The cost of Aventis' Synercid and Pharmacia's Zyvox discourages use of the drugs for resistant disease pathogens, Infectious Disease Society of America representative Louis Rice, MD, Louis Stokes Cleveland Veterans Affairs Medical Center, told FDA's Anti-Infective Drugs Advisory Committee
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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.’
Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.
Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.
Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
