�Bayer's cooperation partner Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) has submitted the new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for rivaroxaban (Xarelto�), a novel anticoagulant taken as one tablet, once-daily. It seeks approval for the use of rivaroxaban in the bar of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.
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
Wednesday, 6 August 2008
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
Coldplay's 'Viva La Vida Or Death And All His Friends' has taken the Number One spot in the UK Album Charts tonight (June 15), despite only being available to buy for three days.
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
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
Jody Hill (right) on the set.Courtesy of Paramount VantageWith an uproarious midnight debut at the Sundance Film Festival in 2006, Jody Hill’s The Foot Fist Way seemed like a prime candidate to be snapped up by a major distributor, with the ensuing massive nationwide release to follow. Despite its shoestring budget and limited resources, this hilarious flick about a small town Tae Kwon Do instructor (the co-writer and comedy star of tomorrow Danny McBride) whose delusions of grandeur collide with his pathetic personal life is an unholy cross between Bottle Rocket, Napoleon Dynamite, and Talladega Nights — only, like, funnier. Yet, amazingly, it took some time for distributors to wise up to the film’s awesomeness. Luckily, it eventually found its way to the eyeballs of kindred spirits Will Ferrell and Adam McKay, who snatched it up and are now releasing it (today!) through Paramount Vantage. Vulture spoke to director Jody Hill via phone in New Mexico, where he is busy shooting his next film.
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
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
NEW YORK (Hollywood Reporter) - Ron Perlman ("Hellboy"), Taryn Manning ("Hustle & Flow"), Joe Pantoliano ("The Sopranos") and Patrick Flueger (USA's series "The 4400") will star in the darkly comic drama "The Job."
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
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
Subscribe to:
Posts (Atom)