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Details:
Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone is being evaluated in phase 3 clinical trials for the maintenance treatment of adult patients who are newly diagnosed with multiple myeloma.
Lead Product(s): Daratumumab,Hyaluronidase,Lenalidomide
Therapeutic Area: Oncology Product Name: Darzalex Faspro
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 January 30, 2024
Details:
Hyqvia is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins (Ig). It is approved as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Lead Product(s): Immune Globulin,Hyaluronidase
Therapeutic Area: Neurology Product Name: HyQvia
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 29, 2024
Details:
Efgartigimod SC (efgartigimod alfa and hyaluronidase-qvfc) subcutaneous injection is being evaluated in phase 3 clinical trials for the treatment of pemphigus vulgaris (PV) and pemphigus foliaceus (PF).
Lead Product(s): Efgartigimod Alfa,Hyaluronidase
Therapeutic Area: Immunology Product Name: Efgartigimod SC
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 December 19, 2023
Details:
Darzalex Faspro (daratumumab) is a CD38 inhibitor antibody drug candidate, which is currently being evaluated in combination with hyaluronidase & bortezomib for the treatment of patients with newly diagnosed multiple myeloma.
Lead Product(s): Daratumumab,Hyaluronidase,Bortezomib
Therapeutic Area: Oncology Product Name: Darzalex Faspro
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 12, 2023
Details:
VYVGART Hytrulo, a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment, and recombinant human hyaluronidase PH20, Halozyme’s ENHANZE® drug delivery technolog, is being developed for in adults with primary immune thrombocytopenia (ITP).
Lead Product(s): Efgartigimod Alfa,Hyaluronidase
Therapeutic Area: Immunology Product Name: Vyvgart Hytrulo
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 November 28, 2023
Details:
EC approved VYVGART (efgartigimod alfa and hyaluronidase-qvfc) injection with ENHANZE for subcutaneous (SC) use for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
Lead Product(s): Efgartigimod Alfa,Hyaluronidase
Therapeutic Area: Immunology Product Name: Vyvgart Hytrulo
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2023
Details:
Hyqvia® is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins (Ig) and approved in the United States to treat adults and children two years of age and older with primary immunodeficiency (PI).
Lead Product(s): Immunoglobulin G 285-292,Hyaluronidase
Therapeutic Area: Immunology Product Name: Hyqvia
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 11, 2023
Details:
Data showed HYQVIA (immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase), reduced relapse of neuromuscular disability and impairment when used maintenance therapy for CIDP, supporting its potential as fSCIG solution for many CIDP patients.
Lead Product(s): Immunoglobulin G 285-292,Hyaluronidase
Therapeutic Area: Neurology Product Name: Hyqvia
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 21, 2022
Details:
Phesgo (pertuzumab) is the world's first fixed dose combination of two monoclonal antibodies Perjeta (pertuzumab) and Herceptin (trastuzumab) in Oncology for the treatment of HER - 2 positive breast cancer.
Lead Product(s): Pertuzumab,Trastuzumab,Hyaluronidase
Therapeutic Area: Oncology Product Name: Phesgo
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2022
Details:
Approval of daratumumab SC-based regimen in Light Chain (AL) amyloidosis is supported by the Phase 3 ANDROMEDA study, which demonstrated significantly higher haematologic complete response rate vs. commonly used standard-of-care regimen.
Lead Product(s): Daratumumab,Hyaluronidase,Bortezomib
Therapeutic Area: Genetic Disease Product Name: Darzalex Faspro
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2021
Details:
DARZALEX FASPRO® is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma and now AL amyloidosis.
Lead Product(s): Daratumumab,Hyaluronidase,Bortezomib
Therapeutic Area: Genetic Disease Product Name: Darzalex Faspro
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2021
Details:
The data showed a significantly higher complete hematologic response rate with DARZALEX FASPRO® treatment in patients with Light Chain Amyloidosis compared to the standard regimen and consistent decreases in markers of disease, indicative of deep hematologic responses.
Lead Product(s): Daratumumab,Hyaluronidase,Cyclophosphamide
Therapeutic Area: Genetic Disease Product Name: Darzalex
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 December 07, 2020
Details:
DARZALEX FASPRO® significantly reduced the risk of progression or death by 37 percent when added to Pd, compared to Pd alone (hazard ratio, 0.63; 95 percent confidence interval).
Lead Product(s): Daratumumab,Hyaluronidase,Pomalidomide
Therapeutic Area: Oncology Product Name: Darzalex Faspro
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 04, 2020
Details:
Phesgo offers faster and less invasive delivery of standard of care treatment with Perjeta and Herceptin, under the skin in just minutes, compared to hours with intravenous infusion.
Lead Product(s): Pertuzumab,Trastuzumab,Hyaluronidase
Therapeutic Area: Oncology Product Name: Phesgo
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2020
Details:
The submission is based on the Phase 3 ANDROMEDA study of daratumumab and hyaluronidase-fihj in combination with VCd as treatment for patients with newly diagnosed AL amyloidosis.
Lead Product(s): Daratumumab,Hyaluronidase,Cyclophosphamide
Therapeutic Area: Genetic Disease Product Name: Darzalex
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
HYQVIA is now indicated for use as a replacement therapy in adults, children and adolescents (0-18 years) with SID who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven scientific antibody failure or serum IgG level of <4 g/l.
Lead Product(s): Immunoglobulin G 285-292,Hyaluronidase
Therapeutic Area: Immunology Product Name: Hyqvia
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2020
Details:
The sBLA is supported by positive results from the Phase 3 ANDROMEDA study. ANDROMEDA evaluated subcutaneous daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone compared to VCd alone and met its primary endpoint.
Lead Product(s): Daratumumab,Hyaluronidase,Cyclophosphamide
Therapeutic Area: Genetic Disease Product Name: Darzalex Faspro
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 September 10, 2020
Details:
The milestone payment is associated with the first commercial sale in the United States of Janssen's DARZALEX FASPROTM (daratumumab and hyaluronidase - fihj) utilizing ENHANZE®, which was recently approved by the U.S. Food and Drug Administration.
Lead Product(s): Daratumumab,Hyaluronidase
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 14, 2020
Details:
The NDA is supported by data from the Phase 3 COLUMBA study which compared daratumumab SC formulation vs daratumumab IV administration in patients with multiple myeloma.
Lead Product(s): Daratumumab,Hyaluronidase
Therapeutic Area: Oncology 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 April 26, 2020
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