Monday, June 21, 2021

eBST News: Flu and COVID-19 Combo Vaccine

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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
 

A preclinical Phase III study of Novovax's combination quadrivalent seasonal flu vaccine (NanoFlu) and COVID-19 vaccine candidate (NVX-CoV2373) demonstrated positive immune responses to both influenza and SARS-CoV-2, the virus that causes COVID-19. read more ]

New Vaccine May Protect Against Multiple Coronaviruses

A team at the Duke Human Vaccine Institute has developed a pancoronavirus vaccine that might be able to protect against multiple coronaviruses in the SARS family, including SARS-CoV-2, as well as the virus most people know as SARS — SARS-CoV-1 — which was responsible for an outbreak in 2003. Current coronavirus vaccines were designed to protect us from one particular coronavirus: SARS-CoV-2, the virus responsible for this pandemic. read more ]

Delay in Pfizer Vaccine Boosts Immunity in Elderly

A study conducted in the United Kingdom has found a delay in giving the second dose of the COVID-19 vaccine by 12 weeks increases antibody response in older people by three-and-a-half times compared to those who receive it at a three-week interval. read more ]

Industry News

Industry News Image

From Pfizer

The U.S Food and Drug Administration has granted approval for Pfizer's 20-valent pneumococcal conjugate vaccine for the prevention of invasive disease and pneumonia in adults. The vaccine will be marketed by the brand name of Prevnar 20. read more ]

From Grifols

HyperHEP B, a new formulation of Grifols' hepatitis B immune globulin (human) for hepatitis B post-exposure prophylaxis is now commercially available. The new formulation, which was approved by the U.S. Food and Drug Administration in December 2020, uses a unique caprylate chromatography process that significantly reduces procoagulant activity and IgG aggregates. read more ]

From Kedrion Biopharma and Kamada Ltd.

The U.S. Food and Drug Administration has approved a label update for KEDRAB (rabies immune globulin [human]), establishing the product's safety and effectiveness in children. It is now indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection in persons of all ages when given promptly following contact with a rabid or possibly rabid animal. read more ]

From Inovio Pharmaceuticals Inc.

A preclinical study of Inovio Pharmaceutical's next-generation Pan-COVID-19 vaccine candidate, INO-4802, demonstrates its potential to induce cross-reactive immune responses against current and emerging viral variants, including the original Wuhan strain, as well as B.1.1.7 (U.K. variant), B.1.351 (South African variant) and P.1 (Brazilian variant). The company plans to conduct Phase I/II clinical trials this year. read more ]

From Sanofi and GlaxoSmithKline

Sanofi and GlaxoSmithKline are moving forward with their experimental COVID-19 vaccine. A late-stage trial showed the vaccine produced strong immune responses in volunteers in a mid-stage study. read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand
     
 
 
 
     

What's New at FFF

CALCITONIN SALMON  (LEUCADIA)

Calcitonin salmon synthetic injection is a calcitonin indicated for the treatment of the following: 1) symptomatic Paget's disease of bone when alternative treatments are not suitable, 2) hypercalcemia and 3) postmenopausal osteoporosis when alternative treatments are not suitable. It is available as a sterile solution in individual 2 mL MDV containing 200 USP units per mL.

For more information about CALCITONIN SALMON, log in to biosupply.fffenterprises.com

CEFAZOLIN  (APOTEX CORP.)

CEFAZOLIN for injection, USP, is a cephalosporin antibacterial indicated for the treatment of the following conditions caused by susceptible isolates of the designated microorganisms: respiratory tract infections, urinary tract infections, skin and skin structure infections, biliary tract infections, bone and joint infections, genital infections, septicemia, endocarditis and perioperative prophylaxis. It is supplied as a sterile white or off-white powder of crystalline powder in a carton containing 25 vials of 1 gram of cefazolin sodium.

For more information about CEFAZOLIN, log in to biosupply.fffenterprises.com

CEFEPIME  (APOTEX CORP.)

CEFEPIME for injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible strains of the designated microorganisms: 1) pneumonia, 2) empiric therapy for febrile neutropenic patients, 3) uncomplicated and complicated urinary tract infections, including pyelonephritis, 4) uncomplicated skin and skin structure infections and 5) complicated intra-abdominal infections (used in combination with metronidazole) in adults. It is supplied in cartons of 10 1 gram or 2 gram single-dose vials.

For more information about CEFEPIME, log in to biosupply.fffenterprises.com

CEFTRIAXONE  (APOTEX CORP.)

CEFTRIAXONE for injection, USP, is indicated for the treatment of the following infections when caused by susceptible organisms: 1) lower respiratory tract infections, 2) acute bacterial otitis media, 3) skin and skin structure infections, 4) complicated and uncomplicated urinary tract infections, 5) uncomplicated gonorrhea (cervical/urethral and rectal), 6) pelvic inflammatory disease, 7) bacterial septicemia, 8) bone and joint infections, 9) meningitis and 10) surgical prophylaxis. It is supplied as a sterile powder in a bulk package bottle containing 10 grams of ceftriaxone; in packages of 10 vials containing 250 mg, 500 mg, 1 gram and 2 grams of ceftriaxone; and in single packages containing 250 mg and 500 mg of ceftriaxone.

For more information about CEFTRIAXONE, log in to biosupply.fffenterprises.com

ALBUTEIN  (GRIFOLS BIOLOGICALS)

ALBUTEIN FlexBag 25% is an albumin solution indicated for hypovolemia, cardiopulmonary bypass procedures, acute nephrosis, hypoalbuminemia, ovarian hyperstimulation syndrome, neonatal hyperbilirubinemia, adult respiratory distress syndrome and prevention of central volume depletion after paracentesis due to cirrhotic ascites. It is supplied in 50 mL (12.5 g) and 100 mL (25 g) single-dose, latex-free, flexible containers free of polyvinyl chloride, diethylhexyl phthalate or other plasticizers.

For more information about ALBUTEIN, log in to biosupply.fffenterprises.com

XEMBIFY  (GRIFOLS THERAPEUTICS)

XEMBIFY (immune globulin subcutaneous, human-klhw) is a 10% immune globulin solution for subcutaneous injection indicated for treatment of primary humoral immunodeficiency in patients 2 years of age and older. It is supplied in 1 g, 2 g, 4 g and 10 g single-use vials.

For more information about XEMBIFY, log in to biosupply.fffenterprises.com

EVKEEZA  (REGENERON PHARMACEUTICALS)

EVKEEZA (evinacumab-dgnab) injection is an ANGPTL3 (angiopoietin-like 3) inhibitor indicated as an adjunct to other low-density lipoprotein-cholesterol lowering therapies for the treatment of adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia. It is supplied as one 345 mg/2.3 mL or 1,200 mg/8 mL single-dose vial per carton.

For more information about EVKEEZA, log in to biosupply.fffenterprises.com

ZILRETTA (FLEXION THERAPEUTICS)

ZILRETTA (triamcinolone acetonide injectable suspension) is an extended-release synthetic corticosteroid indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. It is supplied as 1) a 5 mL single-dose vial to deliver 32 mg of triamcinolone acetonide supplied as a sterile white to off-white powder in a clear vial, and 2) a 5 mL single-dose vial supplied as a sterile, clear liquid solution of 0.9% w/w sodium chloride (normal saline) containing 0.5% w/w sodium carboxymethylcellulose, and 0.1% w/w polysorbate-80 in a glass vial.

For more information about ZILRETTA, log in to biosupply.fffenterprises.com

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 April 1, 2021, through June 30, 2021.

 
Calculate Your Current Medicare IVIG/SCIG Rates
Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
ASCENIV J1554 $963.54 $948.09
BIVIGAM J1556 $140.98 $138.72
FLEBOGAMMA J1572 $72.16 $71.00
GAMMAGARD SD J1566 $128.43 $126.37
GAMMAPLEX J1557 $102.54 $100.89
OCTAGAM J1568 $84.04 $82.69
PANZYGA 90283 / J1599 ** **
PRIVIGEN J1459 $86.07 $84.69
SCIG
CUTAQUIG 90284 / J3590 ** **
CUVITRU J1555 $140.06 $137.81
HIZENTRA J1559 $112.27 $110.47
HYQVIA J1575 $147.32 $144.96
XEMBIFY J1558 $149.76 $147.36
IVIG / SCIG
GAMMAGARD LIQUID J1569 $92.22 $90.74
GAMMAKED J1561 $93.04 $91.55
GAMUNEX-C J1561 $93.04 $91.55

* Reflects 2% sequestration reduction applied to 80% Medicare payment portion as required under Budget Control Act of 2011.
** ASP-based Medicare payment rate not yet available; payment rate assigned by your Medicare Administrative Contractor.

 

Resources

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

•  IG Immune Globulin (Human)
•  Hyperimmune Globulins
•  Anti-Inhibitor, Factor VIIa & IX
•  Factor VIII & von Willebrand Factor
•  Seasonal Influenza Vaccine

Subscribe to IG Living

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Subscribe to BioSupply
Trends Quarterly

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

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