Blog
RSS FeedPosted by Michael Wonder on 18 Oct 2020
First CAR-T cell medicine for mantle cell lymphoma
16 October 2020 - EMA has recommended granting a conditional marketing authorisation in the European Union for Tecartus (autologous anti-CD19 ...
Posted by Michael Wonder on 17 Sep 2020
EMA close to finalising guidance for advanced therapies
16 September 2020 - The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal ...
Posted by Michael Wonder on 17 Jul 2020
EMA validates Bristol Myers Squibb’s application for CAR T cell therapy lisocabtagene maraleucel
17 July 2020 - Application based on positive results from TRANSCEND NHL 001 study and additional TRANSCEND WORLD 001 study. ...
Posted by Michael Wonder on 29 Jan 2020
European Medicines Agency validates Kite’s marketing application for company’s second CAR T cell therapy
28 January 2020 - Investigational KTE-X19 to be first chimeric antigen receptor T cell therapy for mantle cell lymphoma in Europe ...
Posted by Michael Wonder on 02 Dec 2019
Orchard Therapeutics announces the filing and validation of marketing authorisation application by EMA for OTL-200 for the treatment of metachromatic leukodystrophy
2 December 2019 - Application Being Evaluated Under Accelerated Assessment. ...
Posted by Michael Wonder on 16 Jul 2019
Caladrius Biosciences receives advanced therapy medicinal product classification for CLBS12, its CD34+ cell therapy for critical limb ischaemia
15 July 2019 - Caladrius Biosciences announced today that the EMA has granted Advanced Therapy Medicinal Product classification to the Company’s ...
Posted by Michael Wonder on 04 Apr 2019
EMA grants PRIME designation to Janssen’s investigational CAR-T therapy
4 April 2019 - Johnson & Johnson’s Janssen has announced the granting of a PRIME (PRIority MEdicines) designation for its ...
Posted by Michael Wonder on 30 Mar 2019
bluebird bio receives positive opinion from CHMP for Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia who do not have β0/β0 Genotype
29 March 2019 - First gene therapy recommended for approval in the EU for transfusion-dependent β-thalassemia. ...
Posted by Michael Wonder on 29 Mar 2019
Highlights from CHMP 25-28 March 2019 meeting
29 March 2019 - EMA’s human medicines committee (CHMP) adopted recommendations for one new initial marketing authorisation and three extensions ...
Posted by Michael Wonder on 26 Mar 2019
bluebird bio statement on European regulatory status of LentiGlobin
25 March 2019 - A third party press release was issued today stating that the EMA issued an approval for ...
Posted by Michael Wonder on 28 Aug 2018
Yescarta (axicabtagene ciloleucel) receives European marketing authorisation for the treatment of relapsed or refractory DLBCL and PMBCL, after two or more lines of systemic therapy
27 August 2018 - New option for adult patients in Europe as axicabtagene ciloleucel becomes the first CAR T to receive ...
Posted by Michael Wonder on 27 Aug 2018
Novartis receives European Commission approval of its CAR-T cell therapy, Kymriah (tisagenlecleucel)
27 August 2018 - The EC approval is based on the first global CAR-T registration trials, which included patients from eight ...
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 01 Jul 2018
European CHMP adopts positive opinion for Yescarta (axicabtagene ciloleucel) for the treatment of relapsed or refractory DLBCL and PMBCL, after two or more lines of systemic therapy
29 June 2018 - Kite, a Gilead Company, today announced that the EMA's CHMP has issued a positive opinion on the ...
Posted by Michael Wonder on 30 Jun 2018
Novartis receives positive CHMP opinion for Kymriah for treating two aggressive blood cancers, marking important medical advance for patients in Europe
29 June 2018 - First CHMP opinion for a CAR-T cell therapy in two distinct indications - DLBCL in adults ...