PIDD

KORU Medical Systems to Present Data Demonstrating 97% Adherence on Its Freedom Infusion System for Large Volume Subcutaneous Administration at NHIA 2024 Conference

Retrieved on: 
Monday, March 18, 2024
Medical Devices, Health, Pharmaceutical, Clinical Trials, Medical Supplies, Immunodeficiency, Conference, KRMD, PIDD, Therapy, Patient, Impact, Literature, Primary immunodeficiency, Medical device

The study, authored by KORU Medical, analyzed data from a large national specialty pharmacy, capturing drug receipts over 4.5 years for 3,787 US PIDD patients using KORU Medical FREEDOM60® and FreedomEdge® infusion systems for self-administered SCIg therapy.

Key Points: 
  • The study, authored by KORU Medical, analyzed data from a large national specialty pharmacy, capturing drug receipts over 4.5 years for 3,787 US PIDD patients using KORU Medical FREEDOM60® and FreedomEdge® infusion systems for self-administered SCIg therapy.
  • We believe it provides valuable insights into the effectiveness of KORU Medical’s Freedom Infusion System in promoting treatment compliance in large volume subcutaneous delivery.
  • “These findings highlight the positive impact of KORU Medical’s Freedom Infusion System on subcutaneous immunoglobulin therapy for patients with primary immunodeficiency disease," said Brent Rutland, Vice President, Medical Affairs at KORU Medical.
  • These results, with the KORU Freedom Infusion System, also demonstrate the company’s potential to support a broader range of developmental subcutaneous drug therapies.”

KORU Medical Systems, Inc. Receives FDA 510(k) Clearance for FREEDOM60® Infusion System With Hizentra® 50 ML Prefilled Syringes

Retrieved on: 
Tuesday, November 7, 2023
Other Health, Health, Pharmaceutical, Managed Care, Medical Supplies, Linda, KRMD, FDA, Food, PFS, PIDD, Quality of life, KORU, Therapy, CSL Behring, CIDP, Syringe, Patient, Food and Drug Administration, Medical device, Pharmaceutical industry

“Being the first and only FDA-cleared infusion system for use with prefilled syringes demonstrates KORU Medical’s continued commitment to enhance the patient experience for all patients self-administering subcutaneous immunoglobulin (SCIg) therapy in the home,” said Linda Tharby, KORU Medical’s President and CEO.

Key Points: 
  • “Being the first and only FDA-cleared infusion system for use with prefilled syringes demonstrates KORU Medical’s continued commitment to enhance the patient experience for all patients self-administering subcutaneous immunoglobulin (SCIg) therapy in the home,” said Linda Tharby, KORU Medical’s President and CEO.
  • We are now able to deliver PFS benefits to Hizentra® patients through our FREEDOM™ Infusion System portfolio - the FREEDOM60® Infusion System with 50 mL PFS and the FreedomEdge® with 20 mL PFS.
  • When using prefilled syringes with the FREEDOM™ Infusion System, KORU Medical has demonstrated that patients can experience up to an 80% reduction in drug preparation tasks when compared to using vials.
  • The FDA approved the Hizentra® 50 mL prefilled syringe in April 2023, and CSL Behring has announced an early 2024 availability.

ADMA Biologics Announces FDA Approval for Room Temperature Storage of ASCENIV™ & BIVIGAM®

Retrieved on: 
Tuesday, December 13, 2022
IVIG, Food and Drug Administration, Respiratory syncytial virus, RSV, Protein, PIDD, Temperature, Antibody, Bacteria, Wiskott–Aldrich syndrome, FDA, Marketing, 8-K, Immunity, Hepatitis B virus, Blas, Infection, European Patent Office, ADMA, Plasma, Disease, Immunodeficiency, Virus, Risk, Patient, Pharmaceutical industry, Vaccine, PI

RAMSEY, N.J. and BOCA RATON, Fla., Dec. 13, 2022 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced the United States Food and Drug Administration’s (“FDA”) approval for its supplemental Biologics License Applications (BLAs) for both ASCENIV and BIVIGAM to now include room temperature (25°C) storage conditions for up to 4 weeks during the first 24 months of the 36-month approved shelf life. The room temperature approval applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM.

Key Points: 
  • The room temperature approval applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM.
  • ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases.
  • ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida.
  • These forward-looking statements also include, but are not limited to, the anticipated benefits and significance of the FDA’s room temperature storage approval.

ADMA Biologics Announces Third Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, November 9, 2022
Wiskott–Aldrich syndrome, Increase, Transplant, Risk, Sale, Infection, Virus, Company, Conference, San Jose BioCenter, 8-K, Review, Immunity, Forward-looking statement, Plasma, Morgan Stanley, Marketing, RSV, Environment, IVIG, SEC, Immunodeficiency, Collection, U.S. Securities and Exchange Commission, Research, Patient, Private Securities Litigation Reform Act, Protein, PIDD, Hepatitis B virus, Nasdaq, Food and Drug Administration, Antibody, European Patent Office, Bacteria, Growth, FDA, Income, GLOBE, Respiratory syncytial virus, Sex linkage, PIN, Investment, Federation of Clinical Immunology Societies, Publication, Disease, General manager, ADMA, Urinary tract infection, Iron ore, Pharmaceutical industry, Video game, Vaccine, Medical device, Reinsurance, Air cargo, PI

ET

Key Points: 
  • ET
    RAMSEY, N.J. and BOCA RATON, Fla., Nov. 09, 2022 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (ADMA or the Company), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics, today announced its third quarter 2022 financial results and provided a business update.
  • Third Quarter 2022 and Recent Achievements:
    Significant Revenue Growth: Achieved third quarter 2022 total revenues of $41.1 million, as compared to $20.7 million during the third quarter of 2021, an increase of $20.4 million, or approximately 99%.
  • 2022 & Long-Term Financial Guidance:
    2022 Financial Guidance: Enabled by the strong year-to-date execution, ADMA anticipates total 2022 revenues will reach approximately $145 million.
  • Third Quarter 2022 Financial Results:
    Total revenues for the third quarter ended September 30, 2022 were $41.1 million, as compared to $20.7 million during the third quarter of 2021, an increase of $20.4 million, or approximately 99%.

Consortium of Independent Immunology Clinics (CIIC) welcomes the addition of Allergy Partners, PLLC as a New Member

Retrieved on: 
Tuesday, September 13, 2022
General Health, Health, Other Health, MDX, Allergy, PIDD, Immunology, Asthma, Private practice, Health, Partnership, Patient, Physician, CIIC, Trio, Emergency, Research, Education, Pharmaceutical industry, Health insurance, PLLC

Allergy Partners is the nations largest single specialty practice with 136 Board-Certified Allergists representing 64 practices and 124 community locations.

Key Points: 
  • Allergy Partners is the nations largest single specialty practice with 136 Board-Certified Allergists representing 64 practices and 124 community locations.
  • The addition of Allergy Partners expands CIICs patient geography into 6 new states, and into additional metro areas in many of the current states where CIIC already has members.
  • As of Fall 2022, the CIIC now has Allergy, Asthma, and Immunology member practices operating in 27 of the 50 U.S. states, with plans for continued membership growth in 2023.
  • Trio Health (Trio), in partnership with the Consortium of Independent Immunology Clinics (CIIC), launched the creation of a real-world patient ecosystem to deliver research-ready clinical insights and real-time disease surveillance for allergy, asthma and immunology care.

ADMA Biologics Announces Second Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, August 10, 2022
Shift, U.S. Securities and Exchange Commission, GLOBE, SEC, Patent, Method, Marketing, Patient, PIN, European Patent Office, Infection, Urinary tract infection, Collection, Disease, Metapneumovirus, Sex linkage, Risk, Private Securities Litigation Reform Act, Environment, Respiratory syncytial virus, Increase, Conference, Immunity, San Jose BioCenter, Forward-looking statement, Growth, Income, General manager, ADMA, 8-K, Lists of diseases, IVIG, Morgan Stanley, Coronavirus, Virus, FDA, Antibody, Immunodeficiency, RSV, PIDD, Immunoglobulin therapy, Plasma, Company, Bacteria, Wiskott–Aldrich syndrome, United States Patent and Trademark Office, Protein, Hepatitis B virus, Food and Drug Administration, Adoption, Video game, Renewable energy, Vaccine, Medical device, Tutoring, PI

ET

Key Points: 
  • ET
    RAMSEY, N.J. and BOCA RATON, Fla., Aug. 10, 2022 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (ADMA or the Company), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics, today announced its second quarter 2022 financial results and provided a business update.
  • Second Quarter 2022 and Recent Achievements:
    Significant Revenue Growth: Achieved second quarter 2022 total revenues of $33.9 million, as compared to $17.8 million during the second quarter of 2021, an increase of $16.1 million, or approximately 90%.
  • 2022 & Long-Term Financial Guidance:
    2022 Financial Guidance: Enabled by the strong start to the year, ADMA anticipates total 2022 revenues will exceed $130 million.
  • Second Quarter 2022 Financial Results:
    Total revenues for the second quarter ended June 30, 2022 were $33.9 million, as compared to $17.8 million during the second quarter of 2021, an increase of $16.1 million, or approximately 90%.

Augmedix - Trio Health - CIIC First of its Kind Real-World Patient Ecosystem - Standardizing Relevant Clinical Data at the Point of Care

Retrieved on: 
Wednesday, August 3, 2022
EHR, Physician, SAN, CIIC, Patient, PIDD, Documentation, Health, MDX, Private practice, Disease, Natural language processing, Research, Automation, GLOBE, Hospital, Immunology, MD, Allergy, Partnership, Laika (EHR testing framework), Emergency, Asthma, Trio, Pharmaceutical industry, Medical imaging, Medical device

SAN FRANCISCO, Aug. 03, 2022 (GLOBE NEWSWIRE) -- Today, Trio Health (Trio) and Augmedix (Nasdaq: AUGX), in partnership with the Consortium of Independent Immunology Clinics (CIIC), announced the launch of an innovative platform to automate, standardize, and structure clinical patient data, right from the point of care. The Trio, Augmedix and CIIC physicians’ real-world patient ecosystem deliver research-ready clinical insights and real-time disease surveillance for allergy, asthma and immunology care.

Key Points: 
  • The Trio, Augmedix and CIIC physicians real-world patient ecosystem deliver research-ready clinical insights and real-time disease surveillance for allergy, asthma and immunology care.
  • This service saves me hours every week, improves both my clinical note quality and the overall patient experience at my practice.
  • The Augmedix-Trio-CIIC ecosystem is producing:
    We are excited to embrace the partnership with Trio and Augmedix, now that the two technologies are deeply integrated, said Lyn Lewars, Executive Director at CIIC.
  • Trio Health, in collaboration with its patient care stakeholders, delivers robust disease networks, insights and opportunities that do not exist with any other real-world data providers.

Trio Health (Trio) and the Consortium of Independent Immunology Clinics (CIIC) announce the launch of the Trio-CIIC HAE Registry

Retrieved on: 
Thursday, May 12, 2022
Physician, CIIC, Population, Allergy, COO, Asthma, MDX, Immunology, Patient, Health, Hereditary angioedema, PIDD, Trio, Research, FDA, Compliance, Human, EMR, Private practice, HAE, Medical device, Pharmaceutical industry

Trio Health's real-world data platform rapidly converts structured and unstructured EMR data, in real time, including physician notes, laboratory and radiology report data.

Key Points: 
  • Trio Health's real-world data platform rapidly converts structured and unstructured EMR data, in real time, including physician notes, laboratory and radiology report data.
  • The Trio-CIIC HAE Registry offers comprehensive insights into the HAE patient journey, including patient voice.
  • The Trio-CIIC HAE Registry contains 419 physician-confirmed HAE patients with an average of 5.1 years of clinical data per patient, including 3,000 office visit notes detailing HAE attacks, therapy decisions and patient reported outcomes.
  • The Trio-CIIC HAE Registry's mission is to empower regulatory grade evidence and insights in support of patients, providers and biopharma.

ADMA Biologics Announces First Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, May 11, 2022
Wiskott–Aldrich syndrome, ADMA, Disease, Sex linkage, Infection, U.S. Securities and Exchange Commission, Antibody, PIDD, Plasma, Virus, IVIG, Adoption, Private Securities Litigation Reform Act, SEC, Collection, Physician, Income, Marketing, Food and Drug Administration, Respiratory syncytial virus, Growth, GLOBE, Company, General manager, Bacteria, Immunodeficiency, FDA, Hepatitis B virus, Lists of diseases, Protein, RSV, European Patent Office, Risk, ID, Nasdaq, Environment, Patient, Forward-looking statement, Immunity, 8-K, San Jose BioCenter, Morgan Stanley, Video game, Risk management, Pharmaceutical industry, Security (finance), Medical device, Vaccine, PI

RAMSEY, N.J. and BOCA RATON, Fla., May 11, 2022 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced its first quarter 2022 financial results and provided a business update.  

Key Points: 
  • First Quarter 2022 Total Revenues Were Approximately $29.1 Million, an 81% Increase Over First Quarter 2021
    RAMSEY, N.J. and BOCA RATON, Fla., May 11, 2022 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (ADMA or the Company), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced its first quarter 2022 financial results and provided a business update.
  • We are very encouraged with our first quarter financial results, particularly when considering some of the non-recurring dynamics that occurred during the quarter, said Brian Lenz, ADMAs Chief Financial Officer, and General Manager, ADMA BioCenters.
  • First Quarter 2022 and Recent Achievements:
    Executed Financially: Achieved first quarter 2022 total revenues of $29.1 million, as compared to $16.0 million during the first quarter of 2021, an increase of $13.1 million, or approximately 81%.
  • 2022 & Long-Term Financial Guidance:
    2022 Financial Guidance: Enabled by the strong start to the year, ADMA increases 2022 total revenue guidance to $130 million or more, upwardly revised from $125 million.

ADMA Biologics Announces FDA Approval of Extended Shelf Life for ASCENIV™ & BIVIGAM® from 24 to 36 Months

Retrieved on: 
Friday, March 25, 2022
IG, Company, Private Securities Litigation Reform Act, Risk, Hepatitis B virus, Virus, Plasma, NASDAQ, Marketing, Forward-looking statement, Respiratory syncytial virus, Food and Drug Administration, Compliance, Caregiver, Patient, Wiskott–Aldrich syndrome, IVIG, Bacteria, Antibody, Immunity, European Patent Office, ADMA, U.S. Securities and Exchange Commission, Immunodeficiency, PIDD, Sex linkage, GLOBE, 8-K, Physician, Infection, RSV, Lists of diseases, FDA, Protein, Disease, Decision-making, Health insurance, Vaccine, PI

RAMSEY, N.J. and BOCA RATON, Fla., March 25, 2022 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, announced the United States Food and Drug Administration’s (“FDA”) approval to extend the expiration dating from 24 to 36 months for both its ASCENIV and BIVIGAM immune globulin (“IG”) drug product stored at 2-8°C. The expiration date extension applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM in all vial sizes, production scales as well as internal and external fill-finished drug product.

Key Points: 
  • The approval represents an important milestone as it pertains to the culmination of remediation initiatives enacted since ADMA acquired the Boca Raton, FL manufacturing facility in 2017.
  • The new 36-month dating for ASCENIV and BIVIGAM now puts ADMAs IG portfolio on a level playing field with competitor product offerings.
  • The newly approved 36-month dating for ASCENIV and BIVIGAM is immediately effective and product is available to U.S. healthcare providers and patients.
  • ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida.