Monday, May 18, 2020

Study Suggests MMR Vaccine May Be Linked with Fewer Deaths from COVID-19

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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
 

Epidemiological data suggests populations with the highest measles-mumps-rubella (MMR) vaccination rates often have the fewest deaths from COVID-19, which researchers believe could be why children, teenagers and other young adults often have few severe symptoms from COVID-19, and why few deaths are attributed to COVID-19 in young age groups. read more ]

Human Trials Are Underway for Messenger RNA Vaccine to Protect Against COVID-19

Human trials of a potential coronavirus vaccine have begun in the U.S. The vaccine candidate dubbed BNT162, developed jointly by Pfizer and German pharmaceutical company BioNTech, is based on genetic material known as messenger RNA, which carries the instructions for cells to make proteins. The vaccine works by injecting a specially designed messenger RNA into the body to potentially tell cells how to make the spike protein of the coronavirus without actually making a person sick. read more ]

BCG Vaccine Being Studied as Potential Protection Against COVID-19

Because research has shown the Bacillus Calmette-Guérin (BCG) tuberculosis vaccine boosts production of immune cells, the vaccine is currently being trialed in people as potential protection against COVID-19. read more ]

First SARS-CoV-2 Trial Vaccine in Phase II Testing Shows Participants Develop Antibodies to the Virus

Antibody testing in eight of the dozens of study participants in Moderna's SARS-CoV-2 investigational vaccine candidate mRNA-1273 Phase II trial shows they developed neutralizing antibodies to the virus at levels reaching or exceeding the levels in people who have naturally recovered from COVID-19. read more ]

Industry News

 
Industry News Image
 

From CSL Behring

The CoVIg-19 Plasma Alliance, formed in April, has expanded globally to include 10 plasma companies — ADMA Biologics, BioPharma Plasma, Biotest, BPL, CSL Behring, GC Pharma, LFB, Octapharma, Sanquin and Takeda — that will contribute specialist advisory expertise, technical guidance and/or in-kind support to contribute to the goal of accelerating development and distribution of a potential treatment option for COVID-19. read more ]

From Novartis

Novartis has initiated a Phase III clinical trial to examine the efficacy of utilizing canakinumab (Ilaris), an interleukin-1β blocker, to treat a type of severe immune overreaction called cytokine release syndrome in people with COVID-19 pneumonia.  [ read more ]

From Inato

Inato, a marketplace that helps biopharmaceutical companies increase the pool of available patients engaged in clinical trials, has unveiled its anticovid platform, a comprehensive, central repository for all existing clinical trials for SARS-CoV2 (the virus that causes COVID-19). The anticovid platform is public, free to access and offers extensive search and filtering capabilities.  [ read more ]

From HEMA Biologics

The U.S. Food and Drug Administration (FDA) has approved SEVENFACT® (coagulation factor VIIa [recombinant]-jncw) for the treatment and control of bleeding episodes in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies).  [ read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand
     
 
 
 
     

What's New at FFF

HYPERRAB 3 ML (GRIFOLS THERAPEUTICS)

HYPERRAB is now supplied in a 3 mL single-dose vial with a potency value of not less than 300 IU/mL. HYPERRAB is a human rabies immune globulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. Persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis.

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

TEPADINA (AMNEAL BIOSCIENCES)

TEPADINA (thiotepa) is an alkylating drug indicated to reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation for pediatric patients with class 3 beta-thalassemia; for treatment of adenodarcinoma of the breast or ovary; for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities; or for treatment of superfibial papillary carcinoma of the urinary bladder. It is supplied as a unit carton with one single-dose type 1 clear glass 15 mg or 100 mg vial with a bromobutyl stopper.

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

YUTIQ  (EYEPOINT PHARMACEUTICALS)

YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg, for intravitreal injection, is a corticosteroid indicated for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. It is supplied in a sterile single-dose preloaded applicator with a 25-gauge needle, packaged in a sealed sterile foil pouch inside a sealed Tyvek pouch inside a carton box.

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

TYMLOS  (RADIUS HEALTH)

TYMLOS (abaloparatide) injection, for subcutaneous use, is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. It is supplied in a glass cartridge containing 3,120 mcg of abaloparatide in 1.56 mL of sterilized, clear, colorless fluid as a pre-assembled single-patient-use disposable pen packaged in a cardboard carton. Each pen provides a 30-day supply for once-daily injection of 80 mcg abaloparatide in 40 mcL. Sterile needles are not included.

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

DEHYDRATED ALCOHOL  (AKORN)

DEHYDRATED ALCOHOL injection, USP, is indicated for therapeutic neurolysis of nerves or ganglia for the relief of intractable chronic pain in such conditions as inoperable cancer and trigeminal neuralgia (tic douloureux) in patients for whom neurosurgical procedures are contraindicated. Relief of trigeminal neuralgia usually is only temporary. Other conditions for which injection of alcohol has been reported include glossopharyngeal neuralgia, angina pectoris and severe claudication due to peripheral vascular insufficiency. It is supplied in 5 mL vial packages of 10.

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

SODIUM TETRADECYL SULFATE  (LEUCADIA PHARMACEUTICALS)

SODIUM TETRADECYL SULFATE injection 3% is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. It is supplied in a carton containing five 60 mg/2 mL multi-dose vials.

For more information about SODIUM TETRADECYL SULFATE, log in to biosupply.fffenterprises.com

ACYCLOVIR  (FRESENIUS)

ACYCLOVIR (sodium injection) is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) infections and varicella-zoster (shingles) infections in immunocompromised adults and children. It is also indicated for severe initial episodes of herpes simplex infections in patients who may not be immunocompromised. It is available in two sizes: a 10 mL single-dose vial containing acyclovir sodium equivalent to 500 mg acyclovir, packaged in trays of 10 vials; and a 20 mL single-dose vial containing acyclovir sodium equivalent to 1 gram of acyclovir, packaged in trays of 10 vials.

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

ZIRABEV  (INTERNATIONAL MEDICATION SYSTEMS)

ZIRABEV (injection) is indicated for the treatment of metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment, and metastatic colorectal cancer in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. It is supplied as a sterile solution for intravenous infusion supplied in a carton containing one single-dose vial in the following strengths: 100 mg/4 mL (25 mg/mL) and 400 mg/16 mL (25 mg/mL).

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

ALBUMINEX®  (BIO PRODUCTS LABORATORY)

ALBUMINEX [Human 5% and 25%], prepared from the pooled plasma of U.S. donors in FDA-licensed facilities in the U.S., comes in 5% and 25% albumin solutions indicated for adults and children for hypovolemia, ascites, hypoalbuminemia including from burns, acute nephrosis, acute respiratory distress syndrome and cardipulmonary bypass. ALBUMINEX 5% is supplied in 12.5 g and 25 g single-dose vials. ALBUMINEX 25% is supplied in 50 mL and 100 mL single-dose vials.

For more information about ALBUMINEX, 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, 2020, through June 30, 2020.

 
Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
FLEBOGAMMA J1572 $72.03 $70.88
GAMMAGARD SD J1566 $128.18 $126.12
GAMMAPLEX J1557 $110.42 $108.65
OCTAGAM J1568 $80.94 $79.64
PANZYGA 90283 / J1599 ** **
PRIVIGEN J1459 $82.43 $81.11
SCIG
CUTAQUIG 90284 / J3590 ** **
CUVITRU J1555 $138.85 $136.62
HIZENTRA J1559 $104.97 $103.29
HYQVIA J1575 $141.37 $139.10
XEMBIFY 90284 / J3590 ** **
IVIG / SCIG
GAMMAGARD LIQUID J1569 $79.50 $78.23
GAMMAKED J1561 $81.65 $80.34
GAMUNEX-C J1561 $81.65 $80.34

* 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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Trends Quarterly

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

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