Navigation Links
S*BIO Receives Orphan Drug Designation for JAK2 Inhibitor SB1518 for the Treatment of Myeloproliferative Disorders
Date:5/13/2008

SINGAPORE, May 13 /PRNewswire/ -- S*BIO Pte Ltd today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SB1518, its potent and orally-active JAK2 inhibitor for the treatment of myeloproliferative disorders (MPD). The FDA accepted S*BIO's application upon review of preclinical data which demonstrated excellent anti-proliferative and anti-tumor activity, combined with very good tolerability of the JAK2 inhibitor.

"We are pleased to receive orphan drug designation for SB1518," said Dr. Jan-Anders Karlsson, CEO of S*BIO. "There is a great need for effective treatment of MPD caused by aberrant JAK2 signaling and SB1518 could potentially address this unmet medical need. The designation will allow us to optimize our development and regulatory strategy for SB1518."

MPD is a closely related group of hematological malignancies in which the bone marrow develops and functions abnormally. MPD is characterised by an excess of blood cells and the three main disorders include polycythemia vera (excess red blood cell mass), essential thrombocythemia (excess blood platelets) and myelofibrosis.

Orphan Drug Designation in the United States

Orphan drug is a designation by the FDA indicating a therapy developed to treat diseases that affect fewer than 200,000 persons in the United States. Orphan drug designation for SB1518 will entitle S*BIO to tax credits on clinical research after designation and seven years of marketing exclusivity. Other potential benefits include regulatory fee waivers, grants for clinical research and protocol assistance.

About SB1518

SB1518 is a small molecule JAK2-selective kinase inhibitor which has high potency against both the wild type JAK2 kinase and the JAK2 kinase with the V617F mutation. The V617F mutation is found in high frequencies in certain types of hematological disorders. By targeting the JAK2 activating mutation, SB1518 has the potential to interfere w
'/>"/>

SOURCE S*BIO
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
3. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
4. Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
5. IsoTis Receives FDA Clearance for Accell Family of Products
6. Actavis Receives Approval of Fentanyl Transdermal System in the U.S.
7. AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II
8. IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma
9. XTL Receives Staff Letter From NASDAQ
10. XTL Receives Staff Letter From NASDAQ; XTL may Transfer its ADR Listing to the NASDAQ Capital Market
11. Hemo-Stream(TM) Chronic Dialysis Catheter Receives FDA Clearance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2014)... Engineering at the University of Delaware, is known ... energy engineering, environmental sustainability and electronics. , His ... with a well-defined, crystalline structure. At the atomic ... that zeolites can separate molecules with size differences ... of a nanometer), making them useful to the ...
(Date:7/24/2014)... (PRWEB) July 24, 2014 Your ... advances in modeling lithium-ion battery storage capacity. , ... from a theoretical model created at Lawrence ... that predicts how carbon components will perform ... storage emphasizes the urgent need for higher-performance batteries. ...
(Date:7/24/2014)... 2014 2014 Deep Research Report ... a professional and in-depth research report on Potassium ... basic information, including its definition, classification, application, ... research covers the international market analysis, including China’s ... covering macroeconomic environment & economic situation analysis, the ...
(Date:7/24/2014)... The first part of the session ... in Human Studies” will cover comprehensive clinical support in ... With increasing R&D costs and declining industry success in ... the knowledge collected in early Phase I/IIa study data ... late stage development. , Next, the presenters will examine ...
Breaking Biology Technology:University of Delaware researcher describes new approach for creating organic zeolites 2Getting More Life out of Lithium-ion Batteries 2Potassium Sulphate Market & SHMP Industry 2014 (Global, China) Analysis Now Available at DeepResearchReports.com 2Potassium Sulphate Market & SHMP Industry 2014 (Global, China) Analysis Now Available at DeepResearchReports.com 3Potassium Sulphate Market & SHMP Industry 2014 (Global, China) Analysis Now Available at DeepResearchReports.com 4Best Practices for Optimizing Dose Escalation in First in Human Studies, New Webinar August 6th Hosted by Xtalks 2
... April 4, 2011 Reportlinker.com announces that ... in its catalogue: Antiviral ... http://www.reportlinker.com/p0203535/Antiviral-Therapeutics---Technologies-markets-and-companies.html ... of antiviral approaches including vaccines, pharmaceuticals and ...
... 2011 Reportlinker.com announces that a new market ... Nanobiotechnologies- applications, markets and companies ... Nanotechnology is the creation and utilization of materials, ... on the nanometer-length scale (a nanometer is one ...
... 4, 2011 GeneLink, Inc. (OTCBB: GNLK, "the ... reported financial results for the fiscal year ended December 31, ... Gross margin increased from $4,906,710 in 2009 to $4,997,367 in ... 2010 as compared to $8,561,455 in 2009; Operating losses ...
Cached Biology Technology:Reportlinker Adds Antiviral Therapeutics - Technologies, Markets and Companies 2Reportlinker Adds Antiviral Therapeutics - Technologies, Markets and Companies 3Reportlinker Adds Antiviral Therapeutics - Technologies, Markets and Companies 4Reportlinker Adds Nanobiotechnologies - Applications, Markets and Companies 2Reportlinker Adds Nanobiotechnologies - Applications, Markets and Companies 3GeneLink Reports 2010 Results 2
(Date:7/25/2014)... puberty is influenced by ,imprinted genes,a subset of genes whose ... This is the first evidence that imprinted genes can control ... study were published today in the journal Nature . ... a marker for the timing of puberty in females. ... girls, is an inherited trait, and is linked to breast ...
(Date:7/24/2014)... (July 24, 2014) Scientists at The New ... one step closer to creating a viable cell ... own cells. , For the first time, ... lines from skin samples of patients with primary ... accelerated protocol to induce these stem cells into ...
(Date:7/24/2014)... species for food or commercial food sale, has been ... decline of many species of primates and other mammals. ... half of the species being consumed are birds, particularly ... only the meat made available for sale but the ... hunters and brought to villages for consumption, we noted ...
Breaking Biology News(10 mins):Could age of first period influence development of diseases in older women? 2NYSCF scientists one step closer to cell therapy for multiple sclerosis patients 2
... around the ancient spruce woodlands of eastern North ... could respond to climate change? Matt Fitzpatrick of ... Appalachian Laboratory, along with researchers from the University ... received a three-year, $670,000 award from the National ...
... Uppsala University, Sweden, instil hope of efficient hydrogen production with ... scepticism based on previous research. The study, which is published ... view on the ability of green algae which is ... producing fuel from renewable energy sources to replace the fossil ...
... Monell Center molecular neurobiologist Peihua Jiang, PhD, is ... Investigators in Gustation, an annual award presented by the ... scientist who is a rising leader in the field ... the understanding of the structure and function of taste ...
Cached Biology News:Scientists look to ancient past to better predict how species may respond climate change 2Surprising findings on hydrogen production in green algae 2Peihua Jiang receives Ajinomoto Award for Young Investigators in Gustation from AChemS 2
Goat polyclonal to Dysadherin ( Abpromise for all tested applications). entrezGeneID: 53827...
Ku80 Antibody Shipping Temperature: HOT Storage Temperature: -20C...
This antibody detects an ~25 kDa band, corresponding to the expected molecular mass of Rab3A, on immunoblots. The antibody specificity is confirmed in peptide inhibition immunoblotting studies....
Rabbit polyclonal to Shigella (HRP) ( Abpromise for all tested applications)....
Biology Products: