Four companies request CHMP second opinion
This article was originally published in Scrip
Executive Summary
So far in 2014 the European medicines agency's committee for medicinal products for human use (CHMP) has returned four negative opinions for new medicines compared to 16 positive recommendations. However, all four companies who have been unsuccessful with the committee in the New Year have this month called for re-examinations of the decisions.
You may also be interested in...
Helsinn And AB Science Persevere In EU Despite CHMP Setback
Helsinn and AB Science plan to conduct additional studies with their products the CHMP turned down this month, in an effort to secure eventual EU approval in the rejected indications. A third company, XBiotech, hasn’t ruled out similar action. New MAAs would be required.
Accessing Venture Debt From The EIB
Tips from Gergely Krajcsi, senior investment officer at the European Investment Bank, on how biotechs can access loans for faster growth.
In Vivo's 2024 Rising Leaders At A Glance
Top 30 leaders: see the list of industry influencers highlighted in the fifth edition of In Vivo's Rising Leaders series.