�Novartis proclaimed that Gleevec� (imatinib mesylate) tablets has been given priority review status by the US Food and Drug Administration (FDA) as the first therapy to be reviewed for use after surgery in kit-positive gastrointestinal stromal tumors (GIST). FDA priority review status is given to therapies that could potentially fill up a presently unmet medical need and accelerates the standard review timing from ten to six months. Similar regulative submissions have been filed in the European Union and Switzerland and volition be filed in former countries shortly.
The Gleevec submissions are based on data from a Phase III, double blind, randomized, multicenter, international study of more than 700 GIST patients who had surgery to remove their tumors. The results showed a dramatic 89% reduction in risk of infection of kit-positive GIST reversive after surgical operation (adjuvant setting) in patients treated with Gleevec versus placebo.
In early 2007, the study met its primary efficaciousness endpoint, exhibit an advantage for Gleevec in recurrence-free survival. At that sentence, following the recommendation of the sovereign study data monitoring citizens committee to arrest the visitation accrual early, the study investigators made public the interim results and offered Gleevec to patients receiving placebo.
Approximately half of all patients with newly diagnosed GIST are considered candidates for operative resection, or removal of their tumors. Of those who have the surgery, about half will suffer a return. If approved for this indication, Gleevec will be the first treatment option available to GIST patients after surgical process to reduce the risk of exposure of disease recurrence or to maybe prevent the disease from returning.
"The dramatic clinical results from this study of Gleevec in the ancillary GIST mount are especially encouraging when we consider the incremental benefit we typically see with other adjuvant therapies for solid tumors," said Rainer Boehm, MD, Executive Vice President, North American Region Head, Novartis Oncology. "The adjuvant use of Gleevec, if approved, would represent an important advance in the ongoing post-surgery management of GIST."
Gleevec is currently indicated in both the US and EU for the first-line treatment of metastatic or unresectable (inoperable) kit-positive GIST. If sanctioned, the consumption of Gleevec for the treatment of GIST in the adjuvant setting would add to its eight-spot current indications, which include Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) and five former rare diseases. Novartis also has a therapy for the treatment of carcinoid tumors and acromegaly and multiple treatments in the pipeline targeting rare diseases.
http://www.novartis.com
View drug information on Gleevec.
More info
Sunday 31 August 2008
Thursday 21 August 2008
Wolfmother rhythm section exits, band to continue
Wolfmother [ ] bass/keyboard player Chris Ross and drummer Myles Heskett announced they will be leaving the stripe. Singer/guitarist Andrew Stockdale plans to record the adjacent Wolfmother album with raw musicians.
Ross said he is going away due to irreconcilable personal and musical differences. Heskett also has decided to leave preferably than working with a new lineup, according to a affirmation on the band's website.
story_top_holder>
Heskett and Ross have been working in concert on songs separate from Wolfmother [ ] and they plan to focus on that new project in the future.
�
More info
Monday 11 August 2008
Surrogoat
Artist: Surrogoat
Genre(s):
Metal: Death,Black
Discography:
Landscapes Of Condolence
Year: 2004
Tracks: 6
Wednesday 6 August 2008
Rain doesn't pull plug on folk fest
Some 43 years ago, Bob Dylan shocked Newport by sledding electric. Yesterday, as the rains hit hard and furiously at the Newport Folk Festival, it was a monumental electric index outage that provided the surprise. But with author power on the 2 main stages, the express, amazingly, went on.
The folks were plentiful - over 7,five hundred attended - even if the tribe music was sometimes hard to rule at this revamped, revitalised fest.
Who was folky and who was not? That was a surprisingly surd question to answer.
Phish�s Trey Anastasio, one of the day�s least folky performers in hypothesis, was the only act to play unplugged and solo. He sounded as gentle as a mountain dulcimer. The crowd of Phish-heads mouthing his every lyric was hardly reacting to his simply strummed, acoustic advance, though. It was Anastasio�s cult-like condition that was paramount here. The only way Phish fans power be disappointed with his generous set? Anyone expecting electric guitar improvisations.
Steve Earle, meanwhile, unitary of the day�s near rootsy acts, actually used an electronic beatbox to augment his acoustic guitar. Since the folk purists have long ago been weaned from this festival�s fan base, no one was offended. Earle�s wife, Allison Moorer, joined him. The Earle set ranged from the politically incisive (�Christmas in Washington�) to the lyrically insipid (�City of Immigrants�).
Just like his dad, Bob, Jakob Dylan wore a wide-brimmed hat, sunglasses and a stubble beard. His band could have easily been employed by Bob, too. �In case you were speculative, my guitar is acoustic, but plugged in,�Dylan joked. His arenaceous voice is more tuneful than Bob�s, butJakob�s lightweight approach was merely likeable.
Among the strongest sets:Richie Havens, Jim James and the headlining Black Crowes. The Crowes played 90 proceedings of solid, swampy rock, giving jam-band fans some long, torture improvs. Cat Power was sane of temperament and supple of voice, backed by a band that sounded like classic turn down Manhattan tilt. No act went out of their way to fit the definition of a folk festival.
Actually, the name of this event is its only helplessness. Drop the word �folk� and the rootsy, acoustic expectations, and you�d have a finish artistic success. Rain, mud and all.
musingmusic@aol.com/I>
More info
Subscribe to:
Posts (Atom)