Infusion Insider

June 2, 2016

FDA Accepts Biologics License Application for New 5% IVIG Product: Green Cross BioTherapeutics, 5% Solution To Be Available in 2017

Green Cross Corp.’s biologics license application for IVIG-SN (human normal immunoglobulin G for intravenous administration) for the treatment of primary immunodeficiency disease (PI) has been accepted by the U.S. Food and Drug Administration. The approval comes after IVIG-SN demonstrated positive results in a Phase III study in patients with PI that met its primary endpoint of no acute serious bacterial infections. “The expected introduction of IVIG-SN will provide a meaningful

immune globulin product option for clinicians and their patients that further builds on the success already achieved with our products in other parts of the world,” said EC Huh, PhD, president of Green Cross Corp. “IVIG-SN marks a major step toward our ultimate goal of expanding biologics business to the U.S. marketplace.


Ingredients per 1 ml:


  • Human Immunoglobulin-G ……………….. 50mg
  • Maltose ………………………………………….. 100mg


Quantity per pack:


  • 10ml (500mg)
  • 20ml (1,000mg)
  • 50ml (2,500mg)
  • 100ml (5,000mg)
  • 200ml (10,000mg)


*Aiming to commercialize in 2019, IVIG 10% will be manufactured by GCBT for Canada and US market.


Jolin McCleskey

Exec VP, CHS

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MARKETING UPDATES

June is patient and staff appreciation month! We are honored to work with such a wonderful team at NCPC. We are also grateful for our wonderful patients!


To celebrate, we have treats scheduled for each week of June:


  • June 7th: Coffee deliveries
  • June 13th: Spring Fling Cake delivery
  • June 20th: Catered Pinkberry Frozen Yogurt
  • June 27th: Breakfast goodies delivered each day of the week.


We also are giving “wildflower” gifts to patients, staff, and our referral sources throughout the month.


And mark your calendars for June 14th as we treating NCPC staff to a pampering nail party at Heaven Nail Spa. We always have a great time relaxing and socializing!!

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CORINTHIAN CARES

Supporting Families with Myositis Diseases

After being diagnosed with Dermatomyositis Tommy Worthington was transferred to the University of Miami Hospital for specialized care. It was during this time that he received an outpouring of love and support from friends and family. He was overwhelmed by the support and realized that the term "FAMILY" is more than just those related by blood. His "FAMILY" grew to include friends, coworkers and our community.


Tommy felt that having his family by his bedside at all times gave him the strength to fight his battle. He vowed that one day he would start a foundation to help others and to give back. Unfortunately, Tommy passed away five weeks after being hospitalized. We (Dana - his wife and Laurie - his sister) are determined to honor his wishes and co-founded Team Tommy.

Team Tommy was established to provide financial assistance to families with Myositis diseases, finance research, and promote awareness.


Since discovering Team Tommy Foundation in March of 2016, the CHS Case Managers have sent requests to Team Tommy for 2 CHS patients and both have been approved.


Team Tommy was able to provide one CHS infusion patient with $3324 in order to cover her tiered medications and another received $3000 to cover her deductible and out of pocket expenses!


This is a HUGE help to our patients and we are so grateful for the work this amazing organization is doing!

Thank you TEAM TOMMY!!!!

http://www.teamtommy.org/