IVIG

InnoCare Releases 2023 Results and Business Highlights

Retrieved on: 
Thursday, March 28, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, QD, Tafasitamab, Patient, B-cell lymphoma, NDA, SLE, POC, IND, Clinical trial, Bone marrow, IKZF1, Phase, Therapy, IGA, MCD, Dexamethasone, MCL, Neuromyelitis optica spectrum disorder, IKZF3, AML, NMOSD, Outline of health sciences, DLT, Cancer, Autoimmune disease, Safety, TYK2, HSA, NRDL, BLA, Follicular lymphoma, Food, GC, Development, Multiple sclerosis, PD, CRBN, Public, Gordon Ramsay's Bank Balance, Multiple myeloma, ITP, BCL2, Leukemia, Cmax, Gadolinium, HKEX, SRI, AAD, Proteinuria, DLBCL, Glucocorticoid, IVIG, Loss, European Hematology Association, American Academy, EHA, Lenalidomide, NHL, Non-Hodgkin lymphoma, CCR8, US FDA, BTK, NRS, Pharmaceutical industry

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.
  • In 2023, InnoCare has continued to advance its robust pipeline across various clinical stages, continuously unleashing the power of innovation to meet unmet medical needs.
  • In June 2023, the ITP Phase II result was orally presented at the European Hematology Association (EHA) 2023 Hybrid Congress.
  • InnoCare was approved by the Hong Kong Stock Exchange to remove "B" from the stock code from May 12, 2023.

ADMA Biologics Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, February 28, 2024
PIN, Immunotherapy, Marketing, ADMA, Growth, Overalls, Patent, Death, Conference, Vaccine, Risk, Prevalence, Total revenue, GAAP, Depreciation, Patient, Vaccine-naive, FY, IVIG, Plasma, Mortality, CAP, Community-acquired pneumonia, EP

ET

Key Points: 
  • ET
    RAMSEY, N.J. and BOCA RATON, Fla., Feb. 28, 2024 (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 biologics, today announced its fourth quarter and full year 2023 financial results and provided a business update.
  • “We are pleased with our 2023 performance, which marked first-time positive adjusted net income on a full year basis.
  • We believe our unwavering focus on the immune deficient patient segment has allowed ADMA to establish itself as a premier provider of specialty biologics.
  • Fourth Quarter 2023 Financial Results:
    Total revenues were $73.9 million for the quarter ended December 31, 2023, as compared to $50.0 million for the quarter ended December 31, 2022, an increase of $23.9 million, or approximately 48%.

Takeda’s HYQVIA® Approved by European Commission as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Retrieved on: 
Monday, January 29, 2024
Neurology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Medication package insert, Patient, CHMP, Immunodeficiency, Nausea, Itch, PID, Erythema, Civil service commission, European Commission, Edema, Research and development, Aes, Recombinant, Skin, Food, Disease, Safety, Primary immunodeficiency, Committee, Absorption, IVIG, Peripheral nervous system, Headache, Diagnosis, Pharmaceutical industry

Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).

Key Points: 
  • Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).
  • The majority of AEs were mild or moderate, local, did not require suspension of infusions, and resolved without sequelae.
  • The most common (reported in >5% of patients) causally related AEs included headache and nausea, as well as local AEs including infusion site pain, erythema, pruritis, and edema.
  • HYQVIA first received approval from the EC for the treatment of primary immunodeficiency (PID) in 2013 as well as secondary immunodeficiency (SID) in 2020.8

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).

U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Retrieved on: 
Tuesday, January 16, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, CIDP, Patient, CHMP, Itch, Nausea, SCIG, Fatigue, Erythema, European Commission, European, Abdominal pain, Lipase, EMA, Recombinant, Skin, Back pain, Food, Safety, Caregiver, Primary immunodeficiency, Pain, Marketing, Committee, Headache, Absorption, IVIG, Diagnosis, Pharmaceutical industry

Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] 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: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults.
  • 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.
  • “We’re excited that this therapy could offer some adults with CIDP an alternative subcutaneous option that may address some of these challenges and help personalize treatment.”
    HYQVIA is now available as a maintenance therapy for adult patients with CIDP in the U.S.
  • The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for HYQVIA for CIDP throughout the European Union.6

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.

Chronic Inflammatory Demyelinating Polyneuropathy Market to Register Positive Growth During the Study Period (2019-2032), Evaluates DelveInsight | Key Companies to Watch Out - Octapharma, argenx, Immunovant Sciences, Sanofi, Janssen, Takeda

Retrieved on: 
Tuesday, December 12, 2023
Immune system, Electromyography, Disease, Prednisone, Neurological disorder, Pain management, Fatigue, Rituximab, Patient, Gesellschaft mit beschränkter Haftung, EU4, CIDP, Azathioprine, Atrophy, Antibody, Sensation, MRI, Fc receptor, IVIG, Clumsy, Facial muscles, LAS, Neuropathic pain, Diagnosis, Inflammation, Sympathetic nervous system, Pharmaceutical industry, Takeda, Octapharma

LAS VEGAS, Dec. 12, 2023 /PRNewswire/ -- DelveInsight's Chronic Inflammatory Demyelinating Polyneuropathy Market Insights report includes a comprehensive understanding of current treatment practices, chronic inflammatory demyelinating polyneuropathy emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Points: 
  • As per DelveInsight estimates, CIDP in the US showed that males account for the highest number of cases as compared to females in 2022.
  • The promising chronic inflammatory demyelinating polyneuropathy therapies in the pipeline include Panzyga, Efgartigimod, Batoclimab, SAR445088, Nipocalimab, and others.
  • Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare neurological disorder that causes progressive weakness and reduced sensation in the arms and legs.
  • CIDP shows itself through symmetrical weakness in the hands, feet, hips, and shoulders, gradually worsening over a minimum of two months.

Chronic Inflammatory Demyelinating Polyneuropathy Market to Register Positive Growth During the Study Period (2019-2032), Evaluates DelveInsight | Key Companies to Watch Out - Octapharma, argenx, Immunovant Sciences, Sanofi, Janssen, Takeda

Retrieved on: 
Tuesday, December 12, 2023
Immune system, Electromyography, Disease, Prednisone, Neurological disorder, Pain management, Fatigue, Rituximab, Patient, Gesellschaft mit beschränkter Haftung, EU4, CIDP, Azathioprine, Atrophy, Antibody, Sensation, MRI, Fc receptor, IVIG, Clumsy, Facial muscles, LAS, Neuropathic pain, Diagnosis, Inflammation, Sympathetic nervous system, Pharmaceutical industry, Takeda, Octapharma

LAS VEGAS, Dec. 12, 2023 /PRNewswire/ -- DelveInsight's Chronic Inflammatory Demyelinating Polyneuropathy Market Insights report includes a comprehensive understanding of current treatment practices, chronic inflammatory demyelinating polyneuropathy emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Points: 
  • As per DelveInsight estimates, CIDP in the US showed that males account for the highest number of cases as compared to females in 2022.
  • The promising chronic inflammatory demyelinating polyneuropathy therapies in the pipeline include Panzyga, Efgartigimod, Batoclimab, SAR445088, Nipocalimab, and others.
  • Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare neurological disorder that causes progressive weakness and reduced sensation in the arms and legs.
  • CIDP shows itself through symmetrical weakness in the hands, feet, hips, and shoulders, gradually worsening over a minimum of two months.

GC Biopharma USA Announces Publication Describing Proprietary Cation Exchange Chromatography (CEX) Removing FXIa from a 10% Intravenous Immunoglobulin (GC5107) Preparation

Retrieved on: 
Tuesday, December 5, 2023
Frontiers in Cardiovascular Medicine, GC, Safety, Plasma, Kidney disease, Immobilization, CEX, Hemorheology, Patient, Biopharma LLC, IVIG, Manuscript, Cardiology, Pharmaceutical industry

TEANECK, N.J., Dec. 5, 2023 /PRNewswire/ -- GC Biopharma USA announced that a manuscript describing its landmark CEX technology, which removes FXIa from its 10% intravenous immunoglobulin (IVIG) preparation (GC5107), was published in Frontiers in Cardiovascular Medicine.

Key Points: 
  • TEANECK, N.J., Dec. 5, 2023 /PRNewswire/ -- GC Biopharma USA announced that a manuscript describing its landmark CEX technology, which removes FXIa from its 10% intravenous immunoglobulin (IVIG) preparation (GC5107), was published in Frontiers in Cardiovascular Medicine.
  • Numerous licensed IG products formulated for intravenous (IV) or subcutaneous administration are available.
  • GC Biopharma USA's rigorous studies have confirmed that a novel 10% IVIG manufacturing process, including CEX chromatography, is a reliable means of removing FXIa from the final preparation.
  • It is hoped that this novel proprietary manufacturing process will further support the product's safety—especially for high-risk patients who require IVIG.