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:6/3/2015)... 2015  inVentiv Health, a global provider ... services, today announced the appointment of Michael ... Clinical Division and Executive Vice President, inVentiv ... within the CRO industry and has a ... the development of innovative industry strategies. ...
(Date:6/3/2015)... -- Findings presented at the European Organization ... of NeuroOncology (EANO) and European Society for Medical Oncology ... that EDO-S101 is effective in models of human glioblastoma ... radiotherapy (RT). [ 1 ] ... that combines the DNA damaging effect of bendamustine with ...
(Date:6/3/2015)... Wayne, NJ (PRWEB) June 03, 2015 ... and come in preconfigured heights and depths often taking ... – SP Scienceware® Modular Ultra Low 5 Box Freezer ... be easily integrated with existing freezer storage boxes and ... freezers storing samples for multiple experiments or multiple people ...
(Date:6/3/2015)... (PRWEB) June 03, 2015 Innovative biomass ... has announced its platinum sponsorship of the first annual ... at the Royal Sonesta Hotel in New Orleans, June ... industry in an effort to further the advancements of ... programs and policies, overall logistics, yield improvement and more. ...
Breaking Biology Technology:inVentiv Health Names Dr. Michael McKelvey President, Clinical Division And Executive Vice President, inVentiv Health 2inVentiv Health Names Dr. Michael McKelvey President, Clinical Division And Executive Vice President, inVentiv Health 3inVentiv Health Names Dr. Michael McKelvey President, Clinical Division And Executive Vice President, inVentiv Health 4inVentiv Health Names Dr. Michael McKelvey President, Clinical Division And Executive Vice President, inVentiv Health 5Mundipharma EDO GmbH Data Confirm EDO-S101 is Effective in Preclinical Models of Human Glioblastoma 2Mundipharma EDO GmbH Data Confirm EDO-S101 is Effective in Preclinical Models of Human Glioblastoma 3Mundipharma EDO GmbH Data Confirm EDO-S101 is Effective in Preclinical Models of Human Glioblastoma 4Freezer Space Can Now Be Configured Your Way with New Modular Freezer Racks 2Genera to Sponsor Advanced Bioeconomy Feedstocks Conference 2015 2Genera to Sponsor Advanced Bioeconomy Feedstocks Conference 2015 3
... taskforce of forest industry,stakeholders from Eastern Canada ... bio-related opportunities within the forestry sector across ... is comprised of regional government,industry, federal and ... has come together to better understand what,opportunities ...
... the Ferring Research,Infertility and Gynaecology GrAnt (FRIGGA) are ... & Embryology Congress. The two,winners of this new ... and the Universitair Ziekenhuis (UZ) Brussel, Centre for,Reproductive ... for their outstanding,proposals for fundamental research to help ...
... 7 Neurobiological,Technologies, Inc. (NTI(R)) (Nasdaq: NTII ), ... officer (CEO), has announced his,intent to retire on December ... serve on the Board. Mr. Freiman is the former ... Mr. Freiman is retiring after 11 years of ...
Cached Biology Technology:Atlantica BioEnergy Task Force Unveiled 2Ferring Research Infertility and Gynaecology GrAnt (FRIGGA) 2008 Winners Announced 2Ferring Research Infertility and Gynaecology GrAnt (FRIGGA) 2008 Winners Announced 3Neurobiological Technologies' CEO to Retire on December 31, 2008 2
(Date:4/14/2015)... , April 14, 2015  HYPR Corp. ... Online (FIDO ® ) Alliance tm , an ... FIDO members commit to share technology and collaborate ... that are interoperable, more secure and private, and ... biometric identity verification that protects sensitive user information ...
(Date:4/13/2015)... , April 13, 2015 ... TechSci Research, "Global Biometrics Market Forecast & Opportunities, 2020", ... a CAGR of around 14% till 2020. The ... for large scale implementation and review of biometric ... launch of new products with greater efficiency, are ...
(Date:4/10/2015)... Research and Markets ( http://www.researchandmarkets.com/research/cjk4gb/security ... Competitive Profiles - NEC" report to their offering. ... will continue to supply a range of IT security ... company focus on the development of a Big Data ... in the Asia-Pacific region is ...
Breaking Biology News(10 mins):HYPR Corp. Joins the FIDO Alliance 2HYPR Corp. Joins the FIDO Alliance 3Global Biometrics Market to Cross US$ 21 Billion by 2020: TechSci Research 2NEC Security Competitive Profile 2015 2
... for alternative ,medicines, and luxury goods in Asian markets, ... being invested in enforcement, while events such as China,s ... problem. However, research in Conservation Letters ... the ,War on Drugs, as they lack a long-term ...
... of Visualized Experiments , published a modern approach to ... intriguing research questions facing scientists todaythe origin of life ... is comprised of a modern and simplified approach to ... Harold Urey in 1953. Their research evaluated the possibility ...
... air pollution blowing across the Pacific Ocean is often caused ... and Europe, according to findings by UC Irvine and other ... Academy of Sciences . The study is the first ... is from the production in China of cellphones, televisions and ...
Cached Biology News:A 21st century adaptation of the Miller-Urey origin of life experiments 2Made in China for us: Air pollution tied to exports 2
Request Info...
384 Cluster Tube Racks...
Request Info...
Unique enzyme blend containing Taq and Pwo DNA Polymerase and another thermostable enzyme. The Expand 20 kbPLUS PCR System also includes an optimized reaction buffer, MgCl2 solution, and a human cont...
Biology Products: