Acute-phase proteins

Cerus Corporation Announces CMS Has Granted New Technology Add-On Payment for INTERCEPT Fibrinogen Complex

Retrieved on: 
Tuesday, August 3, 2021

Cerus Corporation (Nasdaq: CERS) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted a new technology add-on payment (NTAP) for INTERCEPT Fibrinogen Complex within the Medicare Hospital Inpatient Prospective Payment System (IPPS).

Key Points: 
  • Cerus Corporation (Nasdaq: CERS) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted a new technology add-on payment (NTAP) for INTERCEPT Fibrinogen Complex within the Medicare Hospital Inpatient Prospective Payment System (IPPS).
  • The NTAP was granted under CMS alternative NTAP pathway, which recognizes the transformative nature of products granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).
  • The U.S. FDA granted approval of the INTERCEPT Blood System for Cryoprecipitation, which is used to produce INTERCEPT Fibrinogen Complex for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency, in November 2020.
  • INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.

Ortho Clinical Diagnostics Announces Launch of the Interleukin-6 (IL-6) Reagent Pack, Latest Addition to Ortho's Critical Care Blood Testing Menu

Retrieved on: 
Thursday, July 22, 2021

IL-6 is gaining utility in the evaluation of the most severe forms of respiratory distress, one of the causes of poor outcomes for patients suffering inflammatory diseases.

Key Points: 
  • IL-6 is gaining utility in the evaluation of the most severe forms of respiratory distress, one of the causes of poor outcomes for patients suffering inflammatory diseases.
  • Ortho's comprehensive critical care menu also includes tests for hs Troponin, NT-pro BNP, Ferritin, CRP, D-dimer, Lactate, and PCT.
  • Ortho Clinical Diagnostics (Nasdaq: OCDX) is one of the world's largest pure-play in vitro diagnostics (IVD) companies dedicated to transforming patient care.
  • Ortho helps its customers enhance clinical outcomes, improve efficiency, overcome staffing challenges and reduce costs.

Ortho Clinical Diagnostics Announces Launch of the Interleukin-6 (IL-6) Reagent Pack, Latest Addition to Ortho's Critical Care Blood Testing Menu

Retrieved on: 
Thursday, July 22, 2021

IL-6 is gaining utility in the evaluation of the most severe forms of respiratory distress, one of the causes of poor outcomes for patients suffering inflammatory diseases.

Key Points: 
  • IL-6 is gaining utility in the evaluation of the most severe forms of respiratory distress, one of the causes of poor outcomes for patients suffering inflammatory diseases.
  • Ortho's comprehensive critical care menu also includes tests for hs Troponin, NT-pro BNP, Ferritin, CRP, D-dimer, Lactate, and PCT.
  • Ortho Clinical Diagnostics (Nasdaq: OCDX) is one of the world's largest pure-play in vitro diagnostics (IVD) companies dedicated to transforming patient care.
  • Ortho helps its customers enhance clinical outcomes, improve efficiency, overcome staffing challenges and reduce costs.

Dicerna Announces Interim Results From Phase 1 Trial of Belcesiran for Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease

Retrieved on: 
Wednesday, July 21, 2021

Data from this interim analysis showed dose-dependent reductions in serum alpha-1 antitrypsin (AAT) with administration of a single dose of belcesiran.

Key Points: 
  • Data from this interim analysis showed dose-dependent reductions in serum alpha-1 antitrypsin (AAT) with administration of a single dose of belcesiran.
  • The primary treatment evaluation period for the final dose cohort (12.0 mg/kg) of belcesiran in the Phase 1 trial is ongoing.
  • Alpha-1 antitrypsin (AAT) deficiency is a rare genetic condition caused by mutations in the SERPINA1 gene that results in disease of the liver and lungs.
  • Belcesiran is a clinical-stage, subcutaneously administered, investigational GalXC RNAi therapy targeting alpha-1 antitrypsin (AAT) that is in development for the treatment of AAT deficiency-associated liver disease (AATLD).

Cerus Announces Collaboration with LifeSouth Community Blood Centers to Manufacture INTERCEPT® Fibrinogen Complex

Retrieved on: 
Wednesday, June 30, 2021

Cerus Corporation (NASDAQ: CERS) announced today an agreement with LifeSouth Community Blood Centers (LifeSouth) to serve as a production partner for INTERCEPT Fibrinogen Complex, the companys pathogen reduced cryoprecipitated fibrinogen complex product.

Key Points: 
  • Cerus Corporation (NASDAQ: CERS) announced today an agreement with LifeSouth Community Blood Centers (LifeSouth) to serve as a production partner for INTERCEPT Fibrinogen Complex, the companys pathogen reduced cryoprecipitated fibrinogen complex product.
  • LifeSouth is the fifth production partner for INTERCEPT Fibrinogen Complex, enabling the initial commercial launch of the product to expand into the state of Florida.
  • We are delighted to add LifeSouth as a blood center manufacturing partner for INTERCEPT Fibrinogen Complex, stated Elan Weiner, general manager of Cerus Therapeutics.
  • We believe INTERCEPT Fibrinogen Complex is an exciting innovation in transfusion medicine, and we are pleased to partner with Cerus in the Florida market.

Optime Care’s Patient-First Strategy Helps Physicians Optimize Care for Rare and Orphan Disease Patients with Pulmonary Issues During COVID-19 Pandemic

Retrieved on: 
Wednesday, June 9, 2021

This is especially important for patients with Alpha-1 Antitrypsin Deficiency (Alpha-1), a genetic condition that may result in serious lung disease in adults and/or liver disease at any age.

Key Points: 
  • This is especially important for patients with Alpha-1 Antitrypsin Deficiency (Alpha-1), a genetic condition that may result in serious lung disease in adults and/or liver disease at any age.
  • Optime Cares patient-first approach offers patients a proactive, process-driven telehealth program which mitigates the transmission of infection, such as coronavirus, for these vulnerable individuals.
  • This focus addresses all variables around collecting data, while maintaining frequent communication with patients and their families to ensure compliance and positive outcomes.
  • Listen to Optime Cares Rare Voices podcast episode with Dr. Miskoff here .

DGAP-News: Biotest AG: Biotest accelerates fibrinogen phase III study with additional patient group

Retrieved on: 
Wednesday, April 7, 2021

In order to compensate the fibrinogen deficiency and to effectively stop bleeding, Biotest has developed the fibrinogen concentrate BT524.

Key Points: 
  • In order to compensate the fibrinogen deficiency and to effectively stop bleeding, Biotest has developed the fibrinogen concentrate BT524.
  • The AdFIrst study is a prospective, randomized, active-controlled, multicenter phase III study that investigates the efficacy and tolerability of the fibrinogen concentrate BT524 in patients with acquired fibrinogen deficiency.
  • With the AdFIrst study in acquired fibrinogen deficiency, Biotest is further expanding its development program for the fibrinogen concentrate BT524.
  • The AdFIrst study is a prospective, active-controlled, multicentre phase III study investigating the efficacy and safety of the fibrinogen concentrate BT524 in patients with acquired fibrinogen deficiency.

LFB Announces that the European Medicines Agency (EMA) Has Accepted for Filing the Marketing Authorization Application for eptacog beta (activated), a Recombinant Coagulation Factor VIIa

Retrieved on: 
Monday, March 1, 2021

LFB today announced that the European Medicines Agency (EMA), the European regulatory authority, has accepted for filing the Marketing Authorization Application for eptacog beta, a recombinant coagulation Factor VIIa (rFVIIa).

Key Points: 
  • LFB today announced that the European Medicines Agency (EMA), the European regulatory authority, has accepted for filing the Marketing Authorization Application for eptacog beta, a recombinant coagulation Factor VIIa (rFVIIa).
  • An exclusive license for the commercialization of SEVENFACT in the USA has been granted to HEMA Biologics, a joint venture between LFB and US WorldMeds.
  • Created in France in 1994, LFB is today one of the leading European companies providing plasma-derived and recombinant medicinal products to healthcare professionals.
  • Exploratory in vitro evaluation of thrombin generation of eptacog beta (recombinant human FVIIa) and emicizumab in congenital haemophilia A plasma.

Global Alpha 1 Antitrypsin Deficiency Treatment Market Report 2020 with COVID-19 Impact Insights

Retrieved on: 
Tuesday, December 22, 2020

The global alpha 1 antitrypsin deficiency treatment market grew at a CAGR of around 9% during 2014-2019.

Key Points: 
  • The global alpha 1 antitrypsin deficiency treatment market grew at a CAGR of around 9% during 2014-2019.
  • Looking forward, the global alpha 1 antitrypsin deficiency treatment market to continue its strong growth during the next five years.
  • What has been the impact of COVID-19 on the global alpha 1 antitrypsin deficiency treatment market?
  • What is the structure of the global alpha 1 antitrypsin deficiency treatment market and who are the key players?

Alpha 1 Antitrypsin Deficiency Treatment Market - Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2020-2025 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, December 16, 2020

The "Alpha 1 Antitrypsin Deficiency Treatment Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2020-2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Alpha 1 Antitrypsin Deficiency Treatment Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2020-2025" report has been added to ResearchAndMarkets.com's offering.
  • The global alpha 1 antitrypsin deficiency treatment market grew at a CAGR of around 9% during 2014-2019.
  • Looking forward, the global alpha 1 antitrypsin deficiency treatment market to continue its strong growth during the next five years.
  • What is the structure of the global alpha 1 antitrypsin deficiency treatment market and who are the key players?