Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acacia, Beigene, Biophytis Eusa, Geron, Metvital, Mundipharma, Napp, Rhythm.
The U.S. Centers for Medicare and Medicaid Services (CMS) posted the much-anticipated draft do-over of the mitral valve repair device coverage memo, and in the process renamed the policy the mitral valve transcatheter edge-to-edge repair (TEER) national coverage memo.
Orthopedic implant startup Engage Surgical has received 510(k) clearance from the FDA for its Engage Partial Knee system, the only cementless partial knee implant available in the U.S. The company is introducing the product via a limited release to select surgical centers.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Carag, Engage Surgical, Guided Therapeutics, Kdx Diagnostics, Venus Concept.
Biosimilars referencing Amgen Inc.’s rheumatoid arthritis drug, Enbrel (etanercept), could remain sidelined in the U.S. for nearly another decade, following a Federal Circuit decision Wednesday affirming the validity of two patents protecting etanercept and its manufacturing methods.
The U.S. Department of Veterans Affairs (VA) is looking for more discounts from prescription drug manufacturers, but it likely will be a few years before the ask becomes reality as it will require congressional action and federal rulemaking.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bavarian, Blueprint, EMD, Golden, Hangzhou Yuyuan, Isa, Janssen, Medicinova, Mezzion, Pfizer, Revive, Rhythm, Scpharmaceuticals, Sun, TC, Obseva, Ultragenyx, Y-mabs.