Caladrius Biosciences receives advanced therapy medicinal product classification for CLBS12, its CD34+ cell therapy for critical limb ischaemia

15 July 2019 - Caladrius Biosciences announced today that the EMA has granted Advanced Therapy Medicinal Product classification to the Company’s ...

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Innovation prizes to support cell and gene therapy

2 July 2019 - Personalised cell and gene therapy represent a fundamental therapeutic revolution.  ...

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Health economic assessment of Kymriah in diffuse large B-cell lymphoma

20 June 2019 - TLV has produced a health economic knowledge base for county councils for CAR-T cell treatment Kymriah ...

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FDA grants fast track designation for Torque's first deep-primed T cell cancer immunotherapy program, TRQ-1501

18 June 2019 - Torque announced today that the U.S. FDA granted fast track designation for Torque's first Deep-Primed T cell ...

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Paying for CAR-T therapy amidst limited health system resources

3 June 2019 - CAR-T is paving a new path toward achieving access and reimbursement within limited health-system resources. How do ...

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Mesoblast initiates rolling submission of biologics license application to U.S. FDA for remestemcel-L in the treatment of acute graft versus host disease

30 May 2019 - Mesoblast today announced that it has filed the first component of a rolling submission for a biologics ...

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Extremely high drug prices should be reviewed for appropriateness

21 May 2019 - As medicine advances, a succession of highly efficacious but extremely costly therapeutic drugs have arrived on ...

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Novartis gets approval to sell Kymriah in Japan for $306,000

15 May 2019 - A Japanese government panel approved on Wednesday a price of 33.5 million yen ($305,800) for Novartis’ cancer ...

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Medicare proposes boosting payments for CAR-T cancer therapy

24 April 2019 - The U.S. government is proposing to increase payments for innovative CAR-T cancer therapies, the administrator of ...

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New genetic therapies in cancer treatment could impact benefits plans

12 April 2019 - In September 2018, Health Canada approved, for the first time, the use of a chimeric antigen ...

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FDA agrees to rolling review of Mesoblast's biologic licence application for its cell therapy in children with steroid-refractory acute graft versus host disease

16 April 2019 - Mesoblast announced today that the FDA has agreed that Mesoblast can submit on a rolling basis ...

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Federal Government takes first major step in adopting new wave of personalised medicine for Australian patients

16 April 2019 - Medicines Australia welcomes the Government’s investment in new technology with Kymriah (tisagenlecleucel) CAR-T (Chimeric Antigen Receptor ...

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Future in cancer treatment arrives for Australian children and young adults battling leukaemia

15 April 2019 - Hon Greg Hunt MP Minister for Health today announces availability of novel life-saving cancer treatment CAR-T ...

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EMA grants PRIME designation to Janssen’s investigational CAR-T therapy

4 April 2019 - Johnson & Johnson’s Janssen has announced the granting of a PRIME (PRIority MEdicines) designation for its ...

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Immunocore’s lead asset tebentafusp gains fast track designation for metastatic uveal melanoma

3 April 2019 - Immunocore today announces that the U.S. FDA has granted fast track designation for its development program, ...

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