FDA approves new targeted breast cancer drug

WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.

The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.

Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.

"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."

Cobleigh helped conduct the key studies of the drug at the Chicago facility.

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.

The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.

Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.

Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.

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Oscars expand social media outreach for 85th show

LOS ANGELES (AP) — The Academy of Motion Picture Arts and Sciences is encouraging celebrities to tweet during the Oscars.

The film organization has expanded its digital outreach for the 85th Academy Awards with a new feature that lets stars to snap photos of themselves backstage during Sunday's ceremony and instantly post them online.

What Twitter calls a "Magic Mirror" will take photo-booth-style pictures of participating stars in the green room and send them out on the academy's official Twitter account. Organizers expect multiple celebrity mash-ups.

The backstage green room is a private place for stars to hang out before taking the stage and is typically closed to press and photographers.

The Magic Mirror is "giving access to fans at home a part of the show they never got to experience before," Twitter spokeswoman Elaine Filadelfo said Friday.

A new video-on-demand/instant replay feature also being introduced Sunday will allow Oscar fans to view show highlights online moments after they happen and share them with friends on Twitter and Facebook. Dozens of clips from the red carpet and the awards telecast will be available on the official Oscar website beyond Sunday's ceremony.

Oscar.com also offers other behind-the-scenes interactive features, including various backstage camera perspectives and a new live blog that aggregates the show's presence across social media. It will track the traffic on whatever makes a splash, like Angelina Jolie's right leg did last year.

The academy wants to make its second-screen experience just as rich as its primary one.

"Social media is now mainstream," said Christina Kounelias, chief marketing officer for the academy.

"We're not doing social media to reach out to young kids," said the academy's digital media director, Josh Spector. "We're doing it to connect with all Oscar fans."

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Follow AP Entertainment Writer Sandy Cohen on Twitter: www.twitter.com/APSandy.

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Online:

www.oscar.com

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16 airport investors show interest in Midway

An international array of airport investors and operators have shown interest in developing bids to privatize Midway Airport, the city announced Friday evening.

Sixteen parties responded to the city's "request for qualifications" by a 4 p.m. deadline, indicating they had interest in leasing, operating and improving the Southwest Side airport, the nation's 26th busiest, with about 9 million passengers passing through annually.

"The response generated from the  ... process is encouraging and provides the city with a sense of the strong level of interest in a potential lease," said Lois Scott, the city's chief financial officer. "We must evaluate fully if this could be a win for Chicagoans."

The city and its advisers will review the responses to identify qualified potential bidders.

Of the 16, seven had both the operational and financial capabilities sought in the RFQ. The city identified them as:

-- ACO Investment Group, an investor and operator with global airport experience.

-- AMP Capital Investors Limited, a manager and investor in airports, including Melbourne Airport in Australia and Newcastle Airport, in Britain.

--  Corporacion America Group, an Argentina-based airport operator with 49 airports in seven countries.

-- Global Infrastructure Partners (GIP), which is the controlling investor and active manager of London City Airport, London Gatwick Airport and Edinburgh Airport.

--Great Lakes Airport Alliance, which is a partnership of Macquarie Infrastructure and Real Assets and Ferrovial. Its airport operations include London's Heathrow, Brussels Airport and Copenhagen Airport.

-- Incheon International Airport and Hastings Funds Management, which is the sole owner and operator of Incheon International Airport in South Korea and an investor with 16 airport-related investments.

--  Industry Funds Management and Manchester Airport Group, an investor with interests in 13 airports, including Melbourne Airport and Brisbane Airport, both in Australia, and operator of Manchester Airport and East Midlands Airport, in Britain.

If the city moves forward and seeks proposals, a privatization plan could be submitted to the City Council this summer.

This is the second time Chicago has looked at privatizing Midway. A 99-year lease that would have brought in $2.5 billion died in 2009 when the financial markets froze. That deal had drawn six serious bidders.

Mayor Rahm Emanuel has said any second attempt would have to provide city taxpayers with a better deal than the widely criticized 75-year agreement to privatize parking meter operations, carried out during former Mayor Richard Daley's administration. Proceeds from the earlier deal were used to plug operating deficits, and meter rates rose sharply.

This time, proposed leases must be less than 40 years, which locks in the city for a shorter period.

Rather than making only an upfront payment, the private operator also must share revenue with the city on an ongoing basis. Initial proceeds would be used to pay down debt issued since 1996 to rebuild the airport, the mayor's office said. There is about $1.4 billion in outstanding debt.

Longer term, cash flow would be directed to city infrastructure needs. The mayor has pledged proceeds would not be used to pay for city operations.

kbergen@tribune.com

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Court to Madigan: No rehearing on concealed-carry guns ruling

SPRINGFIELD — A divided federal appeals court today rejected Illinois Attorney General Lisa Madigan’s request for a rehearing on the case where the state has been ordered to allow citizens to carry guns in public.

Madigan made the request following the U.S. Seventh Circuit Court of Appeals decision in December that gave Illinois 180 days to put together a law that would allow concealed weapons in Illinois.

There has been no word yet from Madigan’s office on her next move. She could choose to appeal to the U.S. Supreme Court or decide to let the ruling stand.

The appeals court action officially rejected Madigan’s request for a rehearing by the full court, but the denial came with a stinging dissent from four of the nine members of the appeals court who reviewed the matter. The original order came down from a three-member panel that also had a split vote.

The arguments made in the dissent, written by Judge David Hamilton, could bolster Madigan’s cause if she appeals to the nation’s high court.

“The Supreme Court has not yet decided whether .. the individual right to keep and bear arms at home under the Second Amendment extends beyond the home,” Hamilton wrote.

Illinois is the only state in the nation that does not allow citizens to carry weapons in public in some form.

Hamilton’s dissent also noted the ruling that called for Illinois to allow concealed carry is the “first decision by a federal court of appeals striking down legislation restricting the carrying of arms in public.”

He wrote that three major points are worthy of consideration by the full appellate court rather than simply the three-member panel:

*Whether to extend the right to bear arms outside the home and into the public sphere, a matter that “presents issues very different from those involved in the home itself, which is all the Supreme Court decided” in a case currently viewed as the law of the land.

*How to handle what the panel did not decide. The three-member panel left Illinois a “good deal of constitutional room for reasonable public safety measures concerning public carrying of firearms.”

*How to proceed in future decisions about laws that are more narrowly tailored and any state interests that justify some restrictions on rights.

“Where the law is genuinely in doubt, as it is likely to remain for some time under the Second Amendment, a trial court can do a great service by ensuring the development of a thorough and complete record that provides a reliable, accurate factual foundation for constitutional adjudication,” Hamilton wrote. “The federal courts are likely to do a better job of constitutional adjudication if our considerations are based on reliable facts rather than hypothesized and assumed facts.”

You can read the opinion HERE.

rlong@tribune.com

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Hackers circulate tainted version of China cyber security report

BOSTON (Reuters) - Unknown hackers are trying to infect computers by capitalizing on strong interest in a recent report by a security firm that accuses the Chinese military of supporting widespread cyber attacks on U.S. companies.

Tainted digital versions of the report from cyber forensics firm Mandiant infect PCs with computer viruses that allow hackers to gain remote control of computers after users attempt to read those documents, according to security researchers.

Anti-virus software maker Symantec Corp said on its blog that some of those tainted documents were attached to Japanese-language emails purporting to be from someone recommending the report.

Security engineer Brandon Dixon said on his blog that he had identified a similar document on the Internet, which appeared to have originated in India.

"It was only a matter of time," Mandiant said on its blog, adding that its own network had not been compromised. "Reports downloaded, previously and currently from our website, do not contain exploits."

The report, which is available from Mandiant at http://intelreport.mandiant.com/ charges that a secretive Chinese military unit is behind a series of hacking attacks. It prompted a strong denial from Beijing and accusations that China was in fact the victim of U.S. hacking.

(Reporting By Jim Finkle; editing by Andrew Hay)

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Pistorius granted bail pending murder trial

PRETORIA, South Africa (AP) — A South African magistrate allowed Oscar Pistorius to go free on bail Friday, capping hearings that foreshadow a dramatic trial in the Valentine's Day killing of the star athlete's girlfriend.

Pistorius' family members and supporters shouted "Yes!" when Chief Magistrate Desmond Nair made his decision after a more than 1 hour and 45 minute explanation of his ruling to a packed courtroom.

Radio stations and a TV news network in South Africa broadcast the audio of the decision live, and even international channels like the BBC and CNN went live with it, underscoring the huge global interest in the case.

Nair set the bail at 1 million rand ($113,000), with $11,300 in cash up front and proof that the rest is available. The magistrate said Pistorius must hand over his passports and also turn in any other guns that he owns. Pistorius also cannot leave the district of Pretoria, South Africa's capital, without the permission of his probation officer, Nair said, nor can he take drugs or drink alcohol.

The double-amputee Olympian's next court appearance was set for June 4. He left the courthouse in a silver Land Rover, sitting in the rear, just over an hour after the magistrate imposed the bail conditions. The vehicle, tailed by a motorcycle with a TV cameraman aboard, later pulled into the home of Pistorius' uncle.

The magistrate ruled that Pistorius could not return to his upscale home in a gated community in the eastern suburbs of Pretoria, where the killing of Reeva Steenkamp took place.

Pistorius' uncle, Arnold Pistorius said: "We are relieved at the fact that Oscar got bail today but at the same time we are in mourning for the death of Reeva with her family. As a family, we know Oscar's version of what happened on that tragic night and we know that that is the truth and that will prevail in the coming court case."

Nair made the ruling after four days of arguments from prosecution and defense in Pistorius' bail hearing. During Friday's long session in Pretoria Magistrate's Court, Pistorius alternately wept and appeared solemn and more composed, especially toward the end as Nair criticized police procedures in the case and as a judgment in Pistorius' favor appeared imminent.

Nair had banned cameras from Friday's dramatic bail hearing and complained about cameras constantly "flashing" in Pistorius' face the previous three days of hearings, saying the spectacle made the athlete look like "some kind of species the world has never seen before."

Nair said Pistorius' sworn statement, in which he gave his version of the events of the shooting during the predawn hours of Feb. 14 in a sworn statement, had helped his application for bail.

"I come to the conclusion that the accused has made a case to be released on bail," Nair said.

Pistorius said in the sworn statement that he shot his girlfriend — a model and budding reality TV contestant — accidentally, believing she was an intruder in his house.

Prosecutors say he intended to kill Steenkamp and charged him with premeditated murder, saying the shooting followed a loud argument between the two.

Sharon Steenkamp, Reeva's cousin, had said earlier that the family wouldn't be watching the bail decision and hadn't been following the hearing in Pretoria.

"It doesn't make any difference to the fact that we are without Reeva," she told The Associated Press.

Despite the bail decision, prosecution spokesman Medupe Simasiku said: "We're still confident in our case," outside court.

Pistorius faced the sternest bail requirements in South Africa because of the seriousness of the charge, and his defense lawyers had to prove that he would not flee the country, would not interfere with witnesses or the case, and his release would not cause public unrest.

Nair questioned whether Pistorius would be a flight risk and be prepared to go "ducking and diving" around the world when he stood to lose a fortune in cash, cars, property and other assets. Nair also said that while it had been shown that Pistorius had aggressive tendencies, he did not have a prior record of offenses for violent acts.

He criticized Hilton Botha, the previous lead investigator in the case, for not doing more to uncover evidence that the Olympian had violent tendencies.

"There is ample room and ample time to do that by looking at the background of the accused," he said.

But while Nair leveled harsh criticism at former lead investigator Botha for "errors" and "blunders," he said one man does not represent the state's case and that the state could not be expected to put all the pieces of its puzzle together in such a short time.

Anticipating the shape of the state's case at trial, he said he had serious questions about Pistorius' account: Why he didn't try to locate his girlfriend on fearing an intruder was in the house, why he didn't try to determine who was in the toilet and why he would venture into perceived "danger" - the bathroom area - when he could have taken other steps to ensure his safety.

"There are improbabilities which need to be explored," Nair said, adding that Pistorius could clarify these matters by testifying under oath at trial.

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AP Sports Writer Gerald Imray and AP writer Carley Petesch contributed to this report from Johannesburg.

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FDA approves new targeted breast cancer drug

WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.

The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.

Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.

"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."

Cobleigh helped conduct the key studies of the drug at the Chicago facility.

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.

The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.

Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug.

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

Kadcyla was co-developed by South San Francisco-based Genentech and ImmunoGen Inc., of Waltham, Mass. ImmunoGen developed the technology that binds the drug ingredients together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.

Shares of ImmunoGen Inc. slipped 8 cents to $14.22 in afternoon trading. They have traded in a 52-wek range of $10.85 to $18.10.

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Diane Lane signed divorce doc on Valentine's Day

LOS ANGELES (AP) — Court records show Diane Lane signed her filing to divorce Josh Brolin on Valentine's Day.

Lane's petition to end the actors' marriage after eight and a half years was filed on Feb. 15.

Her filing released Friday lists irreconcilable differences for the couple's breakup and lists Feb. 13 as their separation date. It does not indicate they have a prenuptial agreement.

The actors have no children together. It was a second marriage for both when they tied the knot in August 2004.

Lane received an Oscar nomination for her performance in the 2002 film "Unfaithful" and co-stars in the upcoming Superman film "Man of Steel."

Brolin was Oscar-nominated for his performance in 2008's "Milk" and recently starred in "Gangster Squad."

A representative for the couple confirmed the divorce on Thursday.

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United not planning on Dreamliner until June

The All Nippon Airways Dreamliner 787 arrives at Mineta San Jose International Airport. (Gary Reyes/San Jose Mercury News/MCT / January 22, 2013)

Staff and wire report

1:35 p.m. CST, February 21, 2013

The parent company of United Airlines says it is taking the Boeing 787 off its schedule through June 5 for all but one of its routes.

United Continental Holdings Inc. said it still plans to use the 787 on its flights between Denver and Tokyo's Narita airport starting May 12. It had aimed to start that route on March 31.

United, currently world's largest airline and the only U.S. customer for the 787, said the timing of that reinstatement will depend on resolution of the Dreamliner's current issues.

The 50 Dreamliners in commercial service were grounded worldwide last month after a series of battery-related incidents including a fire on board a parked plane in the United States and an in-flight problem on another jet in Japan. United had only been flying the plance since November.

Sources told Reuters earlier this week that Boeing Co. has found a way to fix the battery problems that involves increasing the space between the lithium ion battery cells.

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Major snowstorm bearing down on Chicago region

A winter storm that is walloping the Great Plains will hit the Chicago area tonight and linger through the morning commute on Friday, possibly dumping up to half a foot of snow here.

A winter weather advisory has been issued for the Chicago area from 9 p.m. Thursday until 6 p.m. Friday,  with snow falling at a rate of an inch per hour overnight in some places and winds blowing at 25 to 30 miles per hour, according to the National Weather Service.

The snow will change over to freezing drizzle Friday morning, the weather service said.

Anywhere from 3 to 7 inches could fall here, but up to 16 inches are expected in Kansas and Nebraska, states expected to bear the brunt of the storm that has already closed schools, scuttled air travel and cut off power to some communities.

The storm could be the worst to hit the Midwest since a storm dumped 1 to 2 feet of snow from central Oklahoma to the lower Great Lakes and central New England between Jan. 31 to Feb. 2, 2011. The storm spawned the infamous Groundhog Day Blizzard that buried Chicago in 20.2 inches of snow.

Winter storm warnings and advisories are in place for much of the central and southern Plains and into the upper Midwest and Mississippi River Valley as the storm moves east, packing snow, sleet and freezing rain, the National Weather Service said.

Ice storm warnings were in effect for parts of northern Arkansas. The massive storm was expected to unleash thunderstorms and rain on its southern edge from eastern Texas to Georgia, the forecaster said.

Missouri Gov. Jay Nixon declared a state of emergency because of hazardous travel and possible power outages. Kansas Gov. Sam Brownback ordered state offices closed because of the storm.

Kansas City encountered an unusual mixture of snow, thunder and lightning, with 2 to 3 inches of snow falling per hour.

"When there is thunder and lightning, it's a pretty screaming clue that you are going to have massive snowfall," said Andy Bailey, a meteorologist with the National Weather Service in Pleasant Hill, Mo. A foot of snow is likely there by Thursday afternoon, he said.

In Nebraska, a woman was killed in a two-car Interstate 80 accident Wednesday afternoon near Giltner. The victim was identified as Kristina Leigh Allen, 19, of Calloway, Neb. The Nebraska State Patrol said weather was a factor.

More than 90 percent of flights out of Kansas City International Airport were canceled Thursday morning, according the airport website.

Some 55 commuter flights were canceled out of Denver International Airport overnight, mostly due to adverse conditions in Midwestern destinations in Kansas and Nebraska, said spokeswoman Laura Coale.

About 30 flights in and out of Omaha's Eppley Airfield were canceled by mid-morning Thursday.

The brunt of the snowstorm churned through Kansas, causing scores of accidents and vehicles sliding off roads, but no fatalities, according to the state highway patrol. Two semi-trucks got stuck on Interstate 35 near Emporia, Kansas, closing the southbound lane Thursday morning, according to transportation officials.

"Most of the issues we are dealing with are people getting stuck in the snow on ramps when they go to exit," said Gary Warner of the Kansas Highway Patrol office in Wichita. Snow on Wednesday resulted in about 50 crashes with no injuries and 11 with injuries on Wichita area highways, he said.

Some parts of southeast Kansas reported power outages because warmer temperatures created sleet and ice on power lines, said Sharon Watson, spokesperson for Kansas emergency management services.

The snowstorm had been predicted well in advance, prompting schools and offices to close and keeping a lot of people off the roads, said Watson.

In Oklahoma, up to 12.5 inches of snow fell in northern parts of the state while schools were closed throughout the Oklahoma City area because of treacherous driving conditions.

Areas of southwest and central Nebraska received 8 inches of snow overnight, according to the National Weather Service. Snowfall of 3 to 4 inches was widespread in central Nebraska.

Omaha and Lincoln in eastern Nebraska were bracing for about 8 or more inches of snow.

Even as students were making their way to school this morning in Iowa, administrators in dozens of districts announced early dismissals.

Few of the 150 members of the Iowa General Assembly were in the state capitol in Des Moines this morning, deciding not to brave the weather.

Snow from the powerful storm fell as far south as Tucson, Ariz. on Wednesday. The rare snowfall halted play at the World Golf Championships-Accenture Match Play tournament near Tucson.

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