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..

Oscars 2013: Live Blog of the Academy Awards

Feb 24, 2013 1:13pm

10: 57 p.m. ET: George Clooney gets the honor of presenting the In Memoriam package. “We thank you for the memories,” the star says.

MORE: Clooney and Stars Sport Stubble on the Red Carpet

10: 49 p.m.: “Lincoln” wins Best Production Design.

READ MORE: Full Wrap of the Oscars

10: 47 p.m.: Dubbed “boy wizard” and “girl vampire” by MacFarlane, Daniel Radcliffe and Kirsten Stewart present the award for Achievement in Production Design. Stewart is sans the crutches she was sporting on the red carpet earlier. Here’s the picture in case you missed it.

Watch Live Oscars Coverage Here

10: 44 p.m. ET: Nicole Kidman introduces the third batch of Best Picture nominees — “Silver Linings Playbook,” “Django Unchained” and ”Amour.”

10:35 p.m. ET: The unstoppable Adele performs her hit “Skyfall.” Our eyes are glued to the TV as our everyone’s backstage, including winner Anne Hathaway, Entertainment Weekly’s Jess Cagle tweeted.

Image credit: Kevin Winter/Getty Images

10: 33 p.m. ET: “Argo” wins Film Editing.

10: 32 p.m. ET: “Editors make so many of us look way better than we ever had a right to,” Sandra Bullock says before presenting the award for Best Film Editing.

10:23 p.m. ET: No surprise! Anne Hathaway takes home Best Supporting Actress. “It came true,” she says, clutching the statue.

Image credit: Kevin Winter/Getty Images

10:20 p.m. ET: Best Supporting Actress time … finally!It’s between Amy Adams, “The Master”; Sally Field, “Lincoln”; Anne Hathaway, “Les Miserables”; Jacki Weaver, “Silver Linings Playbook”; Helen Hunt, “The Sessions.”

10:15 p.m. ET: “We have a tie,” Mark Wahlberg said before announcing the award for Best Sound Editing. The first one goes to “Zero Dark Thirty.” The second one goes to “Skyfall.” Is a tie allowed, you ask? It’s not the first in Oscars history. The most famous was in 1986 when Barbra Streisand and Katharine Hepburn tied for Best Actress, but there were five in total: Best Actor category in 1949, Best Documentary Short Subject in 1968, Best Actress in 1986, Documentary Feature in 1994, and Live Action Short Film, ABC News’ Alexis Shaw reports.

10:13 p.m. ET: Ted wouldn’t be Ted without a Jewish joke. The bear asks Mark Wahlberg if he’s Jewish because he has “a berg” at the end of his name.  ” Wrong answer. Try again. If you want to work in this town… ” he says. “I was born Theodore Shapiro…”

10:11 p.m. ET: Ted is in the house. The stars of MacFarlane’s box office hit, “Ted,” Mark Wahlberg and Ted, presented the award for Sound Mixing to “Les Miserables.”

Image credit: Getty Images

10:01 p.m. ET: The cast of “Les Miserables” is singing “One Day More.” Anne Hathaway stole the show, as expected.

9:59 p.m. ET: No words. Jennifer Hudson is breaking it down with “Dreamgirls’” “And I’m Telling You.”

Credit: Kevin Winter/Getty Images

9:53 p.m. ET: The movie musical tribute is off to a killer start with Catherine Zeta-Jones’ performance of “All That Jazz” from “Chicago.”

9:50 p.m. ET: Best Foreign Language Film is “Amour.”

9:44 p.m. ET: “Searching for Sugar Man” takes home Best Documentary Feature. Jaws music creeps in again … (An aside: there’s an official Twitter handle for Jaws music already with one tweet: “GET OFF THE STAGE!!!!!!!!”)

Full List of Winners

9:42 p.m. ET: MarFarlane gets some laughs at the expense of Ben Affleck and Jessica Chastain. On Affleck’s facial hair: “The first time I saw him with all that facial hair I thought finally the Kardashians have made the jump to film.” On Jessica Chastain’s character in “Zero Dark Thirty” — a movie about a “woman’s innate ability to never let anything go,” he jokes.

9:40 p.m. ET: Second batch of Best Picture nominees — “Argo,” “Lincoln,” “Zero Dark Thirty” – get their moment in the spotlight.

9: 36 p.m. ET: Best Documentary Short Subject goes to “Inocente.”

9: 33 p.m. ET: Shawn Christensen of “Curfew” wins for Live Action Short Film. Stars of “Django Unchained” Kerry Washington and Jamie Foxx present.

9:27 p.m. ET: Standing ovation for Shirley Bassey singing “Goldfinger.” Thoughts on her performance?

9: 22 p.m. ET: Bond… James Bond! A ravishing Halle Berry takes to the stage in Marchesa for the Academy’s tribute to 50 years of James Bond films.

9:20 p.m. ET: “Les Miserables” picks up Best Makeup and Hairstyling.

9:18 p.m. ET: Jennifer Aniston and Channing Tatum Best Costume Designgoes to Jacqueline Durran for “Anna Karenina.” Click here to see her Oscar-winning costumes.

9:11 p.m. ET: And they’re playing people off with Jaws music. Hilarious and brilliant. Nicole Kidman mouths from her seat: “Poor thing.”

9:10 p.m. ET: That’s two for “Life of Pi.” The film picks up another win for Visual Effects.

9:07 p.m. ET:The Best Oscar for Cinematography goes to… Claudio Miranda for “Life of Pi.” The cast of “The Avengers” hands out the award.

Full List of Winners

9:05 p.m. ET: MacFarlane jokes about nine-year-old Quvenzhane Wallis’ age. “It’ll be 16 years till she’s too old for George Clooney.”

9:03 p.m. ET: Reese Witherspoon just gave us a briefing on the three of the Best Picture nominees: “Les Miserables,” “Life of Pi,” and “Beasts of the Southern Wild.” That song from “Les Mis” — “Do You Hear the People Sing?” — is now in my head.

9:00 p.m. ET: Best Animated Feature Oscar goes to….”Brave.”

8: 58 p.m. ET: “Paperman” wins Best Animated Short.

8: 58 p.m. ET: Paul Rudd and Melissa McCarthy lost us in their intro to animated short film.

8: 51 pm. ET: And the Oscar for Best Supporting Actor goes to Christoph Waltz in “Django Unchained.”

Credit: Chris Pizzello/AP

8:49 p.m. ET: Every nominee for Best Supporting Actor already has an Oscar under his belt.

8: 42 p.m. ET: Another musical number with Daniel Radcliffe and Joseph-Gordon Levitt. And then we got a little Disney music too with “Be Our Guest,” which finally scored MacFarlane the “Best Oscars host ever” headline.

Credit: Robyn Beck/AFP/Getty Images

8: 39 p.m. ET: Channing Tatum and Charlize Theron are dancing to MacFarlane singing “The Way You Look Tonight.” A shame not to see the “Magic Mike” star shirtless though.

Credit: Mark Davis/Getty Images

Image credit: Robyn Beck/AFP/Getty Images

8:38 p.m. ET: Captain Kirk from “Star Trek” has descended on the stage to warn MacFarlane that he’s about to ruin the Oscars and be branded the worst Oscar host ever. “The show is a disaster. I’ve come back in time … to stop you from ruining the Academy Awards,” William Shatner says. “You sing an incredibly offensive song that upsets a lot of women in the audience.” Cut to MacFarlane singing “We Saw Your Boobs,” a hilarious number referencing when we’ve seen actresses nude in movies.

Image credit: Robyn Beck/AFP/Getty Images

8:35 p.m. ET: MacFarlane pokes fun at Daniel Day Lewis’ method. “Your process fascinates me. You were totally 100% in character in Lincoln… So if you saw a cell phone, would you have to be like, ‘Oh god, what’s that?’ If you bumped into Don Cheadle on the studio lot, you’d try and free him on the studio lot.”

8: 32 p.m. ET:  Too much? MacFarlane compared “Django Unchained” to Rihanna and Chris Brown’s relationship.

8:30 p.m. ET: Seth MacFarlane is on stage and quips: “The quest to make Tommy Lee Jones laugh begins now.”

8:27 p.m. ET: The stars are seated and the show is about to start. A lot of anticipation about Seth MacFarlane’s opening monologue. Channing Tatum is tweeting that he’s getting ready to take to the stage: “Hope you like what we’ve been working on. Getting ready to hit the #Oscars stage! Wish me luck!” Will there be a musical number right off the bat?

8:20 p.m. ET: Strapless is definitely a trend of the night. We’ve also seen a lot of beauties in blue.

Image credit: Getty Images

8: 15 p.m. ET: We’ve confirmed that Best Supporting Actress nominee Helen Hunt is rocking … H&M! “The Session” actress is in a  custom made midnight-blue full length gown is silk satin gown (also strapless). 

8:14 p.m. ET: Anne Hathaway is talking about her dress. “My mom says it’s business in the front, party in the back.”

8:08 p.m. ET: Do Jacki Weaver and Olivia Munn share a stylist? ABC News’ Alexis Shaw spotted the Best Supporting Actress nominee and Munn in eerily similar crimson gowns with matching gold embellishment on the top. Click here for more.

Credit: Jason Merritt/Getty Images

8:05 p.m. ET: Kristen Stewart is sporting crutches on the red carpet. Might be because she took home the Worst Actress Razzie award last night for “Twilight Saga: Breaking Dawn — Part 2.”

Credit: Christopher Polk/Getty Images

8:00 p.m. ET: The show is now officially a half hour away. In honor of Oscar night, the President tweeted this picture from a White House movie night.

Image credit: Twitter/BarackObama

7: 52 p.m. ET: “Les Mis” star and Best Actor nominee Hugh Jackman just picked up pre-show host Kristin Chenoweth on the red carpet and said she weighs less than an Oscar. Not really though…Each nearly 14-inch-high statue weighs 8.5 pounds and costs $500 to make. Get more Oscar trivia here.

7:40 p.m. ET: If there’s one star you can count on to look fabulous, it’s Jennifer Aniston.  She’s in a Valentino red strapless gown and has fiance Justin Theroux at her side. They’re in the running for Hollywood’s hottest couple on the red carpet.

7:38 p.m. ET: Bradley Cooper brought his mom as his date. She’s rocking a shrug with serious feathers and what look like sneakers with her gown. Cooper is up for Best Actor in “Silver Linings Playbook.”

7:34 p.m. ET: Reese Witherspoon is in head to toe Louis Vuitton. The presenter’s black and royal blue gown with side-swept hairdo scream old Hollywood glamor. Click here.

Credit: Kevin Mazur/WireImage/Getty Images

7: 28 p.m. ET: Fashion miss: Jane Fonda is slightly blinding in bright yellow.

7: 24 p.m. ET: Best actress nominee Naomi Watts is in a gunmetal Giorgio Armani gown in grey sequins. Does she make your best dressed list? See more arrivals here.

7:20 p.m. ET: Anne Hathaway’s dress may raise eyebrows tonight. The “Les Miserables” star is in a backless, halter dress that appears slightly sheer on the red carpet.

Credit: Jason Merritt/Getty Images

7:18 p.m. ET: We can’t get enough of Quvenzhane Wallis. The “Beasts of the Southern Wild” star has her mom’s permission to stay out a little bit later tonight, she told Lara Spencer on the red carpet.

Credit: Kevin Mazur/Getty Images

7:15 p.m. ET: “I feel super tucked in,” Amanda Seyfried said of the corset in her Alexander McQueen gown. “I can’t sit down.” The “Les Miserables” star is performing tonight. Hope she can breathe on stage.

7:07 p.m. ET: Another star goes strapless. Jennifer Lawrence, who’s up for Best Actress in “Silver Linings Playbook,” is in a blush Dior Haute Couture gown with a full skirt.

Credit: Steve Granitz/Getty Images

7:01 p.m. ET: ABC’s pre-show is kicking off! “Red carpet is 500 feet long. That’s about 2,000 of me,” Chenoweth joked. Tune into ABC now and get a behind-the-scenes look via Backstage Pass on the Oscar App.

6:56 p.m. ET: The red carpet is packed, but not everyone is making it through the notorious L.A. traffic. Mark Ruffalo is running late. The actor, who’s presenting tonight, tweeted to the Academy: “Dear @TheAcademy. We are running a good deal behind would you mind starting a little later this year? Mark and Sunrise Ruffalo.”

Credit: ABC News

6:49 p.m. ET: Presenter Kerry Washington is in Miu Miu. The “Django Unchained” and star “Scandal” star always keeps us guessing and never fails to impress.

The Best Apps for Hollywood’s Big Night

6:44 p.m. ET: Who are you most excited to see on the red carpet? What will be the meme of the night? Angelia Jolie’s right leg stole the show last year and Twitter is reminding us. “1 year ago today you met the glorious thing that is ME #neverforget,” @Angelina Jolie’sLeg posted.  

6:35 p.m. ET: The reigning “Sexiest Man Alive” Channing Tatum and a pregnant Jenna Dewan are both glowing on the red carpet. See them canoodling here.

6:25 p.m. ET: Amy Adams looks ethereal in a seafoam green Oscar de la Renta strapless dress. She’s up for Best Supporting Actress for “The Master.”

Credit: Frederic J. Brown/AFP/Getty Images

PHOTOS: Oscar Red Carpet Arrivals

6:22 p.m. ET: Cutest moment of the red carpet so far, as captured by the Academy. Nine-year-old Quvenzhane Wallis, nominated for “Beasts of the Southern Wild” shows off her puppy-shaped purse to fellow Best Actress nominee Jessica Chastain. It’s reportedly named Sammy after her dog at home.

Credit: @TheAcademy/Twitter

6:10 p.m. ET: The winners have arrived, WABC’s Sandy Kenyon reports! In these briefcases are the top secret ballots from the Academy. Read more here.

Credit: Twitter/SandyKenyon7

5:56 p.m. ET: “GMA” anchors Robin Roberts and Lara Spencer smile backstage before the red carpet heats up.

Credit: ABC

5:42 p.m. ET: ABC pre-show hosts Kristin Chenoweth and Kelly Rowland have arrived on the red carpet and are looking fabulous in black and white.

Credit: Jason Merritt/Getty Images

5:30 p.m. ET: See what the stars see as they walk down the grand staircase to the red carpet at the Dolby Theatre. This cool 360 view is courtesy of the Academy.

5:15 p.m. ET: Get your Oscar party on. Impress your friends with these movie-themed recipes and cocktails. We could go for some Spinach “Argo-choke Dip” right about now…

Oscar 2013: Movie-Themed Recipes
9 Cocktails for Your Oscar Party

5:00 p.m. ET: “GMA” anchor Robin Roberts is back and looking better than ever! Roberts, who returned to the morning show Wednesday after undergoing a bone marrow transplant to treat MDS, will be on the red carpet tonight. “To my wonderful, beloved #TeamRobin … This one’s for you. XO,” she tweeted. She’s in a cobalt blue velvet halter gown from designer Marc Bouwer.

Credit: Twitter/RobinRoberts

4:44 p.m. ET: We’re less than an hour away from red carpet arrivals. “Good Morning America” anchor Lara Spencer is getting red-carpet ready to host the Oscar pre-show.  “Hair + Make-up = Butterflies!” @LaraSpencer tweeted. Spencer, actress Kristin Chenoweth, Entertainment Weekly’s Jess Cagle and singer Kelly Rowland will have interviews with all of the stars, starting at 7 p.m. ET/4 p.m. PT on ABC.

Credit: Twitter/LaraSpencer

1:15 p.m. ET: Hollywood’s biggest night of the year is officially here: the Oscars. Funnyman Seth MacFarlane is hosting the 85^th Annual Academy Awards and we’ll be covering all of the big winners, best moments, surprises, and all-important red carpet arrivals. Refresh for the latest updates all night long.

We are just hours away from seeing the gorgeous gowns and finding out who’s going home with those coveted statuettes. It’s not too late to make your picks and predictions on our interactive Oscar ballot. To get up to speed before the festivities begin, check out our complete Oscars coverage.

Credit: Bob D'Amico/ABC

Full List of the Nominees

7 Things to Know About Seth MacFarlane

PHOTOS: The Best Oscar Dresses of All Time

TRIVIA: 15 Things You Don’t Know About the Oscars

PHOTOS: Top 30 Worst Oscar Looks Ever

Backstage Pass: Download the Oscars App for insider views from the red carpet and behind the scenes. Click here to learn how!

Read More..

Michelle Obama's dance moves go viral on YouTube

WASHINGTON - A video clip of First Lady Michelle Obama grooving with a dressed-in-drag Jimmy Fallon on his late-night comedy talk show on Saturday has gone viral on YouTube.

In the video, the pair, each clad in conservative slacks and cardigans, and Fallon with a long brown-haired wig, perform a routine dubbed "Evolution of Mom Dancing," to promote Michelle Obama's "Let's Move!" youth fitness and nutrition campaign.

The dance moves -- with names like "The 'Go Shopping, Get Groceries,'" and "The 'Out of Sync Electric Slide'" according to titles splashed on the bottom of the screen -- progress from a simple side-to-side step and ends with Fallon stalking off set as Michelle Obama rocks a smooth "Dougie."

The clip, which has already been viewed nearly a half million times since being posted Saturday and "liked" more than 10,000 times, has prompted effusive comments about the first lady and her first family.

"For the first time... we have a first lady with soul," wrote zestydude87.

And Rina Lubit wrote, "it may be just me but i really love the presidential family. they just really seem like sincerely good and chill people."

In an interview later on the show, Michelle Obama rates her husband's dance skills a "B," saying "he's got, like, three good moves."

Michelle Obama also touts her "Let's Move!" campaign, saying it has seen progress since she launched it three years ago, but there is still work to do.

"Over the past three years, we've seen a culture shift. Now people understand that this is an issue," she said.

"We've got better lunches in the schools, we've got companies putting grocery stores in under-served communities. We've got our athletes, our Olympians, working to get our kids more active. It's really heartening to see."

Obesity is a major health problem in the United States, where one in three adults and almost one in five children is overweight.

Among other initiatives for "Let's Move," the first lady, an attorney by training, has planted the White House's first garden since World War II and written a book with healthy recipes.

- AFP/ir

Read More..

Ramdev trust, govt keep options open over Feb 27 function

SHIMLA: Having taken possession of 28 acres land leased out to Patanjali Yogapeeth at Sadhupul area of Solan district, the Himachal Pradesh government does not want yoga guru Swami Ramdev to hold his function there on February 27. Fearing stiff resistance from supporters of Swami Ramdev, government had planned to impose section 144 in Sadhupul and surrounding areas and had made heavy deployment of police in the area.

Resultantly, Patanjali Yogapeeth officials are now looking for another venue either at Solan or Kandaghat to hold the function. Sources said that people in Sadhupul area were adamant about holding the function there itself, but Patanjali Yogapeeth officials, after getting inputs about imposition of section 144, decided to change the venue to avoid any confrontation with government.

On Saturday, Yogapeeth officials submitted an application to Solan Municipal Council for holding the function at Thodo ground on February 27, but the civic body has not given any assurance to them about granting them permission. As confusion about the venue continues, Yogapeeth officials have kept the option of holding the function at Kandaghat also open, sources said.

State incharge of Patanjali Yogapeeth and Bharat Swabhiman Trust, Lakshmi Dutt Sharma, said that they will finalise the venue by Sunday evening. "We decided not to hold the function at Sadhupul as officials informed us about government decision to impose section 144 in the area. We are now looking for some other venue as we do not want any law and order problem, but we have not got any assurance from the authorities concerned," he said.

Sources said that to stop Patanjali Yogapeeth from obtaining stay from court, the state government planned to file a caveat in the court, while the Yogapeeth is reportedly planning to approach the court on the issue.

The opposition BJP, on its part, has decided to support Swami Ramdev if he launched an agitation on the issue. State BJP president Satpal Singh Satti has said that his party would extend full support if Ramdev starts an agitation to oppose the government move. He said the previous BJP government had allotted the land to Ramdev as setting up a Patanjali Yogapeeth facility in the area would have benefitted residents of surrounding villages immensely. "We condemn the act of Congress government," he said.

Read More..

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..

Fiery Last-Lap Daytona Crash Injures Dozens

A fiery last-lap crash at the Daytona International Speedway today sent chunks of debris flying into the stands, injuring more than 30 spectators, who were seen being carried away from the stands on stretchers.

At least 14 of the injured were transported to hospitals and more than a dozen others were treated at the speedway, Dayton president Joie Chitwood III. All the drivers involved in the crash have been treated and released, Chitwood said.

ESPN reported that one of the spectators taken to the hospital was on the way to surgery with head trauma.

The 12-car crash happened moments before the end of the Nationwide race, and on the eve of the Daytona 500, one of NASCAR's biggest events.

The crash was apparently triggered when driver Regan Smith's car, which was being tailed by Brad Keselowski on his back bumper, spun to the right and shot up the track. Smith had been in the lead and said after the crash he had been trying to throw a "block."

PHOTOS: Crash at Daytona Sends Wreckage Into Stands

Rookie Kyle Larson's car slammed into the wall that separates the track from the grandstands, causing his No. 32 car to go airborne and erupt in flames.

When a haze of smoke cleared and Larson's car came to a stop, he jumped out uninjured.

His engine and one of his wheels were sitting in a walkway of the grandstand.

"I was getting pushed from behind," Larson told ESPN. "Before I could react, it was too late."

Tony Stewart pulled out the win, but in victory lane, what would have been a celebratory mood was tempered by concern for the injured fans.

"We've always known this is a dangerous sport," Stewart said. "But it's hard when the fans get caught up in it."

Repairs are under way on the fence where the crash happened and are expected to be completed before the Daytona 500 on Sunday, Chitwood said.

He told reporters NASCAR does not anticipate having to move any of their fans for the Daytona 500 and expects all seats will be filled.

Read More..

Abe vows to revive Japanese economy, sees no escalation with China

WASHINGTON (Reuters) - Japanese Prime Minister Shinzo Abe told Americans on Friday "I am back and so is Japan" and vowed to get the world's third biggest economy growing again and to do more to bolster security and the rule of law in an Asia roiled by territorial disputes.

Abe had firm words for China in a policy speech to a top Washington think-tank, but also tempered his remarks by saying he had no desire to escalate a row over islets in the East China Sea that Tokyo controls and Beijing claims.

"No nation should make any miscalculation about firmness of our resolve. No one should ever doubt the robustness of the Japan-U.S. alliance," he told the Center for Strategic and International Studies.

"At the same time, I have absolutely no intention to climb up the escalation ladder," Abe said in a speech in English.

After meeting U.S. President Barack Obama on his first trip to Washington since taking office in December in a rare comeback to Japan's top job, he said he told Obama that Tokyo would handle the islands issue "in a calm manner."

"We will continue to do so and we have always done so," he said through a translator, while sitting next to Obama in the White House Oval Office.

Tension surged in 2012, raising fears of an unintended military incident near the islands, known as the Senkaku in Japan and the Diaoyu in China. Washington says the islets fall under a U.S.-Japan security pact, but it is eager to avoid a clash in the region.

Abe said he and Obama "agreed that we have to work together to maintain the freedom of the seas and also that we would have to create a region which is governed based not on force but based on an international law."

Abe, whose troubled first term ended after just one year when he abruptly quit in 2007, has vowed to revive Japan's economy with a mix of hyper-easy monetary policy, big spending, and structural reform. The hawkish leader is also boosting Japan's defense spending for the first time in 11 years.

"Japan is not, and will never be, a tier-two country," Abe said in his speech. "So today ... I make a pledge. I will bring back a strong Japan, strong enough to do even more good for the betterment of the world."

'ABENOMICS' TO BOOST TRADE

The Japanese leader stressed that his "Abenomics" recipe would be good for the United States, China and other trading partners.

"Soon, Japan will export more, but it will import more as well," Abe said in the speech. "The U.S. will be the first to benefit, followed by China, India, Indonesia and so on."

Abe said Obama welcomed his economic policy, while Deputy Chief Cabinet Secretary Katsunobu Kato said the two leaders did not discuss currencies, in a sign that the U.S. does not oppose "Abenomics" despite concern that Japan is weakening its currency to export its way out of recession.

The United States and Japan agreed language during Abe's visit that could set the stage for Tokyo to join negotiations soon on a U.S.-led regional free trade agreement known as the Trans-Pacific Partnership.

In a carefully worded statement following the meeting between Obama and Abe, the two countries reaffirmed that "all goods would be subject to negotiations if Japan joins the talks with the United States and 10 other countries.

At the same time, the statement envisions a possible outcome where the United States could maintain tariffs on Japanese automobiles and Japan could still protect its rice sector.

"Recognizing that both countries have bilateral trade sensitivities, such as certain agricultural products for Japan and certain manufactured products for the United States, the two governments confirm that, as the final outcome will be determined during the negotiations, it is not required to make a prior commitment to unilaterally eliminate all tariffs upon joining the TPP negotiations," the statement said.

Abe repeated that Japan would not provide any aid for North Korea unless it abandoned its nuclear and missile programs and released Japanese citizens abducted decades ago to help train spies.

Pyongyang admitted in 2002 that its agents had kidnapped 13 Japanese in the 1970s and 1980s. Five have been sent home, but Japan wants better information about eight who Pyongyang says are dead and others Tokyo believes were also kidnapped.

Abe also said he hoped to have a meeting with new Chinese leader Xi Jinping, who takes over as president next month, and would dispatch Finance Minister Taro Aso to attend the inauguration of incoming South Korean President Park Geun-hye next week.

(Additional reporting by Jeff Mason and Doug Palmer; Editing by David Brunnstrom and Paul Simao)

Read More..

Street theatre catches fancy of India's youth

NEW DELHI: Theatre, which is a big part of Indian tradition, has evolved over the years.

An ancient form of theatre which was once practised to drive home political agendas is today being extensively used to create awareness of social issues in the country.

The growing prominence of street theatre has also caught the fancy of the young.

She moves about with her arms stretched, hair strewn and in ragged clothes.

Delivering her dialogue in a shrill tone, she trails around throwing questions at the surprised audience.

This is not a scene from a Bollywood movie but a snippet of a street play on the status of women in India.

With no stage, arch lights, make-up and minimum props, the medium of street theatre - also known as the people's theatre - has gained wide-spread acceptance and popularity in modern India.

As realistic as it gets, street theatre has become a popular medium to spread awareness about pressing social and political issues in the country.

Dramatist and film-maker, Siddhant Malhotra, said: "I think it is the best possible way to spread awareness, because there is a group of 100 people watching your play.

"You can interact with them, you can engage them right on and they will get your point. By performing a 30-minute play, if you're engaging 100 people at a time, you're changing 100 people at a time which even an advertisement cannot do."

As the name suggests, street plays can be performed anywhere on busy roads, market places or outside offices.

This enables it to reach out to the majority of people for whom theatre is not accessible, like in rural and backward areas.

The shows are not ticketed or pre-scheduled, as the main aim is not to make money but to reach out to as many people as possible.

Often packed with dramatic dialogues, catchy songs and hyperbole, street plays have a telling effect on the masses.

Young dramatists, who often use this medium to generate awareness, feel that a casual approach and lack of a formal atmosphere help them in connecting with the viewers.

Ayushi Kumar, a student and dramatist, said: "Street theatre is one of the art form where actually we are so close to the audiences that we are almost with them. So we can talk, we can connect and to bring that feeling in which they can reflect on themselves. I believe street is the strongest form of theatre for that."

Another student and dramatist, Shiva Sreenivasan, said: "You have a lot of fun when you watch it and when you are having fun you are also getting a message in your head. That is the most important thing. You're just not there and watching it like a niche audience that watches a street play. It's not like that.

"The thing is that we address proper moral issues for the society and for the people of the country. So, it is very easy for us to connect with them, explain our point and get our point through."

Street theatre practitioners hope that the tradition can help to bring about long-term change to Indian society, which despite its progress is reeling under the darkness of social evils like rape, dowry and child marriage.

- CNA/ir

Read More..

Hyderabad, hotbed of home-grown terror, under lens

NEW DELHI: For the veterans of security establishment the bomb blasts have revived concerns about the critical nature of Hyderabad and surroundings in the growth of home-grown terrorism in India.

Officials point out that Hyderabad has been intricately linked to the growth of the present phase of domestic terrorism. When the first definite information about Muslim youth going to Pakistan for terror camps emerged more than a decade ago, with Hyderabad resident Shahid Bilal as a key figure, the government was alarmed at the highest levels. Once India confirmed that over 60 youth have gone across to Pakistan from Andhra Pradesh and Karnataka in 2005-06 the issue was taken up with Bangladeshi and Nepalese governments because most of them were going via either of these countries.

"Even if the bombers are from outside, they have received local logistical support," says one official. "There is a history here," he says about Hyderabad's brush with blasts as well as with fringe sympathisers.

A day before the twin blasts, the National Investigation Agency (NIA) had, in fact, filed its first charge sheet in the case of Bangalore-Hubli-Nanded terror module run from Saudi Arabia by LeT-HuJI handlers. One name among the 12 accused stood out: Obaidur Rehman. The 26-year-old Hyderabad resident is the nephew of Maulana Mohammed Naseeruddin, a radical preacher presently languishing in a Gujarat jail in connection with the murder of Gujarat home minister Haren Pandya.

The charge sheet also mentioned the man handling the group from Saudi Arabia as Farhatullah Ghori, maternal uncle of slain HuJI operative Shahid Bilal. Both belong to Hyderabad.

The blasts that followed the charge sheet have only come as a grim reminder of the Andhra Pradesh capital having become a favourite recruiting ground for terror groups. In fact, the city has been in terror crosshairs for close to a decade and a half providing strong base to both LeT and HuJI.

According to intelligence agencies, Hyderabad first came on terror radar in late '90s with several radical religious organizations becoming a springboard to youth taking to terror. While there was an entrenched sense of victimhood and injustice post Babri masjid demolition among Muslims in the state, their anger was first organized and harnessed by Mohammed Abdul Shahid alias Shahid Bilal under aegis of HuJI.

The first effects of this endeavor manifested itself in the terror attack on the office of Hyderabad Special Task Force in 2003. Bilal's maternal uncle Farhatullah Ghori's name prominently cropped up in the investigations. He was also a suspect in the Akshardham Temple attack in Gujarat in 2002.

Following this, Bilal was found to be instrumental in conducting several blasts across south India between 2004 and 2007. During this period he also helped 26/11 accused and LeT operative Zabiuddin Ansari alias Abu Jundal escape to Pakistan via Bangladesh along with his associate Fayyaz Kagzi after the 2006 Aurangabad arms haul in Maharashtra. In October 2007, Bilal was himself killed in Karachi along with his brother Samad. However, sources say, he has five more brothers who are in Pakistan and elsewhere. And the network he has left behind across India, Pakistan and Saudi Arabia keeps recruiting people for Jihadi activities.

In 2008, Maulana Naseeruddin's son, Riyazuddin Nasir, was arrested in Dharwad, Karnataka for planning to carry out terror strikes in the state. In 2012, with Obaidur Rehman's arrest in the Bangalore terror module, the city again struggled to shake off the terror tag.

Read More..

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..