.
The Dow Jones industrial average dropped 51.76 points, or 0.39 percent, in Monday's shortened holiday session.
Failure to work out tax rates in the coming days would cause chaos at the Internal Revenue Service, said analyst Chris Krueger of Guggenheim Securities.
"Next weekend is going to be a total, total debacle," he said. The IRS is unlikely to have enough time to revise its tables for withholding taxes.
"The withholding tables are sort of like an aircraft carrier, you can't turn the thing on a dime." he said.

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UCB gets Japan clearance for two new drugs

Belgian pharmaceutical company UCB has secured two regulatory clearances in Japan, further cementing its worldwide shift to a new generation of drugs.
The company said in a statement on Tuesday that the Japanese Ministry of Health, Labour and Welfare had approved UCB's Neupro patch to treat Parkinson's disease and moderate-to-severe Restleg Legs Syndrome in adults.
Otsuka Pharmaceutical has the exclusive rights for developing and marketing Neupro in Japan, with UCB responsible in all other regions worldwide. Neupro is available in 35 countries.
In a separate statement on Tuesday, UCB said its drug Cimzia had been approved in Japan for treatment of rheumatoid arthritis in adults.
UCB is jointly developing the drug there with Astellas Pharma Inc, with UCB manufacturing it and Astellas managing distribution and sales. UCB said it would receive an unspecified milestone payment from Astellas.
Cimzia is currently being sold in over 30 countries, including the United States and in Europe.
UCB, a central nervous system and immunology specialist, is placing its hopes on three new drugs - Cimzia, Neupro and epilepsy treatment Vimpat - as previous blockbuster Keppra, also for epilepsy, faces patent expiries.

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One in 12 in military has clogged heart arteries

Just over one in 12 U.S. service members who died in the Iraq and Afghanistan wars had plaque buildup in the arteries around their hearts - an early sign of heart disease, according to a new study.
None of them had been diagnosed with heart disease before deployment, researchers said.
"This is a young, healthy, fit group," said the study's lead author, Dr. Bryant Webber, from the Uniformed Services University of the Health Sciences in Bethesda, Maryland.
"These are people who are asymptomatic, they feel fine, they're deployed into combat," he told Reuters Health.
"It just proves again the point that we know that this is a clinically silent disease, meaning people can go years without being diagnosed, having no signs or symptoms of the disease."
Webber said the findings also show that although the U.S. has made progress in lowering the nationwide prevalence of heart disease, there's more work that can be done to encourage people to adopt a healthy lifestyle and reduce their risks.
Heart disease accounts for about one in four deaths - or about 600,000 Americans each year, according to the Centers for Disease Control and Prevention.
The new data come from autopsies done on U.S. service members who died in October 2001 through August 2011 during combat or from unintentional injuries. Those autopsies were originally performed to provide a full account to service members' families of how they died.
The study mirrors autopsy research on Korean and Vietnam war veterans, which found signs of heart disease in as many as three-quarters of deceased service members at the time.
"Earlier autopsy studies... were critical pieces of information that alerted the medical community to the lurking burden of coronary disease in our young people," said Dr. Daniel Levy, director of the Framingham Heart Study and a senior investigator with the National Institutes of Health.
The findings are not directly comparable, in part because there was a draft in place during the earlier wars but not for Operations Enduring Freedom and Iraqi Freedom/New Dawn. When service is optional, healthier people might be more likely to sign up, researchers explained.
Still, Levy said the new study likely reflects declines in heart disease in the U.S. in general over that span.
Altogether the researchers had information on 3,832 service members who'd been killed at an average age of 26. Close to 9 percent had any buildup in their coronary arteries, according to the autopsies. And about a quarter of the soldiers with buildup in their arteries had severe blockage.
Service members who had been obese or had high cholesterol or high blood pressure when they entered the military were especially likely to have plaque buildup, Webber and his colleagues reported Tuesday in the Journal of the American Medical Association.
More than 98 percent of the service members included were men.
"This study bodes well for a lower burden of disease lurking in young people," Levy, who wrote an editorial published with the report, told Reuters Health.
"Young, healthy people are likely to have a lower burden of disease today than their parents or grandparents had decades ago."
That's likely due, in part, to better control of blood pressure and cholesterol and lower rates of smoking in today's service members - as well as the country in general, researchers said.
However, two risks for heart disease that haven't declined are obesity and diabetes, which are closely linked.
"Obesity is the one that has not trended in the right direction," Levy said.
"Those changes in obesity and diabetes threaten to reverse some of the dramatic improvements that we are seeing in heart disease death rates," he added.

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Toll Brothers 4Q net income soars on tax benefit

 Toll Brothers says its fiscal fourth-quarter net income soared, helped by a large income tax benefit and a 48 percent rise in revenue. The luxury homebuilder delivered more homes and its order backlog increased.
CEO Douglas C. Yearley Jr. said in a statement on Tuesday that higher home prices, low interest rates, pent-up demand and improving consumer confidence prompted buyers to return to the housing market this year.
Last week a batch of government reports showed that rising home values, more hiring and lower gas prices pushed consumer confidence in November to the highest level in nearly five years. On Tuesday, Core Logic reported that a measure of U.S. home prices rose 6.3 percent in October compared with a year ago, the largest yearly gain since July 2006.
For the three months ended Oct. 31, Toll Brothers Inc. earned $411.4 million, or $2.35 per share. That's up sharply from $15 million, or 9 cents per share, a year ago.
The latest quarter included an income tax benefit of $350.7 million.
Excluding the tax benefit and other items, earnings were 35 cents per share.
Analysts expected earnings of 25 cents per share for the quarter, which typically exclude one-time items, according to a FactSet poll.
Revenue increased to $632.8 million from $427.8 million, topping Wall Street's forecast of $565.1 million.
Homebuilding deliveries climbed 44 percent to 1,088 units, while net signed contracts jumped 70 percent to 1,098 units. The average price of homes delivered increased to $582,000 from $565,000 a year earlier.
Toll Brothers, based in Horsham, Pa., may benefit by catering to the luxury sector. Its target market includes households that typically make more than $100,000 a year, can afford to make a down payment of as much as 30 percent, have great credit record and an unemployment rate about half that of the general population.
Backlog, a measure of potential future revenue, rose 54 percent to 2,569 units. The cancellation rate declined to 4.6 percent from 7.9 percent.
The company's full-year net income jumped to $487.1 million, or $2.86 per share, from $39.8 million, or 24 cents per share, a year earlier. Annual revenue climbed 27 percent to $1.88 billion from $1.48 billion.
Toll Brothers anticipates delivering between 3,600 and 4,400 homes in 2013 at an average price of $595,000 to $630,000 per home.
Its shares fell 57 cents, or 1.8 percent, to close at $31.86 Tuesday. Its shares peaked for the past year at $37.08 in mid-September.
The company has operations in Arizona, California, Colorado, Connecticut, Delaware, Florida, Illinois, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Texas, Virginia, and Washington

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IRS finalizes new tax for medical devices in healthcare law

The U.S. Internal Revenue Service on Wednesday released final rules for a new tax on medical devices, products ranging from surgical sutures to knee replacement implants, that starts next year as part of President Barack Obama's 2010 healthcare law.
The 2.3-percent tax must be paid, effective after December 31, by device-makers on their gross sales. The tax is expected to raise $29 billion in government revenues through 2022.
Companies including Boston Scientific Corp, 3M Co and Kimberly-Clark Corp have been lobbying the U.S. Congress for a repeal of the tax.
A repeal bill passed the Republican-controlled U.S. House of Representatives in June, but it has not been voted on by the Democratic-controlled Senate.
"The excise tax is on the medical device manufacturers and importers (who) will now have access to 30 million new customers due to the health care law," Treasury Department spokeswoman Sabrina Siddiqui said in a statement.
Many medical devices that are sold over-the-counter - such eyeglasses, contact lenses and hearing aids - are exempt from the tax, as are prosthetics, the IRS said.
The tax applies mostly to devices used and implanted by medical professionals, including items as complex as pacemakers or as simple as tongue depressors.
Products sold for humanitarian reasons, such as experimental cancer treatment devices, are not exempt from the tax.
Some medical device companies are hoping to delay the tax's start date as part of a resolution of the "fiscal cliff" deadline at the end of the year involving many tax and spending measures, said Steve Ferguson, chairman of Cook Group Inc.
"We would like to be part of the punt," Ferguson said, referring to an extension of current tax policy into 2013.
In one potentially problematic aspect of the tax, companies selling dual-use products to medical and non-medical customers must pay the tax on those products, potentially putting them at a competitive disadvantage, said Lew Fernandez, a director at PricewaterhouseCoopers LLP and a former IRS official.
For example, it remains "an open question" when latex gloves come under the tax, he said.

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H&R Block 2Q loss narrows as revenue rises

 H&R Block's fiscal second-quarter loss narrowed, helped by cost-cutting efforts. Revenue climbed mostly because of a strong tax season in Australia.
The nation's largest tax preparation company typically turns in a loss in the August-to-October period because it takes in most of its revenue during the U.S. tax season. H&R Block's quarterly performance beat analysts' estimates and its stock hit the highest level in more than two years.
The company is optimistic and gearing up for its busy season.
"The U.S. tax season is right around the corner and we believe we're on pace to deliver significant earnings and margin expansion in fiscal 2013," President and CEO Bill Cobb said in a statement on Thursday.
For the three months ended Oct. 31, H&R Block Inc. lost $105.2 million, or 39 cents per share. A year earlier it lost $141.7 million, or 47 cents per share, for the quarter.
Its loss from continuing operations was 37 cents per share. Analysts surveyed by FactSet expected a bigger loss of 41 cents per share.
Selling, general and administrative expenses declined and the quarter was free of any impairment charges. The prior-year period included a $4.3 million impairment charge.
Revenue rose 6 percent to $137.3 million from $129.2 million. This topped Wall Street's forecast of $129.6 million.
Shares of H&R Block gained 89 cents, or 5.1 percent, to close at $18.26. Earlier in the session the stock reached $18.40, its highest point since May 2010.
Tax services revenue increased 7 percent primarily due to the strong Australian tax season. Corporate revenue fell because of lower interest income from H&R Block Bank's shrinking mortgage loan portfolio.
H&R Block disclosed in October that it hired Goldman Sachs to help it explore options for its banking arm, H&R Block Bank. Those options, Block said, could result in the company no longer being regulated as a savings and loan holding company by the Federal Reserve.
The Federal Reserve announced some proposed rules in June that would impose higher capital requirements on savings and loan holding companies. H&R Block contends that if the proposed rules are enacted it would have to hold on to significant additional capital.
H&R Block, based in Kansas City, Mo., prepared 25.6 million tax returns worldwide in fiscal 2012.

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Tax filing delay looms if no fix for minimum tax: IRS

The top U.S. tax collector warned on Thursday of a delayed start to 2013's tax season if Congress fails to reset the alternative minimum tax (AMT) on high-income taxpayers so that it does not sweep in millions of middle-income people.
Without another adjustment by lawmakers soon to the AMT, "many of us will see a delayed filing season," said Steven Miller, named just last month as Internal Revenue Service acting commissioner.
Miller did not give an exact date by which Congress must approve an AMT "patch" to prevent a delay to the tax season, which is scheduled to begin on January 22.
"We don't have any drop-dead time in mind," Miller told reporters after a speech at a conference in Washington.
But his remarks came on a day of continued stalemate in Washington between Democrats and Republicans over what to do about the "fiscal cliff" approaching at the end of the year.
The AMT is a crucial part of the assorted tax increases and automatic spending cuts that make up the so-called "cliff," a convergence of events that, absent congressional action, threatens to plunge the U.S. economy back into recession.
"Many people don't realize that they could potentially face a significantly delayed filing season and a much bigger tax bill for 2012," if the AMT is not dealt with, Miller said.
"In programming our systems, the IRS has assumed that Congress will patch the AMT as Congress has for so many years.
"And I remain optimistic that the fiscal cliff debate will be resolved by the end of the year. If that turns out not to be the case, then what is clear is that many of us will see a delayed filing season," Miller said.
The AMT is a tax intended to make sure that at least some tax is paid by high-income people who otherwise could sharply reduce or eliminate their regular income tax bills through using tax loopholes. About 4 million people annually pay the AMT.
Unlike the regular income tax, the AMT is not indexed for inflation. So the thresholds that determine who must pay the tax have to be regularly raised. This prevents the AMT from hitting middle-class people whose incomes may have crept upward on the back of inflation, but who are not wealthy.
Congress last patched the AMT in late 2010. Without another patch, the AMT could hit as many as 33 million people for the 2012 tax year, according to the IRS.
Democratic Senator Charles Schumer of New York said on Thursday he is "hopeful" that the AMT problem will be fixed with a broader "fiscal cliff" resolution before December 31.
Republicans in Congress may see the AMT as leverage in their "fiscal cliff" negotiations with President Barack Obama and the Democrats.
The IRS might have until mid-January to implement an AMT patch and still start the tax season on time, if Congress approves the fix as expected, said Richard Harvey, a tax professor at Villanova University and a former IRS official.
The AMT "is a ticking time bomb that is going to go off some time in January," Harvey said.

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Oregon governor says Nike plans to hire thousands

Sporting goods giant Nike plans to expand its operations in Oregon and hire as many as 12,000 new workers by 2020 but wants the government to promise it won't change the state tax code, prompting a special session of the Legislature.
Gov. John Kitzhaber said he'll call lawmakers together Friday in Salem to create a new law authorizing him to grant Nike's wish.
The governor did not release information about the company's expansion plans but the $440 million project would create 2,900 construction jobs with an annual economic impact of $2 billion a year.
Nike Inc. has its headquarters in Beaverton. Company officials could not immediately be reached.
The Legislature is due to meet in its regular annual session beginning Jan. 14, but Kitzhaber said Nike needed certainty sooner. The company was being wooed by other states, he said.
"Getting Oregonians back to work is my top priority," Kitzhaber said in a news conference.
Either the governor or the Legislature itself can call lawmakers into session at times other than the state Constitution specifies.
For much of the state's history, the Legislature's regular sessions have been held every other year, at the beginning of odd-numbered years. That's the kind of session the Legislature is scheduled to begin early next year.
In recent years, the Legislature has moved to meet annually, running test sessions of briefer sessions in even-numbered years. Those led to voter approval of a constitutional amendment in 2010 that called for annual sessions.
Records list 38 special sessions since Oregon's statehood, ranging from one day on eight occasions to 37 days in 1982.

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