Biosupply Trends Marketplace News
Monday, December 21, 2015
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Gene Therapy Restores Immunity in Children and Young Adults with SCID-X1

doctor injecting liquid into dna strand
 

In this Issue

•  IVIG/Albumin Supply Index
•  Open Market Pricing
•  New Products from FFF
•  Current Medicare
IVIG / SCIG Rates
•  Resources
•  Subscribe to IG Living and BioSupply Trends Quarterly
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A recent study conducted at the National Institute of Allergy and Infectious Diseases found that gene therapy combined with low-dose chemotherapy can safely restore the immune systems of older children and young adults ages 7 to 24 with X-linked severe combined immunodeficiency (SCID-X1). [ read more ]

New Gene Therapy Could Be Safe and Effective for Hemophilia B Patients

In a multi-year, ongoing study, researchers reprogrammed a lentivirus (a large retrovirus) to successfully transfer new factor IX (clotting) genes into animals with hemophilia B, which resulted in a dramatic decrease in spontaneous bleeding. The study suggests that this new kind of gene therapy could be safe and effective for humans with hemophilia B. [ read more ]

Short Course of IVIG May Slow Brain Atrophy and Conversion to Dementia in Persons with MCI Stage of AD

An exploratory controlled, randomized, double-blind study provides limited evidence that a short course of intravenous immune globulin given in the mild cognitive impairment (MCI) stage of Alzheimer’s disease (AD) reduces brain atrophy, slows cognitive decline in late MCI and delays conversion to AD dementia for at least one year; however, its effect appears to wane by two years.
[ read more ]

Industry News

blue molecules

From Baxalta

The U.S. Food and Drug Administration has approved Adynovate (Antihemophilic Factor [Recombinant] PEGylated) for on-demand treatment and control of bleeding episodes, as well as prophylaxis, in adults and adolescents aged 12 years and older with hemophilia A.
[ read more ]

From Novartis Vaccines

A new trivalent seasonal influenza vaccine designed to provoke a stronger immune response in adults age 65 and older has been approved by the U.S. Food and Drug Administration. Fluad contains MF59, an adjuvant containing an oil-in-water emulsion of squalene oil, which enhances or directs the immune response of the vaccinated person. [ read more ]

From Green Cross Corp.

Green Cross Corp., a South Korean biopharmaceutical company, has submitted a biologics license application for IVIG-SN (human normal immune globulin G for intravenous administration) to the U.S. Food and Drug Administration for the treatment of primary immunodeficiency diseases. [ read more ]

IVIG & Albumin Supply Index

 
Log in to BioSupply for IVIG and Albumin Product Pricing
 

Featured Product Of The Month

Bivigam (BioTest)

BIVIGAM (immune globulin intravenous (human) 10% liquid) is indicated for the treatment of primary humoral immunodeficiency, including but not limited to the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies. The product has a median half-life of 30 days, contains no sucrose/glucose/maltose, is stabilized with glycine, has trace amounts of IgA, contains a latex-free stopper, features tamper-evident seals and can be stored for up to 24 months (until expiration date on vial packaging) at 2 degrees to 8 degrees Centigrade.

For more information about Bivigam, go to biosupply.fffenterprises.com

Miacalcin (Mylan Institutional)

MIACALCIN (calcitonin-salmon) synthetic injection is for subcutaneous or intramuscular use and is indicated for the following conditions: 1) hypercalcemia; 2) Paget’s disease of bone; and 3) postmenopausal osteoporosis. It is available as a sterile solution in individual 2 mL multi-dose vials containing 200 IU per mL, and should be refrigerated between 2 degrees to 8 degrees Centigrade.

Zarxio (Sandoz Inc.)

ZARXIO (filgrastim-sndz) injection is for subcutaneous or intravenous use. It is a leukocyte growth factor indicated to: 1) patients with cancer receiving myelosuppressive chemotherapy; 2) patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; 3) patients with cancer undergoing bone marrow transplantation; 4) patients undergoing autologous peripheral blood progenitor cell collection and therapy; and 5) patients with severe chronic neutropenia. This product must be stored in a refrigerator at 2 degrees to 8 degrees in the original pack to protect from light. Do not shake, do not freeze. Prior to injection, the product may be allowed to reach room temperature for a maximum of 24 hours.

Imovax Rabies (Sanofi Pasteur)

IMOVAX Rabies is a vaccine indicated for pre-exposure and post-exposure prophylaxis against rabies and is approved for use in all age groups. The freeze-dried vaccine is stable if stored in the refrigerator between 2 degrees to 8 degrees Centigrade. Do not freeze. The product is a sterile, stable, freeze-dried suspension of rabies virus prepared from strain PM-1503-3M obtained from the Wistar Institute, Philadelphia, PA.

These products can be ordered from FFF Enterprise's BioSupply Online Ordering System or by calling Wow! Customer Care at (800) 843-7477.

Current Medicare IVIG / SCIG Rates

Rates per gram are effective October 1, 2015, through December 31, 2015.

Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
Bivigam J1556 $76.98 $75.75
Carimune NF J1566 $66.21 $65.15
Flebogamma J1572 $71.31 $70.17
Gammagard S/D J1566 $66.21 $65.15
Gammaplex J1557 $74.56 $73.37
Octagam J1568 $85.60 $84.23
Privigen J1459 $76.10 $74.88
SCIG
Hizentra J1559 $84.69 $83.33
HyQvia J3490 or J3590 ** **
IVIG / SCIG
Gammagard Liquid J1569 $77.13 $75.89
Gammaked J1561 $80.59 $79.30
Gamunex-C J1561 $80.59 $79.30

*Reflects 2% sequestration reduction applied to 80% Medicare payment portion as required under Budget Control Act of 2011.
**Pricing not yet available.

Resources

FFF customers may order the following complementary resources to help you with your practice:

Seasonal Flu Poster flu myths and facts brochure
immune globulin reference charts
•  IG Immune Globulin (Human)
•  Hyperimmune Globulins
•  Anti-Inhibitor, Factor VIIa & IX
•  Factor VIII & von Willebrand Factor
•  Seasonal Influenza Vaccine

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BioSupply Trends Quarterly magazine is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace.

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