Blog
RSS FeedPosted 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 04 Apr 2019
Immunocore’s lead asset tebentafusp gains fast track designation for metastatic uveal melanoma
3 April 2019 - Immunocore today announces that the U.S. FDA has granted fast track designation for its development program, ...
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 25 Mar 2019
Melbourne's Peter MacCallum Cancer Centre to be home of 'the next great wave in treatment'
25 March 2019 - A new form of cancer treatment that uses cell therapy to attack the disease will become ...
Posted by Michael Wonder on 12 Mar 2019
SMC says ‘no’ to Novartis’ Kymriah for adults with lymphoma
11 March 2019 - Adults with lymphoma will not be able to access Novartis’ CAR-T therapy Kymriah on the NHS ...
Posted by Michael Wonder on 21 Feb 2019
Japan approves two gene treatments in bid to catch up
21 February 2019 - Potential revolutionary treatments have exorbitant price tags. ...
Posted by Michael Wonder on 20 Feb 2019
Gilead receives approval in Canada for Yescarta (axicabtagene ciloleucel) CAR T therapy for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
19 February 2019 - Yescarta is a chimeric antigen receptor T-cell therapy that is custom-made for each patient from his or ...
Posted by Michael Wonder on 15 Feb 2019
CMS proposes coverage with evidence development for chimeric antigen receptor (CAR) T-cell therapy
15 February 2019 - Proposed decision would provide nationwide consistency in CMS’s coverage of the innovative new cancer therapy, to ...
Posted by Michael Wonder on 12 Feb 2019
Yescarta rejected among other SMC decisions
12 February 2019 - Gilead's CAR-T therapy Yescarta (axicabtagene ciloleucel) has been rejected by the Scottish Medicines Consortium (SMC) for ...
Posted by Michael Wonder on 11 Feb 2019
SMC - February 2019 decisions
11 February 2019 - A medicine used to treat a rare blood cancer in children and young adults has today ...
Posted by Michael Wonder on 01 Feb 2019
NICE recommends another revolutionary CAR T-cell therapy for adults with lymphoma
1 February 2019 - Adults with relapsed or refractory diffuse large B-cell lymphoma will be able to access another revolutionary chimeric ...
Posted by Michael Wonder on 21 Jan 2019
Will price be a barrier to new cancer immunotherapy?
19 January 2019 - Advisory group CADTH recommends no funding for new CAR-T therapy until drug company lowers cost. ...
Posted by Michael Wonder on 17 Jan 2019
Gene therapy drug Kymriah should be publicly covered if manufacturer drops price, report recommends
16 January 2019 - A groundbreaking gene therapy for cancer could cost the Canadian health care system more than $400 ...