API Suppliers
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
0
U.S. Medicaid
Annual Reports
0
Details:
Tysabri® (natalizumab) - a monotherapy for adult patients with relapsing-remitting multiple sclerosis (RRMS) and adults with moderately-to-severely active Crohn’s disease.
Lead Product(s): Natalizumab
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 29, 2022
Details:
PB006 (natalizumab) is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple sclerosis lesion accumulation.
Lead Product(s): Natalizumab
Therapeutic Area: Neurology Product Name: PB006
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Sandoz B2B
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 25, 2022
Details:
Natalizumab a proposed biosimilar to Tysabri is a humanised monoclonal antibody that blocks integrin α4β1-mediated leukocyte migration from blood vessels to the brain and prevent highly active relapsing-remitting multiple sclerosis.
Lead Product(s): Natalizumab
Therapeutic Area: Neurology Product Name: PB006
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Sandoz B2B
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2022
Details:
Tyruko (natalizumab-sztn - biosimilar) is a highly effective anti-α4 integrin monoclonal antibody. It is indicated for the treatment of relapsing-remitting forms of multiple sclerosis.
Lead Product(s): Natalizumab
Therapeutic Area: Neurology Product Name: Tyruko
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 31, 2024
Details:
BioLineRx initiated Phase I clinical trial studies evaluating BL-8040 (motixafortide), CXCR4/SDF-1 inhibitor, as monotherapy and in combination with natalizumab for the treatment of sickle cell disease.
Lead Product(s): Motixafortide,Natalizumab
Therapeutic Area: Hematology Product Name: BL-8040
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2023
Details:
Aphexda (motixafortide) is a CXCR4 antagonist , which is investigated in combination with gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancers.
Lead Product(s): Motixafortide,Natalizumab
Therapeutic Area: Oncology Product Name: Aphexda
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2023
Details:
Natalizumab biosimilar is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple sclerosis lesion accumulation.
Lead Product(s): Natalizumab
Therapeutic Area: Neurology Product Name: PB006
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 24, 2023
Details:
BL-8040 (motixafortide) inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC).
Lead Product(s): Motixafortide,Natalizumab
Therapeutic Area: Oncology Product Name: BL-8040
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 17, 2023
Details:
The aim of the collaboration is to advance a Phase 1 clinical trial that will evaluate the safety and feasibility of BL-8040 (motixafortide) to mobilize CD34+ hematopoietic stem cells (HSCs) for gene therapies in sickle cell disease (SCD).
Lead Product(s): Motixafortide,Natalizumab
Therapeutic Area: Genetic Disease Product Name: BL-8040
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Washington University School of Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 06, 2023
Details:
An updated analysis of Tysabri, confirms results from earlier analyses, which found that EID with IV administration of natalizumab is associated with a significantly lower risk of progressive multifocal leukoencephalopathy (PML) than the approved every four-week (Q4W) dosing.
Lead Product(s): Natalizumab
Therapeutic Area: Neurology Product Name: Tysabri
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2022
Details:
TYSABRI is a well-established treatment indicated for relapsing forms of multiple sclerosis (MS) in adults that has been proven in clinical trials to slow physical disability progression, reduce the formation of new brain lesions and cut relapses.
Lead Product(s): Natalizumab
Therapeutic Area: Neurology Product Name: Tysabri
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2021
Details:
The SC and IV formulations of Tysabri are dosed 300mg, every four weeks by a healthcare provider, but the SC option expands the clinical settings for treatment beyond infusion centres, and offers a shortened time-frame for administration.
Lead Product(s): Natalizumab
Therapeutic Area: Neurology Product Name: Tysabri
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2021