Navigation Links
Pharmion's Oral Azacitidine Granted Fast Track Status for Myelodysplastic Syndromes
Date:8/29/2007

BOULDER, Colo., Aug. 29 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for oral Azacitidine in the treatment of Myelodysplastic Syndromes (MDS).

Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track emphasizes the critical nature of close, early communication between the FDA and sponsors. The benefits of Fast Track include scheduled meetings to seek FDA input into development plans, and the option of submitting a New Drug Application in sections rather than all components simultaneously. These meetings can help the FDA and sponsors reach early agreement on design of the clinical efficacy studies that will be needed to support approval.

The FDA stated that Fast Track designation was granted for oral Azacitidine for MDS because Azacitidine is approved to treat all subtypes of MDS, and because it will potentially provide a safer, more comfortable, more convenient and more efficient route of administration of Azacitidine.

"We are extremely enthusiastic about working closely with Pharmion to drive the development of oral Azacitidine," said Dr. Hagop Kantarjian, chair of the department of leukemia at the University of Texas M.D. Anderson Cancer Center. "Vidaza has now demonstrated a unique and profound survival benefit in higher-risk MDS, and we think oral Azacitidine may provide significant benefit in treating lower risk forms of MDS as well. We are delighted that the FDA shares our view that its developme
'/>"/>

SOURCE Pharmion Corporation
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related biology technology :

1. Mirus granted European patent for gene therapy
2. Platypus granted new liquid crystal patent
3. WARF Granted New Antibiotics Patent
4. Identity theft start up has fast-track growth plans
5. In pursuit of capital, be sure to track your private offering
6. Jellyfish partners for sales tracking technology
7. Medical College team creates website for tracking flu
8. Johnson Controls deals for asset-tracking software
9. RFID system aids hospital in tracking assets
10. State tracks more angel investment, at least $19M last year
11. On track with the FDA -- But what about your coverage and reimbursement strategy?
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... Colo. , Jan. 23, 2015  Array BioPharma Inc. ... has reached a definitive agreement with Novartis Pharma AG ... inhibitor currently in Phase 3 development.  This agreement is conditional ... GlaxoSmithKline PLC (GSK) on April 22, 2014, which are expected ...
(Date:1/22/2015)... 22, 2015 Eckert & Ziegler Vitalea ... (AMS) services to the pharmaceutical and biotech industry, has ... company in the position of Director of Science & ... and valuable experience in drug metabolism and bioanalysis to ...
(Date:1/22/2015)... BOSTON , Jan. 22, 2015  Transwestern | RBJ today ... feet of office space for Shire a leading biopharmaceutical company, ... . Transwestern | RBJ,s Robert Richards , president, and ... the lease for the entire five-floor building at 95 Hayden ...
(Date:1/22/2015)... today announces the firm brokered a long-term lease totaling 202,492 ... company, at Two Ledgemont Center in Lexington, Massachusetts ... and Brian Cohen , senior vice president, represented Shire ... Hayden Ave. Photo - http://photos.prnewswire.com/prnh/20150122/170765 ...
Breaking Biology Technology:Array Announces Agreement To Acquire ENCORAFENIB (LGX818) 2Array Announces Agreement To Acquire ENCORAFENIB (LGX818) 3Array Announces Agreement To Acquire ENCORAFENIB (LGX818) 4Array Announces Agreement To Acquire ENCORAFENIB (LGX818) 5Array Announces Agreement To Acquire ENCORAFENIB (LGX818) 6Array Announces Agreement To Acquire ENCORAFENIB (LGX818) 7Eckert & Ziegler Vitalea Science appoints Mark Seymour, PhD as Director of Science & Technology 2Eckert & Ziegler Vitalea Science appoints Mark Seymour, PhD as Director of Science & Technology 3Transwestern | RBJ Advises Shire in 202,000 SF Lease, Creating Boston's Largest Suburban Biotech Campus 2Transwestern?RBJ Advises Shire in 202,000 SF Lease, Creating Boston's Largest Suburban Biotech Campus 2
... DALLAS, February 1, 2012 The report ... -   Global Trends, Opportunities & Forecasts (2011   - ... and studies the major market drivers, restraints, and opportunities in ... Browse market data tables and in-depth TOC ...
... 2012 New Report Added in ... Global Markets The report provides ... DDS and future opportunities (2011-2021).  Persons with a financial ... to learn how advances in nanotechnology research and development ...
... in Dayton, Ohio, has experimentally confirmed a theory by ... of interesting properties about nanotube growth: That the chirality ... and that armchair nanotubes should grow the fastest. ... the mysteries inherent in what Yakobson calls the "DNA ...
Cached Biology Technology:MarketsandMarkets: Global Biomarkers Market worth $25.79 Billion by 2016 2MarketsandMarkets: Global Biomarkers Market worth $25.79 Billion by 2016 3ResearchMoz: Nanotech Enabled Drug Delivery Therapeutics Market Will be $136 Billion by the Year 2021: Nanotechnology in Drug Delivery: Global Markets 2ResearchMoz: Nanotech Enabled Drug Delivery Therapeutics Market Will be $136 Billion by the Year 2021: Nanotechnology in Drug Delivery: Global Markets 3ResearchMoz: Nanotech Enabled Drug Delivery Therapeutics Market Will be $136 Billion by the Year 2021: Nanotechnology in Drug Delivery: Global Markets 4Rice professor's nanotube theory confirmed 2Rice professor's nanotube theory confirmed 3
(Date:1/22/2015)... S.A. ("Company") (BM&FBOVESPA: VLID3 ON), is pleased to inform its ... of Washington,s Department of Licensing, in the United ... system for driver,s licenses and identification cards to its subsidiary, ... will start in January 2015, with enrollment and card production ...
(Date:1/22/2015)...  A man-made form of insulin delivered by nasal spray ... adults with mild cognitive impairment and Alzheimer,s disease dementia, ... Wake Forest Baptist Medical Center. The study,s ... impairment (MCI) or mild to moderate Alzheimer,s dementia (AD). ...
(Date:1/22/2015)... and Markets ( http://www.researchandmarkets.com/research/wxdglm/global_wearable ) has ... Technologies Market and Applications, Opportunities, Industry Analysis, Segmentation, ... report to their offering. , ... be worn on the user,s body and have ...
Breaking Biology News(10 mins):Valid USA Signs Contract For Washington Driver's License Issuance 2Nasal Spray with Insulin Equivalent Shows Promise as Treatment for Adults with Mild Cognitive Impairment, Alzheimer's Dementia 2Nasal Spray with Insulin Equivalent Shows Promise as Treatment for Adults with Mild Cognitive Impairment, Alzheimer's Dementia 3Global Wearable Technologies Market and Applications, Opportunities, Industry Analysis, Segmentation, Size, Growth, Share, Overview, Trends and Forecast 2014-2020 2
... $15,000 in a national competition for adapting a traditional ... villagers can use to make paper for their children,s ... of a machine to convert farm waste to paper, ... Houston during a ceremony honoring top submissions in the ...
... (11/12/2012) If you,ve eaten fish, gone for a boat ride or ... is a valuable commodity. But just how valuable? That,s always been ... the worth of clean water against societal needs that compromise it, ... Now, however, their ability to do so has been greatly enhanced ...
... have estimated that there are 1.7 million species of ... continue to be discovered. Unfortunately, as new species are ... decrease in biodiversity. The more diversity there is in ... Hence, biodiversity is key to ecosystem resilience. Disease, ...
Cached Biology News:Plan to turn farm waste into paper earns students $15,000 2Study offers new tool for incorporating water impacts into policy decisions 2Persistence or extinction: Through a mathematical lens 2Persistence or extinction: Through a mathematical lens 3