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RSS FeedPosted by Michael Wonder on 11 Jun 2020
Cell and gene therapies: FDA official on COVID-19 impact
10 June 2020 - Speaking at a session on cell and gene therapies at BIO Digital on Monday, a top US ...
Posted by Michael Wonder on 10 Jun 2020
Mallinckrodt completes rolling submission of biologics license application for StrataGraft regenerative skin tissue to U.S. FDA
9 June 2020 - StrataGraft skin tissue is in development as potential new treatment option for patients with deep partial-thickness thermal ...
Posted by Michael Wonder on 04 Jun 2020
TVAX Biomedical receives fast track designation from the FDA for brain cancer
4 June 2020 - TVAX Biomedical announced today receipt of fast track designation from the U.S. FDA for the use of ...
Posted 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 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. ...