Blog
RSS FeedPosted by Michael Wonder on 08 Feb 2016
EMA sets up task force on Zika virus
8 February 2016 - European experts to provide support to global response on the emerging epidemic. ...
Posted by Michael Wonder on 02 Feb 2016
How to facilitate development of cancer immunotherapies
2 February 2016 - A workshop on the challenges for the approval of immunotherapy medicines for cancer will take place at ...
Posted by Michael Wonder on 30 Jan 2016
First specific replacement therapy to treat rare bleeding disorder
29 January 2016 - Coagadex recommended for approval for prevention of bleeding episodes for patients with factor X deficiency. ...
Posted by Michael Wonder on 30 Jan 2016
EMA fast-tracks treatment of multiple myeloma for approval in EU
29 January 2016 - Empliciti is a monoclonal antibody that works by activating the body’s immune system to attack and kill ...
Posted by Michael Wonder on 12 Jan 2016
Human medicines: EMA highlights of 2015
12 Januaru 2016 - The EMA has released an overview of its 2015 key recommendations in relation to the marketing authorisations ...
Posted by Michael Wonder on 19 Dec 2015
Meeting highlights from the CHMP meeting - 14-17 December 2015
18 December 2015 - The European Medicines Agency’s CHMP recommended nine new medicines for marketing authorisation at its December 2015 meeting. ...
Posted by Michael Wonder on 19 Dec 2015
EMA fast-tracks new oral treatment for non-small cell lung cancer
18 December 2015 - The EMA has recommended granting a conditional marketing authorisation for Tagrisso (osimertinib) for the treatment of adults ...
Posted by Michael Wonder on 09 Dec 2015
“EMA ready to address challenges ahead”
9 December 2015 - Support to innovative medicines, transparency and patient involvement will be among the priorities of new EMA Executive ...
Posted by Michael Wonder on 21 Nov 2015
Meeting highlights from the Committee for Medicinal Products for Human Use - 16-19 November 2015
20 November 2015 - Ten medicines, including a first-in-class orphan medicine for narcolepsy, recommended for authorisation in the EU. ...
Posted by Michael Wonder on 21 Nov 2015
Narcolepsy treatment recommended for approval
20 November 2015 - Wakix to target excessive daytime sleepiness and cataplexy. ...
Posted by Michael Wonder on 16 Nov 2015
Guido Rasi takes office as head of EMA
16 November 2015 - Professor Rasi was nominated as Executive Director for a five-year mandate by the Management Board of the ...
Posted by Michael Wonder on 27 Oct 2015
How to improve product lifecycle management
26 October 2015 - The European Medicines Agency (EMA) is hosting a workshop on product lifecycle management from 28 to 29 ...
Posted by Michael Wonder on 27 Oct 2015
Public consultation starts on PRIME - a new scheme to optimise development of priority medicines and facilitate patients’ access
26 October 2015 - PRIME aims to strengthen support to medicines that have the potential to benefit patients who presently have ...
Posted by Michael Wonder on 24 Oct 2015
Meeting highlights from the Committee for Medicinal Products for Human Use - October 2015
23 October 2015 - The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended an advanced therapy medicine for ...
Posted by Michael Wonder on 23 Oct 2015
First oncolytic immunotherapy medicine recommended for approval
23 October 2015 - The European Medicines Agency has recommended authorising Imlygic (talimogene laherparepvec) for the treatment of adults with melanoma ...