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68% of anti-AChR antibody positive gMG patients treated with VYVGART (efgartigimod alfa-fcab) were responders on MG-ADL scale compared with 30% of patients treated with placebo during the first treatment cycle in the Phase 3 ADAPT trial.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2022
Details:
Positive opinion based on Phase 3 ADAPT trial showing Vyvgart (efgartigimod), an antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies provided clinically meaningful improvements in strength and quality of life measures.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2022
Details:
Efgartigimod is approved in the United States as VYVGART® for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and in Japan for the treatment of adults with gMG.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Medison Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 06, 2022
Details:
Interim data suggest long-term treatment with VYVGART (efgartigimod alfa-fcab), provides improvement in generalized myasthenia gravis (gMG) disease scores that remains consistent over multiple treatment cycles.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2022
Details:
ADAPT+ is the global Phase 3 open-label extension study evaluating long-term efficacy, safety and tolerability of VYVGART® (efgartigimod alfa-fcab) in adult patients with generalized myasthenia gravis (gMG).
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2022
Details:
Study met primary endpoint, demonstrating noninferior total IgG reduction at day 29 with subcutaneously administered Vyvgart (efgartigimod alfa-fcab) compared to intravenous (IV) administration.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Halozyme Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2022
Details:
The approval of VYVGART (efgartigimod alfa-fcab) for the treatment of gMG is based on results from the global Phase 3 ADAPT trial. The ADAPT trial met its primary endpoint with 68% anti-AChR antibody positive gMG patients responders on the MG-ADL scale.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2021
Details:
The findings confirm that patients with axSpA who achieve sustained remission benefit from continued certolizumab pegol treatment, either with the full or reduced maintenance dose - over treatment withdrawal.
Lead Product(s): Certolizumab Pegol
Therapeutic Area: Immunology Product Name: Cimzia
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2021
Details:
EMA has approved a label extension for CIMZIA for use in adult patients with axial spondyloarthritis (axSpA) at a reduced maintenance dose of 200 mg every four weeks, once sustained remission is achieved after one year of CIMZIA 200 mg every two weeks or 400 mg.
Lead Product(s): Certolizumab Pegol
Therapeutic Area: Immunology Product Name: Cimzia
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2020
Details:
The acquisition follows two years of successful partnership that brought the first-ever registered stem cell-based veterinary medicine to the European market.
Lead Product(s): Mesenchymal stem cell therapy
Therapeutic Area: Immunology Product Name: Arti-Cell
Highest Development Status: Approved Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Boehringer Ingelheim GmbH
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition July 27, 2020
