CONNAUGHT TYPHIM Vi IS FIRST SINGLE-DOSE TYPHOID VACCINE available in the U.S. following its approval for marketing by the IDA on Nov. 28. The injectable typhoid Vi polysaccharide vaccine was approved for prevention of typhoid fever caused by Salmonella typhi in persons two years of age and older. The single intramuscular dose of 5 ml "increases the likelihood of patient compliance" over oral or injectable multi-dose, alternate-day regimens. The injectable multi-dose formulation is "highly reactogenic," Swiftwater, Penn.-based Connaught commented.
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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.’
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.
The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.
