Navigation Links
CSL Behring Announces FDA Approval of Berinert(R), First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.
Date:10/12/2009

ormal levels of C1-INH. There are estimates of 6,000 to 10,000 or more people with HAE in the U.S.

"For individuals with HAE, episodes of swelling can be extremely painful and frightening, " said Timothy Craig, MD, professor of medicine and pediatrics, Pennsylvania State University Hershey Medical Center. "With the approval of Berinert, healthcare professionals can now provide HAE patients in the U.S. with a safe and effective treatment option that rapidly relieves the symptoms of acute attacks in the face and abdomen."

"Today's approval provides adult and adolescent HAE patients and their physicians with a proven, safe, and effective therapy for treating debilitating, painful, and life-threatening facial and abdominal HAE attacks once they have begun," said Anthony J. Castaldo, President of the United States Hereditary Angioedema Association, a nonprofit patient advocacy organization that represents approximately 6,500 HAE patients in the United States.

About I.M.P.A.C.T.

I.M.P.A.C.T. was a study of 124 HAE patients with acute, moderate, or severe abdominal or facial attacks. C1-INH concentrate was administered at two different doses and compared with placebo. The main study endpoints were time to onset of symptom relief from HAE attacks, proportion of subjects with worsening clinical HAE symptoms, and safety.

The I.M.P.A.C.T. study found that C1-inhibitor concentrate (C1-INH) is effective and safe in rapidly treating acute abdominal and facial skin swellings in adults and adolescents with HAE. The study found that the median time to symptom relief was 30 minutes after receiving C1-INH compared with 1.5 hours with a placebo.

About Berinert®

Berinert, a plasma-derived intravenous therapy, treats the fundamental cause of acute facial and abdominal hereditary angioedema (HAE) symptoms by providing C1-INH deficient adult and adolescent patients with the missing human prote
'/>"/>

SOURCE CSL Behring
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
2. Over $10 Million of CSL Behrings Privigen Was Sold in the U.S. During the Third Quarter of 2008
3. CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
4. CSL Behring Study in Animal Models Shows Feasibility of Developing a Half-Life Extended Recombinant FVIIa that Retains Biologic Activity
5. CSL Behring Reaches Primary Endpoint in Clinical Study of C1-INH for Treatment of Hereditary Angioedema
6. Child Neurology Foundation Announces the Launch of Infantilespasmsinfo.org
7. Elbit Imaging Ltd. Announces Sale of Plaza Centers Shares
8. Onyx Pharmaceuticals Announces Investor Teleconference and Webcast
9. Kensey Nash Corporation Announces Its First Quarter Fiscal Year 2010 Earnings Release Date and Teleconference
10. ADVENTRX Pharmaceuticals Announces Closing of Financing
11. Stereotaxis Announces Pricing of $26 Million Common Stock Offering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... 2014 LifeScienceIndustryResearch.com adds ... Syringe Industry of 178 pages providing 10 ... library. The 2014 Market Research ... a professional and deep research report on ... the report introduces Disposable Syringe basic information ...
(Date:12/24/2014)... , Dec. 23, 2014 Tianyin ... company that specializes in patented biopharmaceutical, modernized traditional ... ingredients (API) today announced that the Company achieved ... Good Manufacturing Practice (GMP) certificate of TPI,s Qionglai ... Administration,s (CFDA). The public notice period is a ...
(Date:12/22/2014)... Dec. 22, 2014 NxStage Medical, Inc. (NASDAQ: ... innovative dialysis products, announced today that the U.S. ... System One™ to perform hemodialysis overnight while the ... nocturnal hemodialysis. NxStage,s® System One is the first ... for this indication. Home nocturnal ...
Breaking Medicine Technology:World Disposable Syringe Market 2014 Report: China and Regional Analysis 2World Disposable Syringe Market 2014 Report: China and Regional Analysis 3World Disposable Syringe Market 2014 Report: China and Regional Analysis 4World Disposable Syringe Market 2014 Report: China and Regional Analysis 5TPI QLF Achieved Public Notice Status of GMP Certification 2TPI QLF Achieved Public Notice Status of GMP Certification 3NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 2NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 3
... 23, 2011 TRX, Inc. ( www.trx.com ) ... process automation, consulting and data services, announced continued ... several leading companies in the pharmaceutical, technology, financial ... to manage their travel and procurement reporting needs. ...
... Relievant Medsystems, Inc. , today announced the ... and chief executive officer and as a member of ... FDA approval of an Investigational Device Exemption (IDE) to ... of RF Ablation for the Treatment of Vertebrogenic Back ...
Cached Medicine Technology:TRX's Data Intelligence Solution, TRAVELTRAX, Helps Fortune 500 Corporations Gain New Insights Into Cost Savings 2Relievant Medsystems Appoints Alex M. DiNello as President and Chief Executive Officer 2
(Date:12/26/2014)... 2014 Cooking and warming equipment ... of 5. This score reflects slightly positive negotiation conditions ... specialization, low switching costs and a low level of ... low availability of substitutes for cooking and warming equipment ... and aluminum, key inputs in the production process of ...
(Date:12/26/2014)... The Biofeedback Federation of Europe annual ... in Rome, Italy and is hosted by the Salesian ... on a wide variety of topics such as ADHD, ... training in athletes. The scientific program will feature the ... monitoring allows clients to see what is going on ...
(Date:12/26/2014)... 2014 “Many people become overwhelmed by ... claim issues and phone calls with insurance companies,” The ... featuring their free eBook on pedestrian and bicycle ... pedestrian and bicycle auto accident claims assures the injured ... of professionally handling their case while they focus on ...
(Date:12/26/2014)... December 26, 2014 Pentec Health, Inc. ... the state of Pennsylvania for 2014. The awards program, ... programs of its kind in the country. The program ... Pennsylvania Department of Community and Economic Development, the Pennsylvania ... and the Central Penn Business Journal. , ...
(Date:12/26/2014)... 2014 Parker & Sons, Inc. ... in heating, cooling and plumbing contractor services throughout ... services in 2014 with regard to air-conditioning systems. ... is known for its incredibly hot summers. Working ... intricacies and details of a wide variety of ...
Breaking Medicine News(10 mins):Health News:Cooking & Warming Equipment Procurement Category Market Research Report from IBISWorld has Been Updated 2Health News:Cooking & Warming Equipment Procurement Category Market Research Report from IBISWorld has Been Updated 3Health News:Final Workshop Line-up Announced for 18th Annual Biofeedback Conference in Rome, Italy 2Health News:Guide to Handling Pedestrian and Bicycle Accidents Released By The Jones Firm, Featured in Recent Article 2Health News:Pentec Health Ranks Fourteenth on The Best Places to Work in PA for 2014 2Health News:Pentec Health Ranks Fourteenth on The Best Places to Work in PA for 2014 3Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 2Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 3
... IRVING, Texas, Nov. 20 RBC Life Sciences, Inc. ... care and pain management products, reported today company-wide net sales of ... net sales of $9.93 million for the same quarter last year. ... $0.01 per share, during the third quarter of 2009, compared to ...
... 20 An emerging body of ... infectious disease transmission patterns. As noted today in a ... of Tropical Medicine and Hygiene (ASTMH), such changes are expected ... "There is concrete evidence that the global climate is changing, ...
... ... ... 20, 2009 -- Late yesterday, democratic leaders in the Senate unveiled their proposal for overhauling ... Democrats argue that the tax, which was a surprise addition to the sweeping 2,074-page bill, ...
... Grant provides hot food to 150 children under 5 for six months ... (TPRF) has given a grant of US $15,000 to provide food for ... victims of recent typhoons in the Rizal province in the Philippines. , ... (PNRC) for a sustainable hot meal program. The delivery of ...
... Honor Recognizes Courageous and Innovative Approaches to Human Rights ... at its annual awards dinner, the Robert F. Kennedy Center ... with the organization,s 2009 Ripple of Hope Award. The ... on humanitarian issues. , (Logo: http://www.newscom.com/cgi-bin/prnh/20091119/DC149610 ) ...
... High irradiances of low-level laser therapy (LLLT) should not be ... BMC Cancer studied the pain relieving, anti-inflammatory ,cold ... mouse model of skin cancer. Jan M. Bjordal from ... researchers to carry out the in vitro and in vivo ...
Cached Medicine News:Health News:RBC Life Sciences Announces Third Quarter 2009 Results 2Health News:RBC Life Sciences Announces Third Quarter 2009 Results 3Health News:RBC Life Sciences Announces Third Quarter 2009 Results 4Health News:RBC Life Sciences Announces Third Quarter 2009 Results 5Health News:Experts Examine Possible Links Between Climate Change and Infectious Disease Transmission 2Health News:Experts Examine Possible Links Between Climate Change and Infectious Disease Transmission 3Health News:Plastic Surgeons Respond To Proposed Cosmetic Surgery Tax 2Health News:Plastic Surgeons Respond To Proposed Cosmetic Surgery Tax 3Health News:The Prem Rawat Foundation Gives Food Aid to Typhoon Victims in Philippines 2Health News:Bono and Wyclef Jean Receive RFK Center for Justice & Human Rights' Ripple of Hope Award 2Health News:Bono and Wyclef Jean Receive RFK Center for Justice & Human Rights' Ripple of Hope Award 3
... Oxoid Pylori Test is a ... the qualitative detection of Helicobacter ... as an aid in the ... pylori. The product is intended ...
... capillary electrophoresis system is designed to ... The CAPILLARYS 2 utilizes liquid flow ... diagnostic setting. Through continuous sample feed ... narrow capillary tubes functioning concurrently, a ...
Inquire...
These Iron Control Slides make an excellent addition to your laboratory. Packed ten (10) control slides per box. Use SDL's Snap n' Stain for Iron Staining Kit alongside to save time an money mixing r...
Medicine Products: