API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
0
USA (Orange Book)
Europe
0
Canada
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
Under the agreement, Incyte gains exclusive global rights for tafasitamab, a humanized Fc-modified CD19-targeting immunotherapy marketed in the U.S. as Monjuvi (tafasitamab-cxix) and outside of the U.S. as Minjuvi (tafasitamab).
Lead Product(s): Tafasitamab
Therapeutic Area: Oncology Product Name: Monjuvi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: $25.0 million Upfront Cash: Undisclosed
Deal Type: Agreement February 05, 2024
Details:
Minjuvi (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting immunotherapy, which is approved in combination with lenalidomide has been approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Minjuvi
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 21, 2024
Details:
Monjuvi® and Minjuvi® (tafasitamab) is a humanized Fc-modified CD19 targeting immunotherapy used in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Minjuvi
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 28, 2023
Details:
Monjuvi® and Minjuvi® (tafasitamab) is a humanized Fc-modified CD19 targeting immunotherapy used in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Monjuvi
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 27, 2022
Details:
Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases. Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy.
Lead Product(s): Orelabrutinib,Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Hibruka
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2022
Details:
Plamotamab (XmAb13676), is generally well tolerated and demonstrates encouraging clinical activity at our recommended intravenous Phase 2 dose, 50 mg flat dosing every two weeks after step-up dosing.
Lead Product(s): Plamotamab,Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: XmAb13676
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Details:
The body of data presented at SOHO shows the long-term duration of response to Monjuvi (tafasitamab) in some patients with relapsed or refractory diffuse large B-cell lymphoma not eligible for autologous stem-cell transplant.
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Monjuvi
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 28, 2022
Details:
Monjuvi (tafasitamab) incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity and Antibody-Dependent Cellular Phagocytosis.
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Monjuvi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: MorphoSys
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2022
Details:
Minjuvi (tafasitamab) incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Minjuvi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2022
Details:
Minjuvi (tafasitamab) incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Minjuvi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2022
Details:
Under the terms of the agreement, Pfizer will initiate a multicenter, international Phase 1b/2 study of TTI-622 with Monjuvi and lenalidomide for patients with relapsed or refractory DLBCL who are not eligible for ASCT.
Lead Product(s): TTI-622,Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: TTI-622
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 13, 2022
Details:
Monjuvi (tafasitamab-cxix), is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab.
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Monjuvi
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 12, 2022
Details:
Under the terms of the agreement, Incyte will be responsible for the development, manufacture and supply of both products tafasitamab (sold as Monjuvi) and pemigatinib (Pemazyre) and ST will be responsible for regulatory, distribution and local marketing related activities.
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Minjuvi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 22, 2021
Details:
Minjuvi (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Minjuvi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: MorphoSys
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2021
Details:
InnoCare will receive the rights to develop and exclusively commercialize tafasitamab in hematology and oncology in mainland China, Hong Kong, Macau and Taiwan.
Lead Product(s): Tafasitamab,Orelabrutinib
Therapeutic Area: Oncology Product Name: Monjuvi
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: InnoCare Pharma
Deal Size: $117.5 million Upfront Cash: $35.0 million
Deal Type: Collaboration August 16, 2021
Details:
If approved, tafasitamab would be commercialized in the EU under the brand name Minjuvi®. The positive opinion from the CHMP is based on data from the Phase 2 L-MIND study evaluating tafasitamab in combination with lenalidomide for patients with relapsed or refractory DLBCL.
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Minjuvi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: MorphoSys
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2021
Details:
U.S Food and Drug Administration approved Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma & who are not eligible for ASCT.
Lead Product(s): Tafasitamab,Lenalidomide,Rituximab
Therapeutic Area: Oncology Product Name: Monjuvi
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 June 25, 2021
Details:
The data showed a preliminary response rate of 91.1% across both arms in a patient population that overall had a poor prognosis, and that the combination of tafasitamab, lenalidomide and R-CHOP has an acceptable tolerability profile.
Lead Product(s): Tafasitamab,Lenalidomide,Rituximab
Therapeutic Area: Oncology Product Name: Monjuvi
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: MorphoSys
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2021
Details:
Under the terms of the agreement, the companies plan to initiate a Phase 1/2 study evaluating the combination of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory DLBCL.
Lead Product(s): Plamotamab,Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: XmAb 13676
Highest Development Status: UndisclosedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Xencor
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration November 11, 2020
Details:
Tafasitamab is MorphoSys' CD19-directed antibody which was recently approved by the U.S. FDA in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Monjuvi(R)
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 04, 2020
Details:
Monjuvi, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, has been approved under accelerated approval by the U.S. FDA based on overall response rate (ORR).
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Monjuvi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2020
Details:
Xencor has earned the milestone payment from MorphoSys under the license agreement between the companies for Monjuvi in connection with the regulatory approval.
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Monjuvi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: MorphoSys
Deal Size: $25.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 31, 2020
Details:
The MAA seeks approval of tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2020
Details:
After a minimum of two years' follow-up, outcomes from the L-MIND study are consistent with the primary analysis and confirm the durability of the response and overall survival of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy.
Lead Product(s): Tafasitamab,Lenalidomide
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2020
Details:
The EAP may provide access to tafasitamab for use in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) in combination with lenalidomide.
Lead Product(s): Tafasitamab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 04, 2020
Details:
MorphoSys and Incyte will co-commercialize tafasitamab in the U.S., while Incyte has exclusive commercialization rights outside of the U.S.
Lead Product(s): Tafasitamab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: $2,000.0 million Upfront Cash: $750.0 million
Deal Type: Collaboration January 13, 2020