Blog
RSS FeedPosted by Michael Wonder on 14 Sep 2018
EMA Priority Medicines scheme (PRIME): will more paying-for-performance agreements be needed due to immature data?
14 September 2018 - The EU’s centralized procedure for the authorization of a new drug is performed by the EMA. ...
Posted by Michael Wonder on 07 Aug 2018
The European Medicines Agency: PRIME’d for access?
7 August 2018 - Regulators around the world have been working for decades to speed up access to the best ...
Posted by Michael Wonder on 04 Aug 2018
EMA grants PRIME status for Roche Huntington's drug
3 August 2018 - The EMA has granted PRIME designation to Roche's RG6042 for treatment of Huntington’s disease. ...
Posted by Michael Wonder on 02 Aug 2018
FDA and EMA to hold workshop on breakthrough therapy and PRIME designations
2 August 2018 - The US FDA and EMA will hold a workshop on early access approaches, including PRIME and ...
Posted by Michael Wonder on 01 Aug 2018
EMA confirms accelerated assessment procedure for Trogarzo
31 July 2018 - Theratechnologies is pleased to announce that the CHMP of the EMA will review the application for marketing ...
Posted by Michael Wonder on 27 Jul 2018
bluebird bio’s LentiGlobin gene therapy granted accelerated assessment by EMA for the treatment of transfusion-dependent β-thalassemia
26 July 2018 - Company on track to submit marketing authorisation application in European Union in 2018. ...
Posted by Michael Wonder on 23 Jul 2018
Rhythm Pharmaceuticals receives European Medicines Agency PRIME designation for setmelanotide in rare genetic disorders of obesity
23 July 2018 - Program offers enhanced support for development of medicines that target unmet medical needs. ...
Posted by Michael Wonder on 12 Jun 2018
Themis receives EMA PRIME designation for Chikungunya vaccine
11 June 2018 -Themis announced today that the EMA has granted PRIority MEdicines (PRIME) designation to its most advanced program ...
Posted by Michael Wonder on 06 Jun 2018
Nohla receives EMA PRIME designation for dilanubicel (NLA101) to treat haematopoietic stem cell transplant patients
6 June 2018 - First product to achieve PRIME designation for haematopoietic stem cell transplant patients. ...
Posted by Michael Wonder on 06 Jun 2018
Audentes announces PRIME designation granted by the EMA to AT132 for the treatment of X-linked myotubular myopathy
5 June 2018 - Audentes Therapeutics today announced that the EMA has granted PRIME designation to AT132 for the treatment ...
Posted by Michael Wonder on 26 Mar 2018
Alnylam receives EMA PRIME designation for accelerated assessment of lumasiran, an investigational RNAi therapeutic for the treatment of primary hyperoxaluria type 1
26 March 2018 - Company intends to advance lumasiran to a Phase 3 study in late 2018. ...
Posted by Michael Wonder on 20 Mar 2018
U.S. FDA grants priority review for a supplemental new drug application for Xtandi (enzalutamide) in non-metastatic castration-resistant prostate cancer
19 March 2018 - Application seeks to expand the indication of Xtandi to include men with non-metastatic castration-resistant prostate cancer. ...
Posted 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 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 26 Jan 2018
Alnylam Announces EMA acceptance of marketing authorisation application for patisiran for the treatment of hereditary ATTR amyloidosis
25 January 2018 - EMA will evaluate the application under accelerated assessment. ...