France, Ireland oppose Mysimba EU approval on safety/efficacy grounds
This article was originally published in Scrip
The EU CHMP's decision to recommend approval of Orexigen's weight loss combination product Mysimba (naltrexone/bupropion) has come under fire from the French and Irish regulatory agencies, whose representatives voted against the product's approval on safety and efficacy grounds at the committee's December meeting and have detailed their objections in a written statement.
You may also be interested in...
A resolution adopted by the EU’s legislative body includes ways of making Europe more resilient to future pandemics and supply chain risks, and ensuring equitable access to affordable vaccines and medicines. Proposals from the European Parliament to share IP and knowledge have been welcomed by medicines access campaigners.
The need to accelerate clinical trials of products for treating and preventing coronavirus has led the EU authorities to propose a more streamlined process for allowing the release of GMO-containing investigational medicinal products into the environment.
The UK’s departure from the EU imposes a number of requirements on sponsors running EU trials, but it seems that many have still not taken steps to fall into line.