Navigation Links
Alexion's Soliris(R) Receives 2008 Prix Galien USA Award for Best Biotechnology Product
Date:9/25/2008

odysplastic syndrome (MDS). (5,6,7,8,9) In patients with thrombosis of unknown origin, PNH may be an underlying cause. (3,9)

Prior to approval of Soliris, there were no therapies specifically available for the treatment of PNH. PNH treatment was limited to symptom management through periodic blood transfusions, non-specific immunosuppressive therapy and, infrequently, bone marrow transplantations -- a procedure that carries considerable mortality risk. (3,9)

About Soliris

Soliris was approved in March 2007 by the U.S. Food and Drug Administration (FDA) as the first treatment for PNH, a rare, debilitating and life-threatening blood disorder defined by hemolysis. In June 2007, the European Commission (EC) also approved the use of Soliris for the treatment of patients with PNH. Soliris is the first drug therapy ever approved under Priority Review in the U.S. and through the Accelerated Assessment procedure in Europe.

Important Safety Information

Soliris is generally well tolerated. The most frequent adverse events observed in clinical studies were headache, nasopharyngitis (a runny nose), back pain and nausea. Treatment with Soliris should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established.

The U.S. product label for Soliris also includes a boxed warning: "Soliris increases the risk of meningococcal infections. Vaccinate patients with a meningococcal vaccine at least two weeks prior to receiving the first dose of Soliris; revaccinate according to current medical guidelines for vaccine use. Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary." During clinical studies, two out of 196 vaccinated PNH patients treated with Soliris experienced a serious meningococcal infection.

Prior to beginning Soliris therapy, all patients and their pres
'/>"/>

SOURCE Alexion Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Alexion Acquires All Rights to OMRF Patents Related to Soliris(R)
2. Kuvan Receives Positive Opinion From CHMP for European Approval
3. Corgenix Receives Third U.S. Patent on AtherOx(R) Technology
4. Sustainable Oils Receives Regulatory Approval for Feeding Camelina Meal in Livestock Diets
5. U.S. Genomics Inc. Receives $4.5 Million Investment from BD
6. AdvanDx Receives FDA 510(k) Clearance for Yeast Traffic Light PNA FISH(TM)
7. PLC Systems Receives Delisting Notice From American Stock Exchange
8. Nephros Receives Non-Compliance Notification from AMEX
9. China Biologic Receives SFDA Approval for Clinical Trial of Human Coagulation Factor VIII
10. Barr Receives Approval for Generic Version of Razadyne(R) ER Capsules
11. Intact Medical Corporations Intact(R) Excise XL Receives 510(K) Marketing Clearance from the FDA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... Selexis SA, a serial innovation company with proven ... for drug discovery to commercial manufacturing, announced today all ... Sequencing (NGS) data packages. The NGS analysis of ... the integrity of the gene, validation of the left ...
(Date:1/22/2015)... Calif. , Jan. 22. 2015  Varian Medical Systems (NYSE: ... software, has been honored for its commitment to sustainability with ... companies. Varian is the highest ranked healthcare equipment company among ... today during the World Economic Forum at Davos, ...
(Date:12/24/2014)... Dec. 24, 2014  United Therapeutics Corporation (NASDAQ: ... MDT ) has submitted a pre-market approval application ... the use of Medtronic,s SynchroMed ® II implantable ... use with United Therapeutics, Remodulin ® (treprostinil) Injection ...
(Date:12/24/2014)... December 23, 2014 “Preparative & ... HPLC, Flash), Consumables (Columns, Solvents, Buffers, Valves, Guages, ... & Agriculture) - Forecasts to 2019” provides a ... opportunities, current market trends, and strategies impacting the ...
Breaking Biology Technology:Selexis Generated Research Cell Banks Now Fully Sequenced Using Next-Generation Sequencing 2Varian Honored Among World's 100 Most Sustainable Corporations 2United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 2United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 3United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 4Preparative and Process Chromatography Market is expected to reach $9 billion by 2019 - New Report by Marketsandmarkets 2Preparative and Process Chromatography Market is expected to reach $9 billion by 2019 - New Report by Marketsandmarkets 3Preparative and Process Chromatography Market is expected to reach $9 billion by 2019 - New Report by Marketsandmarkets 4
... a certain through-the-looking-glass feel to them. We've heard a lot ... partners in IT. Often lost in that clamor is the ... you have before you can hope to improve it. Apparently, ... dating with marriage. You also don't want to confuse the ...
... world today are WWWno further explanation is required , ,There ... the alphabet, W, as in WWI or WWII, ... there's the WWF and WWF. The match between the World ... muscles losing to cuddly pandas, and the wrestlers became the ...
... MADISON, Wis. -- What's more important to a manufacturing company: ... Center for Quick Response Manufacturing , ruthlessly cutting down the ... seen as the best way to reduce costs and end ... ,"It's not usually about buying new equipment," Frank Rath, associate ...
Cached Biology Technology:Customers, clients and partners, oh my! 2Customers, clients and partners, oh my! 3The global power of WWW 2The global power of WWW 3University center offers speed boost to manufacturers 2
(Date:1/22/2015)... FindBiometrics, the leading source of biometrics industry news, interviews and ... "When we launched FindBiometrics 12 years ago the ... founder and CEO of FindBiometrics. "Now it,s maturing very quickly. ... players on a very broad scale.  We are known for ...
(Date:1/22/2015)... , Jan. 16, 2015  A man-made form of ... and other mental capabilities in adults with mild cognitive ... study led by researchers at Wake Forest Baptist Medical ... diagnosed with amnesic mild cognitive impairment (MCI) or mild ...
(Date:1/22/2015)... , Europe,s most prestigious innovation ... to present a video retrospective of the most exciting and innovative ... Toumazou and Sophie Wilson   A different ...   Starting on 22 January 2015 on   http://www.epo.org/european-inventor   ...
Breaking Biology News(10 mins):Identity Industry Leading Publication Debuts New Look As Biometrics Hit Mainstream 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 3Ten Years of the European Inventor Award: A Retrospective Look at the Inventors and Ideas That Have Changed Our Lives 2Ten Years of the European Inventor Award: A Retrospective Look at the Inventors and Ideas That Have Changed Our Lives 3
... Calif.- Children,s Hospital & Research Center Oakland is the ... technology that could revolutionize the way blood is analyzed ... similar to that used in some debit or credit ... a child,s blood sample. The procedure starts with ...
... This release is available in <A HREF=",http://chinese.eurekalert.org/zh/emb_releases/2009-04/sfeb-roc042209.php,">Chinese ... Pennsylvania State University College of Medicine, Hershey, ... the Opioid Growth Factor (OGF, [Met5]-enkephalin), a ... nucleocytoplasmic translocation and reliant on the integrity ...
... at Wake Forest University School of Medicine while studying ... genetic predisposition to epilepsy can develop the disorder. ... Journal of Neuroscience , senior researcher Dwayne W. Godwin, ... report discovering that a gene, already known to predispose ...
Cached Biology News:Children's Hospital Oakland is first pediatric hospital to use 'laboratory-on-a-card' technology 2Regulation of cell proliferation by the OGF-OGFr axis is dependent on nuclear localization signals 2Regulation of cell proliferation by the OGF-OGFr axis is dependent on nuclear localization signals 3Researchers discover that gene switches on during development of epilepsy 2Researchers discover that gene switches on during development of epilepsy 3
... low form culture flask is designed for culturing organisms ... flask has a heavy beaded rim to protect against ... O.D. is 38mm and takes a No. 6.5 rubber ... a heat source smaller than the base of the ...
... be difficult to achieve in many bacterial ... or more restriction and modification (R-M) systems ... as "foreign". TypeOne™ Restriction Inhibitor provides a ... bacterial strains with type I R-M systems. ...
... The loxP-cm-loxP cassette ... in prokaryotic cells. The prokaryotic ... chloramphenicol resistance is a slightly modified ... mediates higher transcription efficiency than the ...
Includes a choice of any 3 EasySep mouse selection kits and EasySep magnet...
Biology Products: