The price of Biogen Idec/Elan's multiple sclerosis treatment Tysabri (natalizumab) upon relaunch in July will be 20.8% higher than when it was first approved in November 2004, according to information on Elan's website. Tysabri's new wholesale acquisition cost will be $2,184.62 per vial compared to $1,808 in 2004. FDA reapproved natalizumab June 5 with an extensive risk management program to prevent cases of progressive multifocal leukoencephalopathy. Biogen/Elan have attributed higher pricing to additional costs associated with administering the risk management plan as well as the inclusion of new efficacy data in labeling (1"The Pink Sheet" June 12, 2006, p. 8)...
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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.’
Kwabena Frimpong-Manso Opuni has been appointed as the new acting CEO of the Ghana Food and Drugs Authority, succeeding Delese Darko, who is now head of the Africa’s pan-continental medicines agency.
The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.
The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.
