France fights to prevent approval of Orexigen's obesity drug
This article was originally published in Scrip
France is pursuing its efforts to prevent the approval of Orexigen's weight loss combination product Mysimba (naltrexone/bupropion) on safety and efficacy grounds, and has taken the matter to the European Commission's Standing Committee on Medicinal Products for Human Use.
You may also be interested in...
New guidance from the UK covers the recognition of EU approvals, accelerated assessment, rolling reviews, and much else besides.
As negotiations between the UK and EU enter a crucial phase, the UK life sciences industry has called for more clarity and guidance on what companies can expect to face at the end of the Brexit transition period.
A legislative provision under which future COVID-19 vaccines can be made available in the UK before they are approved is also being used to offer an unlicensed flu vaccine that officials say has undergone full safety, efficacy and quality tests.