Data from 24-month follow up of 100 patients participating in a randomized, placebo-controlled Phase 2 trial of MPC-06-ID were presented in August 2016 at the 24th Annual Scientific Meeting of the Spine Intervention Society. Mesoblast’s product candidate MSC-100-IV is currently being evaluated in a 60-patient open label Phase 3 trial as a front-line therapy for children with steroid-refractory acute GVHD. The trial was recently successful in a pre-specified interim futility analysis, and Mesoblast expects to fully read out trial results during 2017. Based on guidance from the United States Food and Drug Administration (FDA), Mesoblast believes that positive data from this Phase 3 trial may be sufficient for filing for accelerated approval of MSC-100-IV in the United States. Mesoblast plans to broaden the use of its therapy in adult patients with high-risk steroid-refractory acute GVHD. About Mallinckrodt Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products; and central nervous system drugs. The company’s core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. http://www.feelfreemaldives.com/alyssarobinsongroup/2016/10/03/the-emerging-options-for-elegant-osce-for-national-health-service-methodsThe company’s Specialty Brands segment includes branded medicines and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.
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