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20 year old man died after leukaemia cell was accidently mixed into CAR T therapy
pharmafile
November 20, 2018
A 20 year old man died after a single leukaemia cell accidentally ended up in a batch of cells that were being manufactured into a CAR-T cell therapy, according to researchers at the University of Pennsylvania.
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NICE issues final draft guidelines for Novartis’ Kymriah
pharmatimes
November 19, 2018
NICE has recommended a pioneering cancer treatment for people under the age of 25 with leukaemia in final draft guidelines.
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Patient death following CAR-T therapy highlights serious manufacturing issues
pharmaceutical-technology
October 08, 2018
It is reported that the accidental genetic engineering of a single leukemic cell during the early manufacturing of CAR-T therapy tisagenlecleucel for a phase I study caused the relapse and eventual death of one patient participating in the clinical trial.
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Novartis strike $40m deal with Chinese firm Cellular Biomedicine
pharmafile
September 29, 2018
Swiss multinational Novartis have paired up with Chinese drugmaker Cellular Biomedicine (CBMG) in order to manufacture CAR-T therapy Kymriah in the People’s Republic of China (PRC).
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NICE says no to Kymriah for adult lymphoma despite offer on price
biopharmadive
September 20, 2018
Novartis slashed the U.K. list price for Kymriah by nearly a quarter compared to the U.S. for treating ALL patients under 25 whose disease was refractory, in relapse post-transplant or in second or later relapse.
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NHS England strikes deal with Novartis on Kymriah
pharmatimes
September 14, 2018
Hospitals are gearing up to offer Novartis’ ground-breaking CAR-T therapy Kymriah to children with advanced leukaemia, after the drugmaker reached a deal with NHS England...
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Novartis receives EC approval for Kymriah to treat two cancers
pharmaceutical
August 29, 2018
The European Commission (EC) has granted approval for Novartis’ Kymriah to treat patients with B-cell acute lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL).
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Novartis runs into Kymriah production glitch in new DLBCL indication
fiercepharma
July 19, 2018
Novartis, whose personalized CAR-T cancer treatment Kymriah won an approval in May to treat relapsed large B-cell lymphoma, said today it has run into some manufacturing issues around that condition.
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Novartis becomes first to gain second CAR-T indication
pharmafile
May 04, 2018
Novartis has announced that its CAR T treatment, Kymriah, has successfully been given a second indication for the treatment of relapsed or refractory large B-cell lymphoma after two or more lines of treatment
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Novartis' Car-T Therapy Kymriah receives second FDA approval
worldpharmanews
May 03, 2018
Novartis today announced the US Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for its second indication...