GMG

argenx Announces Approval of VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Japan for Generalized Myasthenia Gravis

Retrieved on: 
Thursday, January 18, 2024
Patient, Euronext, Steroid, Immunoglobulin G, GMG, MHLW, Autoimmunity, Efgartigimod alfa, Pharmaceutical industry

Following this decision, VYVGART is now approved in Japan for both intravenous (IV) and self-administered SC use.

Key Points: 
  • Following this decision, VYVGART is now approved in Japan for both intravenous (IV) and self-administered SC use.
  • “Today’s approval of VYVDURA marks a significant milestone for the gMG community in Japan and furthers our commitment to deliver innovative treatments to autoimmune patients globally,” said Hermann Strenger, General Manager, argenx Japan.
  • ADAPT-SC established the efficacy of VYVDURA by demonstrating a reduction in percent change from baseline in total immunoglobulin G (IgG) levels comparable to VYVGART IV in adult gMG patients.
  • ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of VYVGART in Japan in January 2022.

Cabaletta Bio Receives Additional FDA Fast Track Designations for CABA-201 in Dermatomyositis and Systemic Sclerosis

Retrieved on: 
Monday, January 8, 2024
Dermatomyositis, Food, GMG, IND, Research, FDA, SLE, Organ dysfunction, Scleroderma, Investigational New Drug, Systemic scleroderma, Myositis, Patient, Lupus nephritis, Pharmaceutical industry

PHILADELPHIA, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted separate Fast Track Designations to CABA-201, an investigational 4-1BB-containing fully human CD19-CAR T cell therapy, for the treatment of patients with dermatomyositis to improve disease activity and for the treatment of patients with systemic sclerosis (SSc) to improve associated organ dysfunction.

Key Points: 
  • “The additional Fast Track Designations for CABA-201 in both dermatomyositis and systemic sclerosis, the second and third Fast Track Designations for CABA-201, provide the opportunity for expedited development and review of CABA-201 for the treatment of these autoimmune indications where there is a significant unmet need, despite currently available therapies,” said David J. Chang, M.D., Chief Medical Officer of Cabaletta.
  • “We believe these designations potentially accelerate our ability to launch the first targeted, and potentially curative, cell therapy for autoimmune diseases driven by B cells.
  • To date, Cabaletta has received clearance from the FDA for Investigational New Drug (IND) applications for CABA-201 in multiple autoimmune conditions including systemic lupus erythematosus (SLE), myositis, SSc and generalized myasthenia gravis (gMG).
  • Cabaletta is conducting four Phase 1/2 clinical trials with a total of nine cohorts that can advance simultaneously, employing a similar parallel cohort design and starting dose of 1 x 106 cells/kg without a dose escalation requirement.

argenx Highlights 2024 Strategic Priorities

Retrieved on: 
Monday, January 8, 2024
Immunoglobulin therapy, GMG, FDA, PRV, Congenital myasthenic syndrome, ARDA, Research Councils UK, Euronext, Inflammation, Cohort, PGIC, NRDL, Autoimmunity, Efgartigimod alfa, Dermatomyositis, Conference, MuSK protein, IND, CIDP, Pharmacokinetics, MMN, Safety, Therapy, Patient, ALS, Immune system, IL-6, Medicine, International Myeloma Foundation, IIP, FSS, Neonatal Fc receptor, Multifocal motor neuropathy, Growth, Pharmaceutical industry

argenx is planning to reach more patients commercially in 2024 through its multi-dimensional expansion efforts.

Key Points: 
  • argenx is planning to reach more patients commercially in 2024 through its multi-dimensional expansion efforts.
  • In addition, ARGX-119, a muscle-specific kinase (MuSK) agonist, will initiate Phase 1b/2a studies in congenital myasthenic syndrome and amyotrophic lateral sclerosis in 2024.
  • As of December 31, 2023, argenx had approximately $3.2 billion in cash, cash equivalents and current financial assets*.
  • Based on its current operating plans, argenx expects its combined R&D and SG&A expenses in 2024 to be less than $2 billion.

Rallybio Highlights Portfolio Advances and Outlines Expected Milestones in 2024

Retrieved on: 
Thursday, January 4, 2024
Research, Finance, Clinical Trials, Professional Services, Biotechnology, Health, Pharmaceutical, General Health, Science, Conference, Geographic atrophy, Food, GMG, Risk, Woman, EMA, Paratriathlon, Data, Injection site reaction, AbCellera, HPP, Antiphospholipid syndrome, European Medicines Agency, Pregnancy, Corporation, DSM-IV codes, C5, Hypophosphatasia, ENPP1, Investment, Webcast, Patient, Therapy, Pharmaceutical industry

Rallybio expects to initiate its Phase 2 dose confirmation study for RLYB212 in the second half of 2024.

Key Points: 
  • Rallybio expects to initiate its Phase 2 dose confirmation study for RLYB212 in the second half of 2024.
  • Rallybio expects to complete this manufacturing work and provide an update on the development plan for RLYB116 in the second half of 2024.
  • Rallybio and EyePoint expect to provide an update on this collaboration in the first half of 2024.
  • Rallybio and Exscientia plan to provide an update on the progress of the program in the second half of 2024.

ZILBRYSQ® (zilucoplan) Is Now Commercially Available in the U.S. for the Treatment of Generalized Myasthenia Gravis (gMG) in Adult Patients Who Are Anti-Acetylcholine Receptor (AChR) Antibody Positive

Retrieved on: 
Wednesday, January 3, 2024
Food, Acetylcholine receptor, GMG, Risk, Health care, MuSK protein, Caregiver, Diarrhea, FDA, Eyelid, Disease, Muscle weakness, REMS, Myasthenia gravis, UCB, Insurance, Patient, Pharmacy, Pharmaceutical industry

ZILBRYSQ® (zilucoplan) is now commercially available by prescription in the United States and dispensed by UCB's selected exclusive specialty pharmacy PANTHERx® Rare Pharmacy.

Key Points: 
  • ZILBRYSQ® (zilucoplan) is now commercially available by prescription in the United States and dispensed by UCB's selected exclusive specialty pharmacy PANTHERx® Rare Pharmacy.
  • The most common side effects of ZILBRYSQ include injection site reactions, upper respiratory tract infections, and diarrhea.
  • This support includes refresher injection coaching and information on symptom tracking and ongoing treatment support, as well as help in understanding insurance coverage.
  • If an eligible patient or caregiver is looking for support, please visit http://www.UCBONWARD.com or call 1-844-ONWARD.

Human medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Patient, Medical Subject Headings, Marketing, Meningococcal disease, Protein, Acetylcholine receptor, Autoantibody, INN, GMG, Immune system, Fatigue, Risk, ATC, Antibody, Pain, International, Disease, Nose, Language, Muscle weakness, Vaccination, Neisseria meningitidis, European Medicines Agency, C5, Select, Bruise, Safety, Time, Anatomy, Contract management, Disorder, IIA, Medical device

Human medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Status: Authorised

Human medicines European public assessment report (EPAR): Vyvgart, efgartigimod alfa, Date of authorisation: 10/08/2022, Revision: 6, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Urine, Medical Subject Headings, Marketing, Protein, Acetylcholine receptor, Autoantibody, INN, GMG, Immune system, Fatigue, Lower respiratory tract infection, Infection, ATC, Antibody, International, Disease, Nose, Language, Blood, Muscle weakness, Urinary tract infection, Medicine, B cell, Neonatal Fc receptor, European Medicines Agency, Acetylcholine, Select, Patient, Anatomy, IIA, Medical device

Human medicines European public assessment report (EPAR): Vyvgart, efgartigimod alfa, Date of authorisation: 10/08/2022, Revision: 6, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Vyvgart, efgartigimod alfa, Date of authorisation: 10/08/2022, Revision: 6, Status: Authorised

Graphene Manufacturing Group Commissions Modular Graphene Production Plant

Retrieved on: 
Tuesday, December 19, 2023
GMG, Plasma, PMN, Hydrogen, EPA, The Company, Graphene, Automation, Natural gas, Carbon fibers

BRISBANE, AUS, Dec 19, 2023 - (ACN Newswire) - Graphene Manufacturing Group Limited (TSXV: GMG) ("GMG" or the "Company") is pleased to announce the commissioning of its cutting-edge natural gas to graphene production plant in manufacturing facility at Richlands, Australia.

Key Points: 
  • BRISBANE, AUS, Dec 19, 2023 - (ACN Newswire) - Graphene Manufacturing Group Limited (TSXV: GMG) ("GMG" or the "Company") is pleased to announce the commissioning of its cutting-edge natural gas to graphene production plant in manufacturing facility at Richlands, Australia.
  • GMG expects to be able to install at least an additional 20 graphene production units in the Richlands manufacturing facility with most of the supporting infrastructure for these additional production units already installed as part of this initial project.
  • To view an enhanced version of this graphic, please visit:https://images.newsfilecorp.com/files/8082/191561_fe3fb3fb542d4851_001fu...
    The details of the new modular Graphene Production Plant:
    - Technology is based on GMG's self developed plasma technology which splits natural gas into graphene and hydrogen gas.
  • - The Company expects that Graphene production from both its existing plant and this newly started up plant will be adequate for next year's production.

Rio Tinto & GMG Battery Partnership Video Launch

Retrieved on: 
Monday, November 13, 2023
JDA, Rio Tinto, GMG, Partnership, Mineral, Mining, Success, Heart, Original equipment manufacturer, Investment, Carbon, Originality, Energy, The Company, Graphene

BRISBANE, AUS, Nov 13, 2023 - (ACN Newswire) - Graphene Manufacturing Group Limited (TSXV: GMG) ("GMG" or the "Company") is pleased to provide a business update on the battery development partnership with Rio Tinto ("Rio Tinto").

Key Points: 
  • BRISBANE, AUS, Nov 13, 2023 - (ACN Newswire) - Graphene Manufacturing Group Limited (TSXV: GMG) ("GMG" or the "Company") is pleased to provide a business update on the battery development partnership with Rio Tinto ("Rio Tinto").
  • The launch of this promotional video will celebrate the partnership between GMG and Rio Tinto to develop graphene aluminium ion batteries.
  • Rio Tinto will seek to involve Original Equipment Manufacturers ("OEMs"), including Heavy Mobile Equipment OEMs, to work with GMG and Rio Tinto to align the battery pack development with end-use requirements.
  • Rio Tinto Chief Scientist, Nigel Steward, said, "We are excited with the progress made with our partnership with GMG to date.

Rallybio Announces Preliminary Phase 1 Multiple Ascending Dose Data for RLYB116, an Innovative Subcutaneously Injected Inhibitor of Complement Component 5

Retrieved on: 
Wednesday, December 20, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, GMG, ISR, Aes, Half-life, Incidence, Injection site reaction, Pharmacokinetics, PD, History, Hepatitis, Antiphospholipid syndrome, Corporation, C5, Investment, Webcast, Patient, Safety, Pharmaceutical industry

Rallybio Corporation (Nasdaq: RLYB) today announced preliminary Phase 1 multiple ascending dose (MAD) data for RLYB116, an innovative, long-acting, low volume subcutaneously injected inhibitor of complement component 5 (C5), in development for patients with complement-mediated diseases.

Key Points: 
  • Rallybio Corporation (Nasdaq: RLYB) today announced preliminary Phase 1 multiple ascending dose (MAD) data for RLYB116, an innovative, long-acting, low volume subcutaneously injected inhibitor of complement component 5 (C5), in development for patients with complement-mediated diseases.
  • The Phase 1 MAD study for RLYB116 evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous RLYB116 in healthy participants with multiple dose administration.
  • The reduction in free C5 at 24 hours after the first dose of 100 mg was greater than 99%.
  • “The preliminary results from this Phase 1 multiple ascending dose study of RLYB116 support continued development in patients with gMG,” said Eric Watsky, M.D., RLYB116 Program Lead for Rallybio.