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RSS FeedPosted by Michael Wonder on 25 Apr 2022
FDA grants regenerative medicine advanced therapy designation to Autolus’ CAR T cell therapy, obe-cel, for the treatment of adult B-ALL
25 April 2022 - Autolus Therapeutics today announced that the U.S. FDA has granted regenerative medicine advanced therapy designation to its ...
Posted by Michael Wonder on 20 Apr 2022
FDA grants regenerative medicine advanced therapy designation to AlloVir’s posoleucel for prevention of multiple life-threatening infections from six viruses in allogeneic haematopoietic cell transplant patients
20 April 2022 - Posoleucel’s third regenerative medicine advanced therapy designation marks an unprecedented regulatory distinction among cell and gene therapies. ...
Posted by Michael Wonder on 05 Apr 2022
Bristol Myers Squibb receives European Commission approval for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for certain forms of relapsed or refractory large B-cell lymphoma
5 April 2022 - Approval of Breyanzi is based on results from TRANSCEND WORLD, and TRANSCEND NHL 001, the largest pivotal ...
Posted by Michael Wonder on 05 Apr 2022
Rights watchdog urges quick reimbursement of expensive new drugs
5 April 2022 - The National Human Rights Commission of Korea welcomed the recent reimbursement of CAR-T cell therapy Kymriah ...
Posted by Michael Wonder on 04 Apr 2022
Precigen receives fast track designation for PRGN-3006 UltraCAR-T in patients with relapsed or refractory acute myeloid leukaemia
4 April 2022 - PRGN-3006 UltraCAR-T previously received orphan drug designation in patients with acute myeloid leukaemia by the US FDA. ...
Posted by Michael Wonder on 01 Apr 2022
FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma
1 April 2022 - Today, the Food and Drug Administration approved axicabtagene ciloleucel (Yescarta, Kite Pharma) for adult patients with ...
Posted by Michael Wonder on 28 Mar 2022
Japan's Ministry of Health, Labour and Welfare accepts Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) as a second-line therapy for relapsed or refractory large B-cell lymphoma
25 March 2022 - Bristol-Myers Squibb today announced that the MHLW has accepted the supplemental new drug application for Breyanzi ...
Posted by Michael Wonder on 25 Mar 2022
Highlights from the CHMP 21-24 March 2022 meeting
25 March 2022 - The EMA’s CHMP recommended five medicines for approval at its March 2022 meeting. ...
Posted by Michael Wonder on 25 Mar 2022
Novartis receives positive CHMP opinion for Kymriah CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma in Europe
25 March 2022 - CHMP opinion based on Phase 2 global ELARA trial demonstrating high response rates in heavily pretreated patients; ...
Posted by Michael Wonder on 23 Mar 2022
StemCyte has submitted its application for a biologics license for its allogeneic umbilical cord haematopoietic progenitor cell product "HPC-Cord Blood", to the US FDA
22 March 2022 - The BLA has been accepted for quality review and StemCyte anticipates licensure in 2023 ...
Posted by Michael Wonder on 16 Mar 2022
FDA drafts guidance on genome editing, CAR T cell therapies
16 March 2022 - The U.S. FDA has issued two draft guidances addressing the development of human gene therapy products that ...
Posted by Michael Wonder on 15 Mar 2022
Prolonged price negotiation for Kymriah devastates leukaemia patients
15 March 2022 - Drained by dragging price negotiations between Novartis and the Government for breakthrough cancer treatment Kymriah (tisagenlecleucel), ...
Posted by Michael Wonder on 03 Mar 2022
U.S. Food and Drug Administration grants Cabaletta Bio fast track designation for MuSK-CAART
1 March 2022 - Fast Track Designation granted to improve activities of daily living and muscle strength in patients with ...
Posted by Michael Wonder on 01 Mar 2022
Carvykti (ciltacabtagene autoleucel), BCMA directed CAR-T therapy, receives U.S. FDA approval for the treatment of adult patients with relapsed or refractory multiple myeloma
28 February 2022 - Approval is primarily based on the pivotal Phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate ...
Posted by Michael Wonder on 22 Feb 2022
Health economic assessment of the gene therapy Libmeldy in metachromatic leukodystrophy
22 February 2022 - Within the FINOSE collaboration, TLV, together with the corresponding authorities in Finland and Norway, has produced a ...