Global

News Release Archive

This section features CSL Behring news releases that are more than 18 months old. Click the tabs to select releases in your area of interest. Click Resources to find additional background material on CSL Behring.

All Releases
Corporate
Immunology
Bleeding Disorders
Hereditary Angioedema (HAE)
Pulmonary
Fluid Management
Resources

All Releases

28 September 2015 New Clinical Data on Treatment to Slow the Progression of Emphysema in Patients with Alpha-1 Antitrypsin Deficiency Presented at European Respiratory Society International Congress in Amsterdam

CSL Behring today hosted a symposium highlighting an option to slow the progression of emphysema in adults with documented severe alpha-1 antitrypsin deficiency (AATD), during the European Respiratory Society (ERS) International Congress, which is being held from 26-30 September in Amsterdam, Netherlands. AATD is a hereditary condition marked by a lack of the alpha-1 antitrypsin protein, whose main function is to protect the lungs from inflammation.

> Read More
08 September 2015 Centers for Medicare and Medicaid Services Extends New Technology Add-On Payment for CSL Behring’s Kcentra® for Third Year

CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) again extended the new technology add-on payment (NTAP) for Kcentra® (Prothrombin Complex Concentrate [Human]). The NTAP for Kcentra is available through September 2016 for eligible Medicare beneficiaries treated in the inpatient hospital setting. Kcentra is the first and only non-activated 4-factor prothrombin complex concentrate (4F-PCC) approved by the U.S. Food and Drug Administration (FDA) for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or in need of an urgent surgery or invasive procedure. Kcentra, first approved for use in the U.S. in April 2013, received its NTAP designation effective October 1, 2013.

> Read More
25 August 2015 CSL Behring Receives Marketing Authorization for Respreeza® in Europe

CSL Behring announced today that the European Commission (EC) has granted marketing authorization in all European Union (EU) member states for Respreeza® to treat patients with Alpha-1 antitrypsin deficiency (AATD). Respreeza®, a highly purified Alpha-1 protein derived from human plasma, is the only Alpha-1 proteinase inhibitor that has been proven in a prospective double blind, placebo controlled trial (the RAPID study) to significantly reduce the loss of lung tissue, slowing the progression of emphysema due to AATD. AATD is a hereditary condition marked by a lack of the Alpha-1 antitrypsin protein, whose main function is to protect the lungs from inflammation.

> Read More
25 August 2015 CSL Behring Enrolls First Patient in Global Phase II/III Study of rVIIa-FP for On-Demand Treatment of Patients with Hemophilia A or B with Inhibitors

CSL Behring announced today that the first patient has been enrolled in its Phase II/III clinical study evaluating the pharmacokinetics (PK), efficacy, and safety of the company’s recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) for on-demand treatment in patients with congenital hemophilia A or B who have developed an inhibitor to factor VIII or factor IX replacement therapy. The study will enroll approximately 54 male patients, the first of whom was enrolled in Malaysia.

> Read More
28 July 2015 U.S. FDA Accepts for Review CSL Behring’s Biologics License Application for Its Novel rVIII-SingleChain Therapy for Patients with Hemophilia A

CSL Behring announced today that the U.S. Food and Drug Administration has accepted for review the company’s Biologics License Application (BLA) for its novel investigational recombinant factor VIII single-chain (rVIII-SingleChain) for the treatment of hemophilia A. In the pivotal clinical trial, rVIII-SingleChain met all primary endpoints.

> Read More
Page 1 of 51 Next | Last

Share
LinkedIn Twitter Facebook Google+