More than 7,000 cases of South Beach Beverage Company's SoBe Green Tea and SoBe Energy drinks have been recalled, PepsiCola division says. Products were distributed to convenience stores and other retail outlets in 11 states. Firm initiated Class II recall due to accidental presence of cough/cold active ingredient dextromethorphan, South Beach says in 1Dec. 13 release. Firm says contamination was caused by outside manufacturer, and error was brought to South Beach's attention by consumer complaints of nausea, vomiting, numbness, light-headedness, although no serious AEs have been reported...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.