eBST Newsletter Tuesday, August 20, 2024 
Wednesday, August 21, 2024 NEWSLETTER
  News Industry Insight Resources Issues  
 
 
 
New research has revealed a promising approach to developing a universal influenza vaccine — a so-called “one and done” vaccine that confers lifetime immunity against an evolving virus. The study tested a developed vaccine platform against the virus considered most likely to trigger the next pandemic.   [ Read More ]
 
 
 
 
 
 
A new study indicates that next-generation vaccines that target the SARS-CoV-2 virus’s points of entry — the nose and mouth — may be able to contain the spread of respiratory infections and prevent transmission. Specifically, the study showed that vaccinated hamsters that developed infections did not pass the virus on to others, breaking the cycle of transmission.   [ Read More ]
 
 
 
 
A new study has found a combined blood test for cognitive decline has a 90 percent accuracy rate in determining whether memory loss is due to Alzheimer’s disease. In comparison, neurologists and other memory specialists correctly diagnosed Alzheimer’s in 73 percent of their cases, while primary care doctors had even less success, with only a 61 percent accuracy rate.   [ Read More ]
 
 
 
 
The World Health Organization (WHO) has launched an initiative to help accelerate the development of a human bird flu vaccine using mRNA technology. The project will aim to identify vaccine candidates for manufacturers in low- and middle-income countries.   [ Read More ]
 
 
 
 
 
 
 
 
 
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Industry News
 
 
 
 
The U.S. Food and Drug Administration has approved an expanded label for Grifols’ XEMBIFY (20% subcutaneous immune globulin [SCIG]) to include treatment-naïve patients with primary humoral immunodeficiencies. XEMBIFY is the first 20% SCIG with this extended label, allowing patients to begin therapy without first having intravenous administration. Approval of the supplemental biologics application also includes biweekly dosing.   [ Read More ]
 
 
 
A blood test to screen for colorectal cancer in individuals aged 45 and older with an “average risk” of colon cancer has been approved by the U.S. Food and Drug Administration (FDA). Shield is already commercially available, but FDA approval will help broaden availability and insurance coverage.   [ Read More ]
 
 
 
A biologics license application for Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab) has been approved by the U.S. Food and Drug Administration to treat patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis and atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy.   [ Read More ]
 
 
BioSupply Online Ordering
 
 
 
 
 
 
 
IVIG & Albumin Supply Index
 
IVIG: Days On Hand
Albumin: Days On Hand
 
21 Days Supply or Less
22-29 Days Supply
30+ Days Supply
IVIG and Albumin Supply Index represents FFF's aggregate inventory of both products for all our customers who have established product allocations with us (not individual or group allocations).
 
Immune Globulin Products
Albumin Products
 
 
 
What's New at FFF
 
 
 
 
(BAVARIAN NORDIC INC.)
 
 
JYNNEOS is a vaccine indicated for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. It is supplied in a package of 10 single-dose vials.   [ Learn More ]
 
 
 
 
(BAVARIAN NORDIC INC.)
 
 
RABAVERT is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups. It is supplied as a single-dose kit containing one vial of freeze-dried vaccine containing a single dose, one disposable prefilled syringe of sterile diluent for reconstitution (1 mL), one small needle for injection (25 guage, 1 inch), and one long needle for reconstitution (21 gauge, 1½ inches).   [ Learn More ]
 
 
 
 
(EMERGENT TRAVEL HEALTH)
 
 
VIVOTIF (typhoid vaccine live oral Ty21A) is indicated for immunization in adults and children greater than 6 years of age against disease caused by Salmonella typhi. It is supplied in a single foil blister containing four doses of vaccine in a single package.   [ Learn More ]
 
 
 
 
(CUMBERLAND PHARMACEUTICALS)
 
 
VIBATIV is a lypoglycopeptide antibacterial drug indicated for the treatment of the following infections in adult patients caused by designated susceptible bacteria: complicated skin and skin structure infections (cSSSI); and hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates Staphylococcus aureaus. It is supplied in individual cartons of 750 mg single-dose vials; cartons of 12 individually packaged 750 mg single-dose vials; and cartons of four individually packaged 750 mg single-dose vials.   [ Learn More ]
 
 
 
 
(MODERNA)
 
 
MRESVIA is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. It is supplied as a single-dose prefilled plastic syringe in a blister pack containing one dose of 0.5 mL, and in a carton of 10 single-dose prefilled plastic syringes, each syringe containing one dose of 0.5 mL. Each carton contains 5 blisters, and each blister contains two syringes.   [ Learn More ]
 
 
 
 
(INTERNATIONAL MEDICATION SYSTEM)
 
 
REGADENOSON injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It is supplied as a sterile, preservative-free solution containing 0.08 mg/mL regadenoson in single-dose 5 mL prefilled syringes with a luer-lock fitting.   [ Learn More ]
 
 
 
 
(AMPHASTAR PHARMACEUTICALS)
 
 
GLUCAGON for injection is indicated for the treatment of insulin coma or insulin reaction resulting from severe hypoglycemia (very low blood sugar). It is supplied as 1 mg glucagon for injection (as a sterile, lyophilized white to off-white powder) in a single-dose vial and 1 mL of diluent for glucagon in a prefilled syringe.   [ Learn More ]
 
 
 
 
(DR. REDDY'S LABORATORIES)
 
 
MELPHALAN HYDROCHLORIDE for injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. It is supplied in a carton containing one single-dose clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent.   [ Learn More ]
 
 
 
 
(VALNEVA USA)
 
 
IXCHIQ is a vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. It is supplied in a carton containing one single-dose vial of lyophilized antigen component, live, and one prefilled ungraduated syringe of sterile water diluent component (packaged without needles).   [ Learn More ]
 
 
 
 
(MEITHEAL PHARMACEUTICALS)
 
 
HEPARIN SODIUM injection is an anticoagulant indicated for prophylaxis and treatment of venous thrombosis and pulmonary embolism; prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; atrial fibrillation with embolization; treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); prevention of clotting in arterial and cardiac surgery; prophylaxis and treatment of peripheral arterial embolism; and use as an anticoagulant in blood transfusion, extracorporeal circulation and dialysis procedures. It is supplied in single-dose vials in 1,000, 5,000 and 10,000 USP units per mL, and multi-dose vials in 10,000 USP units per 10 mL, 30,000 units per 30 mL, 50,000 units per 10 mL and 40,000 USP units per 4 mL, packaged in 25 vials per carton.
 
 
 
 
(GLAXOSMITHKLINE)
 
 
HIBERIX is a vaccine indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b in children aged 6 weeks through 4 years (prior to fifth birthday). HIBERIX vial and vial presentation is supplied in a carton packaged without syringes or needles containing 10 single-dose vials of lyophilized antigen component and 10 single-dose vials of sterile saline diluent. HIBERIX vial and prefilled syringe presentation is supplied in a carton containing 10 single-dose vials of lyophilized antigen component and 10 single-dose prefilled ungraduated TIP-LOK syringes of sterile saline diluent packaged without needles.   [ Learn More ]
 
 
 
 
(CSL BEHRING)
 
 
ZEMAIRA is an alpha1-proteinase inhibitor (A 1-PI; human) indicated for chronic augmentation and maintenance therapy in adults with A 1-PI deficiency and clinical evidence of emphysema. It is supplied in single-dose vials containing 1,000 mg, 4,000 mg or 5,000 mg functionally active A 1-PI.   [ Learn More ]
 
 
 
 
(PFIZER-BIONTECH)
 
 
COMIRNATY (mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. It is supplied in cartons of 10 single-dose glass prefilled syringes, single-dose plastic prefilled syringes and single-dose vials.   [ Learn More ]
 
 
 
 
(BPI LABS)
 
 
CARBOPLATIN injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents, and for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin. It is supplied in 5 mL fill in 10 mL, 15 mL fill in 20 mL, 45 mL fill in 50 mL and 60 mL fill in 100 mL multiple-dose vials.   [ Learn More ]
 
 
 
 
(NOVAVAX, INC)
 
 
The Novavax COVID-19 Vaccine (Adjuvanted/Protein Subunit) is a vaccine indicated for active immunization to prevent coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. It is supplied in boxes of 10 doses of 0.5 mL Pre-filled Syringes.   [ Learn More ]
 
 
 
 
(GLAXOSMITHKLINE)
 
 
AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years of age and older. It is supplied as two components: a single-dose vial of lyophilized antigen component (powder) and a single-dose vial of adjuvant suspension component (liquid) (packaged without syringes or needles) in cartons of 10 vials.   [ Learn More ]
 
 
 
 
(PFIZER INC.)
 
 
ABRYSVO is a vaccine indicated for active immunization for the prevention of lower respiration tract disease caused by respiratory syncytial virus in individuals 60 years of age and older. It is supplied in a kit that includes a vial of lyophilized antigen component, a prefilled syringe containing sterile water diluent component and a vial adapter in cartons of one, five and 10 kits.   [ Learn More ]
 
 
 
 
(ASSERTIO)
 
 
INDOCIN is a nonsteroidal anti-inflammatory drug indicated for moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to severe ankylosing spondylitis; moderate to severe osteoarthritis; acute painful shoulder (bursitis and/or tendinitis); and acute gouty arthritis. The 50 mg suppositories (indomethacin suppositories USP) are white, opaque and rectal supplied in boxes of 30.   [ Learn More ]
 
 
 
These products can be ordered from FFF Enterprises' BioSupply Online Ordering System or by calling Wow! Customer Care at  (800) 843-7477.
 
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BioSupply Trends Quarterly magazine is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. [ BST Quarterly Magazine ]

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Current Medicare IVIG / SCIG Rates
 
 
Rates per gram are effective July 1, 2024, through September 30, 2024.
 
 
 
 
Product Offering
J Code
ASP + 6%
(before sequester)
ASP + 4.3%
(after sequester)
IVIG
ALYGLO
J1599
    *    
    *    
ASCENIV 
J1554
$982.81
$967.05
 BIVIGAM 
J1556
$150.34
$147.93
GAMMAGARD SD
J1566
$159.80 
$157.24 
GAMMAPLEX
J1557
$109.13
$107.38
OCTAGAM
J1568
$95.48
$93.95
PANZYGA
J1576
$139.53
$137.29
PRIVIGEN
J1459
$97.34
$95.78
IVIG / SCIG
GAMMAGARD LIQ
  J1569  
 $90.14 
$88.70
GAMMAKED
J1561
$99.16
$97.57
  GAMUNEX-C  
J1561 
$99.16
$97.57
SCIG
CUTAQUIG
J1551
$145.34
$143.01
CUVITRU 
J1555
$168.92
$166.21
HIZENTRA
J1559
$131.88
$129.76
  HYQVIA  
J1575
$172.39
$169.63
XEMBIFY 
J1558
$144.00
$141.69
 
* ASP-based Medicare payment rate not yet available; payment rate assigned by your Medicare Administrative Contractor.
 
 
 
 
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