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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...