NHS patients to benefit from first full access deal in Europe for new CAR-T therapy recommended by NICE

25 February 2021 - NICE has agreed a managed access agreement, via the Cancer Drugs Fund with manufacturer Kite, so more ...

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Tecartus recommended by NICE

24 February 2021 - Treatment with autologous anti-CD19-transduced CD3+ cells (brexucabtagene autoleucel) is recommended for use within the Cancer Drugs Fund ...

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The BCMA CAR-T co-developed by Innovent and IASO was granted breakthrough therapy designation by the NMPA for the treatment of relapsed/refractory multiple myeloma

22 February 2021 - Innovent Biologics today jointly announce that the Center for Drug Evaluation of China's National Medical Products Administration ...

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Immunocore’s tebentafusp granted breakthrough therapy designation for unresectable or metastatic uveal melanoma from FDA

19 February 2021 - Submission of a biologic license application to FDA planned for Q3 2021. ...

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bluebird bio’s beta thalassaemia gene therapy rejected by NICE

12 February 2021 - bluebird bio’s beta thalassaemia gene therapy betibeglogene autotemcel (beti-cel) has not been recommended by the UK’s ...

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Mallinckrodt provides regulatory update on StrataGraft

12 February 2021 - Mallinckrodt today announced that the U.S. FDA has informed the Company that it is deferring action ...

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FDA approves lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma

5 February 2021 - Today, the FDA approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for the treatment of adult patients with ...

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Janssen announces CAR-T therapy ciltacabtagene autoleucel (cilta-cel) accepted for accelerated assessment in Europe for the treatment of patients with heavily pretreated multiple myeloma

1 February 2021 - Janssen announced today that the CHMP of the EMA will perform an accelerated assessment of the ...

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Yescarta approved in Japan for treatment of patients with relapsed/refractory large B-cell lymphomas

22 January 2021 - Approval based on phase 2 study conducted in Japan and previous pivotal trial data. ...

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Organogenesis ReNu receives FDA regenerative medicine advanced therapy designation for osteoarthritis of the knee

11 January 2021 - FDA determines ReNu preliminary clinical evidence indicates potential to address unmet medical needs for the management of ...

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Novadip Biosciences receives rare paediatric disease priority review and orphan disease designation

23 December 2020 - Novadip Biosciences today announces that the U.S. FDA has granted rare paediatric disease designation and Orphan Drug ...

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Janssen initiates rolling submission of a biologics license application to U.S. FDA for BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed and/or refractory multiple myeloma

21 December 2020 - Janssen announced today the initiation of a rolling submission of its biologics license application to the ...

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FDA grants RMAT designation for Cook MyoSite’s investigational autologous muscle derived cells for urinary sphincter repair

17 December 2020 - Cook MyoSite today announced that the U.S. FDA has granted the regenerative medicine advanced therapy designation to ...

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ICER publishes final evidence report and policy recommendations on new therapies for bladder cancer

17 December 2020 - Independent appraisal committee determines current evidence is adequate to demonstrate that nadofaragene firadenovec and oportuzumab monatox ...

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Kite’s Tecartus (KTE-X19) granted conditional marketing authorisation for the treatment of relapsed or refractory mantle cell lymphoma in Europe

16 December 2020 - 93% of patients in ZUMA-2 pivotal trial responded to single infusion of Tecartus. ...

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