Blog
RSS FeedPosted 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 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 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 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 12 Dec 2019
Kite submits biologics license application to U.S. FDA for Company’s second CAR T cell therapy
11 December 2019 - Investigational KTE-X19 to be first chimeric antigen receptor T cell therapy for mantle cell lymphoma if approved. ...
Posted by Michael Wonder on 10 Dec 2019
New report calls for measurement of outcomes and federal funding for research and increased capacity at FDA to advance safe and effective regenerative cell therapies
10 December 2019 - A new report released by the independent, non-profit Alliance for Cell Therapy Now, highlights the need ...
Posted by Michael Wonder on 07 Dec 2019
Janssen announces BCMA CAR-T therapy JNJ-4528 granted U.S. FDA breakthrough therapy designation for the treatment of relapsed or refractory multiple myeloma
6 December 2019 - Newest designation for JNJ-4528 is supported by Phase 1b/2 CARTITUDE-1 study in adults with relapsed or refractory ...
Posted by Michael Wonder on 05 Dec 2019
FDA declines to approve Enzyvant regenerative therapy on manufacturing concerns
6 December 2019 - Privately held drug developer Enzyvant said on Thursday the U.S. FDA declined to approve its regenerative ...
Posted by Michael Wonder on 09 Nov 2019
Triumvira Immunologics announces fast track designation for its first TAC T-Cell therapeutic product candidate: TAC01-CD19
7 November 2019 - Designation confirms significant unmet need remains in DLBCL. ...
Posted by Michael Wonder on 06 Nov 2019
Innovation and access at the mercy of payment policy: the future of chimeric antigen receptor therapies
1 November 2019 - In 2017, the US FDA approved the first chimeric antigen receptor therapies (CAR-Ts), tisagenlecleucel and axicabtagene ...
Posted by Michael Wonder on 10 Oct 2019
FDA grants FX-322 fast track designation
10 October 2019 - The company also announced today that the U.S. FDA has granted fast track designation for FX-322. ...
Posted by Michael Wonder on 20 Sep 2019
SanBio granted regenerative medicine advanced therapy designation from the U.S. FDA for SB623 for the treatment of chronic neurological motor deficits secondary to traumatic brain injury
19 September 2019 - The SanBio Group today announced that the U.S. FDA has granted regenerative medicine advanced therapy designation ...
Posted by Michael Wonder on 27 Aug 2019
DiscGenics receives FDA fast track designation for disc degeneration cell therapy
26 August 2019 - DiscGenics today announced that the U.S. FDA has granted Fast Track designation for its investigational cell ...
Posted by Michael Wonder on 02 Jul 2019
Innovation prizes to support cell and gene therapy
2 July 2019 - Personalised cell and gene therapy represent a fundamental therapeutic revolution. ...