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RSS FeedPosted by Michael Wonder on 29 Nov 2022
Caribou Biosciences announces the FDA granted regenerative medicine advanced therapy and fast track designations to CB-010, an allogeneic anti-CD19 CAR-T cell therapy
29 November 2022 - CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout. ...
Posted by Michael Wonder on 23 Nov 2022
Axicabtagene ciloleucel for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma after one systemic treatment
23 November 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 22 Nov 2022
Tisagenlecleucel for the treatment of patients with follicular lymphoma after two or more therapies
22 November 2022 - NICE is unable to make a recommendation on the use of tisagenlecleucel for the treatment of adults ...
Posted by Michael Wonder on 10 Nov 2022
MSAC can't find a place for Carvykti
10 November 2022 - The outcome from Janssen's application requesting the public funding of ciltacabtagene autoleucel for the treatment of ...
Posted by Michael Wonder on 10 Nov 2022
Aleta Biotherapeutics receives Innovation Passport Designation for biologic CAR T-cell therapy engager ALETA-001
7 November 2022 - ALETA-001 was developed to address the urgent unmet need of patient relapse after CD19 targeted CAR ...
Posted by Michael Wonder on 05 Nov 2022
FDA finalises umbrella trial guidance for cell and gene therapies
4 November 2022 - The US FDA laid out its recommendations for sponsors to study multiple versions of a cellular or ...
Posted by Michael Wonder on 27 Oct 2022
Myeloid Therapeutics announces FDA fast track designation for MT-101 for the treatment of CD5 positive relapsed/refractory PTCL
27 October 2022 - MT-101 is the first mRNA engineered CAR monocyte therapy to be dosed in humans. ...
Posted by Michael Wonder on 18 Oct 2022
CARsgen announces NDA acceptance of BCMA CAR T zevor-cel (CT053) by China NMPA
18 October 2022 - CARsgen Therapeutics announces that the NMPA of China has accepted the new drug application for zevorcabtagene autoleucel ...
Posted by Michael Wonder on 18 Oct 2022
Kite’s Yescarta first CAR T-cell therapy to receive European marketing authorisation for use in second-line diffuse large B-cell lymphoma and high-grade B-cell lymphoma
17 October 2022 - First treatment in 30 years to improve upon standard care for second-line treatment of DLBCL. ...
Posted by Michael Wonder on 15 Oct 2022
CHMP recommends approval of Atara Biotherapeutics’ Ebvallo (tabelecleucel) for the treatment of Epstein-Barr virus positive post transplant lymphoproliferative disease
14 October 2022 - Ebvallo on track to be the first ever allogeneic T-cell therapy approved. ...
Posted by Michael Wonder on 29 Sep 2022
EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products
29 September 2022 - EMA is launching a pilot to support the translation of basic research developments into medicines that could ...
Posted 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 01 Sep 2022
Recell System insurance coverage begins in Japan for treatment of acute burns
1 September 2022 - Reimbursement in Japan will be similar to that of pricing in the United States. ...
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 ...