Wednesday, 6 August 2008
Bayer's Novel Anticoagulant Rivaroxaban Submitted For U.S. Approval
Rivaroxaban was invented in Bayer's Wuppertal laboratories and is being collectively developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Once marketing authorization has been granted in the U.S., rivaroxaban volition be commercialized by Ortho-McNeil, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Rivaroxaban is the first base oral decoagulant to establish superior efficacy over the U.S. sanctioned twice-daily injectable regimen of enoxaparin, with a similar safety profile and no significant increase in major bleeding. Upon FDA approving, rivaroxaban volition be the first novel oral decoagulant introduced in the U.S. market for more than 50 years.
In accession to the FDA submission, filings ar under limited review with regulative agencies around the world. On July 24, rivaroxaban was recommended for favourable reception in Europe for the prevention of venous thromboembolism (VTE) next elective pelvis and genu replacement oR.
"We ar pleased to see rivaroxaban take an important step toward regulative approval so swiftly subsequently demonstrating unequaled success in the rich clinical trial program," aforementioned Dr. Kemal Malik, member of the Bayer HealthCare Executive Committee, responsible for product development. "Current standards of anticoagulation therapy have limitations and new contraceptive therapies ar needed. We are now on the cusp of revolutionizing the care of patients undergoing hip and knee substitute surgery."
The NDA in the U.S. is supported by data from the RECORD clinical program, in which more than 12,500 orthopedic patients experience been investigated - the largest ever so conducted in the bar of VTE in patients undergoing knee joint or pelvic arch replacement surgical procedure. It comprised four polar Phase III clinical trials that compared rivaroxaban with enoxaparin. Rivaroxaban demonstrated superior efficacy over enoxaparin in head-to-head comparisons (RECORD1, 3 and 4), and a comparison of extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin (RECORD2). In all four trials, rivaroxaban and enoxaparin demonstrated similar base hit profiles including low rates of major bleeding.
Almost 50,000 patients ar planned to be evaluated in the total clinical development program which includes trials in prevention and treatment of a tolerant range of acute and chronic blood coagulation disorders. Based on the clinical evidence reported to date from over 32,000 patients (of which more than 18,000 patients take been exposed to rivaroxaban), no safety issues
Thursday, 26 June 2008
Mr. Doctor
Artist: Mr. Doctor
Genre(s):
Rap: Hip-Hop
Discography:
Setripn' Bloccstyle
Year: 1995
Tracks: 14
Jodie Foster - Foster Silences Paparazzi
Thursday, 19 June 2008
Coldplay Number One on three days' sales
According to the Official UK Chart Company, the album has sold 302,000 since its release on Thursday (June 12), outselling the other artists in the top five album chart combined.
'Viva La Vida Or Death And All His Friends' has comfortably beaten the first week sales totals of their albums 'Parachutes' and 'A Rush Of Blood To The Head', but hasn't toppled 'X&Y''s first week total.
The Thursday release has meant that the album is Coldplay's fastest-selling release, however.
Last week's Number One, Paul Weller's '22 Dreams', fell to Number Four, while The Fratellis' 'Here We Stand' charted at Number Five.
In the Singles Chart, Mint Royale's remix of 'Singin' In The Rain' stayed at Number One, while Rihanna's 'Take A Bow' remained a place below.
The Top 10 Singles are:
1. Mint Royale - 'Singin' In The Rain'
2. Rihanna - 'Take A Bow'
3. Ne-Yo - 'Closer'
4. The Ting Tings - 'That's Not My Name'
5. Sara Bareilles - 'Love Song'
6. Gabriella Cilmi - 'Sweet About Me'
7. Duffy - 'Warwick Avenue'
8. Chris Brown - 'Forever'
9. Sam Sparro - 'Black And Gold'
10.Will.I.Am. ft. Cheryl Cole - 'Heartbreaker
Wednesday, 11 June 2008
Wednesday, 4 June 2008
Jody Hill on ‘The Foot Fist Way,’ Tae Kwon Do, and Paying Off Your Credit-Card Debt
How did you make the film? It seems like you basically maxed out all your credit cards.
Right after graduation, I moved to Los Angeles for like five, six years. I worked in a bunch of shitty jobs in reality television. And I just saved everything I could for five years, knowing I wanted to make a movie. And then I went back to my hometown of Concord, North Carolina, and applied for as many credit cards as I could get. But when we were shooting the movie, even that wasn’t enough, and my brother kicked in about $11,000 more, just so we could finish production. It was all basically between me and my brother.
And you’re still paying it back.
Luckily, I sold a screenplay. I’m in Albuquerque right now — that’s why you hear me running out of breath, from the elevation — and I’m shooting a movie called Observe and Report, starring Seth Rogen and Ray Liotta. When I sold that screenplay, I was able to pay off the movie. But just barely: I’ve still got this shitty one bedroom and that kind of stuff.
Were you yourself a Tae Kwon Do student?
I grew up doing Tae Kwon Do. When I was in high school in North Carolina, I started a Tae Kwon Do club. That’s where the idea for the movie came from. And we shot the movie in this big school that an instructor there, Sean Baxter, had built up, and we used all his kids in the movie. So they’re like real Tae Kwon Do kids. There are no real actors in it. Danny McBride was the only one of us who had any acting experience — he’d been in All the Real Girls, directed by David Gordon Green. I met [co-writers and co-stars] Ben Best and Danny in college, and when we shot the movie, I had them come and train for three weeks.
So it was like boot camp?
Yeah. Well, not really. I said three weeks, but they probably went about three times. They didn’t like it too much.
Is any of this film based on your real-life experiences in Tae Kwon Do?
I remember when I first started Tae Kwon Do, I thought my instructor was, like, the coolest guy in the world. And as I got older, I realized he was just a regular guy. It never occurs to you that this is someone who’s got the same problems everybody else does. It’s weird: When you go to martial-arts schools, a lot of the students — regardless of whether they’re kids or guys who are older than the instructor himself — will bow, and call their instructor “Sir” and “Mister So-and-So.” It could definitely go to somebody’s head. When you’re around that more than you’re around your wife or your kids, you can see how that’ll lead to someone being out of touch with reality. That’s where a lot of his bravado comes from.
How does it feel seeing Foot Fist Way now, after all these years?
This movie I’m making now is a big-budget movie. I mean, it’s not The Terminator, but it’s a studio movie. You have all these resources — we have cranes and all these other crazy things. And this product will look really professional. You know, all the color is going to be perfect, that sort of thing. But when I look at Foot Fist Way, I don’t know if I’ll ever be more proud of a movie. When we shot it, we didn’t have any money at all. There was no way we could compete with a studio film. We didn’t even want to try. What we were going for is basically like when you hear a punk bank’s first album that they recorded in a basement somewhere — with pops and hisses, and talking in the background and stuff. Instead of having that be our handicap, we tried to turn that into something that would make it stand out. I’m proud, really, that we were smart enough to realize that, at least. Also, the movie still makes me laugh. If it makes me laugh three years later, that’s cool. —Bilge Ebiri
Saturday, 31 May 2008
Andrea Ross
Artist: Andrea Ross
Genre(s):
Classical
Vocal
Discography:
Moon River
Year: 2007
Tracks: 14
Andrea Ross (Demo)
Year: 2007
Tracks: 5
 
Stallone faced Rambo death threats
Wednesday, 28 May 2008
Four accept Bitterman's "Job" offer
Shem Bitterman is adapting his 1998 play about a hapless man, Bubba (Flueger), who's desperate to find a job and marry the woman he loves (Manning). A drifter (Perlman) hooks him up with a slick employment agent (Pantoliano), but after agreeing to the job, Bubba quickly finds that he's in way over his head.
Bitterman's play won the Los Angeles Drama Critics Circle Award for best new play before transferring to an off-Broadway run. He co-wrote the upcoming action-comedy feature "Play Dead," starring Chris Klein and Fred Durst.
Reuters/Hollywood Reporter
Gary Lewis and the Playboys
Artist: Gary Lewis and the Playboys
Genre(s):
Pop
Rock
Discography:
Everybody Loves a Clown
Year: 1998
Tracks: 27
Legendary Masters Series
Year: 1990
Tracks: 25
Hits! Again (Digitally Remastered)
Year: 1966
Tracks: 12
Hits! Again
Year: 1966
Tracks: 12
 
'American Idol' Elimination: Brooke White Says A Tearful Goodbye; Seacrest Addresses 'Gossip' About Abdul
Her elimination almost seemed like an afterthought given the previous night's gaffe. Not surprisingly, while the two-and-a-half-minute recap of Tuesday's night's performances did show Cowell berating the male contestants for not stepping up and showed Abdul furiously rummaging through her note cards, it conveniently left out the bizarre bit where she pre-judged Castro's second performance before it happened. It was that incident that set off a firestorm of postings from "Idol" fans on Wednesday morning, with many suggesting that it was proof that the judging is not on the up and up, despite multiple post-show interviews in which Abdul explained that she was simply confused due to the last-minute format change.
Seacrest did finally deal with the elephant in the room, admitting 12 minutes in that "last night the judges were thrown a curveball on the air, which is just part of a live show, but it sparked a lot of gossip about Paula," he said. As Abdul looked on, wearing a look of pouty sadness, Seacrest added that he'd read some of the reports about the incident and forcefully refuted, "the rumors, they're not true. She's part of our family, and we love her." Abdul even got a huge and a kiss from Cowell as a show of support.
But there were tears a short time later, as emotionally fragile former nanny Brooke White, 24, got the bad news that she would be going home. After several trips to the bottom three, she was finally done in by her version of guest mentor Neil Diamond's "Daydream Believer," which judge Randy Jackson called a bit karaoke, and Cowell dubbed "a nightmare." White, who shed many a tear during her "Idol" run, embraced Seacrest as she loudly wept and hugged fellow frequent bottom-finisher Syesha Mercado after the verdict was read. With her slightly raspy voice, infectious smile and elegance at the piano, White at turns charmed and frustrated the judges with her vulnerable, erratic performances throughout the season. And when it was time to sing her way home, Seacrest dabbed her tears away as White said, "I just wanna to say thank you. It's gonna be terrible for me now, but thank you."
Perhaps she should have scrawled the lyrics on her palm again, though, just in case. The finalist whom singer Carly Simon recently picked as her favorite forgot the first line to the song and again broke the cardinal rule Abdul warned her of last week: there are no do-overs. Smiling through tears, she soldiered on through "I Am ... I Said," surrounded by her fellow contestants. In a season when several contestants have struggled to deliver their final goodbye, White's last bow was the most emotional, ending with her voice cracking as she turned her back to the audience and attempted to leave the stage.
Given her frequent trips to the bottom, it was not the most shocking conclusion to this dramatic week — especially once Dreadheads who thought Tuesday night's show was proof of a conspiracy to boot Castro got to breathe a sigh of relief at the top of the show. Their man was the first one waved over to the sofa, despite a night of singing that nearly all the judges agreed was pretty weak.
David Archuleta made the early passage to safety as well, helped, no doubt by his rousing rendition of "America," a song choice Cowell called "smart ... clever," putting the teen sensation another step closer to the David vs. David showdown many "Idol" watchers have been predicting. He was followed by the man Abdul has already predicted will be the next "Idol," David Cook, who said that he hoped he did not fall victim to the same fate as last week's eliminee, Carly Smithson, who had joked that she was done in the by curse of Cowell's high praise. No worries, though, as Cook was helped by some of the 45 million people who voted Tuesday night.
It was then down to Syesha Mercado and Brooke White, who both had to wait to hear their fate until after Natasha Bedingfield sang "Pocketful of Sunshine" and the judges handled a few viewer questions. One of the questioners actually managed to make Simon blush a bit, when the woman who had given the acerbic judge his first kiss at age 9 called in to ask whether she or Paula were the better kisser. The show also featured Neil Diamond's performance of his new single, the acoustic mariachi-tinged ballad "Pretty Amazing Grace."
Next week Cook, Archuleta, Castro and last-woman-standing Mercado will each sing two songs from the Rock and Roll Hall of Fame. The following night will feature performances from Maroon 5 and former "Idol" finalist Bo Bice, as the show steams toward the crowning of this year's "Idol" on May 21.
Get your "Idol" fix on MTV News' "American Idol" page, where you'll find all the latest news, interviews and opinions. And relive six seasons of "Idol" hot messes and high notes in six minutes with our video timeline.
New Releases, May 13: Death Cab for Cutie, Duffy, Jason Mraz
Kenny Chesney ties Brooks' ACM record
LAS VEGAS -- Despite a new voting procedure, Kenny Chesney is still the Academy of Country Music entertainer of the year. He won for the fourth straight year Sunday night, tying Garth Brooks for the record.
For the first time ever, the entertainer award was voted for by fans on the Internet, who came to the same conclusion the industry has. "This one is really extra special because long before I had a hit record, the fans came to the shows," Chesney said. "I'm honored to be up here for the fourth year in a row."
Still, Chesney made it clear backstage that he thinks the academy made a mistake by making the award fan-voted. Calling the process a "sweepstakes," he said, "I think it's complete disrespect of the artist. It shouldn't be about pushing people's buttons on the Internet. We need to be careful about how we give this award away in the future."
"I think the fans should be a part of the it," Chesney said, "but not the one award every artist sacrifices to achieve." Chesney had the top country tour of 2007, selling over 1.1 million tickets and grossing over $71 million, according to Billboard Boxscore.
Meanwhile, Miranda Lambert was the surprise winner of album of the year award for "Crazy Ex-Girlfriend." "I was sitting behind Kenny Chesney and I just don't feel right taking this," she said from the stage.
The critically acclaimed album has sold 408,000 copies in the U.S., according to Nielsen SoundScan, but has only spawned two top 20 singles, "Famous in a Small Town" and "Gunpowder & Lead," which she performed on the show. "I've never had a top 10 hit," she added backstage. "I am a little left of center. I'm completely surprised."
Sugarland took home an ACM hat for single and song of the year for "Stay." The song peaked at No. 2 in January on Hot Country Songs. The duo introduced producer Byron Gallimore as "part therapist and magician."
"It was shocking," the duo's Kristian Bush said of the wins backstage. The duo later debuted their sticks-in-your-head new single, "All I Want To Do," which will appear on their July 22 release "Love on the Inside."
Brad Paisley, whose most recent album, "5th Gear," has sold 1 million copies, took home male vocalist honors for the second straight year. "A singer is nothing without inspiration," Paisley said before thanking his wife, actress Kimberly Williams Paisley and son William Huckleberry Paisley. Meanwhile, top video honors went to Paisley's "Online," which was directed by "Seinfeld" star Jason Alexander.
With temperatures topping 100 degrees outside, Carrie Underwood kicked off the show inside with an inspired performance of "Last Name," her current top 10 single, before taking top female honors. Just over a week earlier, Underwood was inducted as a member of the Grand Ole Opry.
Held at Las Vegas' MGM Grand Garden Arena, the show was hosted for the tenth time by Reba McEntire, who performed with top vocal duo winners Brooks & Dunn on "Put a Girl in It."
Garth Brooks was honored with the Crystal Milestone Award for his career achievements and performed a medley of hits, including "The Thunder Rolls," "Friends in Low Places," "We Shall Be Free," "The Dance" and "Ain't Goin' Down (Til The Sun Comes Up)."
Taylor Swift took home top new female honors, besting gal pal Kellie Pickler. "Kellie, I love you," Swift said from the stage before dedicating the award to her mother.
Initially wearing a hoodie, which was torn off by two male dancers to reveal a black dress, Swift sang "Should've Said No," her new single, before being drenched by a cascade of water falling from above the stage. "This is a performance I've been dreaming up since I was 10," Swift said backstage. "I've never had that much fun on stage."
Rascal Flatts, who was honored with an ACM/Home Depot Humanitarian Award, also won top vocal group. Meanwhile, Tracy Lawrence, along with Tim McGraw and Kenny Chesney, picked up the vocal event trophy for "Find Out Who Your Friends Are."
George Strait, who celebrated his 56th birthday at the show, performed two songs back-to-back, his recent No. 1 "I Saw God Today" and "Shiftwork" with Chesney.
Eddy Arnold, who passed away at age 89 on May 8 and who was honored with an ACM pioneer award in 1984, was feted by Paisley and Underwood, who performed "Make The World Go Away."
Jack Ingram, who spent years on the Texas circuit before breaking out nationally with "Wherever You Are" in 2006, picked up the top new male trophy. "It's been a long road to stand in front of as the new male vocalist of the ACM. Dreams come true, never give up," he said.
"I've put in a lot of miles and a lot of hard work and I'm proud of the work I've done," he added backstage.
Lady Antebellum, whose debut single, "Love Don't Live Here," recently reached the top 10 on Hot Country Songs, scored the top new group or duo award only a year after being signed to Capitol Nashville. "Everything that's happened over the last year has been unbelievable," the group's Dave Haywood said backstage. "Being here now is the icing on the cake."
Anchor Bay to distribute 'Surfer'
Matthew McConaughey comedy set to play theaters
Anchor Bay, whose primary business is home entertainment, has been moving toward independent theatrical releases with films such as "The Grand" and "Sex and Death 101."
"The acquisition of 'Surfer, Dude' underscores where this company is headed," Anchor Bay president Bill Clark said. "We will continue to acquire strong titles for theatrical and DVD release while maximizing the abilities of the various divisions at Starz, including our global sales team and the premium entertainment channels."
In "Surfer, Dude," McConaughey -- who also serves as a producer -- stars as a soul-searching surfer who is experiencing an existential crisis. Anchor Bay plans to release the film theatrically in late summer.
Jason Berk and Matt Lane executive produced and financed the project through Berk/Lane Entertainment, with additional financing provided by Winchester Capital Management. McConaughey's production company, jklivin, produced.
Anchor Bay is a Starz Media subsidiary.
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Charlie Sheen - Richards Sheen Agreed To Reality Show
CHARLIE SHEEN tried to use ex-wife DENISE RICHARDS' new reality TV show to negotiate better access to their two daughters, the actress has claimed.
The former Bond girl has been criticised for allowing three-year-old Sam and Lola, two, to appear on Denise Richards: It's Complicated, which debuts in the U.S. on Monday (26May08).
But Richards claims Sheen actually signed the waiver allowing them to feature in the show, and only changed his mind when he realised he could use it to land more access to the girls.
The dispute went to court and a judge ruled in Richards' favour.
Speaking on U.S. morning TV's The Today Show on Wednesday (21May08), she said, "When I originally approached Charlie he didn't have a problem, he signed the waiver that I needed."
She adds that she refused Sheen's demands for a change in the custody arrangement, "(Because) I didn't want to change our custody for the show. They were two completely separate things.
"When people watch the show, my children are on it very little."
Of the deterioration of her relationship with Sheen since their split in 2005, she says, "Charlie is a stranger to me. He's my ex-husband and the father of my children and he's a stranger."
See Also