Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 17 Jan 2018
Novartis granted US FDA priority review for Kymriah (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL
17 January 2018 - Filing acceptance marks second priority review granted to Kymriah by the FDA for two distinct indications, underscoring ...
Posted by Michael Wonder on 17 Nov 2017
Celgene and bluebird bio announce bb2121 anti-BCMA CAR-T cell therapy has been granted breakthrough therapy designation from FDA and PRIME eligibility from EMA for relapsed and refractory multiple myeloma
16 November 2017 - Designations based on preliminary clinical data from ongoing phase I study of bb2121 in heavily pre-treated multiple ...
Posted by Michael Wonder on 14 Nov 2017
Mereo receives EMA PRIME designation for BPS-804
13 November 2017 - BPS-804 to receive EMA ongoing advice with the potential for accelerated regulatory assessment in Europe. ...
Posted by Michael Wonder on 13 Nov 2017
EMA grants Alnylam accelerated assessment of patisiran for patients with hereditary ATTR amyloidosis
13 November 2017 - Company on track to submit marketing authorisation application and new drug application at year end 2017. ...
Posted by Michael Wonder on 18 Oct 2017
Ignyta receives European Medicines Agency Prime designation for entrectinib in NTRK fusion-positive solid tumours
17 October 2017 - Ignyta today announced that the EMA has granted Priority Medicines (PRIME) designation for entrectinib in the ...
Posted by Michael Wonder on 12 Aug 2017
Gilead announces U.S. FDA priority review designation for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for treatment of HIV
10 August 2017 - Final FDA Decision Anticipated by 12 February 2018. ...