Data from additional clinical studies will likely be needed for approval of The Medicines Company's Angiomax (bivalirudin) sNDA for patients with thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome undergoing percutaneous coronary intervention. FDA deemed the supplement "not approvable" because of "deficiencies in the study methods used and in the analysis of the clinical data," the firm says June 3. "We had anticipated a label change in 2004, but this timeframe now seems unlikely," CEO Dave Stack said. The sNDA also includes the REPLACE-2 study of bivalirudin use in combination with glycoprotein IIb/IIIa inhibitors (1Pharmaceutical Approvals Monthly Dec. 1, 2002, p. 6)...
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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 draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.
Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.
At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.
