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Weekly News Recap #Phispers
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
About the Company : BIOTECHNICA DWC LLC has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies al...
About the Company : Conscientia Industrial is a pharmaceutical company, mainly developing, manufacturing, marketing APIs (Active Pharmaceutical Ingredients), intermediates, fine chemicals in China. We...
About the Company : The last few years have seen dramatic growth in outsourcing to India in all areas of technology. The trend has been particularly noticeable in the pharmaceuticals sector. Leading p...
About the Company : KinBio is a rapidly growing biopharmaceutical company based in Rehovot, Israel, with its main focus on developing needed therapies as well as offering a wide range of CDMO services...
About the Company : Established in 1997, Nanogen Pharmaceutical Biotechnology JSC has been striving to become a world-class innovative biotechnology company in the pharmaceutical industry. We are pro...
About the Company : Established in 1997, Nanogen Pharmaceutical Biotechnology JSC has been striving to become a world-class innovative biotechnology company in the pharmaceutical industry. We are pro...
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Details:
Tepkinly (epcoritamab) is an IgG1-bispecific antibody, which is evaluated for the treatment of diffuse large B-cell lymphoma. It is designed to direct cytotoxic T cells selectively.
Lead Product(s): Epcoritamab,Cyclophosphamide,Rituximab
Therapeutic Area: Oncology Brand Name: Tepkinly
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 09, 2024
Lead Product(s) : Epcoritamab,Cyclophosphamide,Rituximab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Two Data Analyses Show Epcoritamab Induces Durable Complete Responses
Details : Tepkinly (epcoritamab) is an IgG1-bispecific antibody, which is evaluated for the treatment of diffuse large B-cell lymphoma. It is designed to direct cytotoxic T cells selectively.
Product Name : Tepkinly
Product Type : Antibody
Upfront Cash : Inapplicable
December 09, 2024
Details:
Updates are based on more than five years of Phase 3 iNNOVATE final analysis data, which demonstrated IMBRUVICA plus rituximab significantly prolonged progression-free survival (PFS) versus rituximab alone in adults with WM.
Lead Product(s): Ibrutinib,Rituximab
Therapeutic Area: Oncology Brand Name: Imbruvica
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 23, 2020
Lead Product(s) : Ibrutinib,Rituximab
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
IMBRUVICA® (ibrutinib) U.S. Prescribing Information Updated to Include Long-Term Data for Waldens...
Details : Updates are based on more than five years of Phase 3 iNNOVATE final analysis data, which demonstrated IMBRUVICA plus rituximab significantly prolonged progression-free survival (PFS) versus rituximab alone in adults with WM.
Product Name : Imbruvica
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 23, 2020
Details:
Submission is based on results of more than five years of follow-up data from the Phase 3 iNNOVATE clinical trial evaluating IMBRUVICA in combination with rituximab for patients with WM. This is the longest follow-up data available for a BTK inhibitor in WM.
Lead Product(s): Ibrutinib,Rituximab
Therapeutic Area: Oncology Brand Name: Imbruvica
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 23, 2020
Lead Product(s) : Ibrutinib,Rituximab
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
AbbVie Reports IMBRUVICA® (ibrutinib) Seeks to Expand U.S. Label with Long-Term Data in Waldenstr...
Details : Submission is based on results of more than five years of follow-up data from the Phase 3 iNNOVATE clinical trial evaluating IMBRUVICA in combination with rituximab for patients with WM. This is the longest follow-up data available for a BTK inhibitor in...
Product Name : Imbruvica
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 23, 2020
Details:
Phase 3 MURANO trial shows median progression-free survival of 53.6 months in previously treated CLL patients taking VENCLEXTA/VENCLYXTO in combination with rituximab Vs. 17.0 months in patients taking bendamustine plus rituximab after three years or more off treatment.
Lead Product(s): Venetoclax,Rituximab
Therapeutic Area: Oncology Brand Name: Venclexta
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: F. Hoffmann-La Roche
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 12, 2020
Lead Product(s) : Venetoclax,Rituximab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : F. Hoffmann-La Roche
Deal Size : Inapplicable
Deal Type : Inapplicable
AbbVie Presents Extended Follow-Up Data for Fixed Duration Treatment VENCLEXTA®/VENCLYXTO® in Ch...
Details : Phase 3 MURANO trial shows median progression-free survival of 53.6 months in previously treated CLL patients taking VENCLEXTA/VENCLYXTO in combination with rituximab Vs. 17.0 months in patients taking bendamustine plus rituximab after three years or mor...
Product Name : Venclexta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 12, 2020
Details:
Ituxredi (rituximab) is an anti-CD20 monoclonal antibody, which is indicated for the treatment of non-hodgkin’s lymphoma, chronic lymphocytic leukemia & rheumatoid arthritis.
Lead Product(s): Rituximab
Therapeutic Area: Oncology Brand Name: Ituxredi
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 29, 2024
Dr. Reddy’s Receives Positive CHMP Opinion from EMA for its Proposed Rituximab Biosimilar
Details : Ituxredi (rituximab) is an anti-CD20 monoclonal antibody, which is indicated for the treatment of non-hodgkin’s lymphoma, chronic lymphocytic leukemia & rheumatoid arthritis.
Product Name : Ituxredi
Product Type : Antibody
Upfront Cash : Inapplicable
July 29, 2024
Details:
DRL_RI is being developed as a biosimilar of Rituxan/MabThera (rituximab), a CD20 directed cytolytic antibody for various indications including treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, and pemphigus vulgaris.
Lead Product(s): Rituximab
Therapeutic Area: Immunology Brand Name: Ituxredi
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 07, 2023
Lead Product(s) : Rituximab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Dr. Reddy’s Proposed Rituximab Biosimilar Application Accepted for Review by USFDA, EMA and MHRA
Details : DRL_RI is being developed as a biosimilar of Rituxan/MabThera (rituximab), a CD20 directed cytolytic antibody for various indications including treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, ...
Product Name : Ituxredi
Product Type : Antibody
Upfront Cash : Inapplicable
December 07, 2023
Details:
DRL_RI is being developed as a biosimilar of rituximab, CD20 directed cytolytic antibody for various indications including treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, pemphigus vulgaris etc.
Lead Product(s): Rituximab
Therapeutic Area: Oncology Brand Name: Ituxredi
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 19, 2023
Dr. Reddy’s Successfully Completes Full Set Of Clinical Studies Of Its Rituximab Biosimilar For ...
Details : DRL_RI is being developed as a biosimilar of rituximab, CD20 directed cytolytic antibody for various indications including treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, pemphigus vulgaris et...
Product Name : Ituxredi
Product Type : Antibody
Upfront Cash : Inapplicable
January 19, 2023
Details:
PTG-007 is a Treg therapy, which is currently being evaluated for preventing symptomatic type 1 diabetes in children.
Lead Product(s): PTG-007,Rituximab
Therapeutic Area: Endocrinology Brand Name: PTG-007
Study Phase: Phase IIProduct Type: Cell and Gene therapy
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 15, 2025
Lead Product(s) : PTG-007,Rituximab
Therapeutic Area : Endocrinology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EMA Backs PolTREG Pediatric Plan for Treg Therapy in Type 1 Diabetes
Details : PTG-007 is a Treg therapy, which is currently being evaluated for preventing symptomatic type 1 diabetes in children.
Product Name : PTG-007
Product Type : Cell and Gene therapy
Upfront Cash : Inapplicable
May 15, 2025
Details:
BI-1206, an antibody targeting FcγRIIB, given in combination with rituximab and acalabrutinib is being evaluated in subjects with indolent B-cell non-hodgkin's lymphoma.
Lead Product(s): BI-1206,Acalabrutinib,Rituximab
Therapeutic Area: Oncology Brand Name: BI-1206
Study Phase: Phase I/ Phase IIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 14, 2025
Lead Product(s) : BI-1206,Acalabrutinib,Rituximab
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
BioInvent Shares Updated Phase 2a Data of BI-1206 Combo for Lymphoma
Details : BI-1206, an antibody targeting FcγRIIB, given in combination with rituximab and acalabrutinib is being evaluated in subjects with indolent B-cell non-hodgkin's lymphoma.
Product Name : BI-1206
Product Type : Antibody
Upfront Cash : Inapplicable
May 14, 2025
Details:
Epkinly (epcoritamab) is a bispecific CD20/CD3 T-cell engager therapy being investigated for adult patients with relapsed/refractory follicular lymphoma in combination with rituximab and lenalidomide.
Lead Product(s): Epcoritamab,Lenalidomide,Rituximab
Therapeutic Area: Oncology Brand Name: Epkinly
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 01, 2025
Lead Product(s) : Epcoritamab,Lenalidomide,Rituximab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Genmab Plans sBLA for Epcoritamab Plus R2 in Relapsed/Refractory FL Patients
Details : Epkinly (epcoritamab) is a bispecific CD20/CD3 T-cell engager therapy being investigated for adult patients with relapsed/refractory follicular lymphoma in combination with rituximab and lenalidomide.
Product Name : Epkinly
Product Type : Antibody
Upfront Cash : Inapplicable
May 01, 2025
Regulatory Info :
Registration Country : South Korea
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Registration Country : South Korea
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : TRUXIMA
Dosage Form : SOLUTION
Dosage Strength : 100MG/10ML
Packaging : 10 ML
Approval Date :
Application Number : 2478382
Regulatory Info : Prescription
Registration Country : Canada
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Registration Country : Australia
Brand Name : Truxima
Dosage Form :
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Packaging : 2
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Registration Country : Australia
Brand Name : Truxima
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Registration Country : Australia
Regulatory Info :
Registration Country : Italy
Brand Name : Mabthera
Dosage Form : Rituximab 500Mg 50Ml 1 Units Parenteral Use
Dosage Strength : 1 vial EV 500 mg 50 ml 10 mg/ml
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Registration Country : Italy
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Registration Country : Switzerland
Brand Name : MabThera subcutane
Dosage Form : Inj L?s
Dosage Strength : 1600mg/13.4ml
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Registration Country : Switzerland
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : RISTOVA® 500
Dosage Form : INF
Dosage Strength : 10mg/ml
Packaging : 50X1mg/ml
Approval Date :
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Regulatory Info : Generic
Registration Country : South Africa
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Registration Country : USA
Brand Name : RITUXAN
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 500MG/50ML (10MG/ML)
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Application Number : 103705
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Registration Country : USA
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Registration Country : Australia
Brand Name : Ruxience
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Packaging : 1
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Registration Country : Australia
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Registration Country : USA
Brand Name : RUXIENCE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 100MG/10ML(10MG/ML)
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Application Number : 761103
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Registration Country : USA
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Registration Country : South Korea
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Registration Country : Iran
Brand Name : Zytux
Dosage Form : Injectable
Dosage Strength : 100MG
Packaging : Vial
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Regulatory Info :
Registration Country : Iran
Packaging : Vial
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Dosage : Injectable
Dosage Strength : 100MG
Brand Name : Zytux
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Registration Country : Iran
Regulatory Info :
Registration Country : Iran
Brand Name : Zytux
Dosage Form : Injectable
Dosage Strength : 500MG
Packaging : Vial
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Registration Country : Iran
Packaging : Vial
Regulatory Info :
Dosage : Injectable
Dosage Strength : 500MG
Brand Name : Zytux
Approval Date :
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Registration Country : Iran
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