Tiziana Life Sciences LTD

By jpalfreyman on
Expanded Access Listings

Intermediate-Size Patient Population Expanded Access: Foralumab in Non-Active Secondary Progressive MS Patients

Conditions
Non-Active Secondary Progressive Multiple Sclerosis

This is an open-label, intermediate-size patient population expanded access treatmentstudy utilizing 1 dose level of nasal Foralumab (50 µg/dosing day) with the possibilityof increasing to 100 µg/dosing day. The goal of this expanded access clinical trial is toevaluate safety, tolerability, and immune effects of intranasal Foralumab in non-activesecondary progressive multiple sclerosis patients. The primary objective is to treatpatients who have failed current available therapy. Participants will visit the clinicfor testing and follow-up every cycle (3 weeks) while administering the medication athome if able three times weekly.

Food Safety Magazine: Another Evaluation of Infant Formula Crisis Concludes FDA Needs More Authorities to Prevent Shortages

Among other recommendations, the NSAEM report reiterates other sentiments expressed by FDA and the Reagan-Udall Foundation, as well as consumer advocacy groups; specifically, that FDA’s authority to oversee manufacturing significantly hindered the agency’s ability to facilitate an effective response or to prevent the shortage that occurred.
Coverage
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