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Wednesday, October 18, 2017

2 results for 'tk'

TK submission for Conditional Approval validated by EMA

By Molmed, published on Apr 1, 2014

TK is an adjunctive treatment in hematopoietic stem cell transplantation for patients affected by high risk leukaemia. TK has been granted orphan drug status by the European Commission.

MolMed is also glad to announce that the Company has been invited by the European Society for Blood and Marrow Transplantation (EMBT) to illustrate the scientific and regulatory path of TK which – with more than 120 patients treated so far – is the largest cell-gene therapy application ever performed. Claudio Bordignon, CEO and president of the Board, will give a presentation on the topic next Tuesday... (more)

Tags: molmed, tk, molmed tk, conditional marketing authorisation

MolMed TK therapy submitted for Conditional Marketing Author

By Molmed, published on Mar 16, 2014

It is estimated that in EU approximately 5,000 leukaemia patients/year lack a fully compatible donor: TK offers to these patients the option of transplantation from a mismatched donor without post-transplant immunosuppression. If approved, TK would be the first cell-gene therapy product on the market for this life threatening condition. The Conditional Marketing Authorisation application is supported by cumulative efficacy and safety results obtained from a completed Phase I-II, multicentre trial (TK007). These data were included in presentations given at the 49th annual congress of... (more)

Tags: molmed, tk, conditional marketing authorisation

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