Cell Therapy

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EMA pilot to provide regulatory support to selected ATMP developers

By Rachel Arthur

The European Medicines Agency (EMA) will provide up to five selected advanced therapy medicinal products (ATMPs) with enhanced regulatory support - and in the process hopes to learn how to improve the regulatory processes for other ATMP drugs in the future.

© GettyImages/acilo

Kite secures third approved cell therapy indication in Europe

By Jane Byrne

The European Commission (EC) has approved Kite’s CAR T-cell therapy, Yescarta, (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.

© GettyImages/Olena_T

Cryoport and Cell Matters team up on cryopreservation services

By Jane Byrne

Cryoport, Inc. has entered into a partnership with specialized Belgian CDMO, Cell Matters, to deliver end-to-end cryopreservation services for leukapheresis derived therapies supporting both autologous and allogeneic cell therapies.

© GettyImages/CiydemImages

Ncardia secures $60m to expand iPSC platform

By Jane Byrne

Ncardia, a human-induced pluripotent stem cell-based (iPSC) technology company, has secured more than US$60m in capital through a strategic partnership with Kiniciti, a US based investor with a focus on the global cell and gene therapy ecosystem.

© GettyImages/PonyWang

Sphere Fluidics closes $40m funding round

By Jane Byrne

Sphere Fluidics, a UK company that has developed and is commercializing single cell analysis systems underpinned by its picodroplet technology, has just closed a US$40m investment round.

© GettyImages/Zarina Lukash

Special Edition: Reviewing the advanced therapy pipeline

Santen looks to ways to reduce hurdles for patients in accessing advanced therapies

By Jane Byrne

As a relatively new player in the field of cell therapy, Santen Pharmaceutical has outlined how it is looking to collaborate with key stakeholders in order to shape relevant policies, forge meaningful partnerships and create an optimal environment for...

© GettyImages/metamorworks

Addressing cell and gene treatment affordability

By Jane Byrne

A panel discussion at the Reuters Events' Cell & Gene Therapy Conference USA 2020 looked at the key challenges in the cell and gene therapy (CGT) space, namely affordability and access, and how to circumvent those.