Round 2 of our weekly Reg Roundup, “things to know in Regulatory Intelligence”
- Medtronic receives FDA approval for first ever cement-augmented spinal screws. While traditional screws can loosen over time, the Medtronic system directly augments a fenestrated screw with cement, thereby increasing screw stability. (MassDevice)
- The FDA Advisory Committees vote in strong support of 2 biosimilar approvals, but litigation strategies for biologics patents are still unclear. (FirstWord)
- Sandoz’s biosimilar application to Amgen’s Neulasta was rejected by the FDA. Sandoz is currently working to resolve issues detailed in the FDA’s complete response letter. (FiercePharma).
- The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee votes in favor of approval for Valeant’s plaque psoriasis drug. Despite strong concerns for the risk of suicide, the drug’s positive efficacy results may be a “game changer” in the treatment of psoriasis. (PharmaTimes)