Navigation Links
EUSA Pharma Submits ERWINASE(R) Biologics License Application (BLA) for Treatment of Acute Lymphoblastic Leukemia
Date:11/9/2010

ecialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ERWINASE(R) (L-asparaginase derived from Erwinia chrysanthemi) for use in the treatment of acute lymphoblastic leukemia in patients with hypersensitivity to E. coli-derived asparaginase. ERWINASE is currently approved in a number of countries, including Canada, the UK and several European Union member states, and is supplied in the United States under a treatment IND.

EUSA Pharma submitted its ERWINASE BLA on a rolling basis, following receipt of Fast Track designation from the FDA. The completed BLA submission requests Priority Review status, which can reduce the regulatory assessment period to six months for major treatment advances. Additionally, the FDA has awarded ERWINASE orphan drug designation, which provides a seven-year period of market exclusivity upon approval.

Dr Tim Corn, EUSA Pharma's Chief Medical Officer, commented, "The submission of our ERWINASE BLA is a major step towards our goal of making this important therapy available as rapidly as possible. Many children with acute lymphoblastic leukemia develop allergy to current asparaginase products, and ERWINASE provides a key therapeutic alternative for this gravely ill group in several countries around the world. By applying for Priority Review status, we hope to shorten the period before EUSA can launch ERWINASE in the U.S., and reduce the time before physicians can provide this potentially life-saving drug to those who may benefit from it."

"Completing the BLA filing for ERWINASE marks a major strategic milestone for EUSA," said Bryan Morton, EUSA Pharma's President and Chief Executive Officer. "Based on new study results and existing clinical experience, we believe ERWINASE has the potential to enhance the treatment of acute lymphoblastic leukemia signific
'/>"/>

SOURCE EUSA Pharma
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Arena Pharmaceuticals Announces Third Quarter 2010 Financial Results and Reviews Recent Developments
2. Anadys Pharmaceuticals Reports Third Quarter 2010 Financial Results and Highlights
3. How IT Helps Solve Pharmas R&D Problems: in silico Drug Discovery
4. UK Pharmaceutical Market Overview - Pricing and reimbursement challenges dampen future growth
5. Opportunities in Emerging Pharma Markets: Strategies for Optimizing Growth in Key Regions and Therapeutic Areas
6. Tianyin Pharmaceutical Co., Inc. to Host First Quarter of Fiscal Year 2011 Earnings Conference Call on Thursday, November 11, 2010 at 9:00 a.m. ET
7. ShangPharma Announces Appointment of Benson Tsang as a Member of the Board of Directors and Audit Committee
8. NovaSperse(SM) Nanoparticle Innovator, PharmaNova, Inc., Awarded Four Government Grants Toward Development of New Therapeutic Products Under Congressional Qualifying Therapeutic Discovery Project Initiative
9. WuXi PharmaTech Awarded GLP Certificate from SFDA for Suzhou Toxicology Facility
10. EnVivo Pharmaceuticals Research Shows EVP-6124 Acts as Acetylcholine Co-Agonist
11. Cadence Pharmaceuticals Reports Third Quarter 2010 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/17/2014)... , The new ... of information concerning the biopharmaceutical Group,s national and international clinical ... to the recently launched institutional website that is receiving accolades ... by a new chapter in the fascinating story of Drug ... and panoramic hub on the world of clinical research, ranging ...
(Date:12/17/2014)... Mass. , Dec. 17, 2014  RXi ... biotechnology company focused on discovering, developing and commercializing ... RNA-targeted technologies, today announced completion of enrollment in its ... from the 3-month observations confirmed the 1-month findings ... Logo - http://photos.prnewswire.com/prnh/20130917/NE80755LOGO ...
(Date:12/15/2014)... , December 15, 2014 ... Am 19. und 20. Februar sind alle ... SAFE MEDICINE ECOSYSTEM PARTNER PROGRAMM ™ 2015 ... besuchen. Diese Tagung soll dazu ... Möglichkeit geben, die neue profitablen Unternehmensdienstleistungen, die ...
Breaking Medicine Technology:Dompé Offers a New "Window" on the World of Scientific Research, with the http://www.dompetrials.com Website, Dedicated to Clinical Trials 2Dompé Offers a New "Window" on the World of Scientific Research, with the http://www.dompetrials.com Website, Dedicated to Clinical Trials 3RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 2RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 3RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 4RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 5Symposium über Aegates Ecosystem-Partner-Programm für sichere Medikamente vom 19. - 20. Februar 2015 in Amsterdam 2
(Date:12/20/2014)... 20, 2014 Parker & Sons, Inc. ... years of experience in contractor services announces reaching a ... for the homeowners of Arizona. Parker and Sons is ... contractor technicians that make customer service the number one ... Arizona and started with one service vehicle and has ...
(Date:12/19/2014)... (PRWEB) December 19, 2014 Sub Zero Ice ... sponsor a blood drive Sunday the 28th from 2pm-6pm at ... & Sawyer Road in Sarasota, FL. , Inquiries regarding time ... you for participating in the donating process, Sub Zero Ice ... flash frozen, custom ice cream. , About Sub Zero Ice ...
(Date:12/19/2014)... 2014 Eufaula, Oklahoma, located just 9 ... the state’s largest lake with more than 600 miles ... to a little more than 3,000 residents, hosted its ... the 6th of December. , Featuring Santa, Christmas lights ... Eufaula on Main Street. Narconon Arrowhead’s parade float ...
(Date:12/19/2014)... warns parents that buying an older car for their teens may ... drivers killed in the United States between 2008 and 2012 were ... lacked important safety features that are available on newer cars, the ... were in cars at least six years old, 34 percent were ... cars 11 to 15 years old, and 17 percent were in ...
(Date:12/19/2014)... 2014 (HealthDay News) -- Dense bunches of bacteria called biofilms ... new study finds. The researchers said these biofilms ... The presence of these biofilms may represent an increased ... to predict a person,s risk for the disease, the researchers ... these biofilms may coat the mucus layer of cells lining ...
Breaking Medicine News(10 mins):Health News:Parker & Sons Announces Reaching A Milestone By Providing 40 Years Of Dedicated Contractor Services For Homeowners Of Arizona 2Health News:Parker & Sons Announces Reaching A Milestone By Providing 40 Years Of Dedicated Contractor Services For Homeowners Of Arizona 3Health News:Shark Tank’s Sub Zero Ice Cream Sponsors Blood Drive 2Health News:Narconon Arrowhead Debuts Float at Checotah and Eufaula Christmas Parades 2Health News:Narconon Arrowhead Debuts Float at Checotah and Eufaula Christmas Parades 3Health News:Older Cars a Bad Choice for Younger Drivers 2Health News:Could Bacteria Play a Role in Colon Cancer? 2
... A majority of Floridians (87%) believe it is important for ... research, according to a new state poll commissioned by Research!America. ... scientific research is important for Florida,s economy in terms of ... believe the state should lead in science and technology education ...
... Are children suffering needlessly after surgery? UC Irvine ... An operation can be one of the most traumatic ... many of them experience unnecessary postsurgical pain lasting weeks ... and treated in adults but has been generally overlooked ...
... have determined that master transcription factors determine the genes ... pathways are targeted to genes that are most relevant ... control cell state, growth, differentiation, and death. ... cell receives instructions from its neighbors and the environment ...
... of the things that makes inhalational anthrax so worrisome for ... inhaled anthrax spores can turn into a lethal infection. By ... something worse than the flu and seeks treatment, it,s often ... help against the spreading bacteria and the potent toxins they ...
... and early adulthood takes its toll on the body, and ... and women, irrespective of how tough things have been in ... University in Sweden and colleagues, experience of social and material ... to a rise in disease risk factors in middle age, ...
... -- The mere presence of a predator causes enough stress ... get at its prey to eat it, say biologists at ... fear of being eaten is an important topic in ecology, ... affect predator and prey interactions," says Professor Locke Rowe, chair ...
Cached Medicine News:Health News:Florida poll: Research important for state economy, jobs 2Health News:Florida poll: Research important for state economy, jobs 3Health News:How major signaling pathways are wired to our genome gives new insight into disease processes 2Health News:How major signaling pathways are wired to our genome gives new insight into disease processes 3Health News:Natural killer cells could be key to anthrax defense 2Health News:Hard times during adolescence point to health problems later in life 2Health News:Insects are scared to death of fish 2
Fracture walker designed to provide maximum comfort, protection and stability...
CAM Walker Fix the ankle or prescribe a range-of-motion. Features adjustable, double-action joints, fixed or up to 45 ROM. Lock-in dorsiflexion or plantar flexion....
... is a cost-effective walking brace that provides ... a lightweight, durable, semi-rigid shell that supports ... rocker sole helps reduce plantar pressures. Housed ... compression and support at the malleoli. Each ...
The UltraLite Post Op Brace provides a fixed or range of motion control. The UltraLite Post Op Brace indications include: , Post knee trauma , Peri-operative use , Conservative management of isolated...
Medicine Products: