A 40-week Phase III trial of Hemispherx Biopharma's chronic fatigue syndrome agent Ampligen showed a statistically significant increase vs. placebo for the primary endpoint of physical performance, the firm announces May 3. Ampligen patients improved treadmill performance 19.4% compared to 5.1% for placebo (p=0.022); the minimum medically significant performance change is 6.5%. Trial design was "reviewed by a specially convened panel of the FDA's Antiviral Advisory Committee," Hemispherx said. The results may offer the first hard evidence to support Ampligen's approval in CFS; Hemispherx has been studying the double-stranded RNA drug in CFS for over a decade, but without convincing results. The immunomodulator/antiviral is also in Phase IIb for HIV/AIDS...
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
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