The FDA has accepted Eagle Pharmaceuticals’ abbreviated new drug application (ANDA) for vasopressin injection, 1ml for filing. This product is the generic version of Endo International plc’s original Vasostrict formulation, which is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. Vasostrict had approximately $400…
Phase III IMpower150 Study Met Endpoint
FDA Approves HIV Treatment For Patients With Limited Options
The U.S. Food and Drug Administration approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV).Trogarzo is administered intravenously once…
J&J Medical Devices Companies Acquire Orthotaxy to Develop Next-generation Robotic-assisted Surgery Platform
Johnson & Johnson Medical Devices Companies, through French affiliate Apsis S.A.S., announced today the acquisition of Orthotaxy, a privately-held developer of software-enabled surgery technologies, including a differentiated robotic-assisted surgery solution. This proprietary technology is currently in early-stage development for total and partial knee replacement, and the Johnson & Johnson Medical Devices Companies plan to broaden…
