Lead Product(s) : Eflapegrastim,Cyclophosphamide,Docetaxel
Therapeutic Area : Oncology
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Assertio Announces Results of Rolvedon® Same-Day Dosing Clinical Study
Details : Rolvedon (eflapegrastim) is a leukocyte growth factor SC injection being investigated in patients with early stage breast cancer with docetaxel and cyclophosphamide.
Product Name : Rolvedon
Product Type : Protein
Upfront Cash : Inapplicable
December 13, 2024
Lead Product(s) : Eflapegrastim,Cyclophosphamide,Docetaxel
Therapeutic Area : Oncology
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Eflapegrastim
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved FDF
Sponsor : Assertio Therapeutics
Deal Size : Undisclosed
Deal Type : Acquisition
Assertio Holdings, Inc. Closes Spectrum Pharmaceuticals Transaction
Details : Through the acquisition, Assertio will expand its product portfolio by including Rolvedon (eflapegrastim-xnst), a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation for the treatment of febrile neutropenia.
Product Name : Rolvedon
Product Type : Protein
Upfront Cash : Undisclosed
July 31, 2023
Lead Product(s) : Eflapegrastim
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Sponsor : Assertio Therapeutics
Deal Size : Undisclosed
Deal Type : Acquisition
Lead Product(s) : Eflapegrastim
Therapeutic Area : Oncology
Study Phase : Phase IV
Sponsor : Hanmi Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy
Details : Undisclosed
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
July 18, 2023
Lead Product(s) : Eflapegrastim
Therapeutic Area : Oncology
Highest Development Status : Phase IV
Sponsor : Hanmi Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Eflapegrastim
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Assertio Therapeutics
Deal Size : $757.0 million
Deal Type : Acquisition
Assertio Holdings, Inc. to Acquire Spectrum Pharmaceuticals, Inc. in All Stock and CVR Transaction
Details : Through the acquisition, Assertio will expand its product portfolio by including Rolvedon (eflapegrastim-xnst), a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation for the treatment of febrile neutropenia.
Product Name : Rolvedon
Product Type : Protein
Upfront Cash : $291.0 million
April 25, 2023
Lead Product(s) : Eflapegrastim
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Assertio Therapeutics
Deal Size : $757.0 million
Deal Type : Acquisition
Lead Product(s) : Eflapegrastim
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Rolvedon
Product Type : Protein
Upfront Cash : Inapplicable
January 31, 2023
Lead Product(s) : Eflapegrastim
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Eflapegrastim
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Rolvedon
Product Type : Protein
Upfront Cash : Inapplicable
September 09, 2022
Lead Product(s) : Eflapegrastim
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Eflapegrastim
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Spectrum Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Rolontis
Product Type : Protein
Upfront Cash : Inapplicable
January 19, 2021
Lead Product(s) : Eflapegrastim
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Spectrum Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Eflapegrastim
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
September 30, 2020
Lead Product(s) : Eflapegrastim
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Eflapegrastim,Cyclophosphamide,Docetaxel
Therapeutic Area : Hematology
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...
Product Name : Rolvedon
Product Type : Protein
Upfront Cash : Undisclosed
July 29, 2020
Lead Product(s) : Eflapegrastim,Cyclophosphamide,Docetaxel
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Jefferies
Deal Size : Undisclosed
Deal Type : Public Offering
Lead Product(s) : Eflapegrastim,Cyclophosphamide,Docetaxel
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Rolvedon
Product Type : Protein
Upfront Cash : Inapplicable
June 22, 2020
Lead Product(s) : Eflapegrastim,Cyclophosphamide,Docetaxel
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable