Primary Immune Deficiency

Gammaplex 10% Gets FDA Approval

By February 07, 2017

Bio Products Laboratory announced that the Food and Drug Administration (FDA) has approved Gammaplex 10% (immune globulin intravenous [human], 10% liquid) for the treatment of primary immunodeficiency (PI) and chronic immune thrombocytopenic purpura (ITP) in adults.

Cuvitru Now Available for Primary Immunodeficiency

By November 16, 2016

Shire announced the launch of Cuvitru (immune globulin subcutaneous [human], 20% solution) indicated as replacement therapy for primary humoral immunodeficiency (PI) in patients aged ≥2 years.

Study Examines Rubella Persistence Post-Vaccine in Immunodeficient Patients

By November 10, 2016

Some patients with primary immunodeficiency disorders may be at risk for rubella virus infection and possible serious skin inflammation after receiving the rubella vaccine, a study published in the Journal of Allergy and Clinical Immunology has found.

Cuvitru Approved for Primary Immunodeficiency

September 14, 2016

Shire announced that the Food and Drug Administration (FDA) has approved Cuvitru (immune globulin subcutaneous [human]) 20% solution for the treatment of primary immunodeficiency in patients aged ≥2 years.

FDA Accepts IVIG-SN BLA for Primary Immunodeficiency

By January 26, 2016

Green Cross announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for IVIG-SN (human normal immunoglobulin G), for the treatment of primary immunodeficiency diseases (PID).

New IVIG BLA Submitted for Primary Immunodeficiency

By November 25, 2015

Green Cross announced that it has submitted its Biologics License Application (BLA) to the FDA for IVIG-SN (human normal immunoglobulin G) for the treatment of primary immunodeficiency diseases (PID).

Why Organ Transplant Patients May Be at Lower Risk for Alzheimer's Disease

By June 09, 2015

A treatment taken by organ transplant patients to prevent organ rejection may help protect against Alzheimer's disease.

Gene Tx May Benefit Wiskott-Aldrich Sx in Children, Teens

April 23, 2015

Gene therapy may benefit children and teens with Wiskott-Aldrich syndrome, a rare immunodeficiency caused by mutations in the WAS gene.

Flexible Dosing Option for Hizentra Approved

By February 02, 2015

CSL Behring announced that the Food and Drug Administration (FDA) has approved a new dosing option for Hizentra (immune serum globulin [human]) 0.2mg/mL (20%) Liquid to include treatment at regular intervals from daily to biweekly in patients with primary immunodeficiency.

Hyqvia Launched for Primary Immunodeficiency Treatment

October 20, 2014

Baxter and Halozyme announced the launch of Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) for the treatment of adults with primary immunodeficiency (PI).

New Gene Therapy for Severe Immunodeficiency May Reduce Leukemia Risk

October 09, 2014

A new form of gene therapy may offer a safe and effective way to treat severe combined immunodeficiency (SCID) with less risk of leukemia.

New SC Inj for Primary Immunodeficiency Approved

September 15, 2014

Baxter and Halozyme announced that the Food and Drug Administration has approved Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) for adult patients with primary immunodeficiency (PI).

High Survival from Severe Combined Immunodeficiency with Screening Programs

August 20, 2014

Newborn screening programs in the United States have identified severe combined immunodeficiency (SCID) in one in 58,000, with high survival seen in SCID-affected infants.

Survival Up for Stem Cell Transplants in SCID

July 31, 2014

For children with severe combined immunodeficiency (SCID), hematopoietic-cell transplantation from matched sibling donors, or from other donors before onset of infection, is associated with excellent survival.

Many Pediatricians Uncomfortable With Genetic Disease Care

November 27, 2013

A majority of primary care pediatricians did not feel competent to provide genetic-related health care.

FDA Approves New Hizentra Dosing Option

September 27, 2013

CSL Behring announced that the FDA has expanded the administration options for Hizentra 0.2mg/mL (20%) liquid for SC injection to include dosing once every 2 weeks in addition to weekly dosing for patients with primary immunodeficiency.

Larger Vial Size for Hizentra Approved

September 04, 2013

The FDA has approved a new 10g (50mL) vial size for Hizentra (immune serum globulin [human]) liquid for primary immunodeficiency.

Recall Alert: Visible Particles Found in One Lot of Bivigam Liquid

April 05, 2013

Biotest Pharmaceuticals is recalling lot # 120016 of Bivigam (exp. 3/14/14) after visible particles were observed during a routine inspection. Under inspectation, no visible particles have been found in other lots. Bivigam is indicated for the treatment of patients with primary humoral immunodeficiency.

New Privigen 40g Vial Size Approved

February 21, 2013

CSL Behring announced that the FDA has approved a 40g (400mL) vial size for Privigen (immune globulin intravenous [human] 0.1g/mL).

Bivigam Now Approved with Thrombin Assay Test

February 01, 2013

Biotest Pharmaceuticals announced that the FDA has approved Bivigam (immune globulin intravenous [human], 10%) liquid with a validated assay for measuring thrombogenic activity.

Bivigam Approved for Primary Humoral Immunodeficiency

December 20, 2012

Biotest announced that the FDA has approved Bivigam (immune globulin intravenous [human] 10% liquid) for the treatment of patients with primary humoral immunodeficiency (PI).