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RSS FeedPosted by Michael Wonder on 13 May 2020
Bristol Myers Squibb and bluebird bio provide regulatory update on idecabtagene vicleucel (ide-cel, bb2121) for the treatment of patients with multiple myeloma
Bristol Myers Squibb and bluebird bio today announced that the companies received a Refusal to File letter from the U.S. ...
Posted by Michael Wonder on 11 May 2020
CRISPR Therapeutics and Vertex Pharmaceuticals announce FDA regenerative medicine advanced therapy designation granted to CTX001 for the treatment of severe hemoglobinopathies
11 May 2020 - CTX001 has received orphan drug designation from the U.S. FDA for transfusion-dependent beta thalassemia and from the ...
Posted by Michael Wonder on 24 Apr 2020
Mesoblast claims coronavirus treatment breakthrough
24 April 2020 - Stem cell-focused biotech Mesoblast has claimed a breakthrough in its experimental therapy to treat patients with ...
Posted by Michael Wonder on 22 Apr 2020
Novartis Kymriah receives FDA regenerative medicine advanced therapy designation in follicular lymphoma
22 April 2020 - US regulatory filing for Kymriah in relapsed/refractory follicular lymphoma anticipated in 2021. ...
Posted by Michael Wonder on 20 Apr 2020
Additional analysis of Kymriah in the treatment of patients with diffuse large-cell B-cell lymphoma
17 April 2020 - TLV has conducted an additional analysis of the earlier evaluation of Kymriah (tisagenleclucel) in the treatment ...
Posted by Michael Wonder on 31 Mar 2020
Bristol Myers Squibb and bluebird bio announce submission of biologics license application for anti-BCMA CAR T cell therapy idecabtagene vicleucel (Ide-cel, bb2121) to FDA
31 March 2020 - Submission includes results from pivotal Phase 2 KarMMa study evaluating ide-cel in a heavily pre-treated patient ...
Posted by Michael Wonder on 30 Mar 2020
Daiichi Sankyo submits application for CAR T therapy axicabtagene ciloleucel for treatment of patients with certain relapsed/refractory B-cell lymphomas in Japan
30 March 2020 - Submission based on previous pivotal trial data and a phase 2 study in Japan in patients ...
Posted by Michael Wonder on 13 Feb 2020
U.S. FDA accepts for priority review Bristol-Myers Squibb’s biologics license application for lisocabtagene maraleucel (liso-cel) for adult patients with relapsed or refractory large B cell lymphoma
13 February 2020 - Application based on results from the TRANSCEND NHL 001 trial, the largest study of CD19-directed CAR T ...
Posted by Michael Wonder on 11 Feb 2020
U.S. FDA grants priority review for Kite’s KTE-X19 biologics license application in relapsed or refractory mantle cell lymphoma
10 February 2020 - If approved, Kite could be first company with multiple commercialised CAR T therapies. ...
Posted by Michael Wonder on 29 Jan 2020
European Medicines Agency validates Kite’s marketing application for company’s second CAR T cell therapy
28 January 2020 - Investigational KTE-X19 to be first chimeric antigen receptor T cell therapy for mantle cell lymphoma in Europe ...
Posted by Michael Wonder on 28 Jan 2020
Expanded access to cutting edge CAR T-cell therapy
28 January 2020 - The Australian Government is expanding access to a cutting edge and potentially curative cancer therapy for patients ...
Posted by Michael Wonder on 27 Jan 2020
'Cutting edge' $500,000 treatment for aggressive blood cancers
28 January 2020 - Australians battling highly aggressive blood cancers could start a groundbreaking treatment within weeks, after the federal ...
Posted by Michael Wonder on 09 Jan 2020
New CADTH process for cell and gene therapies
9 January 2020 - CADTH has undertaken an internal review of our processes for drugs and devices, and established a revised ...
Posted by Michael Wonder on 18 Dec 2019
Bristol-Myers Squibb announces submission of biologics license application for CAR T-Cell therapy lisocabtagene maraleucel (liso-cel) to FDA
18 December 2019 - Submission includes data from TRANSCEND NHL 001 trial evaluating liso-cel in patients with relapsed or refractory ...
Posted by Michael Wonder on 13 Dec 2019
Novartis completes certification of initial sites in Ontario for first approved Canadian CAR-T therapy, Kymriah (tisagenlecleucel)
12 December 2019 - Ontario government to reimburse Kymriah therapy for certain patients with life-threatening cancers who are in critical need. ...