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.’
Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.
