Csl Ltd Unsp ADR (CMXHY) 31.7700 $CMXHY
Does Biogen Idec Inc Have a New Blockbuster Hemophilia Therapy?
Cory Renauer, The Motley Fool - Motley Fool - Mon Apr 07, 1:30PM CDT
The FDA recently approved Biogen Idec 's Alprolix for the treatment of hemophilia B. The longer-lasting therapy's convenient dosing requirements may help it quickly dig into Pfizer 's BeneFIX market share. The Alprolix marketing team better...
Is This Overlooked Stock Primed for More Growth?
Stephen D., Simpson,, The Motley Fool - Motley Fool - Tue Mar 25, 1:30PM CDT
Blood products really don't get that much attention in the health care space, but it's a market worth more than $10 billion a year excluding hemophilia products and growing around 6% to 8% a year as indications and patient identification expand. ...
CNSI Selected by Two Maryland State Agencies for Separate IT Development and Support Contracts
PR Newswire - Tue Jan 21, 10:00AM CST
CNSI today announced it has been selected by the Maryland State Highway Authority (SHA) to provide Application Portfolio Business Services. As part of the task order under the State of Maryland - Consulting and Technical Services (CATS+) Master Contract, CNSI will continue to provide SHA's business applications development and maintenance for the next five years. CNSI also has been selected by the Maryland Port Administration (MPA) to continue providing programming and database management support services for an additional five years.
New Health Benefits Found in ReishiSmooth(TM) Coffee
PR Newswire - Tue Jan 21, 9:47AM CST
MycoTechnology Inc. announced today that their all-natural ReishiSmooth(TM) process delivers a healthier cup of coffee. The health benefits are derived from the beta-glucans found in the coffee, which have been shown to activate the human immune system.
iCo Therapeutics Begins Trading on the OTCQX Marketplace
PR Newswire - Fri Dec 20, 6:00AM CST
iCo Therapeutics (TSXV: ICO) (OTCQX: ICOTF), announced that its common shares will begin trading today on OTCQX International, a segment of the OTCQX marketplace in the U.S., under the symbol "ICOTF." iCo's common shares will also continue to trade on the TSX Venture Exchange under the symbol "ICO".
CMS Approves New Technology Add-On Payment for CSL Behring's Kcentra(TM)
PR Newswire - Tue Aug 13, 9:37AM CDT
CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) has approved a new technology add-on payment (NTAP) for Kcentra(TM) (Prothrombin Complex Concentrate [Human]) for use in the inpatient hospital setting for the urgent reversal of warfarin therapy in adult patients with acute major bleeding. Kcentra, the first non-activated 4-factor prothrombin complex concentrate (4F-PCC), was approved by the U.S. Food and Drug Administration (FDA) in April 2013 for this use.
CSL Behring Presents Population Pharmacokinetic Model for Novel Recombinant Factor IX Hemophilia B Treatment That Supports Less Frequent Administration
PR Newswire - Wed Jul 03, 10:00AM CDT
CSL Behring today presented a population pharmacokinetic model for recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam. The model confirms earlier results from the first-in-human dose escalation trial, which demonstrated improved pharmacokinetics of rIX-FP, with prolonged half-life compared to currently available factor IX.
CSL Behring Presents Phase I Results From Study of Recombinant Fusion Protein Linking Coagulation Factor VIIa with Albumin (rVIIa-FP) in Healthy Volunteers
PR Newswire - Wed Jul 03, 10:00AM CDT
CSL Behring today presented Phase I data of their recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) in healthy volunteers at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.
CSL Behring International Trial Shows Clinical Efficacy of Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) for Once Weekly Prophylaxis in Patients with Severe Hemophilia B
PR Newswire - Wed Jul 03, 7:45AM CDT
Data presented by CSL Behring today showed clinical efficacy of a once-weekly dosing regimen of recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP). Results of the study were presented during an oral session at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.
CSL Behring Announces Results from Study of Recombinant Single-Chain Factor VIII (rVIII-SingleChain) for Treatment of Hemophilia A
PR Newswire - Tue Jul 02, 10:00AM CDT
CSL Behring today announced that pharmacokinetic results for its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) showed improved half-life over octocog alfa (the comparator). It also demonstrated a safety and efficacy profile that supports advancement to late-stage clinical development. The data were presented at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.
CSL Behring to Premiere Data from Broad Recombinant Clinical Development Program in Hemophilia at the International Society of Thrombosis and Haemostasis (ISTH) Congress
PR Newswire - Thu Jun 27, 8:00AM CDT
CSL Behring today announced it will present study data from three ongoing clinical trial programs evaluating the Company's novel recombinant factor VIIa (rVIIa-FP), VIII (rVIII-SingleChain) and IX (rIX-FP) agents for people with hemophilia A and B with and without inhibitors. The data will be presented at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam. CSL Behring is the only company pursuing longer-acting rVIIa-FP and rIX-FP candidates based on recombinant albumin, and a rVIII-SingleChain compound that has been shown to improve the stability and half-life of factor VIII (FVIII).
CSL Behring Doses First Patient in Part 3 of Global Phase I/III Pivotal Study of rVIII-SingleChain (Recombinant Single-Chain Factor VIII) for Treatment of Hemophilia A
PR Newswire - Tue Jun 04, 8:00AM CDT
CSL Behring has dosed the first patient in Part 3 of its AFFINITY clinical trial program, which is now in phase III. AFFINITY is an open-label, non-randomized, multi-center study evaluating the efficacy, safety and pharmacokinetics of its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) for the treatment of hemophilia A. The patient was dosed in Vienna, Austria and had a successful major surgery.
CSL Behring Receives FDA Approval of Kcentra(TM) for Urgent Warfarin Reversal in Patients with Acute Major Bleeding
PR Newswire - Tue Apr 30, 9:13AM CDT
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) approved Kcentra(TM) (Prothrombin Complex Concentrate [Human]), the first non-activated 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients with acute major bleeding. The pivotal clinical trial showed that Kcentra met all efficacy and safety endpoints, including the endpoints of hemostatic efficacy and International Normalized Ratio (INR) reduction compared with plasma, the most widely used agent for warfarin reversal in the United States.
CSL Behring Donates Medicine Used in Treating Bleeding Disorders to World Federation of Hemophilia
PR Newswire Europe - Wed Apr 03, 7:01AM CDT
-- CSL Behring initiates first "installment" of renewed 3-year commitment to WFH to donate coagulation factor to the WFH Global Alliance for Progress program
CSL Behring Receives FDA Approval to Expand the Indication for Corifact®
PR Newswire - Thu Feb 28, 8:00AM CST
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Corifact®, Factor XIII Concentrate (Human), to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital factor XIII (FXIII) deficiency. In 2011, Corifact became the first and only FXIII concentrate approved in the U.S. for the routine prophylactic treatment of congenital factor XIII deficiency.
CSL Behring enrolls first patient in global pediatric Phase III pivotal study of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) to treat hemophilia B
PR Newswire Europe - Mon Jan 21, 8:00AM CST
-- CSL Behring achieves key milestone in PROLONG-9FP program
Does Biogen Idec Inc Have a New Blockbuster Hemophilia Therapy?
Cory Renauer, The Motley Fool - Motley Fool - Mon Apr 07, 1:30PM CDT
The FDA recently approved Biogen Idec 's Alprolix for the treatment of hemophilia B. The longer-lasting therapy's convenient dosing requirements may help it quickly dig into Pfizer 's BeneFIX market share. The Alprolix marketing team better...
Is This Overlooked Stock Primed for More Growth?
Stephen D., Simpson,, The Motley Fool - Motley Fool - Tue Mar 25, 1:30PM CDT
Blood products really don't get that much attention in the health care space, but it's a market worth more than $10 billion a year excluding hemophilia products and growing around 6% to 8% a year as indications and patient identification expand. ...
CNSI Selected by Two Maryland State Agencies for Separate IT Development and Support Contracts
PR Newswire - Tue Jan 21, 10:00AM CST
CNSI today announced it has been selected by the Maryland State Highway Authority (SHA) to provide Application Portfolio Business Services. As part of the task order under the State of Maryland - Consulting and Technical Services (CATS+) Master Contract, CNSI will continue to provide SHA's business applications development and maintenance for the next five years. CNSI also has been selected by the Maryland Port Administration (MPA) to continue providing programming and database management support services for an additional five years.
New Health Benefits Found in ReishiSmooth(TM) Coffee
PR Newswire - Tue Jan 21, 9:47AM CST
MycoTechnology Inc. announced today that their all-natural ReishiSmooth(TM) process delivers a healthier cup of coffee. The health benefits are derived from the beta-glucans found in the coffee, which have been shown to activate the human immune system.
iCo Therapeutics Begins Trading on the OTCQX Marketplace
PR Newswire - Fri Dec 20, 6:00AM CST
iCo Therapeutics (TSXV: ICO) (OTCQX: ICOTF), announced that its common shares will begin trading today on OTCQX International, a segment of the OTCQX marketplace in the U.S., under the symbol "ICOTF." iCo's common shares will also continue to trade on the TSX Venture Exchange under the symbol "ICO".
CMS Approves New Technology Add-On Payment for CSL Behring's Kcentra(TM)
PR Newswire - Tue Aug 13, 9:37AM CDT
CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) has approved a new technology add-on payment (NTAP) for Kcentra(TM) (Prothrombin Complex Concentrate [Human]) for use in the inpatient hospital setting for the urgent reversal of warfarin therapy in adult patients with acute major bleeding. Kcentra, the first non-activated 4-factor prothrombin complex concentrate (4F-PCC), was approved by the U.S. Food and Drug Administration (FDA) in April 2013 for this use.
CSL Behring Presents Population Pharmacokinetic Model for Novel Recombinant Factor IX Hemophilia B Treatment That Supports Less Frequent Administration
PR Newswire - Wed Jul 03, 10:00AM CDT
CSL Behring today presented a population pharmacokinetic model for recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam. The model confirms earlier results from the first-in-human dose escalation trial, which demonstrated improved pharmacokinetics of rIX-FP, with prolonged half-life compared to currently available factor IX.
CSL Behring Presents Phase I Results From Study of Recombinant Fusion Protein Linking Coagulation Factor VIIa with Albumin (rVIIa-FP) in Healthy Volunteers
PR Newswire - Wed Jul 03, 10:00AM CDT
CSL Behring today presented Phase I data of their recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) in healthy volunteers at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.
CSL Behring International Trial Shows Clinical Efficacy of Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) for Once Weekly Prophylaxis in Patients with Severe Hemophilia B
PR Newswire - Wed Jul 03, 7:45AM CDT
Data presented by CSL Behring today showed clinical efficacy of a once-weekly dosing regimen of recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP). Results of the study were presented during an oral session at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.
CSL Behring Announces Results from Study of Recombinant Single-Chain Factor VIII (rVIII-SingleChain) for Treatment of Hemophilia A
PR Newswire - Tue Jul 02, 10:00AM CDT
CSL Behring today announced that pharmacokinetic results for its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) showed improved half-life over octocog alfa (the comparator). It also demonstrated a safety and efficacy profile that supports advancement to late-stage clinical development. The data were presented at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.
CSL Behring to Premiere Data from Broad Recombinant Clinical Development Program in Hemophilia at the International Society of Thrombosis and Haemostasis (ISTH) Congress
PR Newswire - Thu Jun 27, 8:00AM CDT
CSL Behring today announced it will present study data from three ongoing clinical trial programs evaluating the Company's novel recombinant factor VIIa (rVIIa-FP), VIII (rVIII-SingleChain) and IX (rIX-FP) agents for people with hemophilia A and B with and without inhibitors. The data will be presented at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam. CSL Behring is the only company pursuing longer-acting rVIIa-FP and rIX-FP candidates based on recombinant albumin, and a rVIII-SingleChain compound that has been shown to improve the stability and half-life of factor VIII (FVIII).
CSL Behring Doses First Patient in Part 3 of Global Phase I/III Pivotal Study of rVIII-SingleChain (Recombinant Single-Chain Factor VIII) for Treatment of Hemophilia A
PR Newswire - Tue Jun 04, 8:00AM CDT
CSL Behring has dosed the first patient in Part 3 of its AFFINITY clinical trial program, which is now in phase III. AFFINITY is an open-label, non-randomized, multi-center study evaluating the efficacy, safety and pharmacokinetics of its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) for the treatment of hemophilia A. The patient was dosed in Vienna, Austria and had a successful major surgery.
CSL Behring Receives FDA Approval of Kcentra(TM) for Urgent Warfarin Reversal in Patients with Acute Major Bleeding
PR Newswire - Tue Apr 30, 9:13AM CDT
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) approved Kcentra(TM) (Prothrombin Complex Concentrate [Human]), the first non-activated 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients with acute major bleeding. The pivotal clinical trial showed that Kcentra met all efficacy and safety endpoints, including the endpoints of hemostatic efficacy and International Normalized Ratio (INR) reduction compared with plasma, the most widely used agent for warfarin reversal in the United States.
CSL Behring Donates Medicine Used in Treating Bleeding Disorders to World Federation of Hemophilia
PR Newswire Europe - Wed Apr 03, 7:01AM CDT
-- CSL Behring initiates first "installment" of renewed 3-year commitment to WFH to donate coagulation factor to the WFH Global Alliance for Progress program
CSL Behring Receives FDA Approval to Expand the Indication for Corifact®
PR Newswire - Thu Feb 28, 8:00AM CST
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Corifact®, Factor XIII Concentrate (Human), to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital factor XIII (FXIII) deficiency. In 2011, Corifact became the first and only FXIII concentrate approved in the U.S. for the routine prophylactic treatment of congenital factor XIII deficiency.
CSL Behring enrolls first patient in global pediatric Phase III pivotal study of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) to treat hemophilia B
PR Newswire Europe - Mon Jan 21, 8:00AM CST
-- CSL Behring achieves key milestone in PROLONG-9FP program
