Lead Product(s) : Damoctocog Alfa Pegol
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
December 07, 2021
Lead Product(s) : Damoctocog Alfa Pegol
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegfilgrastim
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Accepts for Review Fresenius Kabi’s BLA Submission for Pegfilgrastim Biosimilar
Details : U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for MSB11455, a biosimilar candidate of Neulasta®* (pegfilgrastim).
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
May 27, 2020
Lead Product(s) : Pegfilgrastim
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegfilgrastim
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Fresenius Kabi’s Regulatory Submission for Pegfilgrastim Biosimilar Accepted for Review By EMA
Details : Fresenius Kabi’s MAA submission for pegfilgrastim biosimilar candidate includes analytical, pharmacokinetic, pharmacodynamic, safety and immunogenicity data.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
May 22, 2020
Lead Product(s) : Pegfilgrastim
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Molidustat
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Maintenance Treatment of Renal Anemia in Dialysis Subjects
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 01, 2018
Lead Product(s) : Molidustat
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Molidustat
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 01, 2018
Lead Product(s) : Molidustat
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Molidustat
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 22, 2017
Lead Product(s) : Molidustat
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Molidustat
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 22, 2017
Lead Product(s) : Molidustat
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Molidustat
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 22, 2017
Lead Product(s) : Molidustat
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Idarucizumab
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibody
Upfront Cash : Inapplicable
November 17, 2017
Lead Product(s) : Idarucizumab
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dabigatran Etexilate Mesylate
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 23, 2016
Lead Product(s) : Dabigatran Etexilate Mesylate
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable