The FDA awarded the voucher to Scholar Rock after approving Isembyld, its therapy for spinal muscular atrophy, in September.
Under the agreement, ProBio will receive an upfront payment and may earn additional payments upon the achievement of specified development and commercial milestones.
The acquisition gives the pharmaceutical company access to Omniose’s proprietary bioconjugation platform, which is designed to simplify the development and production of bacterial conjugate vaccines.
DSI Assignments has now opened the sale to potential buyers, offering both VintaBio’s intellectual property and its 22,500-square-foot production facility in Philadelphia, Pennsylvania.
The facility will increase capacity for drug-device combination products, including formulation development and the manufacture of supplies for early- and late-stage clinical trials.
Under the research agreement, the US biotechnology company will collaborate with Duke researchers to conduct molecular profiling of tissue and blood samples stored in the university’s biobanks.
The drug, which will be marketed under the brand name Ashuli, is the first biosimilar of Johnson & Johnson’s Simponi (golimumab) to receive marketing authorisation in China.
The expanded indication covers both radiographic and non-radiographic forms of axSpA in adults who have not responded adequately to conventional treatment or cannot tolerate it.
The collaboration aims to improve the diagnosis of rare genetic conditions that can cause unexplained symptoms, affect multiple organ systems or resemble other diseases.
The approval covers adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed during or after platinum-based chemotherapy and treatment with an anti-PD-(L)1 antibody.