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FFF Enterprises Takes Top Honors in 2011 MarCom Awards Competition

Temecula, Calif. – FFF Enterprises, Inc., the nation’s largest and most trusted distributor of plasma products, vaccines and critical-care biopharmaceuticals and publisher of two magazines, is pleased to announce that it has received a platinum award, two gold awards and one honorable mention in the 2011 MarCom International Awards Competition.

IG Living! Magazine Takes Top Honors in 2010 MarCom Awards Competition

November 3, 2010 – IG Living!, the only magazine dedicated to patients who use immune globulin products and their care providers, has taken top honors in the 2010 MarCom Awards Competition. IG Living won a Platinum award for Magazine/Consumer – a highly competitive category and a significant accomplishment. The publication also received an honorable mention for Design/Magazine Interior. Earlier this year, IG Living was awarded two bronze medals in the 17th annual National Health Information Awards. The program, coordinated by the Health Information Resource Center, recognizes the nation’s best consumer health information programs and materials.

IG Living! Magazine Wins National Health Information Award

October 5, 2010 - IG Living! magazine was recently awarded two bronze medals in the 17th annual National Health Information Awards. The program, coordinated by the Health Information Resource Center, recognizes the nation’s best consumer health information programs and materials.

IG Living! Magazine Launches Enhanced, Redesigned Website

Revamped site features expanded resources, feature articles, upcoming events and a link to the magazine’s Facebook page.

Articles

IDF to Conduct PIDD and Pregnancy Survey

The Immune Deficiency Foundation (IDF) has received an unrestricted educational grant to perform a groundbreaking survey on pregnancy and primary immunodeficiency (PIDD). Mothers of a child with a PIDD or women of any age with a PIDD are asked to contribute to this important research that will be conducted in the fall of 2011 and help IDF make a difference. For more information, contact IDF’s Director of Survey Research at (800) 296-4433.

IDF Launches Nursing Course on PIDD and IG Therapy

The Immune Deficiency Foundation now offers a free accredited online continuing education (CD) course for nurses. The five-credit CE course will consit of four presentations that will focus on the nurse’s role with IG therapy, PIDDs and the difference between subcutaneous immune globulin (SCIG) and intravenous immune globulin (IVIG). The presentations include:

Overview of IG Therapy and Disease States In Which It is Utilized, by Jordan Orange, MD, PhD, University of Pennsylvania School of Medicine, Children’s Hospital of Philadelphia
Primary Immunodeficiencies, Combined T-Cell and/or B-Cell Immune Defects, by Mark Ballow, MD, SUNY Buffalo School of Medicine and Biomedical Sciences, Women and Children’s Hospital of Buffalo
Intravenous Immuneoglobulin Therapy (IVIG), by Kristin Epland, MSN, FNP-C, Midwest Immunology Clinic, Plymouth, Minn.
Subcutaneous Immunoglobulin Therapy (SCIG), by M. Elizabeth Younger, CRNP, PhD, Johns Hopkins University, Baltimore, Md.

The course is sponsored by an unrestricted educational grant from CSL Behring. To register, interested nurses can go to primaryimmune.org.

PANDAS IVIG Clinical Trial Open to Patients

The National Institute of Mental Health and Yale Child Study Center are recruiting children for a pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) intravenous immune globulin (IVIG) clinical treatment study. The study will look at whether children with PANDAS improve with IVIG treatment.

Children who may be able to participate in the study include those who are 4 to 12 years old with sudden repetitive or obsessive thoughts and behaviors after a strep infection. At the start of the study, some children will randomly receive IVIG and some will randomly receive a placebo. After the first six weeks, all families can choose to receive IVIG treatment. All children participating in the study will have to take antibiotics to protect against possible future strep infections. The study is free. For more information, contact Megan Smith at (203) 737-5588 or meg.smith@yale.edu.

CSL Behring Discontinues U.S. Distribution of Vivaglobin

CSL Behring has discontinued distribution of Vivaglobin in the United States market as of April 4, 2011. According to a letter sent to Vivaglobin customers, the product was discontinued due to delays in supply. CSL also manufactures Hizentra, a 20% subcutaneous immunoglobulin replacement therapy for patients with primary humoral immunodeficiency, and a sample program is being offered to Vivaglobin patients, which will provide them with a one-month supply of Hizentra to determine if the product is right for them. For more information, contact IgIQ at (877) 355-IgIQ. Patients can also learn more about the product at www.Hizentra.com.

Povidine Iodine Prep Pads Are Voluntarily Recalled

On March 16, H&P Industries Inc., the parent company of the Triad Group of Hartland, Wis., voluntarily recalled all lots of povidine iodine prep pads. The recalled products all were distributed in the United States and include those pads made by H&P Industries and packaged under the names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety and Total Resources. Read More

Becoming an Empowered Patient

You are part of your medical team every time you take your medications. It is very important that you double-check that you are taking the right dose of the right drug, at the right time, in the correct way. To accomplish this, you need to know as much as possible about your medications. Your pharmacist can be an important member of your healthcare team – use him or her as a resource whenever possible. Below are additional tips for medication safety. Read More

Florida Adds SCID to Newborn Screening Panel

On January 28, Florida voted to add severe combined immunodeficiency (SCID) to the state’s newborn screening panel, a uniform set of newborn screening tests. Florida joins five states and one territory in its decision to add SCID to its panel: California, Louisiana, Massachusetts, New York, Wisconsin and Puerto Rico. In addition, Texas has a limited pilot SCID screening panel in place, where it tested approximately 20,000 infants in 2010.

In the United States, newborn screening began more than 40 years ago, when states and territories mandated newborn screening of all infants born within their jurisdiction for certain disorders that may not otherwise be detected before developmental disability or death occurs. Newborns with these disorders typically appear normal at birth, so when detected at birth, these diseases can be medically treated to allow most affected newborns to develop normally.

Seven other states also have voted to recommend the addition of SCID to their newborn screening panels, but screening has not yet begun. These include Colorado, Delaware, Iowa, Michigan, Minnesota, North Carolina and Rhode Island. In addition, proposals to add SCID have been made in Connecticut, Nebraska, Ohio and Pennsylvania.

Gamunex-C Approved for Subcutaneous Administration

The U.S. Food and Drug Administration (FDA) has approved Talecris Biotherapeutics Gamunex-C (immune globulin injection [human] 10% caprylate/chromatography purified) for subcutaneous administration in the treatment of primary immunodeficiency (PIDD). Gamunex-C can be administered subcutaneously and intravenously, whereas Talecris' previously FDA-approved Gamunex can be administered intravenously only. Intravenous (IV) delivery for both products is FDA-approved to treat PIDD, chronic inflammatory demyelinating polyneuropathy (CIDP) and idiopathic thrombocytopenic purpura (ITP). Gamunex-C has labeling and packaging information that describes both IV and subcutaneous routes of administration. Gamunex has labeling and packaging information that describes only IV administration.

"The FDA approval of Gamunex-C is important because it provides another option for patients with primary immunodeficiency and their healthcare professionals when they are considering the various treatment modalities," says Fred Modell, cofounder of the Jeffrey Modell Foundation. "We consider it significant for patients to have multiple modes of delivery so they can select the option that best suits their individual needs."

FDA Approves Grifols' Flebogamma DIF 10% IVIG

Grifols has obtained U.S. Food and Drug Administration approval for its next generation of intravenous immunoglobulin (IVIG) 10% concentration, under the name Flebogamma 10% DIF. Flebogamma DIF (double inactivation and filtered) is a polyvalent IVIG that incorporates two specific viral inactivation methods and the additional safety step of nanofiltration at 20 nanometers. These processes produce higher yields of the product to maximize the amount of life-saving medicine that can be produced from each plasma donation.

With this approval, Grifols is the first company in the U.S. to offer patients and clinicians two concentrations of liquid IVIG (5% and 10%). The company plans to launch Flebogamma 10% DIF toward the end of 2010.

Octagam Withdrawal Issued for All Lots

Octapharma USA has initiated a voluntary withdrawal of all lots of Octagam (immune globulin intravenous [human] 5% liquid preparation) from the U.S. marketplace due to an unusually high number of thromboembolic events that have been associated with people being administered the drug. This follows an initial announcement in August of a voluntary withdrawal of selected lots of Octagam 5%, which reported at least nine events where blood clots dislodged and traveled through the body, causing injury and pain to patients.

According to Octapharma USA, while the company has not received any reports of thromboembolic events since its initial voluntary market withdrawal, the Food and Drug Administration and Octapharma agree that until a root cause analysis of the previously reported thromboembolic events can be determined, the most prudent course of action is to suspend further administration of Octagam 5%.

The company requests that customers quarantine all lots of Octagam 5% and then contact the Octapharma customer service department at (201) 604-1141 to return the product.

This withdrawal is for Octagam only. Octapharma's Albumin (Human) and Wilate, Von Willebrand Factor/Coagulation Factor VIII Complex (Human), are unaffected and are readily available in all sizes for purchase.

First Neuropathy Summit Scheduled

In conjunction with its 15th anniversary as the leading national organization serving the peripheral neuropathy community, the Neuropathy Association is hosting the 2010 Neuropathy Summit, a first-of-its-kind event that features back-to-back conferences for patients, physicians and other healthcare professionals. The summit will be held December 3 through 5 in Washington, DC. Its theme is “Proving the Paradoxes of Neuropathic Pain” since a large majority of neuropathy patients suffer with chronic and debilitating pain.

The physicians’ conference, scheduled for December 3 through 4, will be a dynamic forum for healthcare professionals, scientists, investigators and clinicians working in the neuropathy field to exchange and share scientific knowledge; accelerate translational research; explore applications in clinical practice to enhance patient care; and foster collaboration and share new ideas in addressing peripheral neuropathy. The patients’ conference will be held December 4 through 5 and is intended for all neuropathy patients, caregivers and family members to take part in interactive informational sessions with featured experts and company representatives in the field of neuropathy. Attendees will learn about the latest research advances; review treatment approaches for neuropathy and neuropathic pain; and connect with and learn from their peers. The event also includes a joint 15th anniversary banquet.

For more information and to register for the event, go to the Neuropathy Summit website. Or, contact Chris Cherkis, registration and exhibit manager, at (202) 973-8616.