Optimer released positive data Feb. 4 from its second pivotal Phase III trial of fidaxomicin, raising hopes that hospitals will soon have a new weapon for fighting new deadly strains of Clostridium difficile, a bacterium that occurs naturally in the gut and is ordinarily benign. Problems arise, however, when antibiotics used to treat hospital-acquired infections eliminate other resident flora, allowing novel and toxic strains of C. diff to proliferate. Outbreaks of the disease, typified by diarrhea, nausea and in severe cases, colitis, sepsis and death, have made headlines in the United Kingdom and Canada.
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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.’
The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.
The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.
Joint procurement, if used by member states to respond to potential pricing and access challenges caused by a US most favored nations pricing policy, would cause more uncertainty for pharmaceutical companies, warn industry representatives.
