Lead Product(s) : Eflapegrastim
Therapeutic Area : Hematology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : ROLVEDON™ (eflapegrastim-xnst) injection is a long-acting G-CSF which decreases the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.
Brand Name : Rolvedon
Molecule Type : Large molecule
Upfront Cash : Not Applicable
January 31, 2023
Lead Product(s) : Eflapegrastim
Therapeutic Area : Hematology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Eflapegrastim
Therapeutic Area : Hematology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Spectrum Pharmaceuticals Receives FDA Approval for ROLVEDON™ (eflapegrastim-xnst) Injection
Details : ROLVEDON™ (eflapegrastim-xnst) injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation,is indicated to decrease the incidence of infection, as manifested by febrile neutropenia.
Brand Name : Rolvedon
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 09, 2022
Lead Product(s) : Eflapegrastim
Therapeutic Area : Hematology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Eflapegrastim
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Spectrum Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Hanmi Pharmaceutical Expects U.S. FDA Approval for 2 New Drugs
Details : Rolontis," a treatment for neutropenia and "Oraxol," as a treatment for metastatic breast cancer are under priority review by FDA. Hanmi is about to announce the results of their BLA/NDA approval respectively.
Brand Name : Rolontis
Molecule Type : Large molecule
Upfront Cash : Not Applicable
January 19, 2021
Lead Product(s) : Eflapegrastim
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Spectrum Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Eflapegrastim,Docetaxel,Cyclophosphamide
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Jefferies
Deal Size : Undisclosed
Deal Type : Public Offering
Spectrum Pharmaceuticals Announces Proposed Public Offering of Common Stock
Details : Spectrum expects to use the net proceeds for general corporate purposes, including the continued development of its pipeline assets, sales and marketing activities, pre-launch activities associated with ROLONTIS and potential business development initiat...
Brand Name : Rolontis
Molecule Type : Large molecule
Upfront Cash : Undisclosed
July 29, 2020
Lead Product(s) : Eflapegrastim,Docetaxel,Cyclophosphamide
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Jefferies
Deal Size : Undisclosed
Deal Type : Public Offering
Lead Product(s) : Eflapegrastim,Docetaxel,Cyclophosphamide
Therapeutic Area : Oncology
Study Phase : Phase I
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : These data in rats suggest that eflapegrastim administered at the time of chemotherapy, rather than waiting 24 hours, may be able to provide prophylaxis against chemotherapy induced neutropenia.
Brand Name : Rolontis
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 22, 2020
Lead Product(s) : Eflapegrastim,Docetaxel,Cyclophosphamide
Therapeutic Area : Oncology
Highest Development Status : Phase I
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Eflapegrastim,Docetaxel,Cyclophosphamide
Therapeutic Area : Oncology
Study Phase : Phase I
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Spectrum Pharmaceuticals Initiates Same Day Dosing Clinical Trial for ROLONTIS® (eflapegrastim)
Details : The trial will evaluate the duration of severe neutropenia when administered at three different time points on the same day following standard chemotherapy in patients with early stage breast cancer.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Not Applicable
April 30, 2020
Lead Product(s) : Eflapegrastim,Docetaxel,Cyclophosphamide
Therapeutic Area : Oncology
Highest Development Status : Phase I
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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