Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sandoz Biologics License Application For Proposed Biosimilar Denosumab Accepted By US FDA
Details : Denosumab is a human monoclonal antibody designed to bind and inhibit RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss, and subsequently the likelihood of fractures and other serious bone condit...
Product Name : Wyost
Product Type : Antibody
Upfront Cash : Inapplicable
June 02, 2023
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sandoz Marketing Authorization Applications For Proposed Biosimilar Denosumab Accepted By EMA
Details : Denosumab is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts. By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss.
Product Name : Wyost
Product Type : Antibody
Upfront Cash : Inapplicable
May 25, 2023
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Denosumab (GP2411) is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts. By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone los...
Product Name : Wyost
Product Type : Antibody
Upfront Cash : Inapplicable
September 19, 2022
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Orphenadrine
Therapeutic Area : Musculoskeletal
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Orphenadrine Citrate recalled, because of the presence of a nitrosamine impurity, has potential to be above the U.S. FDA’s acceptable daily intake limit of 26.5 ng/day, was detected in the lots during recent testing.
Product Name : Orphenadrine Citrate-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 22, 2022
Lead Product(s) : Orphenadrine
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable