If preparation for a possible pandemic is ever going to be sufficient, drug makers need to push for FDA approval of adjuvants and novel technologies in which influenza vaccines can be created, according to a panel of experts
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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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Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.
European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.
The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.