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RSS FeedPosted by Michael Wonder on 28 Sep 2022
CRISPR Therapeutics announces FDA regenerative medicine advanced therapy designation granted to CTX130 for the treatment of cutaneous T-cell lymphomas
28 September 2022 - CRISPR Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to CTX130, ...
Posted by Michael Wonder on 17 Sep 2022
Kite’s CAR T-cell therapy Yescarta first in Europe to receive positive CHMP opinion for use in second-line diffuse large B-cell lymphoma and high-grade B-cell lymphoma
16 September 2022 - Positive opinion based on landmark ZUMA-7 study in which 41% of patients demonstrated event-free survival at ...
Posted by Michael Wonder on 31 Aug 2022
US FDA grants fast track designation for Longeveron’s Lomecel-B product for treatment of hypoplastic left heart syndrome in infants
31 August 2022 - New designation may expedite FDA review and potential approval to address this life-threatening heart condition affecting ...
Posted by Michael Wonder on 25 Aug 2022
Iovance Biotherapeutics initiates biologics license application submission for lifileucel in advanced melanoma
25 August 2022 - First TIL therapy BLA submission initiated with U.S. FDA. ...
Posted by Michael Wonder on 17 Aug 2022
bluebird bio announces U.S. commercial infrastructure to enable patient access to Zynteglo, the first and only FDA approved gene therapy for people with beta thalassaemia who require regular red blood cell transfusions
17 August 2022 - Innovative outcomes-based contract offering includes single upfront payment and up to 80% risk-sharing. ...
Posted by Michael Wonder on 17 Aug 2022
FDA approves first cell based gene therapy to treat adult and paediatric patients with beta thalassaemia who require regular blood transfusions
17 August 2022 - Today, the US FDA approved Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of ...
Posted by Michael Wonder on 15 Aug 2022
Brainstorm to seek FDA approval for ALS stem cell treatment, despite agency objections
15 August 2022 - Last year, the FDA issued a rare public statement to inform the ALS community that a ...
Posted by Michael Wonder on 15 Aug 2022
Ensuring a future for gene therapy for rare diseases
15 August 2022 - Haematopoietic stem cell gene therapy has proven to be an effective treatment for several primary immunodeficiencies, and ...
Posted by Michael Wonder on 01 Aug 2022
Gamida Cell announces FDA acceptance of biologics license application for omidubicel with priority review
1 August 2022 - PDUFA target action date is 30 January 2023. ...
Posted by Michael Wonder on 26 Jul 2022
The FDA needs to get ready to evaluate synthetic cells, the next generation of therapeutics
26 July 2022 - Expanding new medical treatments requires pushing — and sometimes breaking — the boundaries of what currently ...
Posted by Michael Wonder on 23 Jul 2022
Kite’s CAR T-cell therapy Tecartus receives positive CHMP opinion in relapsed or refractory acute lymphoblastic leukaemia
22 July 2022 - Tecartus (brexucabtagene autoleucel) first and only CAR T in Europe to receive positive CHMP opinion to ...
Posted by Michael Wonder on 04 Jul 2022
Report on 'Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives' - TGA response
4 July 2022 - n November 2021 the TGA commissioned MTP Connect to conduct a stakeholder review of the regulatory ...
Posted by Michael Wonder on 26 Jun 2022
U.S. FDA approves Bristol Myers Squibb’s CAR T cell therapy Breyanzi for relapsed or refractory large B-cell lymphoma after one prior therapy
24 June 2022 - In the pivotal Phase 3 TRANSFORM trial, single infusion of Breyanzi significantly outperformed the nearly 30 year ...
Posted by Michael Wonder on 24 Jun 2022
BioNTech Receives Priority Medicines (PRIME) designation from EMA for enhanced regulatory support of CAR-T candidate BNT211 in testicular cancer
23 June 2022 - Designation follows positive interim Phase 1/2 data for BNT211 demonstrating an encouraging safety profile and early signs ...
Posted by Michael Wonder on 21 Jun 2022
European Medicines Agency validates Bristol Myers Squibb’s application for CAR T-cell therapy Breyanzi in relapsed or refractory large B-cell lymphoma after first-line therapy
20 June 2022 - Application based on Phase 3 TRANSFORM study in which Breyanzi outperformed the current standard of care ...