BioCentury | Jul 25, 2020
Regulation

FDA makes Gilead’s Tecartus, for mantle cell lymphoma, third U.S.-approved CAR T

...Kite’s Tecartus has become the third CAR T cell therapy, after Kymriah and Yescarta, to earn...
...begin. The therapy’s manufacturing process differs from that of Gilead’s Yescarta axicabtagene ciloleucel and Kymriah tisagenlecleucel...
...BLA (see “Refusal-to-file Letter for BMS-bluebird Cell Therapy” ). Robin Sawka, BioCentury Staff KTE-X19 Kymriah, tisagenlecleucel (CTL019, cart-19, tisagenlecleucel-t) Yescarta...
BioCentury | May 29, 2020
Politics, Policy & Law

Proposed CMS rule for CAR Ts marks progress in reimbursing new technologies

...new technology add-on payments (NTAPs) for the two marketed CAR T cell therapies -- Kymriah tisagenlecleucel...
BioCentury | May 15, 2020
Product Development

Allogene’s allogeneic CAR T data give first hint of threat to marketed autologous therapies

...ORR with 51% of patients achieving a CR. The Phase II JULIET trial of Kymriah tisagenlecleucel...
...patients showed a 50% ORR, with a 32% CR rate. Novartis AG (NYSE:NVS; SIX:NOVN) markets Kymriah...
...tocilizumab therapy. One patient developed grade 1 neurotoxicity, which resolved without treatment. Both Yescarta and Kymriah...
BioCentury | Feb 6, 2020
Product Development

Early signs CAR NKs could compete with CAR Ts in heme cancers

...which Gilead Sciences Inc. (NASDAQ:GILD) studied Yescarta axicabtagene ciloleucel. Novartis AG (NYSE:NVS; SIX:NOVN) studied Kymriah tisagenlecleucel...
BioCentury | Dec 21, 2019
Product Development

China a priority for Novartis’ Narasimhan

...front, Novartis has been a pioneer of value-based pricing models for its CAR T therapy Kymriah...
...value to the system. If you’re able to deliver what, in our case, Zolgensma and Kymriah...
...we do need reforms in that. It’s not going to change anything for Zolgensma and Kymriah...
BioCentury | Dec 20, 2019
Company News

Regulatory roundup: Gilead, BMS seeking key approvals, plus news about AbbVie, Bavarian Nordic and more

...company Juno Therapeutics Inc. Liso-cel would be the third FDA-approved CAR T therapy, following Kymriah tisagenlecleucel...
BioCentury | Dec 13, 2019
Politics, Policy & Law

Novartis’ Narasimhan calls for value-based pricing--and access

...to come out ahead of its rivals. Novartis launched the first CAR T therapy, Kymriah tisagenlecleucel...
...and the premium would be placed on innovation. If you take the case of our Kymriah...
...in the range of what the various assessing bodies have said. In the case of Kymriah...
BioCentury | Dec 13, 2019
Product Development

Leveraging real-world data to assess the promise of CAR Ts, Dutch style

...the scientific advice working party at EMA. The approvals of the first CAR Ts Kymriah tisagenlecleucel...
...in development to treat adult patients with relapsed/refractory mantle cell lymphoma. ZIN approved reimbursement of Kymriah...
...Editor CAR T cell therapy targeting CD19 Anti-CD19 chimeric antigen receptor (CAR) T cells Kymriah, tisagenlecleucel (CTL019, cart-19, tisagenlecleucel-t) Yescarta...
BioCentury | Dec 9, 2019
Company News

Novartis downsizing internal efforts on CAR T in solid tumors

...focused on blood cancers because we have some nuanced insights there from the development of Kymriah...
...licensing deal with the University of Pennsylvania. The lead program from the deal is Kymriah tisagenlecleucel...
...HAVCR2) - T cell immunoglobulin and mucin domain 3 Stephen Hansen, Associate Editor Kymriah, tisagenlecleucel (CTL019, cart-19, tisagenlecleucel-t) Novartis...
BioCentury | Nov 20, 2019
Company News

Management tracks: Vifor, Relay, I-Mab, Yumanity, Savara and more

...gene therapy unit, where he led the development and launch of CAR T therapy Kymriah tisagenlecleucel...
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