Navigation Links
CSL Behring Receives FDA Orphan Drug Designation for rIX-FP, a Novel Therapy in Development to Treat Congenital Factor IX Deficiency (Hemophilia B)
Date:6/8/2012

KING OF PRUSSIA, Pa., June 8, 2012 /PRNewswire/ -- CSL Behring announced today that the company has been granted Orphan Drug Designation by the United States Food and Drug Administration for its novel recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP). The Orphan Drug Designation is granted for the treatment and prophylaxis of bleeding episodes in patients with congenital factor IX deficiency (hemophilia B). The designation includes routine prophylaxis treatment, control and prevention of bleeding episodes, and prevention and control of bleeding in perioperative settings.

CSL Behring is developing this therapy in collaboration with its parent company CSL Limited (ASX: CSL).

"CSL Behring is pleased to have achieved this important regulatory milestone for our recombinant factor IX," said Val Romberg, Senior Vice President, Research and Development at CSL Behring. "It represents yet another advance that our company is making in the area of recombinant factor development and is extremely encouraging."

CSL Behring has engineered rIX-FP to extend the half-life of Factor IX through genetic fusion with recombinant albumin. Albumin has been chosen as the ideal recombinant genetic fusion partner for coagulation factor proteins due to its long physiological half-life. In addition, albumin has been shown to have a good tolerability profile, low potential for immunogenic reactions and a well-known mechanism of clearance compared to some other technologies. The cleavable linker connecting recombinant factor IX and recombinant albumin has been specifically designed to preserve the native function of the coagulation factor in the fusion protein, while benefiting from recombinant albumin's long physiological half-life.'/>"/>

SOURCE CSL Behring
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. CSL Behring Announces FDA Filing of Biologics License Application for 4-Factor PCC for Urgent Reversal of Vitamin K Antagonist Anticoagulant Therapy
2. CSL Behring Initiates Study of Subcutaneous Administration of C1-esterase Inhibitor in Patients with Hereditary Angioedema
3. PharmaNet/i3 Receives Distinguished Partner Award from the US Chinese Anti-Cancer Association
4. ViewRay Receives FDA 510(k) Clearance for MRI-Guided Radiation Therapy System
5. Breathe Technologies Non-Invasive Open Ventilation (NIOV™) System Receives Medical Design Award
6. The Largest Private Funder Of Melanoma Research Receives Vital Support From Activist Jeffrey Epstein
7. HeartWare International Receives CE Mark Addendum, Expanding Label to Include All Patients at Risk of Death From Refractory, End-Stage Heart Failure
8. Minacs Receives New URAC Pharmacy Benefit Management Accreditations
9. TriReme Medical, Inc. Receives FDA Approval for Glider™ PTCA Catheter
10. Perrigo Receives FDA Approval for Butoconazole Nitrate 2% Vaginal Cream
11. InfuSystem Holdings, Inc. Receives Letter From NYSE MKT Regarding Timely Notice Of Record Date For 2012 Annual Meeting Of Stockholders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/29/2015)... , June 29, 2015 Regeneron Pharmaceuticals, ... the Proceedings of the National Academy of ... that the Company,s proprietary VelociGene ® and ... and preclinical validation of potential candidates that could ... Middle East Respiratory Syndrome (MERS). This involved the ...
(Date:6/29/2015)... Henry Schein , Inc. (NASDAQ: ... care products and services to office-based dental, animal ... has been selected as the Corporation of the ... (AHHE), a national voluntary tax-exempt organization that fosters ... Hispanic health care executives. The Company ...
(Date:6/29/2015)... 29, 2015  Sorrento Therapeutics, Inc. (NASDAQ: SRNE ... to the Russell 2000® Small Cap, Russell 3000®, and ... at the close of trading on June 26, 2015 ... of U.S. and global indexes. Sorrento is already a ... About the Russell Indexes. Russell indexes ...
Breaking Medicine Technology:Regeneron Rapid Response Platform for Emerging Infectious Diseases Described in Proceedings of the National Academy of Sciences Publication 2Regeneron Rapid Response Platform for Emerging Infectious Diseases Described in Proceedings of the National Academy of Sciences Publication 3Regeneron Rapid Response Platform for Emerging Infectious Diseases Described in Proceedings of the National Academy of Sciences Publication 4Regeneron Rapid Response Platform for Emerging Infectious Diseases Described in Proceedings of the National Academy of Sciences Publication 5Henry Schein Selected As Corporation of the Year By The Association of Hispanic Healthcare Executives 2Henry Schein Selected As Corporation of the Year By The Association of Hispanic Healthcare Executives 3Henry Schein Selected As Corporation of the Year By The Association of Hispanic Healthcare Executives 4Henry Schein Selected As Corporation of the Year By The Association of Hispanic Healthcare Executives 5Henry Schein Selected As Corporation of the Year By The Association of Hispanic Healthcare Executives 6Sorrento Added to Russell 2000 Small Cap, Russell 3000 and Global Indexes 2Sorrento Added to Russell 2000 Small Cap, Russell 3000 and Global Indexes 3
... China, May 26, 2011 /PRNewswire-Asia/ -- Winner Medical Group ... "the Company"), a leading manufacturer of medical dressings, medical ... products in China, today announced the resignation of one ... personal reasons. Winner Medical,s Board of Directors voted to ...
... 26, 2011 Reportlinker.com announces that a ... its catalogue: Specialty Pharmaceutical ... http://www.reportlinker.com/p0512130/Specialty-Pharmaceutical-Industry---2011-Yearbook.html?utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology Specialty Pharmaceutical ... Summary GBI Research,s "Specialty ...
Cached Medicine Technology:Winner Medical Appoints New Independent Director 2Winner Medical Appoints New Independent Director 3Winner Medical Appoints New Independent Director 4Reportlinker Adds Specialty Pharmaceutical Industry - 2011 Yearbook 2Reportlinker Adds Specialty Pharmaceutical Industry - 2011 Yearbook 3Reportlinker Adds Specialty Pharmaceutical Industry - 2011 Yearbook 4Reportlinker Adds Specialty Pharmaceutical Industry - 2011 Yearbook 5Reportlinker Adds Specialty Pharmaceutical Industry - 2011 Yearbook 6Reportlinker Adds Specialty Pharmaceutical Industry - 2011 Yearbook 7Reportlinker Adds Specialty Pharmaceutical Industry - 2011 Yearbook 8Reportlinker Adds Specialty Pharmaceutical Industry - 2011 Yearbook 9Reportlinker Adds Specialty Pharmaceutical Industry - 2011 Yearbook 10Reportlinker Adds Specialty Pharmaceutical Industry - 2011 Yearbook 11Reportlinker Adds Specialty Pharmaceutical Industry - 2011 Yearbook 12Reportlinker Adds Specialty Pharmaceutical Industry - 2011 Yearbook 13Reportlinker Adds Specialty Pharmaceutical Industry - 2011 Yearbook 14Reportlinker Adds Specialty Pharmaceutical Industry - 2011 Yearbook 15Reportlinker Adds Specialty Pharmaceutical Industry - 2011 Yearbook 16
(Date:6/29/2015)... ... June 29, 2015 , ... ... within the weekend edition of USA TODAY. This 12-page, glossy, full-color special section ... Today in highly targeted markets totaling approximately 450,000 copies, with an estimated readership ...
(Date:6/29/2015)... ... June 29, 2015 , ... ... “Lake Balboa Care Center”, showcasing its prestigious five-star, premium rating from Medicare. Medicare’s ... Lake Balboa views this rating as indicative of its commitment to providing patients ...
(Date:6/29/2015)... ... June 29, 2015 , ... A state-of-the-art implant designed ... Medical Center. The device is the first of its kind approved by the ... pressure (CPAP), the current standard of care for OSA. , Some 18 million ...
(Date:6/29/2015)... ... June 29, 2015 , ... World Patent Marketing, ... Diaper, a baby invention that makes parenthood less tiring without sacrificing your child's ... market value of USD 52.2 billion in 2017," says Scott Cooper, CEO and ...
(Date:6/29/2015)... ... 29, 2015 , ... National HealthCare Associates recently released a ... the 40-center nursing home group. Sixteen of their centers were rated “Best in ... in one or more customer service areas. Those centers received the prestigious “Customer ...
Breaking Medicine News(10 mins):Health News:Mediaplanet partners with USA TODAY and Kris Letang to raise awareness about the risk of heart attack and stroke 2Health News:Lake Balboa Releases New Facility Video of Patient Testimonials 2Health News:NewYork-Presbyterian/Weill Cornell Medical Center Is First in New York to Offer New Alternative Treatment for Sleep Apnea 2Health News:NewYork-Presbyterian/Weill Cornell Medical Center Is First in New York to Offer New Alternative Treatment for Sleep Apnea 3Health News:NewYork-Presbyterian/Weill Cornell Medical Center Is First in New York to Offer New Alternative Treatment for Sleep Apnea 4Health News:Bringing Up Baby...Millenials Should Check World Patent Marketing's New Baby Invention 2Health News:Bringing Up Baby...Millenials Should Check World Patent Marketing's New Baby Invention 3Health News:Bringing Up Baby...Millenials Should Check World Patent Marketing's New Baby Invention 4Health News:Bringing Up Baby...Millenials Should Check World Patent Marketing's New Baby Invention 5Health News:National HealthCare Centers Receive 'Customer Experience Awards' 2Health News:National HealthCare Centers Receive 'Customer Experience Awards' 3Health News:National HealthCare Centers Receive 'Customer Experience Awards' 4
... by pain, swelling, loose teeth and exposed bone , , ... people taking widely prescribed oral osteoporosis drugs who develop ... previously thought, a new study suggests. , Previous ... of the jaw (ONJ) from bisphosphonates in pill form ...
... scientists has discovered a new syndrome associated with severe ... lack sufficient infection-fighting white cells, and identified the genetic ... catalytic subunit 3 (G6PC3). The findings, which are published ... New England Journal of Medicine , were made by ...
... Of Southern California, School Of Dentistry release results of ... necrosis. The study is among the first to acknowledge ... may leave the jaw vulnerable to devastating necrosis, according ... Journal of the American Dental Association ( JADA ...
... in study participants , , WEDNESDAY, Dec. 31 (HealthDay News) ... its anti-inflammatory and pain-relieving properties, may be something humans ... , Salicylic acid (SA) previously had been found in ... recently -- especially vegetarians. This made sense because ...
... Minn. A new study shows that people who are smokers ... significantly more likely to suffer a stroke from a brain aneurysm ... issue of Neurology , the medical journal of the American ... print issue of Neurology . , The type of stroke, ...
... Priority in 2009SPRINGFIELD, Ill., Dec. 31 The following is ... Illinois:The economic situation is forcing more Illinois families to face ... of people are cutting back on necessities in order to ... it,s too expensive. High health care costs are leaving ...
Cached Medicine News:Health News:Study Links Osteoporosis Drugs to Jaw Trouble 2Health News:Study Links Osteoporosis Drugs to Jaw Trouble 3Health News:Scientists identify new congenital neutropenia syndrome and causative gene mutation 2Health News:Scientists identify new congenital neutropenia syndrome and causative gene mutation 3Health News:USC dentist links Fosomax-type drugs to jaw necrosis 2Health News:Smokers with stroke in the family 6 times more likely to have stroke too 2
... calibration mass for convenient Touch-key ... Fully Automatic Self-Calibration at designated ... are detected, or touch-key calibration ... Interface, Shimadzu WindowsDirect communication function. ...
60 month warranty; Internal Calibration Mass System Diagnostic to alert operator of abnormal weighing conditions; built-in motorized calibration weight enabling automatic self calibration....
Do More with your Workforce. Technology That Makes Walkaway Automation a Reality. Engineered for Accurate Results. Multiple Levels of Control Reduce Contamination. Flexible Sample Preparation Platfor...
... The 3100 system offers continuous, unattended ... injection, separation and detection, and data ... autosampler and importing sample information, the ... "Start Run command. The instrument requires ...
Medicine Products: