Blog
RSS FeedPosted by Michael Wonder on 25 Feb 2021
NHS patients to benefit from first full access deal in Europe for new CAR-T therapy recommended by NICE
25 February 2021 - NICE has agreed a managed access agreement, via the Cancer Drugs Fund with manufacturer Kite, so more ...
Posted by Michael Wonder on 24 Feb 2021
Tecartus recommended by NICE
24 February 2021 - Treatment with autologous anti-CD19-transduced CD3+ cells (brexucabtagene autoleucel) is recommended for use within the Cancer Drugs Fund ...
Posted by Michael Wonder on 23 Feb 2021
The BCMA CAR-T co-developed by Innovent and IASO was granted breakthrough therapy designation by the NMPA for the treatment of relapsed/refractory multiple myeloma
22 February 2021 - Innovent Biologics today jointly announce that the Center for Drug Evaluation of China's National Medical Products Administration ...
Posted by Michael Wonder on 20 Feb 2021
Immunocore’s tebentafusp granted breakthrough therapy designation for unresectable or metastatic uveal melanoma from FDA
19 February 2021 - Submission of a biologic license application to FDA planned for Q3 2021. ...
Posted by Michael Wonder on 15 Feb 2021
bluebird bio’s beta thalassaemia gene therapy rejected by NICE
12 February 2021 - bluebird bio’s beta thalassaemia gene therapy betibeglogene autotemcel (beti-cel) has not been recommended by the UK’s ...
Posted by Michael Wonder on 14 Feb 2021
Mallinckrodt provides regulatory update on StrataGraft
12 February 2021 - Mallinckrodt today announced that the U.S. FDA has informed the Company that it is deferring action ...
Posted by Michael Wonder on 06 Feb 2021
FDA approves lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma
5 February 2021 - Today, the FDA approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for the treatment of adult patients with ...
Posted by Michael Wonder on 02 Feb 2021
Janssen announces CAR-T therapy ciltacabtagene autoleucel (cilta-cel) accepted for accelerated assessment in Europe for the treatment of patients with heavily pretreated multiple myeloma
1 February 2021 - Janssen announced today that the CHMP of the EMA will perform an accelerated assessment of the ...
Posted by Michael Wonder on 22 Jan 2021
Yescarta approved in Japan for treatment of patients with relapsed/refractory large B-cell lymphomas
22 January 2021 - Approval based on phase 2 study conducted in Japan and previous pivotal trial data. ...
Posted by Michael Wonder on 11 Jan 2021
Organogenesis ReNu receives FDA regenerative medicine advanced therapy designation for osteoarthritis of the knee
11 January 2021 - FDA determines ReNu preliminary clinical evidence indicates potential to address unmet medical needs for the management of ...
Posted by Michael Wonder on 26 Dec 2020
Novadip Biosciences receives rare paediatric disease priority review and orphan disease designation
23 December 2020 - Novadip Biosciences today announces that the U.S. FDA has granted rare paediatric disease designation and Orphan Drug ...
Posted by Michael Wonder on 21 Dec 2020
Janssen initiates rolling submission of a biologics license application to U.S. FDA for BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed and/or refractory multiple myeloma
21 December 2020 - Janssen announced today the initiation of a rolling submission of its biologics license application to the ...
Posted by Michael Wonder on 17 Dec 2020
FDA grants RMAT designation for Cook MyoSite’s investigational autologous muscle derived cells for urinary sphincter repair
17 December 2020 - Cook MyoSite today announced that the U.S. FDA has granted the regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 17 Dec 2020
ICER publishes final evidence report and policy recommendations on new therapies for bladder cancer
17 December 2020 - Independent appraisal committee determines current evidence is adequate to demonstrate that nadofaragene firadenovec and oportuzumab monatox ...
Posted by Michael Wonder on 17 Dec 2020
Kite’s Tecartus (KTE-X19) granted conditional marketing authorisation for the treatment of relapsed or refractory mantle cell lymphoma in Europe
16 December 2020 - 93% of patients in ZUMA-2 pivotal trial responded to single infusion of Tecartus. ...