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.’
The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.
