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.’
Although the UK Health Research Authority’s initial proposal for simplified informed consent was rejected by stakeholders, it has yielded valuable insights into reducing trial burden and widening access
Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.
Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.
