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RSS FeedPosted by Michael Wonder on 04 Mar 2018
MeiraGTx receives EMA PRIME designation for achromatopsia gene therapy candidate
2 March 2018 - MeiraGTx announced today the EMA has granted Priority Medicines (PRIME) designation to MeiraGTx’s gene therapy product candidate ...
Posted by Michael Wonder on 04 Mar 2018
EMA started the evaluation of resubmitted marketing authorisation application for biosimilar pegfilgrastim
2 March 2018 - STADA Arzneimittel was informed today by Gedeon Richter that the EMA has accepted the regulatory resubmission ...
Posted by Michael Wonder on 04 Mar 2018
Theresa May reveals UK willing to pay to remain part of European agencies for medicine, chemicals and aviation
2 March 2018 - Theresa May has revealed Britain would be willing to pay to remain part of a series ...
Posted by Michael Wonder on 03 Mar 2018
EMA confirms move to Amsterdam
2 March 2018 - The EMA confirmed that it is moving from London to Amsterdam due to the Brexit on ...
Posted by Michael Wonder on 02 Mar 2018
Biogen and AbbVie announce the voluntary worldwide withdrawal of marketing authorisations for Zinbryta (daclizumab) for relapsing multiple sclerosis
2 March 2018 - Patient safety is the top priority for Biogen and AbbVie. ...
Posted by Michael Wonder on 02 Mar 2018
EMA urgently reviewing multiple sclerosis medicine Zinbryta following cases of inflammatory brain disorders
2 March 2018 - Medicine to be voluntarily withdrawn from the market by the company. ...
Posted by Michael Wonder on 01 Mar 2018
Four more EU Member States benefit from EU-US mutual recognition agreement for inspections
1 March 2018 - Agreement now operational between 12 EU Member States and FDA ...
Posted by Michael Wonder on 28 Feb 2018
Europe follows FDA with plans to help early Alzheimer's drugs
28 February 2018 - European regulators are following in the footsteps of the U.S. Food and Drug Administration with plans ...
Posted by Michael Wonder on 28 Feb 2018
Novo Nordisk files for regulatory approval of long-acting factor VIII (N8-GP) in the US and the EU for treatment of haemophilia A
28 February 2018 - Novo Nordisk today announced the submission of a biologics license applications to the US FDA and ...
Posted by Michael Wonder on 28 Feb 2018
Management Board initiates building approval process for EMA premises in Amsterdam
28 February 2018 - New permanent building to be completed by 15 November 2019. ...
Posted by Michael Wonder on 28 Feb 2018
European Commission approves Roche's Hemlibra for people with haemophilia A with inhibitors
27 February 2018 - First new medicine in over 20 years to treat people with haemophilia A with inhibitors in Europe. ...
Posted by Michael Wonder on 27 Feb 2018
EMA grants accelerated assessment for Shire’s lanadelumab being evaluated for the prevention of attacks in hereditary angioedema patients aged 12 years and older
27 February 2018 - Shire is on track to submit EU marketing authorisation application in the coming weeks. ...
Posted by Michael Wonder on 27 Feb 2018
Shionogi announces FDA new drug application and EMA marketing authorisation application acceptances for lusutrombopag (S-888711)
26 February 2018 - Shionogi announced today that the new drug application for lusutrombopag (S-888711), an investigational, once-daily, orally administered, ...
Posted by Michael Wonder on 27 Feb 2018
EU cancer drugs rejection shows contrasts with FDA
26 February 2018 - Europe’s expert medicines panel has rejected Puma Biotechnology’s breast cancer drug neratinib, citing limitations in its ...
Posted by Michael Wonder on 26 Feb 2018
EU clears rare musculoskeletal disorder drug
26 February 2018 - Doctors can now treat children living in the EU with the rare, chronic progressive musculoskeletal disorder ...