Anne Hathaway's Oscar Dress Had You Talking









02/25/2013 at 08:30 AM EST



The Oscars may honor the best in film, but they'd be nothing without the fashion.

When Anne Hathaway stepped on to the red carpet in a light pink backless Prada gown at Sunday's 85th Annual Academy Awards, she made quite the fashion statement.

While the gown seemed simple from the front, at second glance, an open back and thigh-high slit gave it a sexy edge. Hathaway, 30, told Kristin Chenoweth on ABC's red carpet that her mom called the dress "business in front, party in the back."

Viewers had their own opinions on the dress – which seemed to emphasize Hathaway's bust – which later inspired its own parody Twitter account.

But the dress may have served as a lucky charm for Hathaway, who took home the Oscar for Best Supporting Actress for her role in Les Misérables.

"It came true. Thank you so much to the Academy for this and for nominating me with Helen Hunt, Jacki Weaver, Amy Adams and Sally Field. I look up to you all so much and it's just been such an honor. Thank you," Hathaway said upon receiving her Oscar.

She continued, "There are so many people whose generosity and support is the reason I'm standing here right now. I must thank Hugh Jackman. Hugh, you're the best. The cast, the crew, especially Simon Hayes and the sound wizards. Congratulations on tonight, you guys."

Hathaway continued thanking the cast and the crew before giving a romantic shout out to her husband, Adam Shulman.

"By far and away, the greatest moment of my life is the one when you walked into it. I love you so much. And thank you for this. Here's hoping that someday in the not too distant future the misfortunes of Fantine will only be found in stories and never in real life. Thank you."

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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. 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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Mahony answers questions under oath about clergy sex abuse cases









A "relatively unflappable" Cardinal Roger Mahony answered questions under oath for more than 3 1/2 hours Saturday about his handling of clergy sex abuse cases, according to the lawyer who questioned the former archbishop.


"He remained calm and seemingly collected at all times," said attorney Anthony De Marco, who represents a man suing the Los Angeles Archdiocese over abuse he alleges he suffered at the hands of a priest who visited his parish in 1987.


Mahony has been deposed many times in the past, but Saturday's session was the first time he had been asked about recently released internal church records that show he shielded abusers from law enforcement.





De Marco declined to detail the questions he asked or the answers the cardinal provided, citing a judge's protective order.


The deposition occurred just before Mahony was to board a plane for Italy to vote in the conclave that will elect the next pope. In a Twitter post Friday, Mahony wrote that it was "just a few short hours before my departure for Rome."


Church officials did not return requests for comment.


The case, set for trial in April, concerns a Mexican priest, Nicholas Aguilar Rivera. Authorities believe he molested at least 26 children during a nine-month stay in Los Angeles.


Recently released church files show Aguilar Rivera fled to Mexico after a top Mahony aide, Thomas Curry, warned him that parents were likely to go the police and that he was in "a good deal of danger." Aguilar Rivera remains a fugitive in Mexico.


The archdiocese had agreed that Mahony could be questioned for four hours about the Aguilar Rivera case and 25 other priests accused in the same period. De Marco said he did not get to ask everything he wanted and would seek additional time after the cardinal returned from the Vatican.


Past depositions of Mahony have eventually become public, and De Marco said he would follow court procedures to seek the release of a transcript of Saturday's deposition.


Meanwhile, a Catholic organization Saturday delivered a petition with thousands of signatures asking that Mahony recuse himself from the conclave in Rome.


The group, Catholics United, collected nearly 10,000 signatures making "a simple request" that the former archbishop of Los Angeles not participate in the process because of the priest abuse scandals that happened under his watch, said Chris Pumpelly, communications director for Catholics United.


The petition was delivered Saturday to St. Charles Borromeo in North Hollywood, where the cardinal resides. It was accepted by a church staff member.


After delivering the petition, organizers attended Mass at the parish to pray for healing and for the future of the church.


harriet.ryan@latimes.com


Times staff writer Rick Rojas contributed to this report.





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IHT Rendezvous: Opera for an Era When Money Is Tight

VIENNA—Not long ago it looked as if cuts in arts funding would sound the death knell of the Vienna Chamber Opera, known in German as the Kammeroper, an ensemble esteemed for its chamber-scale productions in an intimate, inviting setting. The Austrian federal government’s decision to eliminate entirely its support, which constituted half of the company’s governmental subsidies (the other half coming from the city) effectively put the Kammeroper out of business.

Yet the 2012-13 season has seen the Kammeroper come roaring back with five new productions—including a “Bohème” finishing up performances this weekend— put on by a resident company with an established orchestra in the pit.

How to explain this turnaround? In fact, the old company, which was founded over 50 years ago by Hans Gabor and was subsequently run by Isabella, his widow, is history. The new Kammeroper, formally known as Theater an der Wien in der Kammeroper, is a case of one opera company rushing to fill the void left by the collapse of another.

Few opera companies today are in a financial position to go into expansionary mode. But, with the city willing to continue its support, the Theater an der Wien saw an opportunity, as its director of artistic administration, Sebastian Schwarz, who oversees the Kammeroper, explained by phone. Surprisingly, as he pointed out, the Vienna Staatsoper lacks a young artists program, so the new venture helps meet a need in the city. It also adds a degree of continuity to the Theater an der Wien’s own operations, which include world-class productions of interesting repertory that are assembled individually, with visiting performers and orchestras.

What has happened at the Kammeroper would be akin the Metropolitan Opera taking over the name and venue of a smaller New York company in financial trouble, giving the city the “Mini-Met” audiences have fancied for decades. The Kammeroper’s venue is especially choice: the gilded former ballroom, dating from the turn of the last century, of the venerable Hotel Post in the old Fleischmarkt district of the city. Outfitted with an orchestra pit, it comfortably seats 300. The performance I attended was packed, and with ticket prices ranging from 16 to 48 euros ($21-64), it is a bargain.

At the core of the new Kammeroper is an ensemble of seven young singers, which Mr. Schwarz described as constituting a “cast for ‘Così Fan Tutte’ ”—two sopranos, a mezzo soprano, a tenor, a baritone and a bass, plus a counter-tenor. In addition to their Kammeroper duties, the singers take smaller roles at the Theater an der Wien.

“La Bohème” can make a special impact when cast with young singers, and so it does here, as performed in Jonathan Dove’s 1986 chamber version with newly composed modernistic music at the start and between acts by Sinem Altan. Basically, the opera is performed straight, but with choral and other big moments from Acts 2 and 3 excised. The interludes, which included prerecorded music, are atmospheric and intermittently engaging, but essentially peripheral. For one not knowing what to expect, it was a relief when—with Rodolfo and Marcello already onstage—the familiar music of Act 1 began to unfold and continued on uninterrupted.

The lively, updated staging is by Lotte de Beer, the young director of Robin de Raaff’s recent “Waiting for Ms. Monroe” at the Netherlands Opera. The set by Clement & Sanôu, who also did the lighting, focuses on the modern kitchen of the bohemians’ apartment, which also, somewhat confusingly seems to be part high-end boutique (at least until the merchandise is removed after Act 2). In any case, it is handsome and full of stylish details. The playwright Rodolfo writes at a laptop and throws pages of his opus into the oven for warmth.

There is an inevitable loss of grandeur in Act 2, but Ms. de Beer nicely handles Rodolfo and Mimi’s growing attraction to each other and the conflicts of Act 3. The setting of Mimi’s hospital room for Act 4 is rather contrived, however, especially since the others, not at first being allowed in, communicate with her from pay phones in the lobby, which detracts from the emotional impact. Mimi has lost her hair, presumably as a result of treating a fatal illness different from that specified by Puccini. Still, this is an engaging show

The vocal ensemble, which is capably augmented by two guests, Oleg Loza as Schaunard and Martin Thoma as Benoit and Alcindoro, is uniformly strong. From the opera’s opening line by Marcello, one admired Ben Connor’s rich, fluent baritone, and it didn’t take long for the tenor Andrew Owens to catch his stride as Rodolfo and spin his own handsomely lyrical phrases and a fine high C.

All the singers displayed ample voices that could be overpowering in a hall this size, but they didn’t allow that to happen. Cigdem Soyarslan’s Mimi was a little uneven at first, but one came to appreciate her warm spinto sound, especially in her Act 3 aria, and Anna Maris Sarra sings Musetta with a glinting soprano that is heard to fine effect in her animated account of the waltz aria.

Igor Bakan brings a full, resonant bass voice and a strong emotional charge to Colline’s farewell to his overcoat. The fine Vienna Chamber Orchestra is in the pit, led with assurance by Claire Levacher.

The newly constituted Kammeroper has thus emerged as a bright spot on the Viennese opera scene.

Two more productions remain this season, a double bill of Britten’s “Curlew River” and “Prodigal Son” and Handel’s “Orlando.”

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You're Invited to PEOPLE.com's Oscars Party!









02/24/2013 at 08:40 AM EST







From left: Bradley Cooper, Oscar, Jessica Chastain


AFP/Getty; Wireimage; Splash News Online


Oscars host Seth MacFarlane isn't the only one gearing up for Hollywood's biggest night – we are too!

Be a part of the glamour and excitement Sunday at 6 p.m. ET when we roll out the red carpet for our PEOPLE.com VIPs.

Here's what you can expect:
• Tune in to our red carpet preshow for exclusive A-list interviews
• Be the first to see the gorgeous gowns – and make your own best-dressed list
• Download your own Oscars ballot – and make your own Academy Awards picks
• Tweet with our editors at #PeopleOscars
• Take our up-to-the-minute Oscars polls

And come back the next day for so much more ...
• See the night's best dresses from all angles with our 360º slideshow
• Come inside the most exclusive Oscars after-parties
• Relive the most memorable quotes of the show
• Get the scoop on the night's biggest shockers and funniest moments everyone is talking about

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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. 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.


Read More..

Paroled sex offenders disarming tracking devices









SACRAMENTO — Thousands of paroled child molesters, rapists and other high-risk sex offenders in California are removing or disarming their court-ordered GPS tracking devices — and some have been charged with new crimes including sexual battery, kidnapping and attempted manslaughter.


The offenders have discovered that they can disable the monitors, often with little risk of serving time for it, a Times investigation has found. The jails are too full to hold them.


"It's a huge problem," said Fresno parole agent Matt Hill. "If the public knew, they'd be shocked."





More than 3,400 arrest warrants for GPS tamperers have been issued since October 2011, when the state began referring parole violators to county jails instead of returning them to its packed prisons. Warrants increased 28% in 2012 compared to the 12 months before the change in custody began. Nearly all of the warrants were for sex offenders, who are the vast majority of convicts with monitors, and many were for repeat violations.


The custody shift is part of Gov. Jerry Brown and the legislature's "realignment" program, to comply with court orders to reduce overcrowding in state prisons. But many counties have been under their own court orders to ease crowding in their jails.


Some have freed parole violators within days, or even hours, of arrest rather than keep them in custody. Some have refused to accept them at all.


Before prison realignment took effect, sex offenders who breached parole remained behind bars, awaiting hearings that could send them back to prison for up to a year. Now, the maximum penalty is 180 days in jail, but many never serve that time.


With so little deterrent, parolees "certainly are feeling more bold," said Jack Wallace, an executive at the California Sex Offender Management Board.


Rithy Mam, a convicted child stalker, was arrested three times in two months after skipping parole and was freed almost immediately each time. After his third release, his GPS alarm went off and he vanished, law enforcement records show.


The next day, he turned up in a Stockton living room where a 15-year-old girl was asleep on the couch, police said. The girl told police she awoke to find the stranger staring at her and that he asked "Wanna date?" before leaving the home.


Police say Mam went back twice more that week and menaced the girl and her 13-year-old sister, getting in by giving candy to a toddler, before authorities recaptured him in a local park. He is in custody on new charges of child molestation.


Californians voted in 2006 to require that high-risk sex offenders be tracked for life with GPS monitors strapped to their bodies.


The devices are programmed to record offenders' movements and are intended, at least in part, to deter them from committing crimes. The devices, attached to rubber ankle straps embedded with fiber-optic cable, transmit signals monitored by a private contractor.


They are easy to cut off, but an alarm is triggered when that happens, as it is when they are interfered with in other ways or go dead, or when an offender enters a forbidden area such as a school zone or playground. The monitoring company alerts parole agents by text message or email.


Arrest warrants for GPS tamperers are automatically published online. The Times reviewed that data as well as thousands of jail logs, court documents and criminal histories provided by confidential sources. The records show that the way authorities handle violators can vary significantly by county.


San Bernardino County releases more inmates early from its cramped jails than any other county in California, according to state reports. But sex offenders who violate parole there generally serve their terms. A spokeswoman said the county closely reviews criminal histories, and those with past sex offenses are ineligible for early release.


By contrast, parole violators in San Joaquin County are often set free within a day of arrest.


A review of the county's jail logs shows that nine of the 15 sex offenders arrested for violating parole in December and January were let out within 24 hours, including seven who immediately tampered with their trackers and disappeared. One of the nine, a convicted rapist named Robert Stone, was arrested two weeks later on kidnapping charges and returned to jail, where he remains.


Raoul Leyva, a sex offender with a history of beating women, was arrested in April for fleeing parole and ordered to remain jailed for 100 days. He was out in 16 days and soon bolted again, after allowing the battery on his device to go dead, according to the documents reviewed by The Times.


Less than two weeks later, a drug dealer led police to a Stockton apartment where Leyva's girlfriend, 20-year-old Brandy Arreola, had lain for days on the floor, severely beaten and in a coma. Now brain damaged and confined to a wheelchair, Arreola spends her time watching cartoons.





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India Ink: In Hyderabad, Anger and Frustration

Srinivas Mahesh, 28, was snacking outside his hostel near the Konark Theater in Dishknagar, his usual hangout in Hyderabad, when he heard a loud explosion Thursday evening. Not long after, he saw smoke filling up the air. Once he realized it was a bomb blast, instead of rushing back to his hostel he resolved to helping the injured.

“I saw disfigured bodies for the first time in my life,” he said. He helped three severely injured people into ambulances and took another injured man by auto to Osmania Hospital.

Mr. Mahesh, who is originally from Kurnool, came to Hyderabad two years ago to do a graduation in engineering from Ashok Institute in Dilsukhnagar. After yesterday’s blasts though, he might have to return home.

“My parents were visiting Hyderabad in 2007, when there were blasts. They had a tough time then,” he said. “After yesterday, they are convinced that this city is cursed and want me home.”

More than 24 hours after two bombs went off near the ever-crowded Dilsukhnagar bus stand, there is palpable frustration and anger in the area. N.Pradeep Reddy, 29, a chartered accountant who lives in Dilsukhnagar, heard the first blast and came to the balcony of his house. Then he saw the second explosion. Aghast, he couldn’t move for several seconds, he said.

Mr. Reddy’s family has been in Hyderabad for 10 years now, but now he is disillusioned with the charm of the city, he said. “No one cares for our lives here – not the politicians, not the media not the police,” he added.

Hyderabad has been the site of numerous explosions in recent years, including two in 2007 attacks that killed dozens of people.

Soon after Thursday’s blasts, the road in front of the Dilsukhnagar bus stand had a median dividing it into two. While traffic was allowed on one side, the other side of the road was cordoned off by the police.

“This is obstructing traffic and adding to the commotion,” said P. Sadanandam, who commutes through the road regularly. “They are not doing this for security, it is just so that the VIPs can visit the blast site and have a photo-op,” he said angrily.

Andhra Pradesh Director General of Police and other senior police officers visited the at blast site today to look for evidence.

All the shops on a two kilometer stretch on the Dilsukhnagar main road were shuttered down all day today. Some security men outside the shops said that this was not due to the bandh, or shutdown, that the Bharatiya Janata Party had called, but because the shop owners were sure that there would be no customers today. They might open on Monday, they said.

Narsing Vennala, 25, sells flowers on the main road. He is one of the only three flower vendors who reopened their shops today. A temple next door needs flowers, he said, and therefore he had to come to work.

His 18-year-old sister is so paranoid about his coming to work a day after the blasts that she keeps calling him every half-an-hour to check if he is alright.  Mr Vennala walks home at 11 p.m. every night, and he plans to do the same even today.

“Whatever had to happen, happened,” he said. “Now how long can we stay hungry and not earn because of that?”

“Bharat mata ki jai,” (Victory for mother India) was loudly shouted by a bunch of residents. They said that was their answer to those that were against peace in the country.  There was also some anti-Pakistan sloganeering.

One resident estimated that there were 500 to 600 educational institutions in Dilsukhnagar. They have offerings ranging from short-term computer courses to three-year degrees. Thousands of students, from smaller towns and neighboring districts, live in hostels around their respective institutions. Many of them were on the streets yesterday to help the injured.

While some students don’t see any option but to stay in the city, others, like Mr. Mahesh, are packing their bags.

“I have to go home, even if I don’t like to,” he said “My family will be worried every day I stay in Hyderabad.”

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Biggest Loser's Francelina Morillo: Jeff Nichols and I 'Have Something Special'






The Biggest Loser










02/23/2013 at 08:30 AM EST







Francelina Morillo and Jeff Nichols


Trae Patton/NBC (2)


Francelina Morillo may have lost the chance to win the title of Biggest Loser, but she has found love.

"We have something special," Morillo said Tuesday about falling for fellow constant Jeff Nichols while on the ranch. "I have found a bond with him that I haven't had with anyone else. It's like a mirror when I look at him."

Morillo, 26, and Nichols, 25, both lost their fathers while in their teens and bonded in the gym as they began to shed their weight – and emotional baggage.

"You get to see the person at their worst and you see them blossom and grow and become this better version of themselves. You learn to appreciate and admire them in a different way," Morillo says of her time with Nichols on the show.

But the couple was temporarily separated when Morillo was sent home for losing the least amount of weight in the episode that aired last Monday.

"I knew I had gathered the tools in there that I needed to survive in the real world," Morillo says of her tearful sendoff. "I've learned I can do this for the rest of my life and that I can keep the weight off – which is my ultimate goal."

Morillo returned home to New York but soon joined Nichols in Chicago. Now the couple are motivating each other to continue to lose weight.

"We balance each other out. He has the nutrition down pat and I am an exercise junky," Morillo says about working out with Nichols, whose status as a finalist or contender for the at-home prize has yet to be revealed. "It's just so much easier when you have the support of somebody else that knows exactly what you're going through."

Morillo arrived at the ranch weighing 267 lbs., after having lost 100 lbs. at home on her own, and now continues to lose weight by working with a trainer, spending two hours a day on the stairmill and monitoring her portion sizes.

"I was eating a lot of healthy stuff, but I was binging on everything," says Morillo, who used to eat large amounts of apples or oatmeal throughout the day. "If you have too much of good thing, it's also bad. Now I'm all about portion size."

With her eye on the $100,000 at-home prize, Morillo is also looking forward to applying to medical school and eventually fulfilling her dream to become a doctor.

"The new me is positive, outgoing, always smiling and wants the best for me," she says. "I've learned the best way to do that is to surround yourself with positive energy, positive people. That's who I am, and that’s what I radiate from now on."

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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. 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.


Read More..