News in brief
- A second market authorisation application for a pandemic influenza vaccine using the new "core dossier" approach, has been submitted to EMEA by Chiron. The application is based on a "mock-up" vaccine.
- A report in the British Journal of Clinical Pharmacology warns that only 7.1% of orphan drug applications submitted to EMEA between August 2000 and December 2004 were approved. The report blames the low rate on flawed design and documentation in orphan drug dossiers and "the paucity of European incentives" for manufacturers.
- The European Commission has released guidance on applications for opinions from its ethic committee regarding clinical trials for human medicines. This is available from: http://pharmacos.eudra.org/F2/pharmacos/new.htm
- The EMEA committee for medicinal products for human use has released a draft guideline on developing human cell-based medicines. (www.emea.eu.int/pdfs/human/cpwp/32377405en.pdf) and advice on scientific data required for plasma master files in MA applications (www.emea.eu.int/pdfs/human/bwp/379403en.pdf).
- Bristol-Myers Squibb is to build a $660m biologics facility in the US, The facility will be used for large-scale multi-product bulk biologics manufacturing.