Fremanezumab Shows Dual Efficacy in Treating Both Migraine and Depression in Landmark Trial
• A groundbreaking clinical trial demonstrates that fremanezumab, a CGRP-targeting monoclonal antibody, significantly reduces both migraine frequency and depressive symptoms in patients with comorbid conditions.
• The UNITE study involving 540 patients across 12 countries showed fremanezumab reduced monthly migraine days by 5.1 compared to 2.9 with placebo, with 40% of treated patients achieving at least 50% reduction in migraine days.
• This represents the first placebo-controlled trial to demonstrate significant improvements in both migraine and depression with a single pharmacological intervention, potentially reducing the cumulative burden on patients.
Federal Circuit Rules Against Teva's Orange Book Patent Listings for ProAir HFA Inhaler
• The U.S. District Court ordered Teva Pharmaceuticals to remove its ProAir HFA inhaler device patents from the FDA's Orange Book, ruling they don't meet statutory listing requirements.
• The Federal Circuit affirmed that patents must claim the drug's active ingredient to be Orange Book listable, rejecting Teva's argument that device component patents qualify.
• The case, sparked by Amneal Pharmaceuticals' generic challenge, has drawn attention from major pharma companies and the FTC, potentially impacting future drug-device patent listings.
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