Chronic inflammatory demyelinating polyneuropathy

Komodo Health & Partners Present 33 Real-World Evidence Research Studies at ISPOR 2024

Retrieved on: 
Monday, May 6, 2024
Technology, Health, Venture Capital, Professional Services, Artificial Intelligence, Oncology, Other Science, Mental Health, Research, Software, Health Technology, Science, COVID-19, Clinical Trials, Komodo, University of Washington, Lennox–Gastaut syndrome, FDA, Public, University, Target, International Society, RWE, Pregnancy, Policy, AI, Prevalence, Colorectal cancer, Myriad Genetics, LGS, Chronic inflammatory demyelinating polyneuropathy, Neutropenia, CRC, Conference, Workflow, REMS, Genetics, Schizophrenia, Takeda Pharmaceutical Company, Mental health, Neurology, RWD, MPH, Patient, Hypertension, Epilepsy, Gestational age, Standard of care, Stillbirth, Pharmacoeconomics, ZS, Merck, ZS Associates, Breast cancer, Mitigation, Pharmaceutical industry

Komodo Health today announced the publication of 33 new health economics and outcomes research (HEOR) studies using its Healthcare Map and AI-powered technology platform.

Key Points: 
  • Komodo Health today announced the publication of 33 new health economics and outcomes research (HEOR) studies using its Healthcare Map and AI-powered technology platform.
  • The studies, to be featured at the 2024 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Global Conference, shed light on important disease trends spanning women’s health, oncology, mental health, hypertension, neurology, and more.
  • Komodo Health researchers studied the differences in patient outcomes for pregnant women who continued or discontinued the use of antidepressants during pregnancy.
  • Komodo Health researchers analyzed whether the COVID-19 pandemic exacerbated inequities in breast cancer care through its impact on breast cancer staging and HCRU.

Hawaii Specialty Pharmacy Announces New Ambulatory Infusion Centers to Serve Maui Community, Invites Local Media and Community Members to Opening Reception

Retrieved on: 
Wednesday, May 8, 2024
Physician, Ulcerative colitis, Makawao, Hawaii, Patient, Cancer, Pharmacy, Hospital, Health, Heart, Chronic inflammatory demyelinating polyneuropathy, Nursing, Doctor of Pharmacy, Rheumatoid arthritis, HSP, Multiple sclerosis, CIDP

MAKAWAO, Hawaii, May 8, 2024 /PRNewswire/ -- Hawaii Specialty Pharmacy (HSP), a leading provider of specialty infusion pharmacy services with a focus on high-touch patient care and a mission to optimize patient health, today announced the opening of two new ambulatory infusion centers in Maui, Hawaii.

Key Points: 
  • MAKAWAO, Hawaii, May 8, 2024 /PRNewswire/ -- Hawaii Specialty Pharmacy (HSP), a leading provider of specialty infusion pharmacy services with a focus on high-touch patient care and a mission to optimize patient health, today announced the opening of two new ambulatory infusion centers in Maui, Hawaii.
  • "Empowering our community with comprehensive healthcare solutions has always been at the heart of Hawaii Specialty Pharmacy's mission," says George Kridner, PharmD, CEO of Hawaii Specialty Pharmacy.
  • Since its inception in 2018, Hawaii Specialty Pharmacy has distinguished itself by offering a local and personalized approach to patients managing complex and rare conditions.
  • Maui is excited to welcome these new infusion centers and their staff into the heart of our community."

argenx Data Highlight Evidence that VYVGART and VYVGART Hytrulo Drive Transformative Outcomes for Patients with Debilitating Autoimmune Disease

Retrieved on: 
Tuesday, April 16, 2024
Autoantibody, FDA, American Academy, Immunoglobulin G, University, Clinical trial, Priority review, Risk, Safety, Food, ECI, Chronic inflammatory demyelinating polyneuropathy, Euronext, Research, Disease, PDUFA, Patient, Principal, AAN, CIDP, Biology, University of Minnesota, GMG, Autoimmunity, Pharmaceutical industry

“Our innovative approach to autoimmunity research is changing expectations for the global immunology community,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx.

Key Points: 
  • “Our innovative approach to autoimmunity research is changing expectations for the global immunology community,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx.
  • “The results of the ADHERE trial show that VYVGART Hytrulo reduces the risk of clinical deterioration in patients with CIDP while minimizing side effects and reducing the treatment burden.
  • VYVGART Hytrulo was well-tolerated, and the observed safety and tolerability profile was consistent with previous clinical trials.
  • Clinical trial data and real-world evidence presented during AAN continue to highlight the differentiated efficacy and safety profile of VYVGART and VYVGART Hytrulo, driving rapid, deep, and sustained improvement across disease scales and with different dosing schedules, including the ability for patients to achieve minimal symptom expression (MSE).

OmniAb Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
Wednesday, March 20, 2024
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Research, Multiple myeloma, Lung cancer, Partner, NMPA, Growth, NSCLC, CIDP, Partnership, Telephone, GSK, Patient, TED, NASDAQ Biotechnology Index, Epitope, Artificial intelligence, Sale, Myasthenia gravis, Neonatal Fc receptor, Fluorouracil, Graves' ophthalmopathy, Investment, Teclistamab, NBI, National Medical Products Administration, Johnson & Johnson, Drug development, Safety, Chicken, Machine learning, Gastrointestinal cancer, Immunoglobulin G, BLA, Chronic inflammatory demyelinating polyneuropathy, Pharmaceutical industry

OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.

Key Points: 
  • OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.
  • OmniAb launched two new technologies during 2023 including OmniDeep™ and, during the fourth quarter, OmnidAb™.
  • Fourth quarter 2023 and recent partner highlights include the following:
    Immunovant reported positive initial results for batoclimab in Graves’ disease (GD).
  • OmniAb was added to the Nasdaq Biotechnology Index (NBI) in the fourth quarter.

argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy

Retrieved on: 
Tuesday, February 20, 2024
Neonatal Fc receptor, Chronic inflammatory demyelinating polyneuropathy, Autoimmune disease, CIDP, FDA, Food, ECI, PDUFA, Euronext, Risk, Autoantibody, Safety, Immunoglobulin G, Patient, Clinical trial, Biology, Pharmaceutical industry

“Today’s announcement brings us one step closer to delivering the transformative innovation of VYVGART Hytrulo to CIDP patients,” said Luc Truyen, Chief Medical Officer of argenx.

Key Points: 
  • “Today’s announcement brings us one step closer to delivering the transformative innovation of VYVGART Hytrulo to CIDP patients,” said Luc Truyen, Chief Medical Officer of argenx.
  • We chose to use a priority review voucher to accelerate review of our submission because CIDP patients have long been waiting for new treatment options.
  • In the open-label Stage A of the study, 67% of patients showed evidence of clinical improvement (ECI) following treatment with VYVGART Hytrulo.
  • VYVGART Hytrulo was well-tolerated with a safety profile that is consistent with prior clinical trials and the known profile of VYVGART®.

Takeda’s GAMMAGARD LIQUID® Approved by U.S. FDA for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Retrieved on: 
Monday, January 29, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, CIDP, Rasch, Patient, Chronic inflammatory demyelinating polyneuropathy, Facial muscles, Paresthesia, Common, Leukopenia, Neutropenia, Anemia, Migraine, University, Abdominal pain, Chills, Head, Recombinant, Tremor, Food, Safety, Antibody, Pain, Neurology, Weakness, Headache, IVIG, Somnolence, Vomiting, Trial of the century, Dizziness

“Together with the recent HYQVIA approval in the U.S., we can now offer induction and maintenance therapy options to adults living with CIDP that may accommodate their personal treatment needs.”

Key Points: 
  • “Together with the recent HYQVIA approval in the U.S., we can now offer induction and maintenance therapy options to adults living with CIDP that may accommodate their personal treatment needs.”
    The approval is based on results from a prospective, open-label, single-arm, multicenter clinical study (ADVANCE-CIDP 2) that evaluated the efficacy and safety of GAMMAGARD LIQUID in adults with CIDP who developed a relapse in the randomized, double-blinded, placebo-controlled study evaluating efficacy, safety and tolerability of HYQVIA (ADVANCE-CIDP 1) in adults with CIDP.
  • Efficacy in ADVANCE-CIDP 2 was based on responder rate, where a responder was defined as a subject who demonstrated an improvement of functional disability.
  • The responder rate was 94.4% (N=18, 95% CI: 74.2% to 99.0%).
  • “Because CIDP is a progressive and complex disease, multiple treatment options are needed, and clinicians now have an additional therapy that can help adults with CIDP manage their disease.”
    GAMMAGARD LIQUID is the only IVIG with multiple neuromuscular disorder indications in the U.S. since it is now approved for CIDP and it is the only FDA-approved IVIG to treat multifocal motor neuropathy as a maintenance therapy to improve muscle strength and disability in adults.1 It is also indicated in the U.S. as a replacement therapy for people two years of age or older living with primary immunodeficiency.1

Halozyme Announces Takeda Received European Commission Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Retrieved on: 
Monday, January 29, 2024
CIDP, Patient, Therapy, Chronic inflammatory demyelinating polyneuropathy, SAN, Food and Drug Administration, European Commission, Food, Takeda, FDA, IVIG

SAN DIEGO, Jan. 29, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Takeda received European Commission (EC) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE® drug delivery technology as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).

Key Points: 
  • SAN DIEGO, Jan. 29, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Takeda received European Commission (EC) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE® drug delivery technology as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).
  • HYQVIA® also recently received U.S. Food and Drug Administration (FDA) approval as maintenance therapy for adults with CIDP.
  • HYQVIA® is the only FDA and now EC-approved combination of immunoglobulin (IG) and hyaluronidase for CIDP and is administered by facilitated subcutaneous infusion.
  • For patients with CIDP, HYQVIA® can be infused up to once monthly (every two, three or four weeks).

Halozyme Announces Takeda Receives FDA Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Retrieved on: 
Tuesday, January 16, 2024
CIDP, Patient, Therapy, Chronic inflammatory demyelinating polyneuropathy, SCIG, SAN, Food and Drug Administration, Food, Takeda, Primary immunodeficiency, FDA, Absorption

SAN DIEGO, Jan. 16, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Takeda received U.S. Food and Drug Administration (FDA) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE® drug delivery technology for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults.

Key Points: 
  • SAN DIEGO, Jan. 16, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Takeda received U.S. Food and Drug Administration (FDA) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE® drug delivery technology for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults.
  • HYQVIA® was first granted FDA approval in 2014 for the treatment of primary immunodeficiency (PI) in adults, which has since been expanded to include children 2-16 years old.1
    HYQVIA® is the only FDA-approved combination of immunoglobulin (IG) and hyaluronidase, which makes it a facilitated subcutaneous immunoglobulin (SCIG) infusion.
  • For adults with CIDP, HYQVIA® can be infused up to once monthly (every two, three or four weeks) due to ENHANZE®, which facilitates the dispersion and absorption of large IG volumes in the subcutaneous space.
  • Because it is delivered subcutaneously, HYQVIA® can be administered by a healthcare professional in a medical office, infusion center or at a patient's home.

Infusion for Health Achieves Accreditation In Nevada, Colorado, Arizona and Washington with ACHC

Retrieved on: 
Friday, December 22, 2023
Patient, Wi-Fi, Pharmacy, ISO 9001:2015, Physician, Crohn's disease, Anemia, Accreditation, CIDP, Prescription, Drink, Infusion, Patient safety, Rheumatoid arthritis, Snack, Nursing, Chronic inflammatory demyelinating polyneuropathy, ACHC, Insurance, Hospice, Safety, Psoriasis, CMS, Environment

Brea, California--(Newsfile Corp. - December 22, 2023) - Infusion for Health proudly announces it has achieved accreditation through Accreditation Commission for Health Care (ACHC) for the services of infusion therapy for its locations in Nevada, Colorado, Arizona and Washington, with California locations scheduled to have accreditation complete in Q1 2024.

Key Points: 
  • Brea, California--(Newsfile Corp. - December 22, 2023) - Infusion for Health proudly announces it has achieved accreditation through Accreditation Commission for Health Care (ACHC) for the services of infusion therapy for its locations in Nevada, Colorado, Arizona and Washington, with California locations scheduled to have accreditation complete in Q1 2024.
  • Accreditation by ACHC reflects an organization's dedication and commitment to meeting standards that facilitate a higher level of performance and patient care.
  • As Dan McCarty, CEO of Infusion for Health says, "This accreditation is a testament to our commitment to clinical excellence and exceptional care for our patients.
  • ACHC accreditation marks a major milestone for Infusion for Health, which opened its first outpatient infusion center in 2015 in Thousand Oaks, CA.

Takeda Receives Positive CHMP Opinion for HYQVIA® as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Retrieved on: 
Friday, December 15, 2023
Pharmaceutical, Science, Health, Research, Peripheral nervous system, European Commission, European Academy of Neurology, Research and development, Chronic inflammatory demyelinating polyneuropathy, European Medicines Agency, Disease, Clinical trial, EMA, Patient, European, CHMP, Marketing, Committee, Caregiver, Advanced Therapy Medicinal Product, CIDP, Neurology, Recombinant, IGS, IVIG, Pharmaceutical industry, Takeda

Takeda ( TSE:4502/NYSE:TAK ) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin therapy (IVIG).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin therapy (IVIG).
  • The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for HYQVIA for CIDP throughout the European Union.
  • This proposed extension of indication for HYQVIA is based on data from the pivotal Phase 3 ADVANCE-CIDP 1 clinical trial, which investigated HYQVIA as maintenance therapy in adult patients with CIDP.
  • HYQVIA is also under regulatory review in the United States for use as a maintenance therapy in adult patients with CIDP.