 Artist: Thom Brennan: mp3 download Genre(s): Ambient New Age Other Thom Brennan's discography:  Vista Cd2 Year: 2005 Tracks: 7  Vista Cd1 Year: 2005 Tracks: 8  The Fall Of Winter Year: 2005 Tracks: 35  Raingardens Year: 2005 Tracks: 4  Silver Year: 2004 Tracks: 8  Signals In Moonlight Year: 2004 Tracks: 9  The Path Not Taken Year: 2003 Tracks: 3  Satori Year: 2002 Tracks: 1  Vibrant Water Year: 2001 Tracks: 4  Strange Paradise Year: 2001 Tracks: 5  Shimmer Year: 2001 Tracks: 5  Secret Faiths Of Salamanders Year: 2001 Tracks: 4  Mist Year: 2001 Tracks: 4  Formation Of Storms Year: 2001 Tracks: 1  Unreleased Tracks Compilation Year: 1999 Tracks: 9  Between Islands Year: 1999 Tracks: 7  Beneath Clouds Year: 1997 Tracks: 2  Mountains Year: Tracks: 6 The aristocratic, ambient, nature-influenced music of Thom Brennan had an early show window in 1987 with his spillage, Mountains, a collaboration with Steve Roach that evoked memories of his childhood on an island in the East China Sea. His following full-length record album, the ocean-inspired Beneath Clouds, wouldn't appear until ennead years later. Another period of quiet followed that album until 2001 when he released several projects for sale on the Internet, including Shimmer, Vibrant Water, Secret Faiths of Salamanders, and Mist. |
Wednesday, 10 September 2008
Mp3 music: Thom Brennan
Monday, 11 August 2008
Meeting Highlights From The Paediatric Committee, 29-31 July 2008 - European Medicines Agency (EMEA)
�Opinions on paediatric investigation plans adopted
The Paediatric Committee (PDCO) adopted positive opinions on pediatric investigation plans (PIPs)
for the following medicines:
-- Dabigatran etexilate, from Boehringer Ingelheim International GmbH, in the alterative area
of haematology and haemostaseology;
-- Thrombin alfa (recombinant), from Bayer HealthCare AG, in the therapeutic region of
hematology and haemostaseology;
-- Pramipexole dihydrochloride monohydrate, from Boehringer Ingelheim International
GmbH, in the sanative area of neurology;
-- Retigabine from Valeant Pharmaceuticals Ltd, in the therapeutic area of neurology.
The PDCO adopted negative opinions for PIPs for ezetimibe and simvastatin, from Merck Sharp &
Dohme, and for nicotinic acid (in an extended release form), simvastatin and laropiprant, from
Merck Sharp & Dohme (Europe) Limited, both in the therapeutic area of endocrinology and
metabolism. The PDCO adopted subsequently on its own apparent movement positive opinions on full waivers for
these medicines in all subsets of the pediatric population, on the grounds that these products do not
represent a significant therapeutic benefit over existing treatments for the paediatric population.
A paediatric investigation be after (PIP) sets out a programme for the developing of a medicine in the
paediatric population. The PIP aims to bring forth the necessary quality, guard and efficaciousness data through
studies to support the authorisation of the medicinal drug for employment in children of all ages. In some cases, a PIP
may include a waiver to study peerless or more age groups of children, or a deferral when it is appropriate
to conduct studies in adults prior to initiating studies in the paediatric population, or when studies in
the paediatric population would take yearner to conduct than studies in adults.
Opinions on product-specific waivers
The PDCO adoptive an opinion for a product-specific release, recommending that the obligation to
submit data obtained through clinical studies with children be waived in all subsets of the paediatric
population, for bortezomib, from Janssen-Cilag International, in the therapeutical area of oncology.
Waivers can be issued if there is grounds showing that the medicinal product concerned is likely to be
ineffective or unsafe in the paediatric population, or that the disease or condition targeted occurs just
in grownup populations, or that the specific medicinal product does not represent a significant therapeutic
benefit over existing treatments for paediatric patients.
The PDCO discussed the applicability of class waivers for products intended to treat conditions
included in the heel of class waivers. Companies developing a product for a condition included in the
lean of social class waivers can request substantiation of whether the cRO of the EMEA conclusion on a class
waiver for a condition is applicable to their product. Upon review by the PDCO, companies will
receive an consequence letter substantiating whether or not their product is considered to fall under the scope
of the EMEA Decision on social class waivers.
Compliance check with PIPs
The PDCO endorsed a document which describes the EMEA obligingness check with an in agreement PIP,
which is a prerequisite for the validation of new marketing authorisation applications and applications
for extensions or variations of indications. In add-on to the Paediatric Committee, the EMEA has
liaised with the EMEA's Committee for Medicinal Products for Human Use (CHMP) and the Coordination
Group for Mutual Recognition & Decentralised Procedures for Human Medicines for the
drawing of this document.
As of 26 July 2008, pharmaceutical companies who submit an application for a marketing
authorization for a medicine take to provide either the results of studies in children conducted in
accordance of rights with an approved PIP or an EMEA determination on a waiver or on a deferral. This will apply
from 26 January 2009 for medicines that ar already authorized and for which a company is
submitting an application for an denotation of indication.
At the request of the Committee for Medicinal Products for Human Use, a competent authority or the
applicant, the PDCO will value and articulate an belief on the compliance of the lotion for
marketing authorisation with the in agreement paediatric probe plan interested, i.e. assess whether all
measures agreed in a PIP have been carried out in accordance with the EMEA decision on the PIP.
Compliance is one of several prerequisites for obtaining the rewards and incentives provided for by
the Paediatric Regulation.
Cooperation with US-FDA
The PDCO welcomed the attendance at the group meeting of a representative of the US Food and Drug
Administration (FDA) in the framework of the Principles of Interaction between EMEA and FDA
Pediatric Therapeutics. According to the terms of these principles, EMEA staff may attend the FDA's
Pediatric Implementation Team meetings and FDA staff may wait on the EMEA's Paediatric
Committee meetings to enable regulators from either delegacy to take note operational activities, and to
optimise mechanisms and timing of data exchanges.
The objectives of the cooperation between the EMEA and FDA in the field of pediatric medicines ar
to facilitate the model for world-wide paediatric evolution plans, compatible for both agencies, with
the aspire of avoiding exposing children to unneeded trials.
The next meeting of the PDCO volition be held on 27-29 August 2008.
1. PDCO opinions on PIPs and waivers ar transformed into EMEA decisions within the
timeframe laid down by the Paediatric Regulation (Regulation (EC) No 1901/2006, as
amended). The decisions canful be establish here.
2. The Principles of Interaction between EMEA and FDA Pediatric Therapeutics can be found on
the EMEA website hither (PDF).
3. The document on procedural advice for validation of new marketing authority applications
for extensions/variations and compliance check with an agreed PIP is published in the
Medicines for children section of the EMEA website.
4. More info about the PDCO and the Paediatric Regulation is available in the 'Medicines
for children' section of the EMEA internet site.
European Medicines Agency
The European Medicines Agency (EMEA) is a decentralised body of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary employment.
http://www.emea.europa.eu
More information
The Paediatric Committee (PDCO) adopted positive opinions on pediatric investigation plans (PIPs)
for the following medicines:
-- Dabigatran etexilate, from Boehringer Ingelheim International GmbH, in the alterative area
of haematology and haemostaseology;
-- Thrombin alfa (recombinant), from Bayer HealthCare AG, in the therapeutic region of
hematology and haemostaseology;
-- Pramipexole dihydrochloride monohydrate, from Boehringer Ingelheim International
GmbH, in the sanative area of neurology;
-- Retigabine from Valeant Pharmaceuticals Ltd, in the therapeutic area of neurology.
The PDCO adopted negative opinions for PIPs for ezetimibe and simvastatin, from Merck Sharp &
Dohme, and for nicotinic acid (in an extended release form), simvastatin and laropiprant, from
Merck Sharp & Dohme (Europe) Limited, both in the therapeutic area of endocrinology and
metabolism. The PDCO adopted subsequently on its own apparent movement positive opinions on full waivers for
these medicines in all subsets of the pediatric population, on the grounds that these products do not
represent a significant therapeutic benefit over existing treatments for the paediatric population.
A paediatric investigation be after (PIP) sets out a programme for the developing of a medicine in the
paediatric population. The PIP aims to bring forth the necessary quality, guard and efficaciousness data through
studies to support the authorisation of the medicinal drug for employment in children of all ages. In some cases, a PIP
may include a waiver to study peerless or more age groups of children, or a deferral when it is appropriate
to conduct studies in adults prior to initiating studies in the paediatric population, or when studies in
the paediatric population would take yearner to conduct than studies in adults.
Opinions on product-specific waivers
The PDCO adoptive an opinion for a product-specific release, recommending that the obligation to
submit data obtained through clinical studies with children be waived in all subsets of the paediatric
population, for bortezomib, from Janssen-Cilag International, in the therapeutical area of oncology.
Waivers can be issued if there is grounds showing that the medicinal product concerned is likely to be
ineffective or unsafe in the paediatric population, or that the disease or condition targeted occurs just
in grownup populations, or that the specific medicinal product does not represent a significant therapeutic
benefit over existing treatments for paediatric patients.
The PDCO discussed the applicability of class waivers for products intended to treat conditions
included in the heel of class waivers. Companies developing a product for a condition included in the
lean of social class waivers can request substantiation of whether the cRO of the EMEA conclusion on a class
waiver for a condition is applicable to their product. Upon review by the PDCO, companies will
receive an consequence letter substantiating whether or not their product is considered to fall under the scope
of the EMEA Decision on social class waivers.
Compliance check with PIPs
The PDCO endorsed a document which describes the EMEA obligingness check with an in agreement PIP,
which is a prerequisite for the validation of new marketing authorisation applications and applications
for extensions or variations of indications. In add-on to the Paediatric Committee, the EMEA has
liaised with the EMEA's Committee for Medicinal Products for Human Use (CHMP) and the Coordination
Group for Mutual Recognition & Decentralised Procedures for Human Medicines for the
drawing of this document.
As of 26 July 2008, pharmaceutical companies who submit an application for a marketing
authorization for a medicine take to provide either the results of studies in children conducted in
accordance of rights with an approved PIP or an EMEA determination on a waiver or on a deferral. This will apply
from 26 January 2009 for medicines that ar already authorized and for which a company is
submitting an application for an denotation of indication.
At the request of the Committee for Medicinal Products for Human Use, a competent authority or the
applicant, the PDCO will value and articulate an belief on the compliance of the lotion for
marketing authorisation with the in agreement paediatric probe plan interested, i.e. assess whether all
measures agreed in a PIP have been carried out in accordance with the EMEA decision on the PIP.
Compliance is one of several prerequisites for obtaining the rewards and incentives provided for by
the Paediatric Regulation.
Cooperation with US-FDA
The PDCO welcomed the attendance at the group meeting of a representative of the US Food and Drug
Administration (FDA) in the framework of the Principles of Interaction between EMEA and FDA
Pediatric Therapeutics. According to the terms of these principles, EMEA staff may attend the FDA's
Pediatric Implementation Team meetings and FDA staff may wait on the EMEA's Paediatric
Committee meetings to enable regulators from either delegacy to take note operational activities, and to
optimise mechanisms and timing of data exchanges.
The objectives of the cooperation between the EMEA and FDA in the field of pediatric medicines ar
to facilitate the model for world-wide paediatric evolution plans, compatible for both agencies, with
the aspire of avoiding exposing children to unneeded trials.
The next meeting of the PDCO volition be held on 27-29 August 2008.
1. PDCO opinions on PIPs and waivers ar transformed into EMEA decisions within the
timeframe laid down by the Paediatric Regulation (Regulation (EC) No 1901/2006, as
amended). The decisions canful be establish here.
2. The Principles of Interaction between EMEA and FDA Pediatric Therapeutics can be found on
the EMEA website hither (PDF).
3. The document on procedural advice for validation of new marketing authority applications
for extensions/variations and compliance check with an agreed PIP is published in the
Medicines for children section of the EMEA website.
4. More info about the PDCO and the Paediatric Regulation is available in the 'Medicines
for children' section of the EMEA internet site.
European Medicines Agency
The European Medicines Agency (EMEA) is a decentralised body of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary employment.
http://www.emea.europa.eu
More information
Thursday, 19 June 2008
Madonna's brother to publish book on big sis
Pop star Madonna's brother Christopher Ciccone has written a memoir called Life With My Sister Madonna, to be published next month by Simon and Schuster.
"Ciccone's extraordinary memoir is based on his life and 47 years of growing up with and working with his sister - the most famous woman in the world," Simon and Schuster imprint Simon Spotlight Entertainment said.
Ciccone, one of Madonna's five siblings, wrote the book with Wendy Leigh. She has also written biographies of John F Kennedy Jr, Britain's Prince Edward, Liza Minelli and ghost-written Zsa Zsa Gabor's autobiography.
Madonna's spokeswoman Liz Rosenberg had no comment.
Madonna, whose original name was Madonna Louise Ciccone, made her debut in 1982.
Her first album, Madonna, which included hits such as Holiday, Borderline and Lucky Star, helped her become one of the best-selling pop artists, with more than 200 million albums sold worldwide.
The book will be published on July 15, a month before Madonna celebrates her 50th birthday.
See Also
Thursday, 12 June 2008
Lily Allen - Lily Allen Signs Up To Be Lesbian Vampire
Pop pixie Lily Allen is set to star as a lady-loving vampire in the forthcoming movie, LESBIAN VAMPIRE KILLERS.
Gavin & Stacey stars Matthew Horne and James Corden have cast the Smile singer in a cameo role in their big-screen debut.
After appearing on Lily's chat show - on which Corden and Allen got particularly friendly - the pair have reportedly wanted to work with the singer ever since.
One source told The Sun: "James wants Lily to take on a bigger part but she is happy with a cameo."
While Lily appears to have charmed Horne and Corden, the Sun reports that THE KOOKS' frontman Luke Pritchard is not impressed after she slated him on her MySpace page last year
"I find it funny she’s a musician now because she never used to be into music at school," he said after she covered the band's hit Naïve as way of a peace offering.
"I don't really like her music all that much."
03/06/2008 13:19:23
See Also
Friday, 6 June 2008
Ex-Busted members lose royalties case
Pre-success Busted members Ki McPhail and Owen Doyle have lost a �10 million royalties battle against their former bandmates.
The pair, who were sacked from the band in 2001, claimed they were forced to sign away their song rights.
McPhail and Doyle said they helped write tracks, including the hits 'Year 3000' and 'What I Go To School For', when the boy band formed back in October 2001.
But the case's judge criticised the pair's evidence and dismissed their claims.
He also said who wrote the songs was irrelevant to his final decision as there had never been a contract or partnership between the band members.
Ex-Busted members James Bourne and Matt Willis released a statement after winning the case.
It said: "This was an opportunistic attempt by Doyle and McPhail to cash in on our success. Their claims were a complete fabrication and we are delighted that the judge has seen through this and totally dismissed them. Our position has been completely vindicated and our achievements with Busted remain untarnished."
According to Newsbeat.com
McPhail and Doyle are now considering an appeal.
The pair, who were sacked from the band in 2001, claimed they were forced to sign away their song rights.
McPhail and Doyle said they helped write tracks, including the hits 'Year 3000' and 'What I Go To School For', when the boy band formed back in October 2001.
But the case's judge criticised the pair's evidence and dismissed their claims.
He also said who wrote the songs was irrelevant to his final decision as there had never been a contract or partnership between the band members.
Ex-Busted members James Bourne and Matt Willis released a statement after winning the case.
It said: "This was an opportunistic attempt by Doyle and McPhail to cash in on our success. Their claims were a complete fabrication and we are delighted that the judge has seen through this and totally dismissed them. Our position has been completely vindicated and our achievements with Busted remain untarnished."
According to Newsbeat.com
McPhail and Doyle are now considering an appeal.
Wednesday, 28 May 2008
Coprofago
Artist: Coprofago
Genre(s):
Metal: Thrash
Discography:
Unorthodox Creative Criteria
Year: 2005
Tracks: 13
Santiago, Chile's Coprofago were formed in 1993 by vocalists/guitarists Pablo Alvarez and Sebastián Vergara, bassist Felipe Castro, and drummer Marcelo Ruiz, wHO recorded their five-track demonstration while tranquil in their teens and then introduced the earth to their highly expert death-jazz metallic element fashion (influenced by Atheist, Cynic, etc.) via 1997's Images of Despair record album. Three old age later, they ultimately produced a follow-up in the Genesis LP, which showed the banding meant occupation by including contributions from Rodrigo Castro on fretless bass. Currently, Coprofago's position is in interrogation due to certain members' relocation to Sweden, merely rumors give birth surfaced that they are still in some way working on new material.
Saturday, 24 May 2008
Tom Cruise wants Katie Holmes to spend less time with Victoria Beckham
Tom Cruise is concerned that wife Katie Holmes is spending too much time with pal Victoria Beckham, it has been claimed.
Sources say the Top Gun star is keen to put some distance between the pair, who have morphed into each other in recent months.
“Katie sees Victoria as a role model,” a source says. “She copies Victoria’s look and even cut her hair the same way.
Sources say the Top Gun star is keen to put some distance between the pair, who have morphed into each other in recent months.
“Katie sees Victoria as a role model,” a source says. “She copies Victoria’s look and even cut her hair the same way.
Thursday, 22 May 2008
Bhakta
Artist: Bhakta
Genre(s):
Electronic
Discography:
Open Transmission
Year: 2002
Tracks: 7
Winehouse to run her own record lebel
Britney Spears In Beverly Hills Fender Bender
Britney Spears In Beverly Hills Fender Bender
Britney Spears was involved in a shaver accident on Los Angeles' famous Sunset Clean in Beverly Hills on Tues afternoon (May 13), after she reportedly rear-ended the automobilist infront of her at a countersink of traffic lights.The singer struck the SUV with her Mercedes afterward seemingly accelerating when the christ Within was still bolshevik.According to reports, Spears' bodyguard assisted the female driver of the other vehicle, world Health Organization chase the popstar back to her gated community in Studio City to deal with the incident, come out of opinion of the paparazzi.Picture courtesy of Jive.
Philip Bailey
Potter star talks about new romance
Potter star talks about new romance
'Harry Potter' star Emma Watson has spoken about her fresh fellow, after organism photographed with him at the Empire Awards after-party.
According to the Mirror, the 17-year-old actress said: "I'm really happy. I'm not certainly if he is 'the one' but yet, we've entirely been expiration come out together for three weeks, only it's brilliant at the second. He is a friend of a friend."
"We've known for each one other for a patch but we only got together shoemaker's last month. He isn't an actor and he didn't go to my school, which is great, we're just having play," she said.
James Watson laughed away previous media rumours which linked her to Razorlight frontman Greyback Borrell and her 'Harry Potter' co-star Daniel Radcliffe.
"I've been linked to so many guys I sound like a wanton woman."
"Daniel and I give birth been couple for the past six-spot age, so we're used to it. Then in that location was Greyback Borrell. But this is my swain now," she said, referring to the freshly man in her life.
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