[{"orgOrder":0,"company":"Fresenius Kabi AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fresenius Kabi\u2019s Regulatory Submission for Pegfilgrastim Biosimilar Accepted for Review By EMA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Fresenius Kabi AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts for Review Fresenius Kabi\u2019s BLA Submission for Pegfilgrastim Biosimilar","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase 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Brazil","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"BRAZIL","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"BeyondSpring","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Beyondspring Submits New Drug Application to FDA and China NMPA for Plinabulin and G-CSF Combination for Chemotherapy-Induced Neutropenia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"BeyondSpring","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BeyondSpring Submits NDA to U.S. FDA and China NMPA for Plinabulin and G-CSF Combo for Prevention of Chemotherapy-Induced Neutropenia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Monopar Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Monopar Initiates Open-Label Phase 1b Clinical Trial Evaluating Camsirubicin in Patients with Advanced Soft Tissue Sarcoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Monopar Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not 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Global","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Large molecule","productStatus":"Biosimilar","date":"March 2022","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"BeyondSpring","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BeyondSpring Presents New Data for the Use of Plinabulin and Pegfilgrastim to Decrease Neutropenia Burden in Peri-Transplant Multiple Myeloma Patients at the 19th International Myeloma Society Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Fresenius Kabi AB Brunna","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not 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Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Monopar Announces Camsirubicin Clinical Program Update - Improved Side Effect Profile Seen to Date Compared to Doxorubicin","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Coherus Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves UDENYCA\u00ae Autoinjector","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"March 2023","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"Coherus Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Coherus Announces U.S. Launch of UDENYCA Autoinjector","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2023","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"Monopar Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Monopar Announces Encouraging Camsirubicin Phase 1b Trial Update","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Monopar Therapeutics","sponsor":"Not 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Pegfilgrastim-cbqv","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2023","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"Coherus Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Coherus Announces U.S. Launch of UDENYCA ONBODY\u2122 a Novel and Proprietary State-of-the-Art Delivery System for Pegfilgrastim-cbqv","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"February 2024","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"Nora Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sunshine Biopharma's Nora Pharma Receives Health Canada Approval for Niopeg(R), a Biosimilar of Neulasta(R)","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Large molecule","productStatus":"Biosimilar","date":"April 2024","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"Sutro Biopharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sutro Biopharma Announces Initiation of Randomized Portion (Part 2) of REFR\u03b1ME-O1 Trial","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"}]
Find Clinical Drug Pipeline Developments & Deals for Neulasta
The partnership with Sutro Biopharma to support the clinical production of Luvelta (luveltamab tazevibulin), a novel FRα-targeting antibody-drug conjugate for the treatment of ovarian cancer.
Lead Product(s):
Luveltamab Tazevibulin,Pegfilgrastim
STRO-002 (luveltamab tazevibulin), is a best-in-class folate receptor alpha (FolRα)-targeting ADC, is being investigated in a phase 2/2 clinical trial for ovarian cancers in combination with Pegfilgrastim.
Lead Product(s):
Luveltamab Tazevibulin,Pegfilgrastim
Niopeg (pegfilgrastim) is a USFDA-approved protein that acts as a G-CSF agonist for the treatment of patients with non-myeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Sutro intends to use the net proceeds of this offering to fund research, clinical, and development of STRO-002 (Luveltamab Tazevibulin) with Neulasta for treating patients with FOLR1-expressed Ovarian Neoplasms.
Lead Product(s):
Luveltamab Tazevibulin,Pegfilgrastim
Udenyca Onbody, the company's on-body injector (OBI) presentation of Udenyca® (pegfilgrastim-cbqv), a CSF-3R agonist. It is indicated for the treatment of decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies.
Udenyca (pegfilgrastim-cbqv), is a FDA-approved biosimilar that acts as a G-CSF agonist for the treatment of patients with non-myeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Udenyca Onbody (pegfilgrastim-cbqv) Autoinjector products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.
Udenyca Onbody (pegfilgrastim-cbqv) Autoinjector products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.
MNPR-201 (camsirubicin) is a novel proprietary analog of widely used cancer drug doxorubicin. Doxorubicin is used to treat adult and pediatric solid and hematologic cancers including breast, gastric, ovarian and bladder cancer, soft tissue sarcomas, leukemias and lymphomas.
Camsirubicin is a novel proprietary analog of the widely used cancer drug doxorubicin. Doxorubicin is used to treat adult and pediatric solid and hematologic cancers including breast, gastric, ovarian and bladder cancer, soft tissue sarcomas, leukemias and lymphomas.