Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 19 Jun 2019
FDA grants fast track designation for Torque's first deep-primed T cell cancer immunotherapy program, TRQ-1501
18 June 2019 - Torque announced today that the U.S. FDA granted fast track designation for Torque's first Deep-Primed T cell ...
Posted by Michael Wonder on 30 May 2019
Mesoblast initiates rolling submission of biologics license application to U.S. FDA for remestemcel-L in the treatment of acute graft versus host disease
30 May 2019 - Mesoblast today announced that it has filed the first component of a rolling submission for a biologics ...
Posted by Michael Wonder on 16 Apr 2019
FDA agrees to rolling review of Mesoblast's biologic licence application for its cell therapy in children with steroid-refractory acute graft versus host disease
16 April 2019 - Mesoblast announced today that the FDA has agreed that Mesoblast can submit on a rolling basis ...
Posted by Michael Wonder on 04 Apr 2019
Immunocore’s lead asset tebentafusp gains fast track designation for metastatic uveal melanoma
3 April 2019 - Immunocore today announces that the U.S. FDA has granted fast track designation for its development program, ...
Posted by Michael Wonder on 15 Jan 2019
Statement from FDA Commissioner and Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies
15 January 2019 - The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced ...
Posted by Michael Wonder on 09 Jan 2019
Biotech proposes paying for pricey drugs by instalment
8 January 2019 - Bluebird Bio develops plan to sell gene-replacement therapy with annual payments contingent on continued effectiveness. ...
Posted by Michael Wonder on 06 Jan 2019
CRISPR Therapeutics and Vertex announce FDA fast track designation for CTX001 for the treatment of sickle cell disease
4 January 2019 - CRISPR Therapeutics and Vertex Pharmaceuticals today announced that the U.S. FDA has granted fast track Designation for ...