Blog
RSS FeedPosted 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 02 Jul 2019
Innovation prizes to support cell and gene therapy
2 July 2019 - Personalised cell and gene therapy represent a fundamental therapeutic revolution. ...
Posted by Michael Wonder on 25 Jun 2019
Health economic assessment of Kymriah in diffuse large B-cell lymphoma
20 June 2019 - TLV has produced a health economic knowledge base for county councils for CAR-T cell treatment Kymriah ...
Posted by Michael Wonder on 19 Jun 2019
FDA grants fast track designation for Torque's first deep-primed T cell cancer immunotherapy program, TRQ-1501
18 June 2019 - Torque announced today that the U.S. FDA granted fast track designation for Torque's first Deep-Primed T cell ...
Posted by Michael Wonder on 05 Jun 2019
Paying for CAR-T therapy amidst limited health system resources
3 June 2019 - CAR-T is paving a new path toward achieving access and reimbursement within limited health-system resources. How do ...
Posted by Michael Wonder on 30 May 2019
Mesoblast initiates rolling submission of biologics license application to U.S. FDA for remestemcel-L in the treatment of acute graft versus host disease
30 May 2019 - Mesoblast today announced that it has filed the first component of a rolling submission for a biologics ...
Posted by Michael Wonder on 21 May 2019
Extremely high drug prices should be reviewed for appropriateness
21 May 2019 - As medicine advances, a succession of highly efficacious but extremely costly therapeutic drugs have arrived on ...
Posted by Michael Wonder on 15 May 2019
Novartis gets approval to sell Kymriah in Japan for $306,000
15 May 2019 - A Japanese government panel approved on Wednesday a price of 33.5 million yen ($305,800) for Novartis’ cancer ...
Posted by Michael Wonder on 25 Apr 2019
Medicare proposes boosting payments for CAR-T cancer therapy
24 April 2019 - The U.S. government is proposing to increase payments for innovative CAR-T cancer therapies, the administrator of ...
Posted by Michael Wonder on 16 Apr 2019
New genetic therapies in cancer treatment could impact benefits plans
12 April 2019 - In September 2018, Health Canada approved, for the first time, the use of a chimeric antigen ...
Posted by Michael Wonder on 16 Apr 2019
FDA agrees to rolling review of Mesoblast's biologic licence application for its cell therapy in children with steroid-refractory acute graft versus host disease
16 April 2019 - Mesoblast announced today that the FDA has agreed that Mesoblast can submit on a rolling basis ...
Posted by Michael Wonder on 16 Apr 2019
Federal Government takes first major step in adopting new wave of personalised medicine for Australian patients
16 April 2019 - Medicines Australia welcomes the Government’s investment in new technology with Kymriah (tisagenlecleucel) CAR-T (Chimeric Antigen Receptor ...
Posted by Michael Wonder on 15 Apr 2019
Future in cancer treatment arrives for Australian children and young adults battling leukaemia
15 April 2019 - Hon Greg Hunt MP Minister for Health today announces availability of novel life-saving cancer treatment CAR-T ...
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 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, ...